FDA Wants To Fully Approve Pfizer Vaccine By Early September: Report

The U.S. Food and Drug Administration is aiming to grant full approval to Pfizer-BioNTech’s COVID-19 vaccine by early next month, according to a New York Times report  published Wednesday that cited unnamed people familiar with the decision-making process.

The Pfizer drug was the first in the country to be granted emergency use authorization from the FDA, which it received in early December. It filed for full approval called a biologics license application with the agency in early May .

The FDA requires drug manufacturers to secure more data  in order to obtain a biologics license instead of an emergency use authorization. 

Full approval is expected to encourage some vaccine-hesitant individuals to finally get inoculated against the coronavirus, which is presently surging in under-vaccinated regions across the country. Employers and other institutions in the U.S. have cited the emergency use authorization as a legal hurdle to issuing vaccine requirements, meaning the full authorization will likely spark more mandates .

FDA leadership recognizes that “for some, the FDA approval of COVID-19 vaccines may bring additional confidence and encourage them to get vaccinated,” the agency said in a statement to HuffPost. 

“Acknowledging the urgency related to the current state of the pandemic, we have taken an all-hands-on-deck approach, including identifying additional resources such as personnel and technological resources from across the agency and opportunities to reprioritize other activities, in order to complete our review to help combat this pandemic surge,” the agency said. It does not comment “on specific timing,” however. 

Doctors and nurses are currently permitted to distribute the Pfizer vaccine to people ages 12 and up; the manufacturer previously said it plans to ask for emergency authorization to distribute the shots to kids ages 2 through 11 in September. 

The FDA announced earlier this summer that it planned to approve the Pfizer drug by January of next year, but the agency’s internal target date is Labor Day, the Times reported. The agency acknowledged previously that approval was likely to come sooner than 2022, but has provided scant public commentary on its timeline.

Moderna, whose COVID-19 vaccine was approved in December for people aged 18 and up, has also applied for full approval from the FDA and is giving the agency new data on a rolling basis. At the request of the FDA, both Pfizer and Moderna are working to expand their vaccine trials for children aged 5 to 11 in order to get a better picture of very rare side effects.