vox--2020-12-17--Why the Covid-19 vaccines may feel different from other routine shots

After months of waiting , we finally have detailed information on the safety and efficacy of the first Covid-19 vaccines that will be distributed in America .
On Thursday , a committee that advises the Food and Drug Administration voted to recommend the Moderna vaccine for an emergency use authorization for people ages 18 and over .
Ahead of the decision , the agency shared the most comprehensive data to date on what we know about the shot .
The same process happened last week with the Pfizer/BioNTech vaccine , which is now being rolled out across America following an @ @ @ @ @ @ @ had already been shown to be highly effective , the new data provides a much more granular picture of their side effects and safety profiles .
What ’ s now clear : An injection with either vaccine , both of which use mRNA technology , can feel more intense than other routine vaccinations ( such as the flu shot ) — with side effects for some recipients such as pain , headache , and fatigue .
And this may be especially true for Moderna ’ s vaccine : About 16 percent of people @ @ @ @ @ @ @ experienced a “ severe ” adverse reaction , a classification the FDA uses to refer to side effects that require medical attention and prevent people from going about their daily activities .
“ We should anticipate that if you got vaccinated that day , you may not want to go to work , ” Peter Hotez , the dean of the National School of Tropical Medicine at Baylor College , said of the vaccines .
That ’ s why health systems are being warned to stagger immunizing their workforces , to avoid “ @ @ @ @ @ @ @ as the vaccine expert group advising the Centers for Disease Control and Prevention ( CDC ) put it .
These side effects are known as reactogenicity , and vaccine developers and regulators allow for some level of reactogenicity in all approved vaccines .
They can be a sign of the body ’ s immune response kicking into gear , said Saad Omer , director of the Yale Institute for Global Health .
“ Think about [ reactogenicity ] as mouthwash — it ’ s hurting while it ’ s working , ” Omer @ @ @ @ @ @ @ prepare people to know this will happen — this may hurt a little , give you a bit of fever — but these are short-term , known side effects that you need to be aware of.
” The stakes for clearly communicating information about each vaccine ’ s risks and benefits are high : More than a quarter of Americans reported that they would probably or definitely refuse to take a Covid-19 vaccine , according to a late-summer survey by the Kaiser Family Foundation , even if it were freely available and deemed @ @ @ @ @ @ @ virus spreading farther and faster in America than just about anywhere else in the world , it ’ s critical that people don ’ t feel caught off guard by the side effects or spread misinformation about the vaccine .
To achieve that , transparency is key , said Brendan Nyhan , a Dartmouth professor of political science who has been thinking about how to build confidence in the Covid-19 vaccines .
“ Millions of people are going to get this vaccine , and we know huge numbers of people are going to @ @ @ @ @ @ @ often indicating that the vaccine is working .
We want to build trust with people so there are no surprises when that happens.
” In that spirit , here ’ s what we know about the side effects of these two shots and how to think about them .
What mild and moderate side effects really mean Before we get into the weeds , it ’ s helpful to understand how these companies classify side effects in the first place .
In general , vaccine developers seeking approval in the US market use @ @ @ @ @ @ @ scale ” to grade side effects and other adverse events from 1 to 4 , from mild and moderate to severe and life-threatening .
Grade 1 “ mild ” side effects are generally easily tolerated and don ’ t interfere with a person ’ s regular activities .
Grade 2 “ moderate ” effects may interfere with regular activities , grade 3 “ severe ” effects are incapacitating and need medical attention , and grade 4 are “ potentially life-threatening , ” usually requiring an emergency room visit or hospitalization .
Let ’ @ @ @ @ @ @ @ vaccination .
Here ’ s how the FDA would classify it : • Moderate : “ Repeated use of nonnarcotic pain reliever > 24 hours or some interference with activity ” • Severe : “ Any use of narcotic pain reliever or prevents daily activity ” So a mild side effect is one you ’ d notice but doesn ’ t require any special care or keep you from living your life ; a moderate side effect can keep you home from work but doesn ’ t warrant medical intervention ; severe adverse @ @ @ @ @ @ @ with your normal life ; and potentially life-threatening is just what it sounds like and usually involves a visit to or stay in the hospital .
In vaccine studies , these events are broken down into “ local ” reactions ( meaning they ’ re specific to one part of the body , like pain or tenderness where the vaccine is injected ) and “ systemic , ” whole-body reactions ( like fever or fatigue ) .
For a vaccine to win FDA approval , any reactions people have during clinical trials have @ @ @ @ @ @ @ And that ’ s because the safety bar for vaccines is really high , even compared to medicines .
Vaccines “ are given to healthy people who have in many cases absolutely nothing wrong with them .
And we are talking about [ giving them ] to literally billions of people .
Even rare side effects if they ’ re serious matter enormously , ” said Charles Weijer , a professor of medicine and an ethicist at Western University in Alberta , Canada .
“ We ’ re more willing to accept adverse @ @ @ @ @ @ @ those are counterbalanced by benefits to the patient.
” Mostly mild and moderate side effects are the safety profiles of both the Moderna and Pfizer/BioNTech vaccines — and that ’ s why the FDA in the US and drug regulators in other countries around the world are rushing to bring them to market .
But there are important differences between the two vaccines .
What we know about Moderna and Pfizer/BioNTech side effects Now let ’ s look at the best data we ’ ve got on the vaccines .
It comes from @ @ @ @ @ @ @ 2 and 3 clinical trials ahead of their emergency use authorization meetings on December 10 for Pfizer/BioNTech and December 17 for Moderna .
( The companies also released their own data for the meeting , but we focused on the agency ’ s independent reviews here . )
The reviews show the vaccines are both safe and that they ’ re extremely good at preventing Covid-19 infections ( with around a 95 percent efficacy rate ) .
That ’ s hugely important at a time when more than 3,000 Americans are dying from @ @ @ @ @ @ @ also give a sense of what side effects we might expect when these vaccines are rolled out .
The Pfizer/BioNTech vaccine caused mild or moderate reactions in most people , and severe reactions were rare .
Moderna didn ’ t share the details of its vaccine trial ’ s mild and moderate side effects , but the FDA said mild and moderate is how they ’ d characterize the bulk of them .
A key difference with the Moderna vaccine , however , is that we know severe reactions were more common in @ @ @ @ @ @ @ into what this means , but with a couple of caveats first .
Because we have no head-to-head study of the two vaccines and the companies haven ’ t reported side effect data in the same way , doing apples-to-apples comparisons is tricky , said Hilda Bastian , an expert in reading medical evidence who has been analyzing the coronavirus vaccine data .
The vaccines also come in different doses : 30µg in the case of Pfizer/BioNTech and 100µg with Moderna .
While they ’ re supposed to be delivered in two shots @ @ @ @ @ @ @ different : The Pfizer/BioNTech shots are three weeks apart , and Moderna ’ s are four weeks .
Pfizer/BioNTech and Moderna also tested their products on different populations .
“ Some of the differences affect risks and so could be affecting outcomes , ” said Bastian .
For example , there were more people of Hispanic/Latino background and with chronic lung disease in the Pfizer/BioNTech trial than the Moderna trial , she added .
And in the real world , when the vaccines roll out to millions , the side effects may again @ @ @ @ @ @ @ mind , here ’ s what we know about each shot .
For Pfizer/BioNTech the most common side effects overall , according to the FDA ’ s analysis of the data , were local reactions at the site of injection ( including pain , redness , swelling ) , fatigue , headache , muscle pain , chills , joint pain , and fever .
Again , these were mostly classified as mild or moderate .
Severe reactions , meanwhile , were rare — occurring in 0 to 4.6 percent of participants , depending @ @ @ @ @ @ @ general , side effects popped up more after the second dose than the first .
They also happened less frequently in people 55 and younger , the FDA said .
You can see the breakdown of adverse events data in younger adults ( 18-55 ) in the chart below following dose 1 and , if you click through , following dose 2 .
( Note : Pfizer/BioNTech found no potentially life-threatening ( grade 4 ) adverse reactions linked to the vaccine in the population they analyzed for safety . )
Now let ’ @ @ @ @ @ @ @ Moderna data .
Again , the company didn ’ t share the details of their mild and moderate adverse events — and revealed fewer details than Pfizer/BioNTech generally .
But we know the most common reactions were injection site pain , fatigue , headache , muscle pain , joint pain , and chills .
Though the FDA said these were mostly mild and moderate , we only have the specific figures for total events and the more severe reactions .
For example , 83 percent of study participants experienced a systemic adverse reaction @ @ @ @ @ @ @ percent experienced a severe “ systemic ” adverse reaction .
Depending on the type , these severe events ranged in frequency from 0.2 to 9.7 percent .
Like the Pfizer/BioNTech shot , side effects were more frequent after the second dose and less common overall in adults 65 and older .
Side effects that required hospitalization or emergency room visit were extremely rare .
According to FDA analysis , “ Across groups and doses , < 0.1 % reported a Grade 4 systemic reaction.
” You can see that below , in a @ @ @ @ @ @ @ younger adults in the study .
So what can we take away from all this ?
“ We know neither of these vaccines carries a high risk of serious adverse events .
And we can expect them to cause typical reactions to vaccines , ” said Bastian .
But there are important differences .
At least in these trials , all side effects and especially severe side effects were more common with the Moderna vaccine .
“ The overall picture is that almost everyone has systemic adverse events with Moderna ’ s vaccine @ @ @ @ @ @ @ how often they were only mild , ” Bastian said .
“ For Pfizer/BioNTech , most people had at least mild reactions , but moderate reactions were common too.
” So , at least for now , it seems reactions to the Pfizer/BioNTech vaccine “ are considerably less severe.
” The vaccines “ are on the fairly reactive side compared to most vaccines we commonly use , ” said Jesse Goodman , a professor of medicine and infectious diseases at Georgetown University and a former FDA chief scientist .
“ It ’ s @ @ @ @ @ @ @ but you do get the feeling these systemic reactions like muscle and joint aches are maybe more common in the Moderna vaccine than Pfizer.
” Goodman also noted that rates of adverse reactions in Moderna ’ s placebo groups were higher , and side effects were generally less severe in people who had already been infected with Covid-19 .
For the general population , though , there isn ’ t anything to fear with either vaccine .
Again , side effects , if they do pop up , will be mostly moderate or @ @ @ @ @ @ @ come as a surprise to vaccine researchers .
“ The side effects [ we ’ re seeing ] are symptoms associated with products of the immune system — cytokines — that are recruited when fighting an infection or responding to a vaccine , ” said Paul Offit , director of the Vaccine Education Center and professor of pediatrics at Children ’ s Hospital of Philadelphia .
“ That ’ s why people over 65 have a lesser rate of these side effects than younger people — just evidence of a more senescent immune @ @ @ @ @ @ @ lot to learn about these vaccines Even with all the available data , there are still unknowns about the two vaccines .
We may not see additional rare side effects or severe reactions that will emerge until millions of people get them , for example .
Bell ’ s palsy , a form of temporary facial paralysis , showed up in three people who got the Moderna vaccine and four people who got the Pfizer/BioNTech shot in the companies ’ late-stage trials .
It ’ s not yet clear whether these cases are @ @ @ @ @ @ @ Bell ’ s palsy can occur in the general population irrespective of vaccination — but because “ we see a similar imbalance in two different studies , it pricks my ears up a bit , ” Goodman said , and it ’ s something we ’ ll learn more about as the vaccines are rolled out .
There are also groups the vaccines weren ’ t tested in , like pregnant women and people with HIV .
In the cases of anaphylaxis in the UK following vaccination with the Pfizer/BioNTech shot , two @ @ @ @ @ @ @ — the kind that force them to carry around EpiPen-type devices — had a potentially life-threatening allergic reaction , were treated , and recovered .
Allergic reactions were very rare in the Pfizer/BioNTech trial ( affecting only 0.63 of people who got the vaccine , according to the FDA ’ s analysis ) .
And people with severe allergies were also excluded from the study .
The CDC is now advising that people with a history of severe allergic reactions to vaccines can still get the Pfizer/BioNTech shot but should be counseled about @ @ @ @ @ @ @ minutes afterward , while those with an allergy to a specific vaccine ingredient shouldn ’ t get the shot .
But , again , there ’ s some reassurance to be taken here : Severe allergic reactions to vaccines are extremely rare generally .
Most serious vaccine reactions — such as the rare neurological disorder Guillain-Barré syndrome — tend to happen within six weeks of getting immunized , said Colleen Kelley , associate professor of medicine at Emory University , who is also a principal investigator in the Moderna trial .
And we @ @ @ @ @ @ @ data on safety and side effects in the two shots .
“ People worry about late or long-term side effects occurring a year or two later — that ’ s not really a thing with vaccination , ” Kelley said .
Instead of taking a large dose of medication for many years , where a side effect may surface only after lots of exposure , with vaccines , Bastian said , you ’ re getting a small dose to stimulate an immune reaction once or a few times .
So it makes sense @ @ @ @ @ @ @ a major problem .
Again , though , this doesn ’ t mean all coronavirus vaccines are entirely safe or that there ’ s not more to learn about these two .
And as other Covid-19 vaccines hit the market , clarity and transparency about what we know will be paramount if we want people to trust and take the vaccines , Bastian said .
“ The evidence says treat people like adults .
Tell people the truth .
Anything else is manipulation and that ’ s a form of lying .
”

