MANILA

Philippines grants EUA for Sinovac vaccine

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(UPDATED) The government has granted an emergency use authorization (EUA) for the inactivated vaccine developed by Chinese pharmaceutical company Sinovac Life Sciences against coronavirus disease 2019 (Covid-19), Food and Drug Administration (FDA) Director General Eric Domingo announced Monday, February 22, 2021.

This means that the Sinovac vaccine shipment that is expected to arrive Tuesday, February 23, would be allowed for use, Domingo said.

The vaccine may be administered on individuals 18 to 59 years old who are clinically healthy.

However, it is not recommended for health workers who are exposed to Covid-19 patients, Domingo said.

He explained that clinical trials in Brazil showed an efficacy rate of only 50.4 percent when the vaccine was administered on health workers at a hospital treating Covid-19 patients.

“So mas mabuti na po ‘yon kaysa sa wala, pero ang rekomendasyon nga po natin, ng ating mga expert, ay hindi po ito ‘yong pinakamagandang bakuna para sa Manila,” Domingo said.

(This is better than nothing, but our recommendation is this is not the best vaccine for healthcare workers.)

The government has allotted the 117,000 doses of Pfizer-BioNTech vaccine that were supposed to arrive in February to healthcare workers. Delivery of the vaccine, however, has been delayed.

On the other hand, Domingo said ongoing clinical trials in Indonesia and Turkey, which involve clinically healthy individuals 18 to 59 years old, have yielded efficacy rates of 65.3 percent and 91.2 percent, respectively. Indonesia has also certified the Sinovac vaccine as halal.

Safety

Domingo said "it is reasonable to believe that the Sars-CoV-2 vaccine (Vero Cell), inactivated (CoronaVac), may be effective" in preventing Covid-19.

"The benefits of using the vaccine outweighs the known and potential risks," he added. The vaccine will be administered in two doses, 0.5 ml each, given four weeks apart.

Adverse reactions to the Sinovac vaccine were transient, and mostly mild to moderate, similar to common vaccine reactions, Domingo said.

"No specific safety concerns were specified, but it must be noted that this only reflects limited follow-up and more adverse effects will emerge, that's why close surveillance and monitoring is needed after the immunization," he added.

Domingo also said the Sinovac vaccine is a good option for individuals who have allergies to components of other available vaccines. The World Health Organization earlier advised against giving the Pfizer-BioNTech and Moderna vaccines to individuals with a history of anaphylaxis to polyethylene glycol (PEG).

The government is expecting delivery of 600,000 doses of the Sinovac vaccine on February 23.

The shipment includes 100,000 doses that were donated by the Chinese government to the Department of National Defense (DND).

Sinovac is the third vaccine developer to get an EUA in the Philippines, after Pfizer and AstraZeneca on January 14 and 28, respectively.

Other vaccines

The Philippines has been allotted 117,000 doses of the Pfizer-BioNTech vaccine by Covax, the WHO initiative to ensure global equitable access to vaccines. This will be administered to healthcare workers from 32 facilities in Metro Manila, Vicente Sotto Memorial Medical Center in Cebu City and Southern Philippines Medical Center in Davao City.

Covax has also committed up to 9.29 million doses of the AstraZeneca vaccine to the Philippines in the first half of 2021.

Read: Covax allots 9.4M doses of Pfizer, AstraZeneca vaccines for PH

Applications for EUA that are still pending in the Philippines are those from Gamaleya and Bharat Biotech.

Domingo said Gamaleya submitted the requirements on Friday, February 19. Bharat, on the other hand, has not submitted its clinical trials data.

The EUA, effective only for the duration of the public health emergency, is not a marketing authorization nor a certificate of product registration. It can't be sold commercially, Domingo stressed.

Sinovac's local partner, IP Biotech, can only sell the vaccine to the Department of Health and the National Task Force Against Covid 19 or their local partners in the immunization program. (Marites Villamor-Ilano / SunStar Philippines)


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