The Food and Drug Administration (FDA) on Monday granted emergency use authorization (EUA) to Sinovac Biotech’s vaccine for the coronavirus disease 2019 (Covid-19) vaccine after a thorough review by the country’s medical and regulatory experts.
“It is decided that all conditions for an EUA are present and that the benefit of using the vaccine outweighs the known potential risks. The interim data from the ongoing Phase 3 trial shows that when the vaccine is used on clinically healthy members of the community age 18 to 59, it has an efficacy of 65.3 to 91.2 percent after the first dose,” FDA Director General, Dr. Eric Domingo said in an online press briefing.
Domingo noted that the 65.3-efficacy rate was seen in Indonesia while the 91.2 efficacy rate was seen in Turkey.
However, he added that the vaccine has a lower efficacy rate of 50.4 percent when used on healthcare workers exposed to Covid-19 so it is not recommended for use to this group.
The vaccine regimen consists of two equal standard doses of 0.5 ml each, given four weeks apart.
Domingo said the adverse events reported were transient and mostly mild to moderate, similar to common vaccine reactions and no specific safety concerns were identified.
He said close monitoring and surveillance are needed after immunization in case more adverse events may emerge.
“The vaccine is a good option for individuals who have allergies to components of other available vaccines which cause anaphylaxis and other severe allergies. It is also certified Halal by Indonesian authorities,” he added.
The EUA granted to the vaccine is not a marketing authorization or a Certificate of Product Registration, as stated under Executive Order No. 121.
Domingo said IP Biotech Inc., the manufacturer’s local representative, would supply the vaccine only to emergency response stakeholders consistent with the terms and conditions of the EUA or their designees authorized to procure the vaccine in line with the Covid-19 vaccination program.
The country has signed a deal with the company for 17 million doses of its vaccine and the first tranche of deliveries is expected to arrive in May.
Sinovac Biotech’s Covid-19 vaccine, also known as the Coronavac, is the third vaccine to be granted an EUA. AstraZeneca and Pfizer-BioNTech’s Covid-19 vaccines received their EUAs last month. SOVEREIGNPH