thevaccinereaction--2020-07-19--Pfizer/BioNTech’s COVID-19 Vaccine Causes Adverse Reactions in Over Half of Clinical Trial Volunteer

Pfizer/BioNTech’s COVID-19 Vaccine Causes Adverse Reactions in Over Half of Clinical Trial Volunteers

In clinical trials of the experimental messenger RNA ( ribonucleic acid ) COVID-19 vaccine ( BNT162b1 ) , which is being developed by Pfizer , Inc. of New York and BioNTech SE of Mainz , Germany , adverse reactions have occurred in more than 50 percent of the adult participants .
The Phase 1/2 human trials of BNT162b1 vaccine , which were conducted May-June 2020 , involved 45 healthy adults between the ages of 18 and 55 years.1 In the trials , 12 of the adults were injected with a 10-microgram dose of the BNT162b1 vaccine , and 12 adults @ @ @ @ @ @ @ 100-µg dose , while nine adults were given a placebo of a sterile saline solution ( 0.9 percent sodium chloride injection , in a 0.5-mL dose ) .
Within seven days after vaccination , seven ( 58.3 percent ) of the participants in the 10-µg group reported adverse reactions ( pain ) near the injection site and 24–or 100 percent–in the 30-µg and 100-µg groups and two ( 22.2 percent ) in the placebo group reported reactions .
Severe pain was reported by one participant who received 100-µg dose.1 2 Three weeks after @ @ @ @ @ @ @ , each one of the clinical trial participants was given a second dose of the vaccine at the same dosage .
Of the participants in the 10-µg group , 8.3 percent developed fevers .
Of those in the 30-µg group , 75 percent developed fevers .
More than 50 percent of the adults , who were given either a 10-µg or 30-µg dose , experienced an adverse reaction such as fever and sleep disturbances.1 2 Two participants suffered severe reactions .
A Grade 3 fever of over 101.3°F two days after vaccination was @ @ @ @ @ @ @ group and sleep disturbance one day after vaccination was experienced by one adult in the 100-µg group.1 2 Grade 3 reactions are described by the U.S. Department of Health and Human Services ( HHS ) 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.
” 3 According to the published results of the trials for the BNT162b1 COVID-19 vaccine @ @ @ @ @ @ @ The most common systemic events reported in the 7 days after each vaccination in both BNT162b1 and placebo recipients were mild to moderate fatigue and headache .
Reports of fatigue and headache were more common in the BNT162b1 groups compared to placebo .
Additionally , chills , muscle pain , and joint pain were reported among BNT162b1 recipients and not in placebo recipients .
Systemic events increased with dose level and were reported in a greater number of subjects after the second dose ( 10 µg and 30 µg groups ) .2 There @ @ @ @ @ @ @ .
HHS classifies Grade 4 reactions as “ life-threatening.
” 2 3 The clinical trial found that the experimental BNT162b1 vaccine was successful in generating antibodies against the SARS-CoV-2 virus .
A recent STAT article noted , that some of the antibodies had a neutralizing effect in that they “ appear to prevent the virus from functioning.
” But it also pointed out that it is unclear if these antibody neutralizing levels will produce immunity to SARS-CoV-2.1 2 Pfizer and BioNTech plan to conduct larger clinical studies on their BNT162b1 vaccine later this @