Pfizer/BioNTech COVID-19 vaccine set to receive full US FDA approval

USA – The U.S. Food and Drug Administration has made public its aim to give full approval to Pfizer’s COVID-19 vaccine this coming week.  

Previously, the regulator had set a deadline for September sixth, during which they would give the approval.

This approval could boost the vaccination campaign by convincing more unvaccinated Americans that Pfizer’s shot is safe and effective and also make local officials more comfortable in implementing vaccine mandates.

The U.S. military is expected to require that service members get vaccinated soon after Pfizer’s shot is authorized and other major U.S. employers could follow suit.

Vaccine hesitancy has been a major hurdle to the White House’s goal of getting all eligible Americans vaccinated against the coronavirus.

Only around 60% of adults aged 18 and over have been fully vaccinated even as the new Delta variant of COVID-19 has contributed to a surge in cases.

Full approval of Pfizer’s shot would also make it easier for physicians to prescribe a third booster shot to people who could benefit from an additional dose.

The FDA has authorized Pfizer’s shot as a booster for people with weakened immune systems, but the White House plans to offer them much more widely in the coming months.

There is growing concern about breakthrough infections in vulnerable populations in the United States as the country sees a huge spike in new infections from the contagious Delta variant of the coronavirus.

The vulnerable group makes up less than 3% of U.S. adults, Rochelle Walensky, director of the CDC, had said before the authorization.

After a thorough review of the available data, the FDA determined that this small, vulnerable group may benefit from a third dose of the Pfizer-BioNTech or Moderna vaccines,” Janet Woodcock, the FDA’s acting commissioner said.

The White House earlier this week said it plans to give out 100 million booster shots, many supplied by Pfizer, to at-risk Americans, including anyone whose initial inoculation is more than 8 months old, starting in September.

Some experts, including at the World Health Organization say there is not yet enough data be certain boosters are needed.

Pfizer’s vaccine was authorized for emergency use in December and more than 203 million people in the United States have so far received it. None of the three authorized COVID-19 vaccines have received full FDA approval.

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