After months of waiting, we finally have detailed information on the safety and efficacy of the first Covid-19 vaccines that will be distributed in America.
On Thursday, a committee that advises the Food and Drug Administration voted to recommend the Moderna vaccine for an emergency use authorization for people ages 18 and over. Ahead of the decision, the agency shared the most comprehensive data to date on what we know about the shot. The same process happened last week with the Pfizer/BioNTech vaccine, which is now being rolled out across America following an EUA Friday night.
While both vaccines had already been shown to be highly effective, the new data provides a much more granular picture of their side effects and safety profiles.
What’s now clear: An injection with either vaccine, both of which use mRNA technology, can feel more intense than other routine vaccinations (such as the flu shot) — with side effects for some recipients such as pain, headache, and fatigue. And this may be especially true for Moderna’s vaccine: About 16 percent of people who got the shot in clinical trials experienced a “severe” systemic adverse reaction, a classification the FDA uses to refer to side effects, like fever or fatigue, that require medical attention and prevent people from going about their daily activities.
“We should anticipate that if you got vaccinated that day, you may not want to go to work,” Peter Hotez, the dean of the National School of Tropical Medicine at Baylor College, said of the vaccines. That’s why health systems are being warned to stagger immunizing their workforces, to avoid “potential clustering of worker absenteeism,” as the vaccine expert group advising the Centers for Disease Control and Prevention (CDC) put it.
These side effects are known as reactogenicity, and vaccine developers and regulators allow for some level of reactogenicity in all approved vaccines. They can be a sign of the body’s immune response kicking into gear, said Saad Omer, director of the Yale Institute for Global Health.
I think it will be very important to communicate to the population that these vaccines have more reactogenicity (injection site pain, transient fatigue, headache, elev temp) than most other licensed vaccines. Not dangerous but unpleasant. People need to know what to expect. https://t.co/51R1J8vRKQ — Florian Krammer (@florian_krammer) December 2, 2020
“Think about [reactogenicity] as mouthwash — it’s hurting while it’s working,” Omer said. “The key is to prepare people to know this will happen — this may hurt a little, give you a bit of fever — but these are short-term, known side effects that you need to be aware of.”
The stakes for clearly communicating information about each vaccine’s risks and benefits are high: More than a quarter of Americans reported that they would probably or definitely refuse to take a Covid-19 vaccine, according to a late-summer survey by the Kaiser Family Foundation, even if it were freely available and deemed safe by regulators. And with the virus spreading farther and faster in America than just about anywhere else in the world, it’s critical that people don’t feel caught off guard by the side effects or spread misinformation about the vaccine.
To achieve that, transparency is key, said Brendan Nyhan, a Dartmouth professor of political science who has been thinking about how to build confidence in the Covid-19 vaccines. “Millions of people are going to get this vaccine, and we know huge numbers of people are going to have normal side effects, which are often indicating that the vaccine is working. We want to build trust with people so there are no surprises when that happens.”
In that spirit, here’s what we know about the side effects of these two shots and how to think about them.
What mild and moderate side effects really mean
Before we get into the weeds, it’s helpful to understand how these companies classify side effects in the first place. In general, vaccine developers seeking approval in the US market use the FDA’s “toxicity assessment scale” to grade side effects and other adverse events from 1 to 4, from mild and moderate to severe and life-threatening.
Grade 1 “mild” side effects are generally easily tolerated and don’t interfere with a person’s regular activities. Grade 2 “moderate” effects may interfere with regular activities, grade 3 “severe” effects are incapacitating and need medical attention, and grade 4 are “potentially life-threatening,” usually requiring an emergency room visit or hospitalization. Let’s use the example of headache following vaccination. Here’s how the FDA would classify it:
Mild: “No interference with activity”
Moderate: “Repeated use of nonnarcotic pain reliever > 24 hours or some interference with activity”
Severe: “Any use of narcotic pain reliever or prevents daily activity”
Potentially life-threatening: “ER visit or hospitalization”
So a mild side effect is one you’d notice but doesn’t require any special care or keep you from living your life; a moderate side effect can keep you home from work but doesn’t warrant medical intervention; severe adverse events require medical care and definitely interfere with your normal life; and potentially life-threatening is just what it sounds like and usually involves a visit to or stay in the hospital.
In vaccine studies, these events are broken down into “local” reactions (meaning they’re specific to one part of the body, like pain or tenderness where the vaccine is injected) and “systemic,” whole-body reactions (like fever or fatigue).
For a vaccine to win FDA approval, any reactions people have during clinical trials have to be mostly mild and moderate. And that’s because the safety bar for vaccines is really high, even compared to medicines.
Vaccines “are given to healthy people who have in many cases absolutely nothing wrong with them. And we are talking about [giving them] to literally billions of people. Even rare side effects if they’re serious matter enormously,” said Charles Weijer, a professor of medicine and an ethicist at Western University in Canada. “We’re more willing to accept adverse effects [with drugs], provided those are counterbalanced by benefits to the patient.”
Mostly mild and moderate side effects are the safety profiles of both the Moderna and Pfizer/BioNTech vaccines — and that’s why the FDA in the US and drug regulators in other countries around the world are rushing to bring them to market. But there are important differences between the two vaccines.
What we know about Moderna and Pfizer/BioNTech side effects
Now let’s look at the best data we’ve got on the vaccines. It comes from the FDA’s analyses of phase 2 and 3 clinical trials ahead of their emergency use authorization meetings on December 10 for Pfizer/BioNTech and December 17 for Moderna. (The companies also released their own data for the meeting, but we focused on the agency’s independent reviews here.)
The reviews show the vaccines are both safe and that they’re extremely good at preventing Covid-19 infections (with around a 95 percent efficacy rate). That’s hugely important at a time when more than 3,000 Americans are dying from Covid-19 each day on average.
They also give a sense of what side effects we might expect when these vaccines are rolled out. The Pfizer/BioNTech vaccine caused mild or moderate reactions in most people, and severe reactions were rare. Moderna didn’t share the details of its vaccine trial’s mild and moderate side effects, but the FDA said mild and moderate is how they’d characterize the bulk of them. A key difference with the Moderna vaccine, however, is that we know severe reactions were more common in the trials.
Let’s get into what this means, but with a couple of caveats first. Because we have no head-to-head study of the two vaccines and the companies haven’t reported side effect data in the same way, doing apples-to-apples comparisons is tricky, said Hilda Bastian, an expert in reading medical evidence who has been analyzing the coronavirus vaccine data. The vaccines also come in different doses: 30µg in the case of Pfizer/BioNTech and 100µg with Moderna. While they’re supposed to be delivered in two shots per person, the time intervals are different: The Pfizer/BioNTech shots are three weeks apart, and Moderna’s are four weeks.
