Chinese regulators pen requirements for COVID-19 vaccine approval—and they're stricter than the FDA's

Drugmakers from China and the U.S. are among the front-runners in COVID-19 vaccine development, and how regulators in those two countries decide to deem a product approvable could set the standard for the rest to come.

Weeks after the FDA rolled out its standards for green-lighting COVID-19 vaccines, its Chinese counterpart Friday released guidance (Chinese) with some similar criteria.

Specifically, China’s National Medical Products Administration (NMPA) will require that a COVID-19 shot demonstrate in a clinical trial that it’s at least 50% more effective at fending off the disease than placebo.

The efficacy endpoint—and the statistical success criteria included in China’s requirements—match the FDA’s guidelines, released in June. But the Chinese authority went one step further in that department, recommending that a shot’s efficacy “preferably” reach 70%.

It’s also asking that a shot protect humans for at least six months, though it said it prefers to see one year of protection. In contrast, the FDA didn’t specify how long it expects a vaccine’s defense to last, only saying that it wants to see safety assessments in all study participants for at least six months after completion of vaccinations.

Both agencies said they would require postmarketing monitoring for long-term safety and efficacy data.

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The FDA has recently come under fire over its hasty emergency use authorizations for some treatments and diagnostic tests. These include the now-rescinded emergency nod for antimalaria drug chloroquine and its derivative hydroxychloroquine, which came right after President Donald Trump advocated it as a potential “game changer.” The drug was later shown to be ineffective at helping COVID-19 patients recover or preventing the disease.

In its COVID-19 vaccine guidance, the FDA again left open the possibility that it would grant emergency use authorization for a vaccine before the completion of large phase 3 efficacy trials. Without giving specifics on that pathway, the agency said such decisions will be made on a case-by-case basis considering “the totality of the available scientific evidence relevant to the product.”

China’s NMPA, in its version, also allows for conditional approval if an interim analysis finds “clear and acceptable” efficacy from an experimental shot before final readouts.

The FDA’s history with hydroxychloroquine, plus Russia’s rushed approval for a coronavirus vaccine—sans data from large-scale efficacy trials—have drawn concerns that the U.S. agency might once again yield to political pressure on its review of a vaccine. FDA Commissioner Stephen Hahn has said his agency will not “cut corners” in approving a shot in the U.S., despite the administration’s Operation Warp Speed vaccine acceleration program.

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Right now, AstraZeneca’s University of Oxford-partnered adenovirus-based candidate, AZD1222, as well as mRNA products by Moderna and a partnership between Pfizer and BioNTech, are in late-stage development and could be among the first to be approved in the U.S.

In China, an adenovirus-based program by local vaccine player CanSino Biologics has already been allowed for military use. The company has secured a deal to conduct a phase 3 in Saudi Arabia, and it just began late-stage testing in Russia, Reuters reported Monday, citing a Russian registry.

China’s state-owned Sinopharm has launched a phase 3 trial of an inactivated vaccine in the United Arab Emirates. Fellow Chinese company Sinovac picked Brazil and Indonesia as its phase 3 testing sites for its inactivated vaccine.