U.S. vaccine program chief backs stricter rules for emergency use of COVID-19 shot

[September 25, 2020]  By Julie Steenhuysen

CHICAGO (Reuters) - The scientific head of the U.S. government program designed to speed development of COVID-19 vaccines said on Thursday he supports stricter rules to grant emergency use of new inoculations against the novel coronavirus.

Speaking at a virtual Town Hall with Black physicians and community leaders, Operation Warp Speed scientific lead Dr. Moncef Slaoui said he supports recommendations being drafted by the U.S. Food and Drug Administration that companies wait two months after the last administration of their vaccine before seeking emergency use authorization (EUA) of their products.

Operation Warp Speed already has recommended the vaccine candidates it is supporting observe "a two-months follow-up after completion of the immunization process before the company will consider filing for an emergency use authorization," Slaoui said.

Concern is rising among public health experts and citizens that a vaccine could be rushed without proper safety checks, especially as the Nov. 3 presidential election nears.

Dr. Leon McDougle, president of the National Medical Association, on the call raised concern that the White House might block new, stricter FDA recommendations. U.S. President Donald Trump said on Wednesday he may or may not approve any new, more stringent FDA standards for an EUA of a COVID-19 vaccine.

Trump has repeatedly said a vaccine for COVID-19, thedisease caused by the coronavirus, could be ready fordistribution ahead of the election.

"We completely agree with it," Slaoui said, referring to the stricter FDA regulations during the virtual Town Hall event on Thursday organized by the Rainbow Push Coalition in Atlanta.

The draft FDA regulations were reported by the Washington Post on Tuesday as a way to boost transparency and public trust in the face of rising fears that the Trump administration might be interfering in the approval process, the newspaper said.

According to a Pew Research Center survey earlier this month, only 32% of Black adults said they would definitely or probably get a COVID-19 vaccine, compared with 52% of White adults, 56% of Hispanics and 72% of Asian Americans.

A representative of the Department of Health and Human Services declined to comment on the draft regulations, but said in an email that "career experts at the FDA will make an independent determination on the safety and efficacy of a vaccine submitted to them for authorization or licensing."

Pfizer Inc <PFE.N>, which expects to have vaccine data as early as late October, said in an email that the company is committed to providing regulators with sufficient data, including the median of two months' safety data after the second dose, to be submitted on a rolling basis.

Moderna Inc <MRNA.O> did not immediately respond to a request for comment on the two-month waiting period. The company has said it expects to have data on whether its vaccine works by November or possibly late October.

(Reporting by Julie Steenhuysen in Chicago; Additional reporting by Michael Erman in New York; Editing by Peter Henderson and Matthew Lewis)

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