Chinese Drug Regulators Approve Sinovac Vaccine

Sinovac Vaccine

Chinese drug regulators have given conditional market approval to the COVID-19 vaccine developed by Sinovac, a Chinese company that Thailand is counting on to get its stalled vaccination programme off the ground.

The approval came after multiple domestic and overseas trials of CoronaVac in countries including Brazil and Turkey, although “efficacy and safety results need to be further confirmed”, Sinovac said in a statement on Saturday.

The Thai Food and Drug Administration is currently reviewing Sinovac’s application for emergency use approval and is waiting for some additional documents before reaching a decision.

Thailand is expecting to take delivery of 2 million doses of CoronaVac between now and April and to start vaccinating health workers and high-risk people, subject to FDA approval.

The biggest vaccination programme in history is underway across the world, but Thailand has been slow to get started. As of Saturday, more than 124 million doses had been administered across 73 countries, according to data collected by Bloomberg.

Thailand has encountered problems obtaining promised shipments of AstraZeneca vaccine following a European Union crackdown on exports. The government is now hoping to source 150,000 AstraZeneca jabs from an undisclosed production site in Asia. The Serum Institute of India is the world’s largest producer of the AZ vaccine.

The local company Siam Bioscience is scheduled to manufacture millions of doses of the AstraZeneca vaccine under a technology transfer agreement, but the first of those will not be available until June at the earliest.

All told, Thailand has an agreement with AstraZeneca for the supply of 61 million doses of its vaccine. Public Health Minister Anutin Charnvirakul insisted this week that even if Siam Bioscience faces production problems, it will be the responsibility of the European pharmaceutical firm to make sure Thailand gets the agreed supplies from somewhere.

In the meantime, the country has no Plan B. It emerged this week that Thailand is one of the few countries not participating in Covax, the World Health Organization-backed programme to secure vaccine supplies at affordable cost.

Covax has reached preliminary agreements to supply a total of 336 million doses of vaccines made by either AstraZeneca or Pfizer to 131 countries. The interim distribution details are documented in a report released by Gavi, the Vaccine Alliance, a public–private global health partnership.

Of the 10 Southeast Asian countries, all but Thailand are in line to receive a total of 32,310,600 million doses through Covax in the first and second quarters of this year, subject to various conditions. The tentative allocations are as follows:

Brunei 100,800
Cambodia, 1,296,000
Indonesia 13,708,800
Laos 564,000
Malaysia 1,624,800
Myanmar, 4,224,000
Philippines 5,617,800
Singapore 288,000
Vietnam 4,886,400

The Sinovac vaccine is already being used in China on key groups at higher risk of exposure to coronavirus, but Saturday’s approval allows for its use on the general public.

The green light comes several weeks after regulators in Beijing gave the local company Sinopharm approval to put its vaccine on the market.

Sinovac said late-stage trial data from Brazil and Turkey showed its vaccine prevented hospitalisation and death in COVID-19 patients but had a much lower efficacy rate in blocking infections.

It said human trials in Brazil had shown around 50% efficacy in preventing infection but 80% efficacy in preventing cases requiring medical intervention.

Indonesia, Turkey, Brazil, Chile, Colombia, Uruguay and Laos have all granted emergency authorisations for the CoronaVac vaccine, Sinovac said.

Indonesia and Brazil are already using CoronaVac due to their participation in large-scale human trials conducted by the company.

Sinovac Life Sciences, the Sinovac subsidiary that is in charge of CoronaVac production, is 15% owned by Thailand’s Charoen Pokphand Group. CP acquired the stake in December when its China-based subsidiary Sino Biopharmaceutical Ltd invested US$515 million in Sinovac Life Sciences.