Pfizer/BioNTech and Moderna also tested their products on different populations. “Some of the differences affect risks and so could be affecting outcomes,” said Bastian. For example, there were more people of Hispanic/Latino background and with chronic lung disease in the Pfizer/BioNTech trial than the Moderna trial, she added. And in the real world, when the vaccines roll out to millions, the side effects may again look different.
With all that in mind, here’s what we know about each shot. For Pfizer/BioNTech the most common side effects overall, according to the FDA’s analysis of the data, were local reactions at the site of injection (including pain, redness, swelling), fatigue, headache, muscle pain, chills, joint pain, and fever. Again, these were mostly classified as mild or moderate. Severe reactions, meanwhile, were rare — occurring in 0 to 4.6 percent of participants, depending on the specific side effect.
In general, side effects popped up more after the second dose than the first. They also happened less frequently in people 55 and younger, the FDA said. You can see the breakdown of adverse events data in younger adults (18-55) in the chart below following dose 1 and, if you click through, following dose 2. (Note: Pfizer/BioNTech found no potentially life-threatening (grade 4) adverse reactions linked to the vaccine in the population they analyzed for safety.)
Now let’s look at the FDA’s Moderna data. Again, the company didn’t share the details of their mild and moderate adverse events — and revealed fewer details than Pfizer/BioNTech generally. But we know the most common reactions were injection site pain, fatigue, headache, muscle pain, joint pain, and chills.
Though the FDA said these were mostly mild and moderate, we only have the specific figures for total events and the more severe reactions. For example, 83 percent of study participants experienced a systemic adverse reaction of any level of severity while 15.7 percent experienced a severe “systemic” adverse reaction and 7 percent, a severe “local” reaction. Depending on the type, these severe events ranged in frequency from 0.2 to 9.7 percent.
Like the Pfizer/BioNTech shot, side effects were more frequent after the second dose and less common overall in adults 65 and older. Side effects that required hospitalization or emergency room visit were extremely rare. According to FDA analysis, “Across groups and doses, <0.1% reported a Grade 4 systemic reaction.” You can see that below, in a chart focusing on safety data in the younger adults in the study.
So what can we take away from all this?
“We know neither of these vaccines carries a high risk of serious adverse events. And we can expect them to cause typical reactions to vaccines,” said Bastian. But there are important differences. At least in these trials, all side effects and especially severe side effects were more common with the Moderna vaccine.
“The overall picture is that almost everyone has systemic adverse events with Moderna’s vaccine, and we don’t know how often they were only mild,” Bastian said. “For Pfizer/BioNTech, most people had at least mild reactions, but moderate reactions were common too.” So, at least for now, it seems reactions to the Pfizer/BioNTech vaccine “are considerably less severe.”
The vaccines “are on the fairly reactive side compared to most vaccines we commonly use,” said Jesse Goodman, a professor of medicine and infectious diseases at Georgetown University and a former FDA chief scientist. “It’s hard to compare between the two, but you do get the feeling these systemic reactions like muscle and joint aches are maybe more common in the Moderna vaccine than Pfizer.” Goodman also noted that rates of adverse reactions in Moderna’s placebo groups were higher, and side effects were generally less severe in people who had already been infected with Covid-19.
For the general population, though, there isn’t anything to fear with either vaccine. Again, side effects, if they do pop up, will be mostly moderate or mild. And this doesn’t come as a surprise to vaccine researchers. “The side effects [we’re seeing] are symptoms associated with products of the immune system — cytokines — that are recruited when fighting an infection or responding to a vaccine,” said Paul Offit, director of the Vaccine Education Center and professor of pediatrics at Children’s Hospital of Philadelphia. “That’s why people over 65 have a lesser rate of these side effects than younger people — just evidence of a more senescent immune system.”
There’s still a lot to learn about these vaccines
Even with all the available data, there are still unknowns about the two vaccines. We may not see additional rare side effects or severe reactions that will emerge until millions of people get them, for example.
Bell’s palsy, a form of temporary facial paralysis, showed up in three people who got the Moderna vaccine and four people who got the Pfizer/BioNTech shot in the companies’ late-stage trials. It’s not yet clear whether these cases are actually linked with the vaccines — since Bell’s palsy can occur in the general population irrespective of vaccination — but because “we see a similar imbalance in two different studies, it pricks my ears up a bit,” Goodman said, and it’s something we’ll learn more about as the vaccines are rolled out.
There are also groups the vaccines weren’t tested in, like pregnant women and people with HIV. In the cases of anaphylaxis in the UK following vaccination with the Pfizer/BioNTech shot, two people with a history of severe allergies — the kind that force them to carry around EpiPen-type devices — had a potentially life-threatening allergic reaction, were treated, and recovered. Allergic reactions were very rare in the Pfizer/BioNTech trial (affecting only 0.63 of people who got the vaccine, according to the FDA’s analysis). And people with severe allergies were also excluded from the study.
Clinical trials are not the real world of people; they all have inclusion/exclusion criteria.
Like no history of anaphylaxis (protocol ).
The same day @Pfizer vaccine rolled out, 2 cases of severe allergic reactions in healthcare workers.
There will be more safety issues ahead. pic.twitter.com/9SRrWyPPDu — Eric Topol (@EricTopol) December 9, 2020
The CDC is now advising that people with a history of severe allergic reactions to vaccines can still get the Pfizer/BioNTech shot but should be counseled about the risks and be monitored for 30 minutes afterward, while those with an allergy to a specific vaccine ingredient shouldn’t get the shot.
Long-term Covid-19 vaccine side effects are “not really a thing”
But, again, there’s some reassurance to be taken here: Severe allergic reactions to vaccines are extremely rare generally. Most serious vaccine reactions — such as the rare neurological disorder Guillain-Barré syndrome — tend to happen within six weeks of getting immunized, said Colleen Kelley, associate professor of medicine at Emory University, who is also a principal investigator in the Moderna trial. And we already have more than six weeks of data on safety and side effects in the two shots.
“People worry about late or long-term side effects occurring a year or two later — that’s not really a thing with vaccination,” Kelley said.
Instead of taking a large dose of medication for many years, where a side effect may surface only after lots of exposure, with vaccines, Bastian said, you’re getting a small dose to stimulate an immune reaction once or a few times. So it makes sense that the longer-term risks aren’t a major problem.
Again, though, this doesn’t mean all coronavirus vaccines are entirely safe or that there’s not more to learn about these two. And as other Covid-19 vaccines hit the market, clarity and transparency about what we know will be paramount if we want people to trust and take the vaccines, Bastian said. “The evidence says treat people like adults. Tell people the truth. Anything else is manipulation and that’s a form of lying.”
Correction, February 10, 2021: An earlier version of a graphic displaying Moderna vaccine side effects misstated the reported frequency in clinical trials of some mild reactions.


