AZN AstraZeneca PLC

By Thomas M. Burton 

U.S. health regulators have drafted guidelines that would require a Covid-19 vaccine to meet rigorous standards to gain a speedy clearance for use, according to people familiar with the matter, an effort to ensure the shots work safely before they are widely distributed.

Among the proposed requirements is that a coronavirus shot reduce the rate of infections by 50% compared with a placebo, which the regulators have already required for a regular approval of any Covid-19 vaccines.

The regulators' plans have been caught up in partisan fighting over the safety and timing of a Covid-19 vaccine, and they are unfolding amid concerns the Trump administration is putting politics ahead of science while interfering in the decisions of federal health agencies.

The draft requirements indicate the Food and Drug Administration wants to hold Covid-19 vaccines to high standards similar to what it would have used for a typical review of the shots, the people said, even though the agency plans to conduct the review more quickly than normal because of the urgent need created by the coronavirus pandemic.

Their strict requirements, if they hold up, could ease the concerns of many Americans who polls show are hesitant to get a shot -- partly out of concerns the administration is trying to rush out a vaccine.

The White House must sign off on the plan. The FDA submitted the draft plan for review last week to Secretary of Health and Human Services Alex Azar, according to the people. The White House Office of Management and Budget is also reviewing the plan, the people said.

The draft proposes the safety and effectiveness standards that a Covid-19 vaccine would need to meet for the FDA to permit use, called an emergency-use authorization because the agency plans to issue the decision on an accelerated timeline due to the pandemic.

If the Trump administration signs off on the guidelines, it would make it difficult for a vaccine to be authorized for emergency use before Election Day, the people said.

The administration could weaken the requirements, however, so that a vaccine could gain emergency-use authorization earlier.

Mr. Azar and other administration officials didn't raise serious objections to the proposals during a meeting Tuesday, people familiar with the matter said. It was unclear when the administration might sign off on the guidelines or call for revisions.

The Washington Post first reported that the FDA planned relatively tough standards for greenlighting a Covid-19 vaccine.

Covid-19 vaccines from AstraZeneca PLC, Moderna Inc. and Pfizer Inc. are in the final stage of testing. The trials for the Moderna and Pfizer vaccines could start providing some key results in late October or early November, according to the companies.

Before the vaccines can be made available to the public, the FDA must sign off. Normally, the agency decides whether to approve a vaccine. Given the urgency of the pandemic, the agency plans to issue an authorization for emergency use, which the FDA can do faster.

The guidelines for granting an emergency-use authorization have been a subject of great interest, because of concerns the Trump administration wants to champion a vaccine's clearance ahead of the Nov. 3 election.

Fueling the concerns are President Trump's own comments, including a recent promise there would be an FDA-authorized vaccine as early as October. "We're going to have a vaccine very soon, maybe even before a very special date," he said at a recent press conference, referring to election day. "You know what date I'm talking about."

Mr. Trump and his administration have sought to shape previous health-related guidelines. Under pressure from the administration, the Centers for Disease Control and Prevention in July updated its recommendations to encourage schools to reopen.

This week, the CDC removed guidelines that acknowledged the coronavirus can spread through tiny particles that travel widely across the air, just days after the guidelines were updated. The agency said the revisions were posted in error.

The president also has contradicted or criticized top health officials, such as CDC Director Robert Redfield and National Institutes of Allergy and Infectious Diseases Director Anthony Fauci.

Word that the FDA would green light any Covid-19 vaccine through an emergency-use authorization, rather than the normal approval process, triggered concerns in some quarters the administration would try to pressure the agency to allow use before a shot is fully vetted.

Emergency-use authorizations are a kind of interim FDA clearance the agency uses during pandemics to speed up the use of urgently needed medicines. The authorization is temporary, and differs from a full approval, which any vaccine would still ultimately need to stay on the market after the pandemic ends.

To grant the authorization, the agency typically eases the standards for a traditional FDA approval and merely balances the benefits of the medicine's use with any risks like side effects from taking it.

In the case of Covid-19 vaccines, the draft EUA document calls for more stringent standards than is usual, the people said, largely because a vaccine may be given to millions of healthy people.

The standard is quite similar to that for traditional vaccine approval, according to the people. For example, FDA's already-stated standard for full approval of a Covid-19 vaccine also requires that the shot reduce the rates of infection 50% better than a placebo in a late-stage trial.

The late-stage, or Phase 3, trials for a Covid-19 vaccine must randomly assign subjects to the experimental vaccine or a placebo, just as the FDA requires for a standard vaccine approval.

Also, the draft guidelines wouldn't allow clearance of a vaccine simply based on showing an increase in antibodies to Covid-19 in a patient's bloodstream, according to the people familiar with the plan.

Write to Thomas M. Burton at tom.burton@wsj.com

(END) Dow Jones Newswires

September 22, 2020 19:51 ET (23:51 GMT)

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