White House blocks FDA safety rules which would delay Covid vaccine until after election

The White House has blocked proposed guidelines by the Food and Drug Administration (FDA), which would have likely prevented an approved Covid-19 vaccine by the US election on 3 November.

Last month, the Washington Post reported that the FDA was going to announce tougher standards for the approval of a coronavirus vaccine.

The FDA planned on asking any manufacturers seeking an emergency approval for a Covid-19 vaccine to go through a more rigorous process than is normally the case.

The agency suggested that manufacturers follow participants involved in late-stage trials for two months after they had been administered their second vaccine shot, in order to collect enough data on participants to convince the public the dose is safe.

However, a senior official in the Trump administration confirmed to Reuters on Monday that the White House believed that there was “no clinical or medical reason” for the proposed additional requirement, just a day after the US president said vaccines are “coming momentarily.”

The official added that the White House was focused on creating a safe vaccine and wanted to make sure “additional loopholes” were not added that would slow down the process.

The decision follows comments made by Donald Trump last month, where he claimed that any regulatory changes that could affect the authorisation of a vaccine would be “a political move more than anything else.”

Five pharmaceutical companies are in the final stage of testing vaccines, and Moderna and Pfizer began their trials on 27 July, and got to the halfway stage of 15,000 participants, of a planned 30,000, a month later.

The FDA’s proposed guidelines would have likely ended speculation that a vaccine would be ready in time for 3 November, as manufacturers would not have been able to make it through the process in time.

President Donald Trump claimed at a campaign rally last month that a vaccine will be approved by the US election on 3 November, but two of his top scientific advisers have said that it is unlikely that one will be ready, as trials will not have collected enough data by that point.

Dr Moncef Slaoui, the scientific head of vaccine development programme Operation Warp Speed, told NPR in early September that an approval is “extremely unlikely but not impossible,” while US surgeon general Dr Jerome Adams said it is “improbable”.

The Post reported that the FDA is concerned that the president’s claims, combined with reports of his administration interfering with federal science agencies throughout the pandemic, has lowered trust among Americans on a potential vaccine.

A report by the Pew Research Centre released in late September showed that only 50 per cent of US citizens said they would get a vaccine if it was available today, compared to 72 per cent in May.

Concerns over interference from the Trump administration on health agencies’ response to the pandemic were reignited last month, as Alex Azar, the secretary of health and human services, took away the FDA’s authority to sign new regulations into law.

The power has been reserved for Mr Azar, and in a statement, HHS attempted to justify the decision, and said that it “minimises litigation risk…prevents potential future abuse of authority, and is consistent with congressional intent.”

However, earlier on Monday, FDA commissioner Dr Stephen Hahn confirmed that any potential vaccine will have to meet the safety criteria set by the agency, and added that “those decisions will be made by the career scientists and staff,” according to Forbes.

Dr Hahn added: “We have processes in place to make sure that the Centers are protected from any outside pressure, and that they’re focused solely on looking at the science and the data.

“I have absolute faith and confidence in those decisions.”

According to Johns Hopkins University some 7.4m people have now tested positive for coronavirus in the US and the death toll has reached 210,195.

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