I've so far never read any news stories about the "old-fashioned" inactivated-virus vaccines from China, such as Sinovac and Sinopharm, being made available in the United States, even once they pass Phase III trials. Are there legitimate medical and regulatory reasons for this, or is it solely due to political tensions between America and China?
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7Has Sinovac applied for US FDA approval? Drug approval is done on a country by country basis, and it's challenging and expensive to satisfy each regulator. It's possible that Sinovac might not think it's worth the difficulty of getting approval in the US when there's plenty of demand from the rest of the world– divibisanDec 23, 2020 at 16:43
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@divibisan: And (eventually) plenty of supply from US vaccine producers. The same question could be asked about the Russian vaccine, or the British Oxford/AstraZeneca one.– jamesqfDec 23, 2020 at 18:01
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The US already has contracts with AstraZeneca for 300 million doses, so they’ve done half the work already.– M DevelopmentDec 24, 2020 at 1:47
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China, unlike the USA, is participating in the COVAX initiative.– Rebecca J. StonesDec 24, 2020 at 3:47
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2@jamesqf: AstraZeneca did apply to the FDA. It looks like it was not yet approved theguardian.com/business/2020/dec/09/… It seems they'll have to wait until Feb at least dailymail.co.uk/health/article-9053513/…– FizzDec 24, 2020 at 4:20
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They'll be unavailable because the Chinese companies likely will not apply for FDA authorization. As far as I know, none of the Chinese companies are conducting trials in the US. And the FDA has complex rules for accepting results from trials conducted in other countries, rules which mandate a lot of [FDA] oversight and early involvement in trial design, e.g.:
"Differences in clinical facilities and levels of clinical skill can also affect OUS (outside the U.S.) study data to the extent that such data may not be generalized to US clinical practice and the differences could impact the data's usefulness in supporting the safety and/or effectiveness of the device," the FDA says.
The agency also says that providing subgroup analysis is particularly important when submitting data from overseas clinical trials because of the different characteristics of overseas populations compared to Americans, such as the foreigners' height, weight, possession of certain biomarkers like the BRCA cancer gene, and behavioral tendencies like smoking.
As is often the case, the guidance recommends reaching out to the agency early and often. "By seeking FDA feedback prior to initiating the OUS study, sponsors who intend to use an OUS study to support US clearance or approval, regardless of whether or not they intend to use that study to also support marketing authorization in another country, can help facilitate efficient clinical trial design and reduce the possibility that additional clinical studies may be needed to support marketing authorization in the US," the guidance says.
Of some note, the Oxford/AstraZeneca one (which may fit the bill as a "old-fashioned" vaccine) was held to the coal fire by both the US regulator and the US press, if the British press' account is to be believed. Now there have been objective reasons for this as questions over efficacy findings etc. Supposedly AstraZeneca might receive FDA authorization in February. But it goes to show that the US is a tough market for vaccines.
(CanSino uses an adenovirus platform, like Oxford-AstraZeneca and the [Russian] Gamaleya one do. Sinovac and Sinopharm use an inactivated platform. As far as I know, there are no trials for inactivated platform Covid-19 vaccine[s] being done in the US.)
According to an expert quoted by the BBC, the wide (emergency) distribution of Sinopharm's vaccines before results of phase III trials being published is not something that would be acceptable in the West:
Sinopharm, a Chinese state-owned company, is developing two Covid-19 vaccines, which, like Sinovac are also inactivated vaccines that work in a similar way.
Both of its vaccines are also in phase three trials and have already been distributed to nearly a million people in China under an emergency programme.
"It is normal to wait for an analysis of phase three trials before ramping up a vaccine programme through emergency use authorisation," Professor Dale Fisher of the National University of Singapore earlier told news site CNBC.
Prof Fisher said such a move was "unconventional", adding that this would be "unacceptable" in the West.
The UAE and Bahrain appear to have already given formal approval to Sinopharm's vaccine(s), although phase III trials are also ongoing in other countries.
