RALEIGH, N.C. (WNCN) – On Friday, the FDA will discuss Pfizer’s request for authorization for its booster.
In documents posted online, the FDA took note of conflicting data concerning boosters.
The FDA said in a briefing document, “Some observational studies have suggested declining efficacy of COMIRNATY over time against symptomatic infection or against the Delta variant, while others have not.”
Comirnaty, which refers to Pfizer’s COVID-19 vaccine, represents a combination of the terms COVID-19, mRNA, community and immunity.
Data submitted to the FDA by Pfizer break down side effects experienced after the boosters. Pfizer asked its trial participants to submit their symptoms using an electronic diary.
The company said injection site pain was the most common side effect with most side effects lasting up to two days.
Pfizer said severe side effects were rarely reported but when they were, it was severe fatigue and muscle pain. Trial participants ages 18 to 55 were the most likely to report side effects.
|SYMPTOM||18-55 YEAR OLDS||65-85 YEAR OLDS|
|Injection site pain||83%||66.7%|
Other side effects felt less frequently were chills and new/worsened joint pain.
Several studies supporting boosters have been conducted in Israel, something the FDA also took note of saying US-based studies “may most accurately represent vaccine effectiveness in the US population.”
The FDA said data available to them showed the vaccines were still effective in preventing severe illness.
Doctors in San Diego said they are eager to hear who will be prioritized in the booster process.
“Is it people who are in high risk in the 60 and over age range, is it people in health care?” Dr. Abisola Olulade, a family medicine practitioner for Sharp Rees-Stealy Downtown, said.
Booster shots from Pfizer have already been made available for those with underlying medical conditions.
Medical experts say while Pfizer and Moderna have announced their successful booster programs, public health doctors will make their own independent assessment.
“The pharmaceutical companies are not going to determine when you are going to get a booster. Public health officials have to look at this and the data and make a recommendation based on the evidence,” Dr. Olulade said.
Some medical ethicists have raised concerns about if it’s reasonable for Americans to get their third shots while developing countries are still waiting for their first.
The FDA is expected to make their recommendations early Friday morning.