Sinopharm wins ok from FDA, the 5th approved Covid-19 vaccine

Thailand adds another Covid-19 vaccine to its arsenal, as the Food and Drug Administration has just approved the Sinopharm vaccine for emergency use. Biogenetech Co. submitted a registration application that has been under consideration by the FDA until receiving approval today. Sinopharm joins Sinovac, AstraZeneca, Johnson & Johnson, and Moderna to be officially approved for use in Thailand.

Today Sinopharm was approved shortly after it was revealed that Princess Chulabhorn had negotiated a private batch of 1 million Sinopharm vaccines for the Chulabhorn Royal Acadamy that she sponsors, set to arrive next month. The declaration appeared to catch government officials off guard, as they were seemingly unaware of the deal until the announcement. The academy was not registered with the FDA to import Covid-19 vaccines, nor did it have any permits for importing medication. 20 million Sinopharm vaccines in total were arranged to be sold from Accap Assets Co to the Royal Academy.

The Sinopharm vaccine had already been approved by the World Health Organization for emergency use, but still was required to be evaluated in Thailand for its safety and effectiveness. It is manufactured by the Beijing Institute of Biological Product Co. and is an inactivated vaccine. The recommended dosage is 2 injections spaced 28 days apart, similar to other approved vaccines.

Thailand’s government is currently administering Sinovac and AstraZeneca vaccines only, leaving the other 3 available for private enterprises to negotiate importing the jabs. But private companies will likely still need to work through the government to legally import the vaccines by applying for registration for permission to import with the FDA. Biogenetech Co. had registered already to import Sinopharm following proper channels.

While Sinopharm is now approved, documentation is still being prepared for submission to register the Covacxin vaccine and Russia’s Sputnik V vaccine. Moderna was the most recent to win approval on May 13, while Johnson & Johnson was approved on March 25, though no plans to import it have been made public yet. Sinovac was approved on February 22, and AstraZeneca was the first to receive approval on January 20, after confirmation that Thailand would manufacture it locally.

SOURCE: Bangkok Post