US president Joe Biden urged employers to require workers to get vaccinated against Covid-19 after the Food and Drug Administration granted full approval to the BioNTech/Pfizer jab.
"If you're a business leader, a non-profit leader, the state and local leader, who has been waiting for full FDA approval to require vaccinations, I'm calling on you now to do that, require it," he said in a statement from the White House on Monday.
“All around the world, people want these vaccines. Here in America, they’re free, convenient and waiting for you. So please go today, for yourself, for your loved ones, for your neighbours, for your country,” he added.
The FDA’s decision on Monday makes the two-dose mRNA jab, which will now be sold under the brand name Comirnaty, 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-use authorisation.
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Since December the two-dose jab had been administered under that protocol, given the urgent need for a vaccine to combat the pandemic.
"This is a pivotal moment for our country in the fight against the pandemic," Janet Woodcock, the acting head of the FDA, said on Monday. "For some, an FDA-approved Covid vaccine may instil in them the confidence to go and get vaccinated," she added.
The approval comes as US employers are increasingly seeking proof of full vaccination from their staff and customers. Immediately after the FDA’s announcement, New York city said all its public school teachers and staff would be required to get a Covid-19 vaccine, and the Pentagon said military service members would have to get the jab. More employers were expected to follow suit.
‘Best tool’
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.”
Peter Marks, the head of the FDA's Center for Biologics Evaluation and Research, defended the organisation against accusations it had been too slow to issue full legal approval. He noted that officials had gone as far as to visit individual trial sites to check the reliability of their data during the evaluation period.
The highly transmissible Delta variant has led to a surge in infections and hospitalisations in the US in recent weeks, primarily among those who have not received their jab, although lagging vaccination rates have 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 for six months after being fully vaccinated.– Copyright The Financial Times Limited 2021