vox--2020-12-17--10 ways Biden should fix the EPA

10 ways Biden should fix the EPA

President-elect Joe Biden will nominate Michael Regan , secretary of the North Carolina Department of Environmental Quality , to head the Environmental Protection Agency , according to multiple news reports .
Regan has two decades of experience in environmental policy and positions at the Environmental Defense Fund as well as the EPA , and would be the first Black man to run the agency in its 50-year history if confirmed .
Regan and the Biden administration will need to not only restore our nation ’ s premier environmental regulator but also to remake it , adapting it to tackle mounting @ @ @ @ @ @ @ faltered , from climate change to rampant environmental injustice to toxic pollutants old and new .
It might seem like an impossible task , given that climate-linked disasters keep multiplying , many curbs on greenhouse gas emissions have vanished , and environmental enforcement has plummeted .
But our new leaders and all Americans can take inspiration from how we have done it before .
Fifty years ago , our rivers were on fire , smog choked our urban centers , and state and local governments struggled to respond .
In the single month @ @ @ @ @ @ @ the EPA , its new head William Ruckelshaus came out swinging against water polluters and industry-dominated state pollution boards , and Congress finalized the Clean Air Act , which Nixon then signed into law .
Since then , the EPA has brought substantial improvements in our air , water , and dealings with hazardous waste , benefitting not just our health but also our economy .
Over the last four years , however , EPA political appointees tied to industries regulated by the agency have set about stripping this vital agency of its @ @ @ @ @ @ @ ’ ve done so even as environmental pollution still contributes substantially to premature mortality , cancer , and heart disease , as its effects still weigh most heavily on our society ’ s most vulnerable and exploited , and as climate disasters impose ever more unmistakable impacts on Americans ’ health and well-being .
What can be done to reverse the EPA ’ s systematic weakening under Trump , while retooling it to meet today ’ s challenges ?
The wisdom of staffers as gathered from the Environmental Data and Governance Initiative ’ @ @ @ @ @ @ @ with our own analysis suggests there ’ s much that a Biden administration and the EPA itself can do .
Here are 10 things the new leadership should do to fix the EPA .
As the world ’ s largest historical emitter of greenhouse gases and still the second-largest annual contributor , the US has for too long shirked its global duty in helping alleviate the climate crisis .
The first step to rectifying this will be rejoining the Paris climate agreement and then translating our Paris commitments into policies that speed emissions @ @ @ @ @ @ @ Air Act and the courts have placed largely in EPA ’ s hands .
To make up for four years of EPA inaction under Trump , the Biden EPA must reverse the Trump administration ’ s rollback of Obama-era policies for curbing greenhouse gases and strengthen them in durable ways including possible legislation , and improve emissions reporting so that everyone can easily follow policies ’ impacts .
The EPA ’ s staff has declined 22 percent since 1999 , and its inflation-adjusted budget is now less than in 1979 .
Its budget @ @ @ @ @ @ @ its ability to carry out long-standing work such as enforcing the Clean Air and Water Acts and ensuring clean drinking water nationwide , while impeding its response to newer challenges , from tracking and lowering greenhouse gas emissions to preparing for and responding to the heatwaves , wildfires , superstorms , and other threats posed by climate change .
To start fixing that , President-elect Biden should propose — and Congress should approve — a 10 percent or more increase to the agency ’ s funding .
This would allow the EPA to @ @ @ @ @ @ @ responsibilities and decisively tackle climate change .
In the Trump EPA , political appointees — as well as scientific advisers — have had extensive ties to industries regulated by the agency ( such as the fossil fuel and chemical industries ) .
But the agency ’ s decisions must be based on science and the public ’ s health , rather than an industry ’ s bottom line .
The federal government needs to create better ways to prevent these sorts of conflicts of interest that undermine sound science and public confidence .
@ @ @ @ @ @ @ much more people of color are exposed to pollution .
To better rectify this , the Biden administration should prioritize environmental justice not just through agency-wide administrative actions ( which can be backpedaled later ) , but by advocating for greater legislative authority in this arena .
Among the promising recent legislative proposals , a proposed Public Health Air Quality Act mandating more fenceline monitoring would greatly aid the agency ’ s ability to recognize and respond to these communities ’ dilemmas .
An environmental justice bill passed in New Jersey as well @ @ @ @ @ @ @ Sen. Cory Booker ( D-NJ ) would also give the agency stronger legal tools to limit pollution in overburdened communities .
The EPA has had limited success ensuring the safety of chemicals used in everyday products , guarding against lead contamination of drinking water , and banning chemicals like asbestos that cause deadly diseases .
To tackle these toxics , the agency should improve implementation of the 2016 Frank R. Lautenberg Chemical Safety for the 21st Century Act .
It should also strengthen air quality and other standards to prioritize protection of pregnant @ @ @ @ @ @ @ hazardous chemicals .
And it should do more to protect children from lead — one way to do this is to dedicate funding to rapidly replace the millions of lead service lines that still carry drinking water in many parts of the country .
The EPA ’ s ability to protect human health and enforce environmental laws hinges on science and scientists .
But during the Trump administration , scientists were sidelined from top-level decision-making , and hundreds left the agency , weakening its expertise .
To make the EPA a place where @ @ @ @ @ @ @ the hiring system , providing them with sufficient resources for their work , and also heeding their knowledge and recommendations .
The EPA must reinvigorate its scientific workforce , advisory system , and research to ensure that environmental decision-making is grounded in science .
The EPA ’ s power and willingness to enforce environmental laws has undergone long-term erosion but dropped off precipitously under Trump — even as noncompliance remains frequent .
To increase pressure on polluters on behalf of the public , the EPA needs to step up enforcement , especially when @ @ @ @ @ @ @ To do so , its enforcement capacity needs rebuilding ( environmental and compliance staff fell 23 percent under Trump ) , and from the outset , the new Administrator and his team need to announce and pursue a serious commitment to taking on violators .
Much of the federal government ’ s existing environmental data infrastructure remains fragmented , partial , and outmoded .
The EPA should update technology for measuring and monitoring pollution and better integrate its data systems across programs .
This promises to improve the agency ’ s work by @ @ @ @ @ @ @ targeting of violators .
It should also strive to help people and advocacy groups better understand what is going on .
Even EPA ’ s best current digital interfaces pose challenges for ordinary citizens seeking to learn about nearby facilities , from unfamiliar acronyms to unexplained numbers .
EPA data on polluters as well as its own actions or inaction needs to be made more transparent , accessible , and interpretable to the public , so as to better inform communities about the environmental risks surrounding them .
Making it easier to analyze @ @ @ @ @ @ @ should be an agency priority .
9 ) Be a better steward of information The EPA should be a national force for educating the public about the science that grounds our environmental laws .
Under Trump , this agency slid in the opposite direction , removing not just references to climate change but much other scientific information from its websites , abandoning many environmental education efforts , and even turning its press office into a megaphone for conservative op-eds by its political appointees .
The incoming leadership should ensure not just that the @ @ @ @ @ @ @ and user-friendly information , but that it actively promotes environmental science literacy .
To accomplish many of these goals , the agency needs support from advocacy groups , educators , and other environmentally concerned citizens .
These partnerships will provide new avenues for communicating accurate information about environmental problems , including more “ citizen science ” to enhance the agency ’ s work .
They will also fortify efforts to push for local , state , and federal actions to improve environmental health and address climate change , and to further strengthen EPA @ @ @ @ @ @ @ , the EPA has played a critical role in making our air cleaner , providing safe drinking water , and ensuring that rivers no longer spontaneously catch fire .
Let ’ s rebuild and strengthen the agency so that it is equipped to prevent the fires , both literal and figurative , of our present and future .
Marianne Sullivan is a professor of public health at the William Paterson University of New Jersey and a member of the Environmental Data and Governance Initiative ( EDGI ) .
Christopher Sellers is a professor @ @ @ @ @ @ @ a research fellow at the Institute for Historical Studies at the University of Texas-Austin , and on the coordinating committee of EDGI .
He is the author of Crabgrass Crucible : Suburban Nature and the Rise of Environmentalism in 20th-Century America , and forthcoming books on the history of environmental politics in Atlanta , Texas , and Mexico .

