White House halts release of new FDA standards for the Emergency Use Authorization of COVID-19 vaccine
pharmafile | October 6, 2020 | News story | Manufacturing and Production | FDA, Trump, Vaccine, coronavirus vaccines
The Trump White House is blocking new federal guidance for the emergency release of coronavirus vaccines that would essentially ensure none would be approved before the presidential election.
This follows months of debate between the FDA and Trump administration. Trump has insisted that a vaccine would start being rolled out before the general election on 3rd November. It is believed that private sector objections are another reason the guidelines are being blocked.
The FDA is seeking other ways to ensure that the vaccines meet their guidelines that they set out late last month. This may include sharing the guidelines with an outside advisory committee of experts that is supposed to meet publicly before any vaccine is authorised for Emergency Use Authorization (EUA).
According to The Washington Post, these guidelines would ask manufacturers who seek an emergency authorisation to follow participants in late-stage clinical trials for a median of at least two months, beginning when they received a second vaccine shot. The FDA will also assess at least five severe coronavirus patients in the placebo group of each trial. It is also expected that the regulator will require data for an emergency clearance, which is nearly as extensive as the information needed for a general approval. If followed, these restrictions would make the regulatory process far longer, which means it is extremely unlikely that a vaccine would be ready before the election.
The government’s decision to undercut the FDA’s guidance will confirm the fears of many Americans that the vaccine is being politicised and may not be safe and effective. A Kaiser Family Foundation poll last month found that 62% of Americans believe that political pressure from the Trump administration will cause the FDA to rush the approval of a vaccine before the election. When broken down by political affiliation it found that 85% of Democrats, 61% of independents and 35% of Republicans believe this.
Last Thursday, Michelle McMurry-Heath, President and Chief Executive Officer of the trade group BIO, which represents biotechnology companies and academic institutions, wrote a letter to Alex Azar, the Health and Human Services Secretary. She wrote: “We cannot allow a lack of transparency to undermine confidence in the vaccine development process. The public must have full faith in the scientific process and the rigor of FDA’s regulatory oversight if we are to end the pandemic.”
Conor Kavanagh
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