Any experimental COVID-19 vaccine that aspires to obtain regulatory approval from the Food and Drug Administration must prevent or lessen the severity of the disease in at least 50 percent of people, the agency announced Tuesday.
The criterion is part of a broader set of guidelines published by the agency to develop a vaccine to stop the spread of the pandemic coronavirus, SARS-CoV-2, which causes COVID-19 and is now accelerating in much of the country after months of sustained devastation.
With the guidelines, the FDA tried to allay fears that the rush to develop a COVID-19 vaccine may come 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. “While the FDA is committed to expediting this work, we are not going to cut our decisions short and are making clear through this guide 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 to make regulatory decisions during the pandemic, avoiding its reliance on efficacy and safety data. Most notable is the case of hydroxychloroquine, an antimalarial drug known to have serious potential side effects, including the triggering of potentially fatal cardiac arrhythmias. Despite the lack of evidence of its effectiveness against COVID-19, President Trump touted the drug as a “game changer” and even admitted to taking it himself.
The FDA made the unusual decision to issue an Emergency Use Authorization (USA) for hydroxychloroquine and the related drug, chloroquine, in late March. The EUA allowed physicians to use the medications to treat COVID-19 patients outside of clinical trials, despite the lack of evidence. As data accumulated that the drugs are ineffective against COVID-19 and carry serious risks, the FDA revoked the US in mid-June.
Although political leaders, health experts, and media reports have suggested that the Trump administration influenced the FDA’s initial decision to issue a US, Hahn has denied it. In a congressional hearing on June 23, he stated that “I have not felt political pressure nor should the FDA make any decision in a specific direction.”
Echoing the point in today’s announcement of the vaccine guidelines, he said: “We have not lost sight of our responsibility to the American people to maintain our regulatory independence and to ensure that our decisions regarding all medical products, including those COVID-19 vaccines, based on science and available data. “
In the announcement, the FDA noted that while the guidelines state what is needed for full approval, the agency may still consider issuing a US to COVID-19 candidate vaccines “on a case-by-case basis.” The agency said it would consider a US based on “the target population, product characteristics, and all relevant and available scientific evidence, including data from preclinical and human clinical studies on the safety and effectiveness of the product.”
