Pfizer’s Covid-19 vaccine fully approved by US regulator for use in over-16s
“Vaccines are one of our greatest weapons against the virus,” acting FDA Commissioner Janet Woodcock said. “We hope this approval will bolster confidence in those who’ve been wavering.”
On Monday, the FDA made Pfizer’s Covid-19 shot the first vaccine in America to be granted full approval for use in adults. The jab had been authorized for emergency use since mid-December 2020.
The FDA stated that the vaccine will retain its emergency use authorization for use in adolescents aged 12-15, and for those requiring a third dose due to other health conditions.
According to the Centers for Disease Control and Prevention, around 92 million people in the US have been fully vaccinated by the Pfizer jab. The shot has also been widely used around the world.
It is believed that a small number of people in the US had been waiting for the vaccine to be fully approved before receiving their lifesaving shots, according to US Surgeon General Dr. Vivek Murthy, who spoke to CNN on Sunday.
Early studies suggested the vaccine was at least 90% effective in preventing symptomatic Covid-19, although the presence of variants, along with other factors, is likely to have reduced this figure.
US officials are preparing to make booster shots widely available in September, as studies suggest that vaccine efficacy – including that of Pfizer – wanes over time.
It is likely that the Pfizer vaccine will be widely used once again for America’s follow-up jabs, with early data from Israel indicating a considerable increase in the presence of neutralizing antibodies after the third dose.
Full approval of Pfizer’s COVID-19 vaccine means it meets the same “very high standards required of all the approved vaccines we rely on every day,” said Dr. Jesse Goodman of Georgetown University, a former FDA vaccine chief. That should help “anyone who still has concerns gain confidence” in the shots.
The FDA’s action may also lead to more vaccine mandates covering students, employees and customers.
“Mandating becomes much easier when you have full approval,” said Dr. Carlos del Rio of Emory University. “I think a lot of businesses have been waiting for it.”
This month, New York City, New Orleans and San Francisco all imposed proof-of-vaccination requirements at restaurants, bars and other indoor venues. At the federal level, President Joe Biden is requiring government workers to sign forms attesting that they have been vaccinated or else submit to regular testing and other requirements.
An article on two highly effective mRNA vaccines for COVID-19 published by MedRxiv, a server platform founded by Cold Spring Harbor Laboratory (CSHL), Yale University, and BMJ, a global healthcare knowledge provider. The scientists compare the effectiveness of two full-length Spike protein-encoding mRNA vaccines from Moderna (mRNA-1273) and Pfizer/BioNTech (BNT162b2) in the Mayo Clinic Health System over time from January to July 2021, during which either the Alpha or Delta variant was highly prevalent.
To determine vaccine effectiveness, they matched demographically and “clinically similar” unvaccinated, Moderna-vaccinated, and Pfizer-vaccinated individuals by sex, race, ethnicity, state of residence, SARS-CoV-2 PCR testing history, and date of vaccination, yielding 43,895 “matched triples.”
