FDA head defends Sinovac Covid vaccines as safe

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FILE PHOTO: An employee inspects vials containing CoronaVac, Sinovac Biotech's vaccine against the coronavirus disease (COVID-19), at Butantan biomedical center in Sao Paulo, Brazil, January 12, 2021. REUTERS/Amanda Perobelli/File Photo

Food and Drug Administration (FDA) Director General Eric Domingo on Monday said that the Sinovac Biotech’s vaccine for the coronavirus disease 2019 (Covid-19) is safe with an efficacy rate of 65.3 to 91.2 percent.

We can see in the data, its safety profile is good, its adverse events are mild to moderate, the usual pain in the arm and feeling feverish…the rate of possibility of allergies, severe allergies or anaphylaxis is low,” Domingo said in an online public briefing in Filipino.

However, he said the vaccine is recommended for use on clinically healthy members of the community aged between 18 to 59 years old only and not on healthcare workers who are exposed to the threat of Covid-19.

What we saw in the trial in Brazil – this was given to healthcare workers at hospitals treating Covid-19 – is 50.4 percent efficacy. This efficacy is better than none but our experts recommend that this is not the best vaccine for them,” Domingo said in Filipino.

The Sinovac vaccine regimen includes two equal standard doses of 0.5 milliliters each, given four weeks apart.

It is the third vaccine to be granted an emergency use authorization (EUA) in the country after AstraZeneca and Pfizer-BioNTech’s Covid-19 vaccines that got the EUA from FDA last month.

Meanwhile, the Department of Health said specific details as to the shipment dates and volume of the 600,000 doses of Sinovac are currently being finalized by vaccine czar Secretary Carlito Galvez Jr.

“Timeline of COVAX doses and other procured vaccines are also currently being finalized by the vaccine cluster,” the DOH said in a statement.

 

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