President-elect Joe Biden has nominated Michael Regan, secretary of the North Carolina Department of Environmental Quality, to head the Environmental Protection Agency, according to the transition team. Regan has two decades of experience in environmental policy and positions at the Environmental Defense Fund as well as the EPA, and would be the first Black man to run the agency in its 50-year history if confirmed.
Climate change is the most significant challenge humanity faces. We’ll make meaningful progress together by listening to every voice—from our youth & frontline communities to scientists & our workforce. I will be honored to be part of that work as EPA Administrator.
— Michael Regan (@Michael_S_Regan) December 18, 2020
Regan and the Biden administration will need to not only restore our nation’s premier environmental regulator but also remake it, adapting it to tackle mounting environmental problems against which it has long faltered, from climate change to rampant environmental injustice to toxic pollutants old and new.
It might seem like an impossible task, given that climate-linked disasters keep multiplying, many curbs on greenhouse gas emissions have vanished, and environmental enforcement has plummeted. But our new leaders and all Americans can take inspiration from how we have done it before.
Fifty years ago, our rivers were on fire, smog choked our urban centers, and state and local governments struggled to respond. In the single month of December 1970, President Nixon opened the EPA, its new head William Ruckelshaus came out swinging against water polluters and industry-dominated state pollution boards, and Congress finalized the Clean Air Act, which Nixon then signed into law.
Since then, the EPA has brought substantial improvements in our air, water, and dealings with hazardous waste, benefiting not just our health but also our economy. Over the past four years, however, EPA political appointees tied to industries regulated by the agency have set about stripping this vital agency of its power to act. Tragically, they’ve done so even as environmental pollution still contributes substantially to premature mortality, cancer, and heart disease, as its effects still weigh most heavily on our society’s most vulnerable and exploited, and as climate disasters impose ever more unmistakable impacts on Americans’ health and well-being.
What can be done to reverse the EPA’s systematic weakening under Trump, while retooling it to meet today’s challenges? The wisdom of staffers as gathered from the Environmental Data and Governance Initiative’s EPA oral history project and interwoven with our own analysis suggests there’s much that a Biden administration and the EPA itself can do.
Here are 10 things the new leadership should do to fix the EPA.
1) Take quick climate action
As the world’s largest historical emitter of greenhouse gases and still the second-largest annual contributor, the US has for too long shirked its global duty in helping alleviate the climate crisis.
The first step to rectifying this will be rejoining the Paris climate agreement and then translating our Paris commitments into policies that speed emissions reductions, a job that the Clean Air Act and the courts have placed largely in EPA’s hands. To make up for four years of EPA inaction under Trump, the Biden EPA must reverse the Trump administration’s rollback of Obama-era policies for curbing greenhouse gases and strengthen them in durable ways including possible legislation, and improve emissions reporting so that everyone can easily follow policies’ impacts.
2) Restore the budget and staff
The EPA’s staff has declined 22 percent since 1999, and its inflation-adjusted budget is now less than in 1979. Its budget has shrunk despite added responsibilities, limiting its ability to carry out longstanding work such as enforcing the Clean Air and Water acts and ensuring clean drinking water nationwide, while impeding its response to newer challenges, from tracking and lowering greenhouse gas emissions to preparing for and responding to the heat waves, wildfires, superstorms, and other threats posed by climate change.
To start fixing that, President-elect Biden should propose — and Congress should approve — a 10 percent or more increase to the agency’s funding. This would allow the EPA to hire adequate staff to meet its current responsibilities and decisively tackle climate change.
3) Keep industry out
In the Trump EPA, political appointees — as well as scientific advisers — have had extensive ties to industries regulated by the agency (such as the fossil fuel and chemical industries). But the agency’s decisions must be based on science and the public’s health, rather than an industry’s bottom line. The federal government needs to create better ways to prevent these sorts of conflicts of interest that undermine sound science and public confidence.
4) Make environmental justice a priority
The EPA has long struggled with how much more people of color are exposed to pollution. To better rectify this, the Biden administration should prioritize environmental justice not just through agency-wide administrative actions (which can be backpedaled later), but by advocating for greater legislative authority in this arena.
Among the promising recent legislative proposals, a proposed Public Health Air Quality Act mandating more fenceline monitoring would greatly aid the agency’s ability to recognize and respond to these communities’ dilemmas. An environmental justice bill passed in New Jersey as well as a similar federal bill introduced by Sen. Cory Booker (D-NJ) would also give the agency stronger legal tools to limit pollution in overburdened communities.
5) Tackle toxic chemicals
The EPA has had limited success ensuring the safety of chemicals used in everyday products, guarding against lead contamination of drinking water, and banning chemicals like asbestos that cause deadly diseases.
To tackle these toxics, the agency should improve implementation of the 2016 Frank R. Lautenberg Chemical Safety for the 21st Century Act. It should also strengthen air quality and other standards to prioritize protection of pregnant women, infants, and children from hazardous chemicals. And it should do more to protect children from lead — one way to do this is to dedicate funding to rapidly replace the millions of lead service lines that still carry drinking water in many parts of the country.
6) Reinvigorate science
The EPA’s ability to protect human health and enforce environmental laws hinges on science and scientists. But during the Trump administration, scientists were sidelined from top-level decision-making, and hundreds left the agency, weakening its expertise. To make the EPA a place where top scientists want to work means improving the hiring system, providing them with sufficient resources for their work, and heeding their knowledge and recommendations. The EPA must reinvigorate its scientific workforce, advisory system, and research to ensure that environmental decision-making is grounded in science.
7) Enforce the law
The EPA’s power and willingness to enforce environmental laws has undergone long-term erosion but dropped off precipitously under Trump — even as noncompliance remains frequent. To increase pressure on polluters on behalf of the public, the EPA needs to step up enforcement, especially when and where the states do not. To do so, its enforcement capacity needs rebuilding (environmental and compliance staff fell 23 percent under Trump), and from the outset, the new administrator and his team need to announce and pursue a serious commitment to taking on violators.
8) Upgrade data
Much of the federal government’s existing environmental data infrastructure remains fragmented, partial, and outmoded. The EPA should update technology for measuring and monitoring pollution and better integrate its data systems across programs. This promises to improve the agency’s work by, for one, enabling more prompt targeting of violators. It should also strive to help people and advocacy groups better understand what is going on.
Even the EPA’s best current digital interfaces pose challenges for ordinary citizens seeking to learn about nearby facilities, from unfamiliar acronyms to unexplained numbers. EPA data on polluters as well as the agency’s own actions or inaction need to be made more transparent, accessible, and interpretable to the public, so as to better inform communities about the environmental risks surrounding them. Making it easier to analyze environmental justice impacts at the community level should be an agency priority.
9) Be a better steward of information
The EPA should be a national force for educating the public about the science that grounds our environmental laws. Under Trump, this agency slid in the opposite direction, removing not just references to climate change but much other scientific information from its websites, abandoning many environmental education efforts, and even turning its press office into a megaphone for conservative op-eds by its political appointees. The incoming leadership should ensure not just that the agency provides factual, technically accurate, and user-friendly information, but that it actively promotes environmental science literacy.
10) Partner with the American public
To accomplish many of these goals, the agency needs support from advocacy groups, educators, and other environmentally concerned citizens. These partnerships will provide new avenues for communicating accurate information about environmental problems, including more “citizen science” to enhance the agency’s work. They will also fortify efforts to push for local, state, and federal actions to improve environmental health and address climate change, and to further strengthen the EPA’s abilities.
For 50 years, the EPA has played a critical role in making our air cleaner, providing safe drinking water, and ensuring that rivers no longer spontaneously catch fire. Let’s rebuild and strengthen the agency so that it is equipped to prevent the fires, both literal and figurative, of our present and future.
Marianne Sullivan is a professor of public health at the William Paterson University of New Jersey and a member of the Environmental Data and Governance Initiative (EDGI).
Christopher Sellers is a professor of history at Stony Brook University, a research fellow at the Institute for Historical Studies at the University of Texas at Austin, and on the coordinating committee of EDGI. He is the author of Crabgrass Crucible: Suburban Nature and the Rise of Environmentalism in 20th-Century America, and forthcoming books on the history of environmental politics in Atlanta, Texas, and Mexico.


vox--2020-12-17--What are hot chocolate bombs and why are they suddenly everywhere?

‘ Tis the season for hot chocolate , and an especially decadent version of everyone ’ s favorite holiday drink ( suck it , cider ) is exploding on TikTok and in suburban communities across the country .
A basic-bitch packet of Swiss Miss mix just can ’ t compete with the visually compelling and viral glory of hot chocolate bombs .
For the unfamiliar , hot chocolate bombs , or glossy chocolate orbs filled with cocoa mix , marshmallows , sprinkles , and other edible baubles , are a truly over-the-top way to level up your cocoa game .
@ @ @ @ @ @ @ warm milk , the bombs open up in dramatic fashion , revealing the goodies inside and creating a decadent cup of hot cocoa once stirred together .
Hot cocoa bombs are seriously trendy right now , written up in the New York Times , popping up in cafes , fancy chocolate shops , and even luxury retailers — Neiman Marcus is currently hawking a $ 32 hot chocolate bomb that ’ s painted pink and shaped like a snowman , made by Dallas chocolatier Kate Weiser .
At the Ganachery in Florida ’ @ @ @ @ @ @ @ a virally popular bomb shaped like Olaf from the movie Frozen .
They ’ re also all over Etsy , including vegan options , extra-large bombs topped with whole Oreos , and white chocolate bombs decorated to look like unicorns .
On TikTok , where the hashtag # hotchocolatebombs has been used more than 181 million times , the world of hot chocolate bombs is much more homemade .
Thousands of tutorials demonstrate how to carefully temper the chocolate and pour it into silicone molds .
The half-spheres are left to harden , @ @ @ @ @ @ @ and “ glued ” together with melted chocolate .
At the end of the process , the bombs are drizzled with even more chocolate and decorated with festive sprinkles .
One video with more than 800,000 views depicts a “ gender reveal ” bomb that ’ s full of bright blue marshmallows .
The festive treats are also immensely popular in the 100,000-member strong Instant Pot Facebook group , where members are showing off how they ’ re using their pot as a double-boiler to melt the chocolate , and repurposing the silicone @ @ @ @ @ @ @ of Starbucks ’ s popular sous vide egg bites to make their own hot chocolate bombs .
Considering that we ’ re all stuck indoors with plenty of time on our hands as we try to slow the spread of the novel coronavirus , there ’ s really no better time to learn the challenges in crafting fancy chocolate confections .
Alongside the videos of perfectly crafted chocolate bombs are a litany of fail videos that showcase people who are learning exactly how difficult it is to temper chocolate properly and fill the @ @ @ @ @ @ @ delicate shell .
But unlike the typical fail , these at least will still result in a delicious mug of hot chocolate .
Nobody cares that your hot chocolate bomb looked more like an oddly shaped poop than a professional confection , so long as it doesn ’ t taste like one once it ’ s fully melted into a mug of warm milk .
And maybe this is just a good time to get experimental with hot chocolate .
Also on TikTok , people are encouraging others to boil the metal grinders @ @ @ @ @ @ @ milk to make a hot chocolate that will , allegedly , be delicious while getting you stoned .
Unfortunately , that ’ s not exactly true .
First , cannabis has to go through a process called decarboxylation to activate its psychoactive elements when eaten , and the idea of consuming hot chocolate that ’ s infused with decades of stoner hand germs and weed pesticides is just not appealing .
But while you might hope to avoid a mug of hot cocoa ruined by impotent weed dust , there ’ s no @ @ @ @ @ @ @ bomb , even if they are a little ridiculous and kitschy .
We could all use a little magic , and rich dark chocolate , in our cups right now .

