Sinovac is safe despite not being listed by WHO, FDA insists

THURSDAY, MAY 13, 2021

The Sinovac Covid-19 vaccine is safe to use despite not being listed on the World Health Organisation’s Emergency Use Listing (EUL), said Food and Drug Administration (FDA) secretary-general Dr Phaisan Dankhum.

“There have been questions regarding the safety of the Sinovac vaccine, that it is not on the WHO's EUL,” he said.

“The EUL procedure is used in the Covax project and could be applied in countries where the vaccine registration and administration system is not yet complete. This does not mean that Sinovac has failed the qualification process, since the registration of vaccines in each country does not necessarily have to refer to the WHO listing,” Phaisan said.

He also pointed out that other Covid-19 vaccines made by Pfizer, Moderna, AstraZeneca and Johnson & Johnson had been registered in the United States, the United Kingdom and other European countries before they were listed on the EUL.

“In Thailand, the FDA had registered the AstraZeneca vaccine for use in our country before it was listed on WHO’s EUL, which indicates that being on the EUL is not a prerequisite for a vaccine to be used in any country,” he said.

Phaisan went on to say there are studies proving that Sinovac is effective in preventing Covid-19, which resulted in the Chinese vaccine being registered in 45 countries.

“The vaccine can prevent virus contraction of up to 50 per cent, prevent death from Covid-19 up to 100 per cent and is also 77.9 per cent effective in keeping patients from developing severe symptoms after infection, according to a phase 3 study in Brazil,” he said.

“Furthermore, a study by virology specialist Dr Yong Poovorawan has indicated that vaccine recipients in Thailand have seen increased immunity of 99.4 per cent against the virus within a month of receiving the second Sinovac dose, while immunity in patients who had already been infected for 4-8 weeks also increased to 92.4 per cent after the second jab,” Phaisan added.