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

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

FILE PHOTO: Former GlaxoSmithKline pharmaceutical executive Moncef Slaoui, who will serve as chief adviser on the effort to find a vaccine for the coronavirus disease (COVID-19) pandemic, adjusts his protective face mask after speaking as President Donald Trump holds a coronavirus disease vaccine event in the Rose Garden at the White House in Washington, U.S., May 15, 2020. (REUTERS/Kevin Lamarque)

BY JULIE STEENHUYSEN

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 meeting 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 a 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 percent of Black adults said they would definitely or probably get a COVID-19 vaccine, compared with 52 percent of White adults, 56 percent of Hispanics and 72 percent of Asian Americans.

The Department of Health and Human Services did not immediately respond to a request for comment on Slaoui’s statements.

Pfizer Inc, 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 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.

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