United States regulators were set to begin the first steps in approving a Covid-19 vaccine on Friday with the submission of an emergency use authorisation request by vaccine developers Pfizer/BioNTech.
This is the first time that regulators anywhere in the world will start the approval process for a vaccine that many hope will turn the tide on the coronavirus pandemic.
The emergency authorisation is temporary or conditional and is granted by the US Food and Drug Administration in response to a situation such as a pandemic.
“Pfizer’s partner BioNTech has announced that tomorrow they intend to file for emergency use authorization at the FDA,” US health secretary Alex Azar told a press conference on Thursday in Washington.
The FDA did not say how long it would take to review the data on vaccine efficacy and safety, the two main criteria considered for granting approval.
Moncef Slaoui, the scientific head of the US government’s Warp Speed programme to develop a vaccine, said he hoped the Pfizer/BioNTech jab would be approved as soon as next month.
He told AFP there is a chance they could receive the green light from the US “this year,” and even start delivering the vaccine by December.
BioNTech/Pfizer announced its vaccine was 90 per cent effective last week, with additional data this week showing it generated a good immune response in older people. Also this week, US biotech Moderna said its vaccine was 94 per cent effective.
These are both mRNA vaccines – a brand new type of vaccine technology that has been years in development. Unlike conventional vaccines that are produced using a weakened form of the virus mRNA vaccines use the pathogen’s genetic code.
The Pfizer/BioNTech vaccine has to be kept at minus 70 degrees celsius, which will prove a headache for mass distribution, while the Moderna jab remains stable in the fridge for 30 days.
On Thursday researchers behind the AstraZeneca/Oxford University vaccine – a more traditional vaccine technology – announced promising Phase II findings and said they hoped to publish final results next month.
The UK and European drug regulators have been reviewing the data from all three vaccines as they have become available in a rolling review but have yet to start the formal approvals process for any vaccine.
The UK has ordered 350 million doses of six different vaccines and earlier this week scrambled to order five million doses of the Moderna shot.
But the speed at which all the vaccines have been developed – the vaccine development timeline has been squeezed from an average of 10 years to less than one – have led some to worry about how safe the vaccines will be.
Dr Richard Hatchett, chief executive of the Coalition for Epidemic Preparedness Innovations, an organisation that funds vaccine developers including Moderna and Oxford/Astra Zeneca shots, told a Telegraph event earlier this week safety had not been compromised.
“Everything that would be done to ensure safety has been done with these vaccines – it’s just happened in a very compressed timeframe,” he said.
Experts say this is not a rubber stamping process and regulators will apply the same stringent criteria to Covid vaccines as they would to others.
Nick Jackson, head of programmes at Cepi, said since the beginning of the pandemic regulators had strived to coordinate recommendations and guidelines.
He added: “However, each national regulatory agency may still come to different conclusions – which is normal – because each must make their own benefit risk assessment. Nuances between countries such as the Covid-19 situation, demographic differences and varying at-risk groups, all influence the assessment.
“Nevertheless, we anticipate that continued discussions between regulators will land on similar decisions.
“It’s important to note that associated expert bodies make recommendations for how the vaccine will be used once the licence is granted. The different needs of countries may result in different recommendations for use.”
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