‘Tis the season for hot chocolate, and an especially decadent version of everyone’s favorite holiday drink (suck it, cider) is exploding on TikTok and in suburban communities across the country. A basic-bitch packet of Swiss Miss mix just can’t compete with the visually compelling and viral glory of hot chocolate bombs.
For the unfamiliar, hot chocolate bombs, or glossy chocolate orbs filled with cocoa mix, marshmallows, sprinkles, and other edible baubles, are a truly over-the-top way to level up your cocoa game. Once plopped inside a mug full of warm milk, the bombs open up in dramatic fashion, revealing the goodies inside and creating a decadent cup of hot cocoa once stirred together.
Hot cocoa bombs are seriously trendy right now, written up in the New York Times, popping up in cafes, fancy chocolate shops, and even luxury retailers — Neiman Marcus is currently hawking a $32 hot chocolate bomb that’s painted pink and shaped like a snowman, made by Dallas chocolatier Kate Weiser. At the Ganachery in Florida’s Disney Springs, there’s a virally popular bomb shaped like Olaf from the movie Frozen. They’re also all over Etsy, including vegan options, extra-large bombs topped with whole Oreos, and white chocolate bombs decorated to look like unicorns.
On TikTok, where the hashtag #hotchocolatebombs has been used more than 181 million times, the world of hot chocolate bombs is much more homemade. Thousands of tutorials demonstrate how to carefully temper the chocolate and pour it into silicone molds. The half-spheres are left to harden, then filled with cocoa mix and marshmallows and “glued” together with melted chocolate. At the end of the process, the bombs are drizzled with even more chocolate and decorated with festive sprinkles. One video with more than 800,000 views depicts a “gender reveal” bomb that’s full of bright blue marshmallows.
The festive treats are also immensely popular in the 100,000-member strong Instant Pot Facebook group, where members are showing off how they’re using their pot as a double-boiler to melt the chocolate, and repurposing the silicone molds they originally purchased to make dupes of Starbucks’s popular sous vide egg bites to make their own hot chocolate bombs.
Considering that we’re all stuck indoors with plenty of time on our hands as we try to slow the spread of the novel coronavirus, there’s really no better time to learn the challenges in crafting fancy chocolate confections. Alongside the videos of perfectly crafted chocolate bombs are a litany of fail videos that showcase people who are learning exactly how difficult it is to temper chocolate properly and fill the spheres without breaking the bomb’s delicate shell.
But unlike the typical fail, these at least will still result in a delicious mug of hot chocolate. Nobody cares that your hot chocolate bomb looked more like an oddly shaped poop than a professional confection, so long as it doesn’t taste like one once it’s fully melted into a mug of warm milk.
And maybe this is just a good time to get experimental with hot chocolate. Also on TikTok, people are encouraging others to boil the metal grinders they use to crush up marijuana in milk to make a hot chocolate that will, allegedly, be delicious while getting you stoned. Unfortunately, that’s not exactly true. First, cannabis has to go through a process called decarboxylation to activate its psychoactive elements when eaten, and the idea of consuming hot chocolate that’s infused with decades of stoner hand germs and weed pesticides is just not appealing.
But while you might hope to avoid a mug of hot cocoa ruined by impotent weed dust, there’s no denying the appeal of a hot chocolate bomb, even if they are a little ridiculous and kitschy. We could all use a little magic, and rich dark chocolate, in our cups right now.


vox--2020-12-17--A second Covid-19 vaccine has been recommended for emergency use by FDA advisers

An advisory committee to the Food and Drug Administration voted on Thursday 20-to-0 , with one abstention , to recommend the Moderna Covid-19 vaccine for an emergency use authorization for people ages 18 and older , determining that the benefits of the vaccine outweigh the risks .
This makes the Moderna Covid-19 vaccine the second one to receive a green light from the committee .
The FDA is expected to accept the recommendation from the Vaccines and Related Biological Products Advisory Committee within days , at which time the vaccine , which has an efficacy of almost 95 percent , @ @ @ @ @ @ @ and high-risk populations .
“ We ’ re in an unparalleled crisis , and I did not think an EUA was the way to go , but since the train has left the station , I appreciate that Moderna has given us a very transparent and thorough study that even from the beginning seemed very well organized , ” said A. Oveta Fuller , an associate professor of microbiology at the University of Michigan and a temporary voting member of the committee , explaining her vote in favor .
The vote in favor @ @ @ @ @ @ @ after a similar approval for the Covid-19 vaccine developed by Pfizer and BioNTech , which also uses an mRNA platform to generate immunity and is administered as two doses spaced several weeks apart .
That vaccine has begun deliveries in the United States this week across all 50 states .
Operation Warp Speed , the $ 10 billion program from the Department of Health and Human Services aimed at accelerating Covid-19 vaccine development , is expecting to have 12.5 million doses of the Moderna vaccine ready to dispense before the end of the @ @ @ @ @ @ @ Alex Azar said at a press conference Wednesday that the program has purchased 100 million doses of the Moderna vaccine and 100 million doses of the Pfizer/BioNTech vaccine to be delivered by the end of March .
Unlike Pfizer , Moderna received direct support from the US government for its research and development , totaling $ 4.1 billion for clinical trials and manufacturing .
Moderna ’ s vaccine also has less strict cold storage requirements .
It demands long-term storage at minus 20 degrees Celsius ( minus 4 degrees Fahrenheit ) and is @ @ @ @ @ @ @ 8°C ( 36° to 46°F ) .
Pfizer and BioNTech ’ s vaccine , on the other hand , requires temperatures of minus 70°C ( minus 94°F ) or lower .
An emergency use authorization for the Moderna vaccine would give the company the green light to increase manufacturing to deliver protection from Covid-19 to more Americans .
But as with the Pfizer/BioNTech vaccine , there will not be enough doses to go around right away , so health officials will have to make tricky decisions about who gets the shots first .
@ @ @ @ @ @ @ short of full approval , which means there remain some critical questions about the vaccine that need to be addressed with further clinical trials .
What we learned recently about the Moderna Covid-19 vaccine The public received details about the Moderna vaccine for the first time outside of the company ’ s press releases in a briefing document published by the FDA on Tuesday .
Looking at 30,351 participants in their phase 3 clinical trial , Moderna ’ s latest results showed its vaccine had an efficacy of 94.1 percent against confirmed Covid-19 @ @ @ @ @ @ @ detected 185 Covid-19 cases in the placebo group and 11 cases in the group that received the vaccine .
The vaccine is administered as two doses spaced 28 days apart .
However , it seems to begin to offer protection against Covid-19 shortly after the first dose , with protection continuing to build after the second .
In a presentation to the FDA vaccine committee , Moderna also highlighted that its vaccine not only prevents disease but also seems to prevent infection , including infections that don ’ t generate any symptoms .
@ @ @ @ @ @ @ that were positive in the vaccine group as compared to the placebo group at the pre-dose 2 timepoint , suggesting that some asymptomatic infections start to be prevented after the first dose , ” according to Moderna ’ s briefing .
This is hugely valuable for fighting the Covid-19 pandemic .
The virus has shown an ability to spread between people before the infected show any symptoms and some of the infected can be completely asymptomatic .
That means people can unwittingly spread the virus .
But with a vaccine that lowers asymptomatic @ @ @ @ @ @ @ spread of Covid-19 can be more easily controlled .
However , the results this week also shed some light on the side effects of the Moderna vaccine .
In the phase 3 trial , about 16 percent of people in the vaccine group had a severe adverse reaction , defined by the FDA as a reaction that requires medical attention and prevents people going about their daily lives .
“ The most common solicited adverse reactions associated with mRNA-1273 [ Moderna vaccine ] were injection site pain ( 91.6 % ) , fatigue @ @ @ @ @ @ @ 63.0 % ) , muscle pain ( 59.6 % ) , joint pain ( 44.8 % ) , and chills ( 43.4 % ) ; severe adverse reactions occurred in 0.2 % to 9.7 % of participants , were more frequent after dose 2 than after dose 1 , and were generally less frequent in participants ≥65 years of age as compared to younger participants , ” according to Moderna ’ s briefing to the FDA .
The briefing also acknowledged that there are many critical questions that remain unresolved .
One is @ @ @ @ @ @ @ will last , something that will require continued monitoring of the participants in the clinical trial and potential recipients under an EUA .
There is also limited information about how well the vaccine works in people with compromised immune systems and pregnant people .
There is no information about the efficacy of the vaccine in people under the age of 18 since they were excluded from the clinical trials .
It ’ s also not clear how well the vaccine blocks transmission relative to other measures like wearing face masks and social distancing @ @ @ @ @ @ @ trial pool for two years and will conduct additional studies among the people who receive the vaccine under an EUA in order to get answers to these questions .
In the meantime , the FDA will consider the recommendation from its advisers .
The FDA granted an EUA to the Pfizer/BioNTech vaccine just over a day after it received a vote of confidence from the vaccine advisory committee , so an authorization for the Moderna vaccine could come as soon as Friday .

