China's CanSino Biologics is currently lobbying regulators abroad to grant its vaccine candidate the equivalent of the U.S. Food and Drug Administration's emergency use authorization (EUA). The company's Senior Vice President for International Business, Pierre Morgon, revealed this in a story published Friday in The Wall Street Journal.
Morgon said that his company is talking to regulators in numerous countries, declining to name any save for Pakistan. He also said that discussions are occurring with unnamed nations in Latin America and elsewhere.
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According to Morgon, receiving emergency authorization from national regulators "helps to build the safety database and certainly build the confidence in the fact that the vaccine is safe. If, in the meantime, if it is demonstrated as being effective in the Phase 3 trials, then it might be an accelerator for future contracts for vaccine supply."
Although there are a great many COVID-19 vaccine candidates currently in development around the world, none has yet to be approved for widespread use by any major regulator. CanSino's candidate -- currently in a phase 3 clinical trial -- received a Chinese version of an EUA for its candidate to be used by members of that country's military; that authorization does not cover the general population, however.
Only a relatively small number of vaccine candidates are also undergoing late-stage, human clinical trials. Prominent ones include Moderna's (MRNA 0.87%) mRNA-1273 and Pfizer's (PFE 1.70%) BNT162b2 in collaboration with previously low-profile German biotech BioNTech (BNTX +0.11%).
Another, Sputnik V, being developed by Russia's Gamaleya Research Institute, is likewise in late-stage trials. Sputnik V has received an EUA-like "conditional registration certificate" in that country but has yet to be authorized or approved anywhere else.
