President Donald Trump suggested that he could veto any tightening of US rules for the immediate clearance of a coronavirus vaccine, a step that could raise fears that ahead of the presidential election the race to find a Covid-19 shot is being politicised.
It is expected that the Food and Drug Administration will soon release final recommendations for an emergency-use authorization. Over the past few weeks, regulators and drugmakers have promised to listen to science, not politics, in determining when a vaccine is ready to enter the market.
At a Wednesday news conference, Trump said it “sounds like a political change” when asked if the FDA was seeking tighter authorization requirements, indicating that if it felt the agency was too stringent, the White House might intercede.
That’s for the White House to approve, “Trump said.” “It may or maynot be accepted by us.”
An official for the FDA declined to comment.
If a vaccine shows encouraging early signs of being safe and reliable, hitting the market on an emergency basis may be approved until full clinical trial results are available. Pfizer Inc.
businesses, including. In late-stage clinical studies, Moderna Inc., AstraZeneca Plc, and Johnson & Johnson have vaccine candidates. As soon as October, some of these studies could generate efficacy results.
In polls ahead of the November election, Trump is trailing Democrat Joe Biden, with surveys showing that a majority of citizens of America disapprove of the president’s treatment of the virus.
Although maintaining that his administration is doing a decent job managing the virus, Trump has tried to concentrate on other issues.
The president has vowed that within weeks a coronavirus vaccine will be approved — a gambit to turn a pandemic inoculation for his failing re-election campaign into an October surprise.
Trump and his supporters have also asked whether his attempts to fight the virus are being sabotaged by government employees. The president blamed the FDA in August for harboring “deep state” workers slowing down vaccine and medication work to politically damage him. There’s no proof that’s the case.
FDA officials also suggested that they will hold a vaccine to a higher standard than other drugs usually obtained by the department for emergency exemptions.
Earlier this month, Peter Marks, head of the Agency’s biologics office, proposed what he called a EUA-plus program that would speed up a vaccine’s evaluation but include data requirements similar to those used while the FDA is considering full approval.
Marks also said at the time that after they receive the vaccine, the FDA would like companies to have a median of two months of follow-up on trial participants.
Marks said, “We’re hoping for that,”. “About a month and a half after vaccination, most adverse effects can occur.”
He also said any emergency authorization strategy will require longer-term follow-up once the vaccine is on the market.
As Trump openly pushes for a vaccine to be accepted by the Nov. 3 referendum, the FDA has been attempting to restore confidence.
FDA Commissioner Stephen Hahn was criticised for exaggerating last month’s advantage of a plasma drug approved by the agency for use against the virus.
Since that outside FDA advisers will review vaccine results, Hahn has tweeted multiple times.
