Home News Covid News Pfizer & BioNTech Plan to Seek FDA Approval for Booster Dose

Pfizer & BioNTech Plan to Seek FDA Approval for Booster Dose

Pfizer & BioNTech Plan to Seek FDA Approval for Booster Dose

Pfizer along with its European partner BioNTech are about to take the nod from the US government for a booster dose. This is to follow the norms of Pfizer’s r dose COVID-19 vaccine, as stated by a company news release.

Pfizer has previously stated that the effectiveness of its vaccine is is going to wane with the passage of time. As per a clinical trial, 306 patients who received the 3rd dose of the vaccine after taking their 2nd dose (5-8 months back) had the levels of neutralizing antibodies over 3 times as compared to the 2nd dose.

Pfizer, in its latest news release stated that the company further plans to procure a sBLA (supplemental Biologics License Application) from the FDA by the upcoming week. Now, if sBLA grants permission to the company, then Pfizer will become the first booster shot authorized by the US government.

In the meanwhile, US health officials continue to stress on the need of receiving COVID-19 booster doses 8 months after receiving their 2nd Pfizer or Moderna vaccines.

As per the report, people who have previously received Moderna or Pfizer vaccines need to start receiving their booster shots from September 20 onward. This is what the Biden administration stated last week.

The company also stated that patients in the clinical trial had received some minor reactions like joint pain, fatigue headaches and injection site pain.

The report also says that the FDA has granted approval to the vaccine recently. The vaccine had been administered since mid-December that will come under emergency use to those who have attained 16 years of age at the time of administering the vaccine.


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