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FDA publishes new guidelines for COVID-19 vaccine approval

New rules mean a COVID-19 shot is unlikely to be approved pre-election in the US

The US Food and Drug Administration (FDA) has released new guidance detailing how it will grant emergency use authorisations (EUA) to COVID-19 vaccines.

The most notable guideline to emerge from the FDA’s new advisory stipulates that data from phase 3 studies of any potential COVID-19 vaccine should include a median follow-up duration of at least two months after patient’s receive their final dose.

This guidance ensures that no COVID-19 vaccine is likely to be approved before the US presidential election, which is taking place on 3 November. US president Donald Trump has said a number of times over the last few months that a vaccine for COVID-19 could come before election day, however with the White House endorsing the new FDA rules, this is now highly unlikely.

'We're going to have a great vaccine very, very shortly. I think we should have it before the election, but frankly the politics gets involved,” Trump said in a video recorded outside the White House on Wednesday.

A number of COVID-19 vaccines have entered late-stage phase 3 trials, raising concerns among experts that companies may seek regulatory authorisation before sufficient safety data is collected.

In September, a joint letter written by leading researchers and bioethicists urged Pfizer to delay submitting a marketing authorisation application for its potential COVID-19 vaccine.

Pfizer recently reported that it expects initial efficacy results from its BioNTech-partnered phase 3 trial in late October. The company’s chief executive officer Albert Bourla criticised the politicisation of COVID-19 vaccine development last week, according to the Financial Times.

Referencing the first presidential debate in the US, Bourla wrote in a memo to staff – seen by FT – “I was disappointed that the prevention for a deadly disease was discussed in political terms rather than scientific facts. People, who are understandably confused, don’t know whom or what to believe”.

Bourla, along with the leaders of AstraZeneca, Johnson & Johnson, Merck, Moderna, Novavax and Sanofi and GlaxoSmithKline, co-signed a pledge in September promising to uphold rigorous safety and efficacy protocols for their respective COVID-19 vaccines.

In the joint pledge, the companies promised to “only submit for approval or emergency use authorisation after demonstrating safety and efficacy through a phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as the FDA”.

Article by
Lucy Parsons

9th October 2020

From: Regulatory



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