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Scientists in the US have expressed fears that the Trump administration may brush aside safety concerns in a bid to deliver a Covid-19 vaccine in time for the November election.
Experts say they are worried that the White House will push the Food and Drug Administration to overlook insufficient data from clinical trials. The threshold for vaccines is typically much higher than for other drugs because they are used in millions of otherwise healthy people. This means that even rare side effects could affect many more people than a drug that treats a specific illness.
Donald Trump announced in May the Operation Warp Speed initiative to develop and deliver 300 million doses of a safe, effective vaccine by January 2021. The date has since been brought forward. In a tweet last month, the president explicitly tied vaccines to his re-election hopes.
“There are a lot of people on the inside of this process who are very nervous about whether the administration is going to reach their hand into the Warp Speed bucket, pull out one or two vaccines, and say ‘We’ve tested this on a few thousand people, it looks safe, and now we are going to roll it out,’” Dr Paul Offit of the University of Pennsylvania, who is a member of the FDA’s vaccine advisory committee, told the New York Times.
“They are really worried about that,” he added. “And they should be.”
https://www.telegraph.co.uk/news/20...-administration-overlooking-concerns-produce/
Could the FDA be pushed by the administration into doing that? For once, the anti-vaxxers would have a point.
Experts say they are worried that the White House will push the Food and Drug Administration to overlook insufficient data from clinical trials. The threshold for vaccines is typically much higher than for other drugs because they are used in millions of otherwise healthy people. This means that even rare side effects could affect many more people than a drug that treats a specific illness.
Donald Trump announced in May the Operation Warp Speed initiative to develop and deliver 300 million doses of a safe, effective vaccine by January 2021. The date has since been brought forward. In a tweet last month, the president explicitly tied vaccines to his re-election hopes.
“There are a lot of people on the inside of this process who are very nervous about whether the administration is going to reach their hand into the Warp Speed bucket, pull out one or two vaccines, and say ‘We’ve tested this on a few thousand people, it looks safe, and now we are going to roll it out,’” Dr Paul Offit of the University of Pennsylvania, who is a member of the FDA’s vaccine advisory committee, told the New York Times.
“They are really worried about that,” he added. “And they should be.”
https://www.telegraph.co.uk/news/20...-administration-overlooking-concerns-produce/
Could the FDA be pushed by the administration into doing that? For once, the anti-vaxxers would have a point.