An advisory committee to the Food and Drug Administration voted on Thursday 20-to-0, with one abstention, to recommend the Moderna Covid-19 vaccine for an emergency use authorization for people ages 18 and older, determining that the benefits of the vaccine outweigh the risks. This makes the Moderna Covid-19 vaccine the second one to receive a green light from the committee.
The FDA is expected to accept the recommendation from the Vaccines and Related Biological Products Advisory Committee within days, at which time the vaccine, which has an efficacy of almost 95 percent, can begin being distributed to health workers and high-risk populations.
“We’re in an unparalleled crisis, and I did not think an EUA was the way to go, but since the train has left the station, I appreciate that Moderna has given us a very transparent and thorough study that even from the beginning seemed very well organized,” said A. Oveta Fuller, an associate professor of microbiology at the University of Michigan and a temporary voting member of the committee, explaining her vote in favor.
The vote in favor of the Moderna vaccine comes a week after a similar approval for the Covid-19 vaccine developed by Pfizer and BioNTech, which also uses an mRNA platform to generate immunity and is administered as two doses spaced several weeks apart. That vaccine has begun deliveries in the United States this week across all 50 states.
Operation Warp Speed, the $10 billion program from the Department of Health and Human Services aimed at accelerating Covid-19 vaccine development, is expecting to have 12.5 million doses of the Moderna vaccine ready to dispense before the end of the month. Health and Human Services Secretary Alex Azar said at a press conference Wednesday that the program has purchased 100 million doses of the Moderna vaccine and 100 million doses of the Pfizer/BioNTech vaccine to be delivered by the end of March.
Unlike Pfizer, Moderna received direct support from the US government for its research and development, totaling $4.1 billion for clinical trials and manufacturing. Moderna’s vaccine also has less strict cold storage requirements. It demands long-term storage at minus 20 degrees Celsius (minus 4 degrees Fahrenheit) and is stable for 30 days between 2° and 8°C (36° to 46°F). Pfizer and BioNTech’s vaccine, on the other hand, requires temperatures of minus 70°C (minus 94°F) or lower.
An emergency use authorization for the Moderna vaccine would give the company the green light to increase manufacturing to deliver protection from Covid-19 to more Americans. But as with the Pfizer/BioNTech vaccine, there will not be enough doses to go around right away, so health officials will have to make tricky decisions about who gets the shots first.
And an EUA is still a step short of full approval, which means there remain some critical questions about the vaccine that need to be addressed with further clinical trials.
What we learned recently about the Moderna Covid-19 vaccine
The public received details about the Moderna vaccine for the first time outside of the company’s press releases in a briefing document published by the FDA on Tuesday.
Looking at 30,351 participants in their phase 3 clinical trial, Moderna’s latest results showed its vaccine had an efficacy of 94.1 percent against confirmed Covid-19 illness that produced symptoms. The study detected 185 Covid-19 cases in the placebo group and 11 cases in the group that received the vaccine.
The vaccine is administered as two doses spaced 28 days apart. However, it seems to begin to offer protection against Covid-19 shortly after the first dose, with protection continuing to build after the second.
In a presentation to the FDA vaccine committee, Moderna also highlighted that its vaccine not only prevents disease but also seems to prevent infection, including infections that don’t generate any symptoms.
“There were approximately 2/3 fewer swabs that were positive in the vaccine group as compared to the placebo group at the pre-dose 2 timepoint, suggesting that some asymptomatic infections start to be prevented after the first dose,” according to Moderna’s briefing.
This is hugely valuable for fighting the Covid-19 pandemic. The virus has shown an ability to spread between people before the infected show any symptoms, and some of the infected can be completely asymptomatic. That means people can unwittingly spread the virus. But with a vaccine that lowers asymptomatic infections in addition to disease, the spread of Covid-19 can be more easily controlled.
Really important about Moderna vaccine
After 1 dose, it reduces asymptomatic infections by about 67%
We don't know what happens after 2nd dose (yet) but as I have been saying, these vaccines likely reduce spread of asymptomatic disease
Now some evidence that is true https://t.co/6TcfT9w09m — Ashish K. Jha, MD, MPH (@ashishkjha) December 15, 2020
However, the results this week also shed some light on the side effects of the Moderna vaccine. In the phase 3 trial, about 16 percent of people in the vaccine group had a severe adverse reaction, defined by the FDA as a reaction that requires medical attention and prevents people going about their daily lives.
“The most common solicited adverse reactions associated with mRNA-1273 [Moderna vaccine] were injection site pain (91.6%), fatigue (68.5%), headache (63.0%), muscle pain (59.6%), joint pain (44.8%), and chills (43.4%); severe adverse reactions occurred in 0.2% to 9.7% of participants, were more frequent after dose 2 than after dose 1, and were generally less frequent in participants ≥65 years of age as compared to younger participants,” according to Moderna’s briefing to the FDA.
The briefing also acknowledged that there are many critical questions that remain unresolved. One is how long the protection from the vaccine will last, something that will require continued monitoring of the participants in the clinical trial and potential recipients under an EUA.
There is also limited information about how well the vaccine works in people with compromised immune systems and pregnant people. There is no information about the efficacy of the vaccine in people under the age of 18 since they were excluded from the clinical trials. It’s also not clear how well the vaccine blocks transmission relative to other measures like wearing face masks and social distancing.
Moderna has committed to monitoring its trial pool for two years and will conduct additional studies among the people who receive the vaccine under an EUA in order to get answers to these questions.
In the meantime, the FDA will consider the recommendation from its advisers. The FDA granted an EUA to the Pfizer/BioNTech vaccine just over a day after it received a vote of confidence from the vaccine advisory committee, so an authorization for the Moderna vaccine could come as soon as Friday.


vox--2020-12-17--Why veterans groups want Trump’s VA secretary to resign

America ’ s six leading veterans organizations have joined together to demand the resignation of the secretary of veterans affairs after a federal investigation found he aimed to discredit a female veteran who filed a sexual harassment claim instead of properly investigating the matter .
In a letter to President Donald Trump this week , the heads of the American Legion , Veterans of Foreign Wars , Disabled American Veterans , AMVETS , Vietnam Veterans of America , and Paralyzed Veterans of America demanded that he remove VA Secretary Robert Wilkie from his post .
“ His actions not only @ @ @ @ @ @ @ at VA , but also undermine the efforts of VA staff who have been working to bring an end to sexual harassment throughout the department , ” the groups wrote .
Wilkie , however , has defied calls to step down .
Joe Chenelly , the national executive director for AMVETS , called the effort to oust Wilkie “ unprecedented.
” “ We ’ ve never before had all big six organizations call for the resignation of the VA secretary or any other official , ” Chenelly told me .
But they went @ @ @ @ @ @ @ with only a few weeks left in the Trump administration , because “ we felt it was important for history , ” he said .
That sentiment stems from a damning report by the VA ’ s inspector general , released last week , that revealed the conduct of Wilkie and his staff during a sexual harassment investigation aimed more at hurting the claimant than understanding exactly what happened to her .
That conclusion , it ’ s safe to say , has angered much of the nation ’ s veterans community and @ @ @ @ @ @ @ snack at a VA medical center in Washington , DC , on September 20 , 2019 , Navy veteran Andrea Goldstein said , a male contractor at the facility “ bumped his entire body against mine and told me I looked like I needed a smile and a good time.
” House Veterans ’ Affairs Committee Chair Mark Takano ( D-CA ) , whom Goldstein works for as a senior policy adviser , asked the VA ’ s inspector general to look into the incident .
That matter was closed this January without @ @ @ @ @ @ @ but investigators made clear the decision not to prosecute didn ’ t necessarily reflect the merits of the case .
Then , in February , someone sent an anonymous complaint to the House Veterans ’ Affairs Committee alleging that VA Secretary Robert Wilkie had sought damaging information on Goldstein during the inspector general ’ s probe into the sexual assault claim .
ProPublica obtained that document and got two other people to confirm Wilkie ’ s conduct .
Takano , citing the complaint and the reporting , asked the VA ’ s inspector @ @ @ @ @ @ @ time to see if the allegations about the secretary — which Wilkie had vigorously denied — were true .
The report with those findings , which involved interviews with 65 individuals and “ extensive reviews of emails , telephone records , and other documentation , ” came out last week .
And it was pretty damning .
“ Secretary Wilkie had obtained potentially damaging information about the veteran ’ s past , ” the report found , though the IG ’ s office couldn ’ t “ substantiate that [ he ] investigated @ @ @ @ @ @ @ veteran ’ s background.
” According to the report , the “ potentially damaging ” information in question included that Goldstein had filed “ at least six EEO-type complaints ” — that is , discrimination complaints like those filed with the Equal Employment Opportunity Commission — while serving on active duty , and that “ these complaints were lodged when the veteran was not satisfied with her performance evaluations.
” One possible source of that damaging information may have been Rep. Dan Crenshaw ( R-TX ) , a retired Navy SEAL .
Investigators @ @ @ @ @ @ @ deputies who said the secretary had talked about information Crenshaw gave him .
One witness told investigators “ that Secretary Wilkie later verified with Congressman Dan Crenshaw that the veteran had previously filed frivolous complaints when the two were serving in the same command in the Navy , ” the report said .
However , Wilkie said that Crenshaw approached him during a fundraiser and said he and Goldstein had served in the same unit in the Navy — nothing more .
Veterans are now also calling on Crenshaw to resign .
When @ @ @ @ @ @ @ , his communications team referred me to a Twitter thread in which the Congress member denied the allegations , calling them “ partisan garbage.
” Whatever the source , Wilkie did obtain the information , according to six witnesses , and he mentioned having it often during internal meetings .
What ’ s more , with or without Wilkie ’ s knowledge — investigators couldn ’ t determine that part — the information against Goldstein was then used by the secretary ’ s staff to pressure VA authorities to further dig into her @ @ @ @ @ @ @ outlets , namely saying that she was prone to making false claims .
“ [ Y ] ou may want to look into—see—if she ’ s done this sort of thing in the past , ” VA spokesperson Curtis Cashour said to an unnamed journalist , per the IG report .
The responsibility for that and other conduct , the inspector general found , fell squarely on Wilkie ’ s shoulders .
“ The tone set by Secretary Wilkie appears to have influenced aspects of the initial VA police investigation and the conduct @ @ @ @ @ @ @ report concluded , adding that same tone “ was at minimum unprofessional and at worst provided the basis for senior officials to put out information to national reporters to question the credibility and background of the veteran who filed the sexual assault complaint.
” However , the inspector general couldn ’ t fully conclude if Wilkie violated government standards or laws .
But the evidence against Wilkie and his team ’ s reported conduct did put him on the wrong side of the six major veterans groups — and they ’ re letting @ @ @ @ @ @ @ won ’ t go .
But many want him to .
Wilkie still denies he did anything wrong , and a spokesperson for his department insists he “ will continue to lead the department.
” The president also hasn ’ t said anything on the report or the letter .
But Wilkie continues to face immense pressure .
Top Democrats — namely House Speaker Nancy Pelosi and House Majority Leader Steny Hoyer — have called for Wilkie ’ s resignation .
Even Republican Sen. Jerry Moran from Kansas , the Senate Veterans ’ @ @ @ @ @ @ @ statement that “ when it comes to ensuring that veterans feel respected and safe , the VA leadership team ’ s treatment of this case fails to meet the standard we expect VA facilities across the country to meet.
” And , of course , the veterans groups aren ’ t done with this issue .
“ There should be no safer place than a VA medical center , ” Chenelly , AMVETS ’ national executive director , said .
“ That ’ s clearly not the message after this.
” Chenelly told @ @ @ @ @ @ @ to testify , under oath , that the allegations in the inspector general ’ s report are false .
That would be the only way for Wilkie to at least claw back some of the trust he lost during this whole episode — assuming , of course , that what he would say under oath was actually the truth .
“ It ’ s absolutely crucial that veterans can trust the VA , ” Chenelly told me .
“ It ’ s about trust for us , and about trust for our members.
@ @ @ @ @ @ @ administration takes steps to clear up any potential confusion , the groups will continue “ to let the president know how serious we ’ re taking this as a group .
”

