FDA Grants Full Approval To Pfizer-BioNTech COVID-19 Vaccine In US

The FDA granted full approval to the Pfizer-BioNTech COVID-19 vaccine in the US.

On Monday, the US Food and Drug Administration (FDA) granted full approval to the Pfizer-BioNTech COVID-19 vaccine that had earned emergency use authorization (EUA) last December, making it the first COVID-19 vaccine to secure such FDA validation as health authorities struggled to win over vaccine skeptics.

The FDA granted full approval to the Pfizer-BioNTech COVID-19 vaccine in the US.
Photo source: Manila Bulletin

The FDA approved the said vaccine for use in people aged 16 and older. Public health officials hoped that the action will convince more unvaccinated Americans that the said vaccine was safe and effective.

Rappler reported that vaccine hesitancy among some Americans has hindered the United States’ response to the coronavirus pandemic.

While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated,” FDA acting commissioner Janet Woodcock.

Health officials in the United States also expected that the full approval will prompt more state and local governments, as well as private employers, to employ COVID-19 vaccine mandates.

The Food and Drug Administration’s approval was based on updated data from the company’s clinical trial. Overall, in follow-ups to Pfizer’s original late-stage study, approximately 12,000 recipients of the said vaccine have been followed for at least six months.

Based on the longer-term follow-up data that we submitted, today’s approval for those aged 16 and over affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed,” Pfizer CEO Albert Bourla said in a statement.

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According to the FDA, the Pfizer-BioNTech COVID-19 vaccine will be marketed under the name “Comirnaty”.

Some cities in the United States – including New York and San Francisco – have already implemented rules requiring vaccination to work in government offices or dine at restaurants, among other activities.

The said approval made it easier for physicians to prescribe a third dose of the said vaccine off-label for those who they thought could benefit from additional protection against COVID-19.

This month, the Food and Drug Administration and an advisory panel for the US Centers for Disease Control and Prevention (CDC) said that additional booster shots from Moderna or Pfizer can be given to those with weakened immune systems.

Based on a report on Rappler, the Pfizer-BioNTech COVID-19 vaccine has not yet been authorized for more widespread use as a booster.

Meanwhile, vaccine czar Secretary Carlito Galvez, Jr on Monday said that Pfizer and Moderna may apply for full authorization once their vaccines were approved in their countries.

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