thevaccinereaction--2020-05-25--Healthy Clinical Trial Subjects Suffer Grade 3 Side Effects to Moderna’s mRNA COVID-19 Vaccine

On May 18 , 2020 , Moderna , Inc. of Cambridge , Massachusetts announced that it had obtained “ positive interim clinical data ” from a Phase I human clinical trial of its experimental mRNA-1273 COVID-19 vaccine that began on Mar .
16 .
The biotechnology company said that eight of the 45 healthy adult volunteer trial subjects developed antibodies that may provide protection from the SARS-CoV-2 virus that causes COVID-19.1 2 3 The company also reported that four participants suffered Grade 3 vaccine reactions .
These interim Phase 1 data , while early , demonstrate that vaccination with mRNA-1273 @ @ @ @ @ @ @ caused by natural infection starting with a dose as low as 25 µg .
When combined with the success in preventing viral replication in the lungs of a pre-clinical challenge model at a dose that elicited similar levels of neutralizing antibodies , these data substantiate our belief that mRNA-1273 has the potential to prevent COVID-19 disease and advance our ability to select a dose for pivotal trials .
Severe Adverse Events Reported After One or Two Vaccine Doses Each of the 45 participants was given two doses of the Moderna vaccine about a @ @ @ @ @ @ @ 25 , 100 or 250 micrograms ( µg ) .
Moderna said that the four participants who received doses of 25 µg developed antibodies against SARS-Cov-2 about two weeks after the second dose was administered and that the same was true for the four participants given doses of 100 µg .
The company noted that the vaccine was “ generally safe and well tolerated.
” 1 2 The mRNA-1273 vaccine reportedly produced a “ Grade 3 adverse event ” in one participant among those who received doses of between 25 µg and 100 @ @ @ @ @ @ @ 3 erythema or a rash around the injection site .
A Grade 3 rash can mean blistering , open ulcers , wet peeling ( moist desquamation ) or a serious rash over large areas of the body.4 5 Three participants in the clinical trial who received a vaccine dose of 250 µg doses experienced “ Grade 3 systemic symptoms ” following administration of the second dose .
Moderna described these as the “ most notable ” of the adverse events and said that they had been “ transient and self-resolving.
” 1 2 @ @ @ @ @ @ @ Services ( HHS ) describes a Grade 3 adverse event as “ severe or medically significant but not immediately life-threatening ; hospitalization or prolongation of hospitalization indicated ; disabling ; limiting self care ” such as “ bathing , dressing and undressing , feeding self , using the toilet , taking medications.
” 6 Moderna said that none of the participants in the clinical trial experienced Grade 4 adverse events .
HHS lists grade 4 events as “ life-threatening consequences ; urgent intervention indicated.
” It describes Grade 5 events as “ death @ @ @ @ @ @ @ ” 1 6 All 45 of the participants in Moderna ’ s Phase I clinical trial were healthy individuals 18 to 55 years of age.1 7 Clinical Trial Report Sends Moderna ’ s Stock Price Higher But Some Doubt Significance of the Report News of the results of the Phase I trial produced a 20 percent spike in the value of Moderna stock on May 18 .
According to Barron ’ s : But some vaccine researchers have expressed concern about the limited nature of the Phase I trial data released by Moderna @ @ @ @ @ @ @ which it was made public .
Professor Anna Durbin , MD of Johns Hopkins University ’ s Bloomberg School of Public Health said : I do think it ’ s a bit of a concern that they haven ’ t published the results of any of their ongoing trials that they mention in their press release .
They have not published any of that .
I would like to see the data to make my own interpretation of the data.7 John Rose , MD , professor emeritus of pathology at Yale University , @ @ @ @ @ @ @ their numbers are marginal or they would say more.
” 7