FDA approves use of Sinovac vaccine on senior citizens

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Metro Manila (CNN Philippines, April 7) — The Food and Drug Administration took a 180-degree turn and approved the use of the vaccine from China’s Sinovac Biotech on senior citizens.

“After considering the recommendation of the experts and the current situation of high COVID-19 transmission and limited available vaccines, the FDA is allowing the use of Sinovac on senior citizens,” FDA Director General Eric Domingo said in a statement.

He said the approval was based on reports from other countries shared by the vaccine expert panel, “but all factors were considered.”

Domingo also noted that vaccination should be preceded by an evaluation of the receiver’s health status and exposure risk to assure that benefits outweigh risks.

Initially, the FDA previously recommended the use of Sinovac’s CoronaVac on clinically healthy individuals aged 18-59 under the Emergency Use Authorization it granted to the manufacturer because of its low efficacy rate of 50.4% for high-risk groups.

Domingo said the letter of approval was already sent to the Department of Health to inform them of the change.

In a joint statement, the FDA and the Department of Health said that the health status of senior citizens must be evaluated first before getting inoculated with CoronaVac.

"The DOH and FDA emphasized that the vaccination of senior citizens using CoronaVac should strictly be preceded by careful evaluation of the person's health status and exposure risk," read the statement. "There is a Phase I/II safety and immunogenicity data for seniors but efficacy data is not yet sufficient to establish vaccine efficacy."

Domingo also reiterated that CoronaVac is allowed for adults with controlled comorbidities.

RELATED: Here's what adults with comorbidities need to know before getting the COVID-19 vaccine

During the Laging Handa briefing on Wednesday, Dr. Nina Gloriani, head of the government’s Vaccine Development Expert Panel, said they already recommended to the regulator the use of the said vaccine on the elderly to ensure continuity of the immunization program.

Mayroon na kaming ganoong rekomendasyon,” she said when asked about the matter.

[Translation: We already have that recommendation]

Gloriani explained that their call is also based on the continuing surge in new infections, thus there is a need to use whatever vaccine supply the country has to ensure protection of Filipinos, especially the priority sector.

This recommendation was also due to the depletion of the supply of AstraZeneca vaccine in the country, the brand that can be given to senior citizens, and the possible delay in the delivery of additional doses from the World Health Organization-led COVAX facility, she added.

Vaccine czar Carlito Galvez Jr. also said last month that they are targeting to inoculate up to 9 million Filipino senior citizens using Sinovac's vaccine.

Other countries, specifically China, have started the use of the said vaccine on citizens aged 60 and above despite lack in enough data since only a small number of senior citizens were included in previous trials.

Gloriani assured that based on their previous evaluation, CoronaVac has a good safety profile, causing only mild to moderate side effects that would last up to just two days, and also prevents severe COVID-19 cases.

Speaking to CNN Philippines’ News Night, she said based on previous studies, anti-bodies produced by the elderly who received the vaccine were almost the same as those produced by people aged 18-59 years old.

Gloriani said there is still not much data regarding its efficacy on variants, but that there is a “theoretical possibility” it will work well against them given that it is an inactivated vaccine, or it uses killed viral particles.

"Nasa pandemiya po tayo ngayon at hindi po tayo pwedeng mag-delay nang mag-delay [ng vaccination] dahil iyong bakuna na hinihintay natin ay hindi pa dumarating," she said. "Kung ano po iyong mayroon tayo sana ay magamit na natin."

[Translation: We are in a pandemic and we cannot delay vaccination just because the vaccine we are waiting for has not arrived yet. We hope that whatever we have will be used already.]

The China-made vaccine earlier caused concern for its use on healthcare workers due to its low efficacy rate of 50.4%. Despite this, the Inter-Agency Task Force for the Management of Emerging Infectious Diseases approved the recommendation for its use to medical workers to already give them the protection they need amid the fight against the virus.

Local government units already started vaccinating senior citizens and people with comorbidities late March following the rollout for the country's 1.7 million healthcare workers. Vaccine supply mostly came from donations from China and the COVAX facility.

By end of the year, the government targets to vaccinate up to 70 million Filipinos.