US regulators have confirmed the Pfizer/BioNTech Covid vaccine is 95% effective, paving the way for it to be approved for emergency use.
According to new documents released by the US Food and Drug Administration, the vaccine starts to work within about 10 days of the first dose. It also showed Covid-19 cases began to taper off among those who had been vaccinated after just over a week, raising hopes that the inoculation could help ease pressures on overwhelmed hospitals soon after it is rolled out.
The data was released two days before a committee of scientific experts review the case for authorising the vaccine and make a recommendation to the FDA.
The regulator is asking the advisers to consider whether it is reasonable to believe that the vaccine prevents Covid-19 in people aged 16 and over, and if the benefits outweigh the risks. The FDA is not bound by its advisers’ decisions.
The regulator’s scientists did not raise any significant concerns about safety, although the report on Tuesday said there was not enough evidence about how safe it is in children, pregnant and breastfeeding women, and people with compromised immune systems, such as those with HIV.
On Thursday FDA’s vaccine advisory panel will discuss these materials in advance of a vote on whether to recommend authorization of the vaccine.
Meanwhile, Pfizer CEO Dr Albert Bourla said discussions around the coronavirus vaccine have been “severely politicized” in the United States leading to a certain amount of doubt.
“That makes people confused and they don’t know who to believe and what to believe because the discussion was happening on political rather than on scientific terms,” the Pfizer chief said.
“We didn’t cut any corners, that we tested this vaccine with the exact same way that we are testing any vaccine that is circulating out there, that this vaccine actually was tested even — because of the scrutiny — with even higher standards in terms of how we do things.”
The Trump administration is coming under scrutiny for reportedly failing to lock in a chance to buy millions of additional Pfizer doses during the summer.
That decision could delay the delivery of a second batch of US doses until Pfizer fulfills other international contracts.
British regulators have already approved the Pfizer vaccine, and doctors there began administering doses on Tuesday. The UK’s decision to approve it so quickly attracted some criticism in the US, with Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, saying the British process had been “rushed” — although he later apologised for any “misunderstanding” his comments had caused.
In the US the process has proved politically divisive, and President Donald Trump has criticised Pfizer and the FDA for not moving faster.
Rita Osakwe/Agency Reports