Pfizer’s Covid-19 shot fully approved by US regulator for use in over-16s

The US drugs regulator has granted full approval for Pfizer/BioNTech’s Covid-19 vaccine for use in people over 16, although it will remain under emergency use authorization for those aged 12-15 and for booster shots.

On Monday, the US Food and Drug Administration (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.

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