The U.S. Food and Drug Administration released a 53-page report that summarized data from Pfizer and German partner BioNTech’s COVID-19 vaccine trial. The trial data support earlier findings that the COVID-19 vaccine is safe and efficient, preventing 95 percent of people from becoming sick with the coronavirus. The companies are now asking the FDA for authorization to use the vaccine on people ages 16 and up.
The FDA noted, “Safety data from approximately 38,000 participants [greater than or equal to] 16 years of age randomized 1:1 to vaccine or placebo with a median of 2 months of follow up after the second dose suggest a favorable safety profile, with no specific safety concerns identified that would preclude the issuance of an EUA.” The report did note that the most common side effects were a skin reaction at the injection site, which was followed by headaches, muscle pain, and fatigue. The proposed dosing regimen for the COVID-19 vaccine is to administer two 30 microgram doses 21 days apart. However, the briefing document also shows that the vaccine, which is being called BNT162b2, appears to provide “some protection” against the coronavirus with just one dose.
Pfizer’s COVID-19 Vaccine Data Did Not Raise Safety Concerns
Scientists have also begun testing COVID-19 vaccines in ages 12 to 15 but have not yet accumulated enough safety data in order to request any authorization of the first dose in that age group. The report also provides more detail on how certain groups of people reacted with the Pfizer vaccine, including people over 65 years old, Those who have pre-existing medical conditions such as diabetes, and those who are Hispanic or black, all of them appear to be protected as a general population.
Around one-third of the participants’ definition of obesity, lower than the general population of the United States, but it’s still high. The average age of the participant what’s 51 years old. They appear to be well or better protected than everyone else, which counted the concern that the coronavirus vaccine might not work as well as people with these conditions. According to infectious disease expert at Vanderbilt University School of Medicine in Nashville Tennessee, Dr. William Shaffner, he received a briefing on the material there; he would not say who percent of the briefing or who else had received it. He noted, “The group I was with who heard the data arrived interested and left the presentation enthusiastic. The extraordinary thing is that there were no major areas of concern.”Independent experts are set to discuss and vote on whether they do recommend the vaccine to be authorized for emergency use authorization.