FDA gives full approval to BioNTech/Pfizer Covid vaccine


Covid-19 vaccines updates

The US Food and Drug Administration has granted full approval to the BioNTech/Pfizer Covid-19 vaccine, in a step that could encourage reluctant people to get immunised and give new impetus to vaccine mandates from employers.

The decision on Monday makes the mRNA jab the first Covid-19 vaccine to receive full approval for use in people aged over 16. It continues to be used for children aged 12-15, and as a booster shot for people with weakened immune systems, under an emergency authorisation.

Since December, the two-dose BioNTech/Pfizer jab had been administered under the emergency use authorisation, given the urgent need for a vaccine to combat the pandemic.

“As the first FDA-approved Covid-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness and manufacturing quality the FDA requires of an approved product,” Janet Woodcock, acting head of the FDA, said in a statement on Monday.

“While millions of people have already safely received Covid-19 vaccines, we recognise that for some the FDA approval of a vaccine may now instil additional confidence to get vaccinated.”

The approval comes as employers are increasingly seeking proof of full vaccination from their staff and customers. Immediately after the FDA’s announcement, New York City said that all its public school teachers and staff would be required to get a Covid-19 vaccine, and more employers were expected to follow suit.

A survey in August by employment law firm Littler Mendelson found that 21 per cent of employers were planning to or had already mandated Covid vaccines for their staff, compared with less than 10 per cent in January.

“I am hopeful this approval will help increase confidence in our vaccine, as vaccination remains the best tool we have to help protect lives and achieve herd immunity,” said Albert Bourla, chief executive of Pfizer.

Eric Topol, a professor of molecular medicine at the Scripps Research Institute, said: “This is overdue and would have made an enormous difference in May or June before [the] Delta [variant] became dominant.

“But it still will likely promote far more vaccinations by alleviating concerns among the large group of hesitant people. And it will have an even bigger impact by leading to mandates by health systems, municipalities, private companies and other large employers.”

Pfizer’s share price rose 4 per cent in morning trading in New York, while BioNTech’s shares jumped 10 per cent.

The highly transmissible Delta variant has led to a surge in infections and hospitalisations in recent weeks, primarily among those who have not received their jab, although lagging vaccination rates has picked up recently in some states.

The FDA said its assessment of the vaccine’s effectiveness involved data from 20,000 vaccine recipients and 20,000 placebo recipients, while its safety was analysed from data in 22,000 people from both groups. About 12,000 trial participants were followed six months after being fully vaccinated.