Enlarge /. Stephen Hahn, Commissioner for Food and Drugs to the United States Food and Drug Administration (FDA), speaks during a hearing of the Senate Committee on Health, Education, Work and Pensions on June 30, 2020 in Washington, DC.
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All experimental COVID-19 vaccines that seek regulatory approval from the Food and Drug Administration must prevent or reduce the severity of the disease in at least 50 percent of people, the agency said on Tuesday.
The criterion is part of a larger set of guidelines released by the agency to develop a vaccine to curb the spread of the pandemic coronavirus SARS-CoV-2, which causes COVID-19 and is accelerating across large parts of the country after months of continued development Devastation.
With the guidelines, the FDA attempted to dispel fears that the rush to develop a COVID-19 vaccine could be at the expense of adequate safety testing. "We recognize the urgent need to develop a safe and effective vaccine to prevent COVID-19," said FDA commissioner Stephen Hahn in a statement. "Although the FDA is committed to speeding up this work, we will not compromise our decisions and use these guidelines to clarify what data should be submitted to meet our regulatory standards."
The agency also hopes to address concerns that it has succumbed to the Trump administration's political pressures to make regulatory decisions during the pandemic and does not rely on efficacy and safety data. Most notable is the case of hydroxychloroquine, a malaria drug that is known to have serious potential side effects, including triggering potentially fatal arrhythmias. Despite the lack of evidence of its effectiveness against COVID-19, President Trump praised the drug as a "game changer" and even admitted to having taken it himself.
The FDA made the unusual decision to issue an Emergency Use Authorization (EUA) for hydroxychloroquine and the related drug chloroquine in late March. The EUA allowed doctors to use the medication to treat COVID-19 patients outside of clinical trials, although there was no evidence. In mid-June, as data piled up that the drugs against COVID-19 were ineffective and held serious risks, the FDA revoked the EUA.
Although political leaders, health experts and media reports have indicated that the Trump administration influenced the FDA's original decision to issue an EEA, Hahn has denied this. In a congressional hearing on June 23, he said, "I have felt no political pressure, nor has the FDA made a decision in any direction."
Repeating the point in today's vaccination policy announcement, he said, "We have not lost sight of our responsibility to the American people to maintain our regulatory independence and ensure that our decisions regarding all medical devices, including COVID-19 -Vaccines, on which science and the available data are based. "
In the announcement, the FDA noted that although the guidelines set out what is required for full approval, the agency may consider issuing an EUA for COVID-19 vaccine candidates on a case-by-case basis. The agency said it would consider an EUA based on "the target population, the characteristics of the product and the entirety of the relevant scientific evidence available, including preclinical and clinical data on human clinical trials on the safety and efficacy of the product".