MANILA (UPDATE) — The Food and Drug Administration has granted an emergency use authorization for the COVID-19 vaccine of China's Sinovac Biotech, paving the way for its delivery to the Philippines, an official said Monday.
“After a thorough and rigorous review of the currently available published and unpublished data by our regulatory and medical experts, the FDA is granting an emergency use authorization to the COVID-19 vaccine of Sinovac Life Sciences Company, known as SARS-CoV-2 vaccine Vero Cell Inactivated, o yung trade name nya ay CoronaVac," FDA Director General Eric Domingo said during a Laging Handa briefing.
"The benefit of using the vaccine outweighs the known and potential risk,” he added.
Domingo said that interim data from Sinovac show the vaccine has an efficacy rate on patients aged 18 to 59 years of 65.3%, based on trials in Indonesia, and up to 91.2% based on trials done in Turkey.
“However, it has a lower efficacy rate of 50.4% when used on health care workers exposed to COVID-19. Therefore, it is not recommended for use in this group,” the official said.
3 TO 5 DAYS
Before the announcement, Health Secretary Francisco Duque III said during the same briefing that China’s Sinovac is the COVID-19 vaccine brand likely to arrive in the Philippines before the month ends.
“Malamang, Sinovac po yan ang posibleng dumating na 600,000 doses (Sinovac’s 600,000 doses is likely to arrive). Good for 300,000 individuals,” Duque said.
He said that once the EUA is released, it will only take 3 to 5 days for the Chinese Embassy to prepare the shipment of the vaccines.
This is the third COVID-19 vaccine product that has received an EUA in the Philippines, following those developed by Pfizer and AstraZeneca.
Palace spokesman Harry Roque earlier said 600,000 Beijing-donated Sinovac shots would arrive on Feb. 23. He said 100,000 of these doses would go to the military, and the rest to health workers.
However, Roque later said that the lack of an EUA might delay the arrival of the Sinovac vaccines.
MILD TO MODERATE SIDE EFFECTS
Domingo said experts recommend two equal and standard doses of 0.5 mL each, given 4 weeks apart, for patients receiving Sinovac's vaccine.
“The adverse events reported were transient and mostly mild to moderate similar to common vaccine reactions," he said.
"No specific safety concerns were identified. But it must be noted that this only reflects limited follow-up, and more adverse effects may emerge that’s why close surveillance and monitoring is needed after the immunization,” he added.
Besides being certified Halal by Indonesia, Domingo said Sinovac is a “good option for individuals who have allergies to components of other available vaccines such as the polyethylene glycol and polysorbate.”
The 2 ingredients are said to cause anaphylaxis and severe allergies, although such effects were very rare.
Polyethylene glycol is said to be among the ingredients of mRNA vaccines like that of Pfizer’s, while polysorbate is said to be in viral vector vaccines.
Before Sinovac’s EUA was approved, the government was expecting Pfizer to send the first batch of doses through the COVAX Facility.
But the shipment was delayed due to a pending indemnification agreement. The Philippine government said it already signed the agreement with COVAX, but the World Health Organization, which is a member of COVAX Facility, said it is still waiting a separate indemnification deal from Pfizer.
Vaccine czar Carlito Galvez, Jr. previously said the delay will only take a week. There is still no update as of press time.
The FDA is currently evaluating the EUA application of Russia’s Gamaleya Institute, and awaiting documents from India’s Bharat Biotech.
Several countries, including in Asia, have already rolled out their respective COVID-19 vaccination programs.
More than 561,000 coronavirus infections have been confirmed in the Philippines, as of Sunday, including 26,238 active cases.