America’s six leading veterans organizations have joined together to demand the resignation of the secretary of veterans affairs after a federal investigation found he aimed to discredit a female veteran who filed a sexual harassment claim instead of properly investigating the matter.
In a letter to President Donald Trump this week, the heads of the American Legion, Veterans of Foreign Wars, Disabled American Veterans, AMVETS, Vietnam Veterans of America, and Paralyzed Veterans of America demanded that he remove VA Secretary Robert Wilkie from his post.
“His actions not only threaten to deter veterans from seeking care at VA, but also undermine the efforts of VA staff who have been working to bring an end to sexual harassment throughout the department,” the groups wrote.
Wilkie, however, has defied calls to step down.
Out now: Big six vets groups (@DAVHQ @PVA1946 @AMVETSHQ @VVAmerica @VFWHQ @AmericanLegion) sends a letter to Trump asking for @SecWilkie to be fired. "He no longer has the trust or confidence of America’s veterans and should be removed." pic.twitter.com/zXNDnBYacB — Leo Shane III (@LeoShane) December 16, 2020
Joe Chenelly, the national executive director for AMVETS, called the effort to oust Wilkie “unprecedented.”
“We’ve never before had all big six organizations call for the resignation of the VA secretary or any other official,” Chenelly told me. But they went ahead with the joint letter, even with only a few weeks left in the Trump administration, because “we felt it was important for history,” he said.
That sentiment stems from a damning report by the VA’s inspector general, released last week, that revealed the conduct of Wilkie and his staff during a sexual harassment investigation aimed more at hurting the claimant than understanding exactly what happened to her.
That conclusion, it’s safe to say, has angered much of the nation’s veterans community and leadership.
What the VA inspector general found
While she was buying a snack at a VA medical center in Washington, DC, on September 20, 2019, Navy veteran Andrea Goldstein said, a male contractor at the facility “bumped his entire body against mine and told me I looked like I needed a smile and a good time.”
House Veterans’ Affairs Committee Chair Mark Takano (D-CA), whom Goldstein works for as a senior policy adviser, asked the VA’s inspector general to look into the incident.
That matter was closed this January without any charges filed against the contractor, but investigators made clear the decision not to prosecute didn’t necessarily reflect the merits of the case.
Then, in February, someone sent an anonymous complaint to the House Veterans’ Affairs Committee alleging that VA Secretary Robert Wilkie had sought damaging information on Goldstein during the inspector general’s probe into the sexual assault claim. ProPublica obtained that document and got two other people to confirm Wilkie’s conduct.
Takano, citing the complaint and the reporting, asked the VA’s inspector general to open another investigation, this time to see if the allegations about the secretary — which Wilkie had vigorously denied — were true. The report with those findings, which involved interviews with 65 individuals and “extensive reviews of emails, telephone records, and other documentation,” came out last week. And it was pretty damning.
“Secretary Wilkie had obtained potentially damaging information about the veteran’s past,” the report found, though the IG’s office couldn’t “substantiate that [he] investigated or asked other officials to investigate the veteran’s background.”
According to the report, the “potentially damaging” information in question included that Goldstein had filed “at least six EEO-type complaints” — that is, discrimination complaints like those filed with the Equal Employment Opportunity Commission — while serving on active duty, and that “these complaints were lodged when the veteran was not satisfied with her performance evaluations.”
One possible source of that damaging information may have been Rep. Dan Crenshaw (R-TX), a retired Navy SEAL. Investigators spoke with two of Wilkie’s deputies who said the secretary had talked about information Crenshaw gave him. One witness told investigators “that Secretary Wilkie later verified with Congressman Dan Crenshaw that the veteran had previously filed frivolous complaints when the two were serving in the same command in the Navy,” the report said.
However, Wilkie said that Crenshaw approached him during a fundraiser and said he and Goldstein had served in the same unit in the Navy — nothing more.
Veterans are now also calling on Crenshaw to resign.
When I reached out to Crenshaw for comment, his communications team referred me to a Twitter thread in which the Congress member denied the allegations, calling them “partisan garbage.”
This is partisan garbage, and typical of the left’s reliance on narrative-building over facts.
As I have stated repeatedly and unequivocally, I have never participated in a “smear campaign” against anyone, much less a fellow veteran.
THREAD https://t.co/9vhdJN0Cxu — Dan Crenshaw (@DanCrenshawTX) December 16, 2020
Whatever the source, Wilkie did obtain the information, according to six witnesses, and he mentioned having it often during internal meetings.
What’s more, with or without Wilkie’s knowledge — investigators couldn’t determine that part — the information against Goldstein was then used by the secretary’s staff to pressure VA authorities to further dig into her background and disparage her in multiple media outlets, namely saying that she was prone to making false claims.
“[Y]ou may want to look into—see—if she’s done this sort of thing in the past,” VA spokesperson Curtis Cashour said to an unnamed journalist, per the IG report.
The responsibility for that and other conduct, the inspector general found, fell squarely on Wilkie’s shoulders.
“The tone set by Secretary Wilkie appears to have influenced aspects of the initial VA police investigation and the conduct of other VA employees,” the report concluded, adding that same tone “was at minimum unprofessional and at worst provided the basis for senior officials to put out information to national reporters to question the credibility and background of the veteran who filed the sexual assault complaint.”
However, the inspector general couldn’t fully conclude if Wilkie violated government standards or laws.
But the evidence against Wilkie and his team’s reported conduct did put him on the wrong side of the six major veterans groups — and they’re letting the Trump administration know it.
Wilkie won’t go. But many want him to.
Wilkie still denies he did anything wrong, and a spokesperson for his department insists he “will continue to lead the department.” The president also hasn’t said anything on the report or the letter.
But Wilkie continues to face immense pressure. Top Democrats — namely House Speaker Nancy Pelosi and House Majority Leader Steny Hoyer — have called for Wilkie’s resignation.
Even Republican Sen. Jerry Moran from Kansas, the Senate Veterans’ Affairs Committee chair, said in a statement that “when it comes to ensuring that veterans feel respected and safe, the VA leadership team’s treatment of this case fails to meet the standard we expect VA facilities across the country to meet.”
And, of course, the veterans groups aren’t done with this issue. “There should be no safer place than a VA medical center,” Chenelly, AMVETS’ national executive director, said. “That’s clearly not the message after this.”
Chenelly told me they’re now pushing Wilkie to testify, under oath, that the allegations in the inspector general’s report are false. That would be the only way for Wilkie to at least claw back some of the trust he lost during this whole episode — assuming, of course, that what he would say under oath was actually the truth.
“It’s absolutely crucial that veterans can trust the VA,” Chenelly told me. “It’s about trust for us, and about trust for our members.” Unless and until Wilkie or the administration takes steps to clear up any potential confusion, the groups will continue “to let the president know how serious we’re taking this as a group.”