Pfizer submits clinical data to FDA for vaccine booster shot approval

Leading vaccine developers, Pfizer and BioNTech have recently submitted primary stage clinical data to the U.S. FDA (Food and Drug Administration) as a part of their efforts to authorize booster vaccine shot for COVID-19 for everyone aged above 16, including ones with weak immune system.

In a press release, the companies said that volunteers in the clinical trial received a third dosage of the two-dose vaccine roughly eight to nine months following their second shot. In the trial, the vaccine booster dose generated higher neutralizing antibodies against the original coronavirus strain and the beta and delta variants.

Pfizer CEO, Albert Bourla says that the data they have seen suggests that third dose of vaccines produces higher antibodies than those produced after both doses. As a result, they are thrilled to submit this application to the FDA as they continue to collaborate to meet the pandemic's growing challenges.

According to the firm, late-stage research results evaluating the third dose are anticipated soon and will be submitted to the FDA and other regulatory agencies worldwide.

The drug makers announcement comes after the federal health officials approved using Covid booster shots on Americans with weak immune system, which comprises HIV and cancer patients and people who have undergone organ transplants.

The new data from the U.S. suggests that immune-compromised individuals do not produce enough immune response after getting jabbed with two doses of the Covid vaccine.

Although, Federal health officials still don’t recommend the booster dose for the general public, White House chief medical advisor, Dr. Anthony Fauci has indicated that every individual would require a booster shot at some point.

Similarly, Covid vaccine makers, including Pfizer and Moderna, have said that every individual will need a booster shot and possibly extra doses each year like seasonal flu.

Source Credit - https://www.cnbc.com/2021/08/16/covid-vaccine-booster-shot-pfizer-submits-data-to-fda-for-approval.html