White House blocking FDA guidelines which would delay release of coronavirus vaccine

White House chief of staff Mark Meadows

Credit: Saul Loeb/AFP 

Food and Drug Administration guidelines which would delay the approval of a coronavirus vaccine ahead of next month’s presidential election are being blocked by the White House.

With Covid-19 having claimed more than 213,000 lives in the US, the Trump administration, which has been under fire for its handling of the pandemic,  has been keen to fast track the introduction of a vaccine.

Just over a fortnight ago, Donald Trump told an election town hall in Philadelphia that a vaccine could be only three weeks away.

He added that the process would have taken far longer if the Democrats had been in power "because of the FDA and all the approvals".

Republican strategists believe announcing the approval of a vaccine ahead of polling day could be a vote winner.

The president’s determination to accelerate the timeline has put him at odds with scientific experts including those within his own administration.

Last month Stephen Hahn, the FDA Commissioner, insisted that career scientists and not politicians would decide when a vaccine would be introduced.

Anthony Fauci, a leading member of the White House coronavirus task force, said he believed that a vaccine would be ready by November or December.

Other experts believe 2021 is more realistic.

The dispute between the White House and the FDA centres on how long should be allowed after vaccination trials to evaluate whether the drug is safe.

According to FDA guidelines, which were submitted to the White House budget office on September 21,  a  decision on authorisation should not be taken until two months after the administration of the final dose.

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This has been questioned by Mark Meadows, the White House chief of staff, the New York Times reported who believes there is no clinical or medical justification for the delay.

The Biotechnology Innovation Organisation, the trade body representing vaccine manufacturers, has called for the FDA guidance to be released to strengthen confidence in vaccines when they are released.

In a letter to health secretary Alex Azar, the organisation’s president Michelle McMurry-Heath, wrote: "The public must have full faith in the scientific process and the rigour of FDA’s regulatory oversight if we are to end the pandemic."