FDA to issue guidance on COVID-19 vaccine approval

Alex Azar touts biomedical teamwork to combat coronavirus

Health and Human Services Secretary Alex Azar on developing potential coronavirus therapeutics and when he expects a vaccine to become available.

WASHINGTON—The Food and Drug Administration plans to release guidance Tuesday outlining its conditions for approving a Covid-19 vaccine, including a requirement that any vaccine be at least 50% more effective than a placebo in preventing the disease.

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The FDA said that no vaccine would be approved unless a vaccine company had “clearly demonstrated” proof of a vaccine’s safety and effectiveness through a clinical study, according to a summary of the guidance viewed by The Wall Street Journal.

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According to the summary, the FDA also said a vaccine wouldn’t be approved simply if it leads to antibodies in the bloodstream of patients, on grounds that it is not known what level of antibodies will confer protection to patients.

The FDA said it would also require a vaccine maker to conduct further monitoring of safety after any approval and recommended that people getting the vaccine be followed for a year after treatment. The summary document said that such “post-market studies” may be necessary to “further assess known or potential serious risks.”

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In this Friday, April 24, 2020, file photo, Stephen Hahn, commissioner of the U.S. Food and Drug Administration, speaks about the new coronavirus in the James Brady Press Briefing Room of the White House, in Washington, as Vice President Mike Pence l

The guidance is expected to be discussed by FDA Commissioner Stephen Hahn in an appearance Tuesday before a Senate committee, which is holding a hearing on the steps needed to get businesses, schools and other institutions to fully reopen.

Developing a vaccine is a priority for the Trump administration, which has dubbed the initiative Operation Warp Speed. The FDA has vowed to use all its available authority to expedite a safe and effective Covid-19 vaccine, fueling hopes that a preventive treatment can be developed quickly.

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At the same time, the FDA says in the guidance that it “will not reduce its standards or cut corners in its review to approve a vaccine.”

The FDA has sometimes been faulted for moving too quickly in the campaign to prevent and treat the virus.

At least 160 antibody tests for Covid-19 entered the U.S. market without previous FDA scrutiny in March, as the agency rushed to get them to the public quickly. Under fire, the FDA mandated stricter review.

The agency also granted emergency-use authorization for two malaria drugs, chloroquine and hydroxychloroquine, for Covid-19 treatment, which it later revoked after determining both were ineffective.

Guidances are a method the FDA uses to state its policy to an industry, in this case vaccine makers. A virus vaccine could be granted approval two ways—either as a full approval or as emergency authorization.

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A full approval by the FDA would require a vaccine company to amass trial data and submit all the details to an advisory committee of outside experts, a process that typically takes months.

An emergency authorization could happen more quickly than a full FDA approval, but would still require the vaccine maker to show through a clinical study that the vaccine produced lower levels of disease, according to the summary viewed by the Journal.

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Government and industry officials have concluded that the standards the FDA is espousing for full approval will need at least 30,000 people in a clinical trial. But since the coronavirus pandemic has flared up again in the U.S.—including in Arizona, Florida and Texas—it may well be relatively easy for companies and doctors to sign up patients eager to see if they can participate in a vaccine study that might protect them.

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