FDA to fully approve Pfizer vaccine by early September: report

The United States Food and Drug Administration aims to give full approval to Pfizer-BioNTech’s COVID-19 vaccine by early next month, according to a New York Times report on Wednesday that quotes anonymous people familiar with the decision making process.

Pfizer’s drug was the first in the country to gain emergency use clearance from the FDA, which it received in early December. He filed a full approval application – called an organic product license application with the agency in early May.

The FDA is forcing drugmakers to secure more data in order to obtain a biologic license instead of emergency use authorization.

Full approval should encourage some hesitant people to finally get vaccinated against the coronavirus, which is currently booming in under-vaccinated areas of the country. Employers and other institutions in the United States have cited emergency use authorization as a legal barrier to issuing vaccine requirements, meaning full authorization will likely trigger more warrants.

The FDA recognizes that full approval could inspire more confidence in COVID-19 vaccines and has “taken a holistic approach” to the situation, according to a statement the agency gave to The Times. The agency also told HuffPost last week that it was moving “as quickly as possible” on requests for approval from drugmakers, but did not immediately respond to HuffPost’s request for further comment on Wednesday.

Doctors and nurses are currently licensed to distribute Pfizer vaccine to people 12 years of age and older; the manufacturer had previously said it plans to seek emergency authorization to distribute the injections to children aged 2 to 11 in September.

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

Moderna, whose COVID-19 vaccine was approved in December for people aged 18 and older, has also sought full FDA approval and provides the agency with new data on an ongoing basis. At the request of the FDA, Pfizer and Moderna are working to expand their vaccine trials for children aged 5 to 11 to get a better idea of ​​very rare side effects.


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