China is at War With The FDA; Guess Who’s Winning?

Dr. David Gortler
Contributor
Healthcare
Fmr. FDA medical officer/analyst & Sr. Advisor to the FDA commissioner
China recently informed its embassies of a new visitor vaccine protocol. In addition to earlier requirements that all entrants be tested via an absurd and unnecessary swab technique, China is allowing only those vaccinated with its proprietary vaccines—such as the one developed by Sinovac or the vaccine developed and manufactured by its government-owned SinoPharm company—to enter their country.

Yet as of this writing, the US FDA hasn’t received an initial submission from China for any vaccine. Initial efficacy reports for Sinovac appear to sharply pale in comparison to America’s mRNA vaccines currently authorized for use by the FDA.

The Trump-commissioned state-of-the-art mRNA vaccines have efficacy rates of around 91%, demonstrated in both clinical trials and recent real-world studies. Data from Sinovac’s vaccine shows it to be notably less effective, with recent interim data from a phase 3 trial showing only 56.5% efficacy. No public clinical trial data has been released for the SinoPharm vaccine.

China’s Sinovac vaccine use an older technique of vaccine production utilizing chemically inactivated viruses. This technology dates back to the 1950s and the advent of the polio vaccine.

Right now, there is no Chinese-made vaccine for any disease approved for use in the United States, nor is there likely to be any time soon. Furthermore, neither Chinese-made vaccine has been approved by the World Health Organization. While some countries have authorized the vaccines, they have later, puzzlingly not recommended the vaccine — illustrating a sensible lack of confidence based on efficacy findings.

These findings represent a problem when it comes to the regulation of drugs for American consumers: China’s vaccine entry requirements make it nearly impossible for the FDA to fully staff regulatory operational activity in China.

For about a year now, the FDA has halted official inspection visits on pharmaceutical facilities due to the Covid-19 scare. America is currently in a precarious situation, being dependent on overseas companies for production of 80% of the drugs used in America’s hospitals and pharmacies.

When the FDA gets permission to perform in-China inspections, they must be announced long beforehand through Chinese/U.S. State departments, giving both the Chinese government and the facilities plenty of time to prepare. Even with this preparation time for these “staged” inspections, FDA officials have found patterns of serious regulatory violations. Announced inspections are a luxury that pharmaceutical manufacturers in other countries (and the USA) do not get.

In the past, Chinese manufacturers have routinely flaunted basic standards of honesty, testing techniques and/or quality control. At one “sterile” manufacturing site in China, several departments were forced to use a single leaking, dirty bathroom, with no running water. (Interestingly, this enforcement letter was deleted from the FDA webpage and no longer shows up in a search within the FDA website.) The FDA currently has very limited power to respond to such tactics other than issue an online import alert; an obscure website many in the industry are unaware of, and to which various state boards of pharmacies and major chain pharmacies give no heed, when they choose the least expensive drugs to dispense to their patients.