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Pfizer says it will seek FDA approval for a COVID-19 vaccine booster dose

Pfizer says it will seek FDA approval for a COVID-19 vaccine booster dose

Pfizer and BioNTech claim that a third COVID-19 booster shot given six months after the second boosts vaccination efficacy against novel coronavirus mutations, according to an initial report from their booster shot research. According to Pfizer Chief Scientific Officer Mikael Dolsten, while the COVID-19 vaccine remains 95 percent effective in avoiding serious infections, efficacy against acquiring the disease has begun to decline in people in the UK and Israel roughly six months after receiving the second vaccination dose. According to The Associated Press, the business wants to seek emergency permission approval from the US Food and Drug Administration in August.

At the same time, federal health officials indicated that they would proceed with caution when it came to prospective booster shots, emphasizing that the currently available vaccines are effective in preventing coronavirus infection.

The news comes after the vaccine was found to be less effective against the SARS-CoV-2 virus’s Delta form. According to a study published in the journal ‘Nature,’ a single dose of the Pfizer-BioNTech vaccine, or even the AstraZeneca vaccine, “barely” generates neutralizing antibodies against the Delta Covid-19 strain.

The Centers for Disease Control and Prevention and the Food and Drug Administration hit the brakes on Thursday evening in an uncommon joint statement, saying they are working on determining whether and when a booster is needed. “This may include data from individual pharmaceutical firms, but it does not rely solely on their statistics.”

The statement emphasized that available vaccines are effective and that nearly all persons hospitalized and dying from the illness are now unvaccinated — a message that indicates a concern that Pfizer’s news may fuel growing vaccine skepticism in general.

Dolsten identified that the government is going public with its plans because preliminary data appears to be persuasive, as well as growing concern about viral mutations, such as the ultra-transmissible delta form that is spreading across many countries.

“There is a lot of fear and concern” about variants, Dolsten said. “We are confident that such a boost will be highly effective against the delta variant.”

More research is needed in this area, and the businesses ready to continue clinical trials in August, pending regulatory approval.

“The companies expect to publish more definitive data soon as well as in a peer-reviewed journal and plan to submit the data to the FDA (Food and Drug Administration), EMA (European Medicines Agency) and other regulatory authorities in the coming weeks,” the statement said.

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