Thursday, March 4, 2021

Sinovac Covid-19 Vaccine Is Safe: FDA

Sinovac Covid-19 Vaccine Is Safe: FDA

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

“Nakikita po natin ang datos, ang safety profile niya is good, ‘yung mga adverse event po nito is mild to moderate, the usual po na pananakit sa braso, konting sinat..mababa po ang posibilidad na magkaroon ng allergies or yung severe allergy o anaphylaxis sa bakunang ito (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.

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.

“Ang nakita po kasi dun sa trial sa Brazil – binigay po ito sa mga health workers na nagta-trabaho sa (What we saw in the trial in Brazil – this was given to healthcare workers at) hospitals treating Covid-19 – is 50.4 percent efficacy,” Domingo said. “Mas mabuti naman po iyon kaysa sa wala pero ang recommendation ng ating mga expert ay hindi po ito ang pinakamagandang bakuna para sa kanila (This efficacy is better than none but our experts recommend that this is not the best vaccine for them).”

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. (PNA)

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