Sun. Oct 2nd, 2022
A serious man in a suit speaks into a microphone.
enlarge Stephen Hahn, Commissioner for Food and Drugs at the United States Food and Drug Administration (FDA), speaks at a hearing of the Senate Committee on Health, Education, Labor and Pensions on June 30, 2020 in Washington, DC.

Any experimental COVID-19 vaccines that seek regulatory approval from the Food and Drug Administration must prevent or reduce disease severity in at least 50 percent of people, the agency announced Tuesday.

The criterion is part of a larger set of guidelines released by the agency for the development of a vaccine to prevent the spread of the pandemic coronavirus SARS-CoV-2 – which causes COVID-19 and is now spreading across much of the country. accelerating after months of ongoing destruction – to a halt .

With the guidelines, the FDA sought to allay fears that the rush to develop a COVID-19 vaccine could come at the expense of adequate safety testing. “We recognize the urgent need to develop a safe and effective vaccine to prevent COVID-19,” FDA Commissioner Stephen Hahn said in a statement. “While the FDA is committed to expediting this work, we will not cut corners on our decisions and through this guidance, we are clarifying what data must be submitted to meet our regulatory standards.”

Exceptions

The agency also hopes to allay concerns that it has succumbed to political pressure from the Trump administration in making regulatory decisions during the pandemic — not relying on efficacy and safety data. Most notable is the case of hydroxychloroquine, a malaria drug known to have serious potential side effects, including causing potentially fatal cardiac arrhythmias. Despite a lack of evidence for its efficacy against COVID-19, President Trump touted the drug as a “game changer” and even admitted to using it himself.

The FDA made the unusual decision in late March to issue an Emergency Use Authorization (EUA) for hydroxychloroquine and its related drug chloroquine. The EUA allowed doctors to use the drugs to treat COVID-19 patients outside of clinical trials, despite the lack of evidence. As data piled up that the drugs are ineffective against COVID-19 and pose serious risks, the FDA revoked the EUA in mid-June.

While political leaders, health experts and media reports have suggested that the Trump administration influenced the FDA’s initial decision to issue an EUA, Hahn has denied it. At a Congressional hearing on June 23, he testified, “I have not felt any political pressure, nor has the FDA made a decision in any specific direction.”

Reiterating the point in today’s vaccine guidelines announcement, he said, “We have not lost sight of our responsibility to the American people to maintain our independence from regulation and to ensure that our decisions regarding all medical products, including COVID-19 vaccines, are based on science and the available data.”

In the announcement, the FDA noted that while the guidelines outline what is needed for full approval, the agency may still consider issuing an EUA on a case-by-case basis on COVID-19 candidate vaccines. The agency said it would consider an EUA based on “the target population, the characteristics of the product and the totality of the relevant available scientific evidence, including preclinical and clinical trial data in humans on the product’s safety and effectiveness.”

By akfire1

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