Mexico will not follow FDA in approving Gilead’s COVID-19 drug

MEXICO CITY (Reuters) – Mexico will not necessarily follow the U.S. Food and Drug Administration (FDA) in approving Gilead Science Inc’s antiviral drug remdesivir for use in COVID-19 patients, a top Mexican health official said on Friday.

Mexico’s health regulator Cofepris has already twice denied approval for the drug with a “non-favorable” opinion, deputy health minister Hugo Lopez-Gatell told his regular nightly news conference.

“We have no mandate from the FDA,” he said. “Cofepris has identified that the evidence does not suggest a usefulness, a sufficient efficacy.”

The FDA approved remdesivir on Thursday, making it the first and only drug approved for the disease in the United States.

Remdesivir, given intravenously, was one of the drugs used to treat U.S. President Donald Trump during his bout with COVID-19.

The World Health Organization’s (WHO) Solidarity drug trial last week concluded remdesivir has little or no impact on a patient’s chances of surviving COVID-19, and a top WHO scientist on Friday recommended the FDA consider all available evidence.

Lopez-Gatell said Gilead had sent a letter to doctors in Mexico refuting the results of the Solidarity trial, and that officials were looking to see if the letter could be cause for sanction, given that remdesivir is not registered with Mexican health authorities.

“It confuses the population and generates a false expectation of the possibility of having a treatment option,” he said.

Gilead did not immediately respond to a request for comment.

(Reporting by Sharay Angulo and Daina Beth Solomon; Editing by Sonya Hepinstall and Tom Hogue)

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Guidelines for approving a coronavirus vaccine will be the focus of FDA advisers meeting Thursday

The vaccine advisory committee, meeting remotely in an all-day session, will not review a specific vaccine because no company has applied for the FDA’s imprimatur. Rather, the group will provide views on the FDA’s standards governing whether a vaccine is sufficiently safe and effective to warrant an emergency use authorization. It will also weigh in on the conduct of clinical trials once a vaccine is cleared and monitoring safety on an ongoing basis.

Even a general discussion is an important milestone, especially after protracted political melodrama involving the vaccine review process, experts said.

“The visual of scientists sitting around the table carefully discussing what a safe and effective vaccine might look like is an important moment for the FDA,” said Jason L. Schwartz, assistant professor of health policy and management at the Yale School of Public Health. “For months, all the FDA could do was offer promises about how science would guide its decisions on the vaccine. This shows how that will happen as data begins to come in.”

The panel will offer the agency advice for navigating the “extraordinary and unprecedented steps” of clearing a vaccine on an emergency basis, said M. Miles Braun, former director of the FDA’s division of epidemiology and an adjunct professor at the Georgetown University School of Medicine, during a media briefing Wednesday. FDA officials will want to know they are “on firm ground, and not missing any issues,” Braun said.

The FDA has said it will hold additional advisory committee meetings to consider applications from vaccine makers, which could begin arriving as soon as mid-November.

The panel, called the Vaccines and Related Biological Products Advisory Committee, is made up mostly of academic experts in infectious diseases, immunology and biostatistics. Some members recused themselves because they work at hospitals where coronavirus vaccine trials are being conducted or are involved in the trials. They were replaced by temporary members, including Arnold Monto, a University of Michigan epidemiologist who will serve as committee chairman, according to documents on the FDA website.

The FDA on Wednesday posted the topics it wants to discuss with the committee, including the effects of vaccines in specific populations. One of the most complicated questions centers on how to continue clinical trials after a vaccine is authorized. Should participants who received the placebo be notified and allowed to get the vaccine? If so, will that hurt the trial’s ability to collect useful data on an ongoing basis, and how can that be mitigated?

The FDA has used advisory committees for decades to bulk up its expertise and win buy-in from the public and outside scientists on its decisions. The FDA is not required to take advice from the panels but often does. The vaccine committee is expected to play an especially important role given the political pressure exerted by the White House on the FDA in recent weeks and months.

The White House held up the guidance, but the FDA circumvented the blockade by publishing it as part of briefing materials provided

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