Early results from Pfizer suggests the COVID-19 vaccine is safe and effective according to an FDA report released Tuesday. Compiled ahead of an advisory committee scheduled for Thursday, the FDAs briefing document found the vaccine could possibly be administered to people as young as 16.
The FDA’s preliminary findings could signal good news for Pfizer as it seeks to gain approval for emergency use administration. Analysis of the data indicated the vaccine was effective after the first dose, but taking both doses of the vaccination as designed was recommended. Incidence of severe reactions was rare. Common side effects reported included reaction at the injection site, headaches, and fatigue. About a third of those administered the vaccine experienced muscle pain and chills.
Thursday’s meeting will focus on two questions. First, is it reasonable to find the Pfizer vaccine will be effective in preventing COVID-19 in people over the age of 16. And second, do the benefits of the vaccine outweigh the possible risks for people over the age of 16.
The FDA is clear that even if it approves the emergency use authorization, the manufacturer will need to continue to study the safety and effectiveness of the vaccine. The committee could also order additional studies to be conducted to provide more information.
While there were no specific safety concerns found during the review, other areas of follow up include how long the vaccine will last, effectiveness in people previously infected with COVID-19, effectiveness in certain groups high-risk for severe COVID-19 such as those with HIV/AIDS or otherwise immunocompromised, effectiveness against asymptomatic infection, and effectiveness against long-term effects of COVID-19.
Understanding the reservations some Black people have about the COVID-19 vaccination, Black health professionals are making a concerted effort to get good verifiable information into the hands of Black communities across the country. During an interview on CNN Monday, Dr. Reed Tuckson called the “disease of distrust” almost as important a battle to fight as COVID-19.
Reed, a co-founder of the Black Coalition Against COVID, says that a coalition of Black medical institutions have committed to bringing Black communities accurate and verifiable information about COVID-19 and vaccine safety. As reported last week, trustworthiness needs to be built into the vaccine administration process.
White House coronavirus advisor Anthony Fauci joins Black medical professionals for a live streamed conversation about COVID-19 Tuesday at 6pm ET.