Why FDA is allowing Sinovac's COVID-19 vaccine for seniors

Kristine Sabillo, ABS-CBN News

Posted at Apr 09 2021 07:48 PM | Updated as of Apr 09 2021 08:20 PM

MANILA — The Food and Drug Administration (FDA) on Friday acknowledged that while Sinovac’s vaccine is proven safe even for senior citizens, there is still insufficient data on whether it is effective against COVID-19.

When asked about the basis for allowing the vaccine’s use for those 60 years old and above, FDA Director General Eric Domingo said, “Unang una nakita na nga natin may more than 700 na senior citizen health care workers dito sa Pilipinas na nagpabakuna. At ung tinignan natin yung adverse effects sa kanila are within reasonable levels, acceptable levels.”

(First of all, we saw 700 senior citizens in the Philippines vaccinated with it. And if we look at their adverse events, it’s within reasonable levels, acceptable levels.)

This, after a day the FDA reversed its decision that Sinovac cannot be used by senior citizens, citing the recommendation of the vaccine expert panel, the surge in COVID-19 cases and the lack of other vaccines.

Domingo said there are no concerns about the safety of the vaccine. 

However, he admitted, “Talagang ang efficacy (data) ay very limited. That’s true.”

(Its efficacy data is very limited. That’s true.)

The FDA official said the only data that they have on Sinovac’s efficacy for senior citizens is the Brazil trial, which only involved a few hundred elderly people out of thousands of participants, and Phase 1 and Phase 2 trials.

In a separate statement, the National Task Force Against COVID-19’s Task Group on Vaccine Evaluation and Selection said experts also took into consideration reports from countries already using Sinovac for the elderly.

“While the general safety profile of the vaccine based on available data is deemed to be acceptable, the FDA reiterates that their guidance may change and evolve as more efficacy, immunogenicity and safety data become available,” the task force said.

The group said “special attention” will be given to senior citizens with hypertension and that there will be a screening process for the vaccinees.

The FDA previously said that the Phase 3 efficacy data is “insufficient.”

“But knowing also na wala naman tayong vaccine right now na maaaring gamitin sa mga senior citizens dahil wala pa tayong maexpect na supply for April other than the Sinovac, we found that it is more beneficial to vaccinate them now than to wait for ibang vaccine,” he said.

(Knowing that we don’t have any other vaccine now for senior citizens and we are not expecting any supply for April other than Sinovac, we found that it is more beneficial to vaccinate them now than to wait for ibang vaccine.)

He said that the “benefit-to-risk ratio is favorable" for senior citizens who are at much higher risk for severe illness or death due to COVID-19.

Domingo said this is especially important as the transmission rate of COVID in Metro Manila and nearby provinces is very high.

On Friday, the Philippines recorded 12,225 new cases, which is the 3rd highest since the start of the pandemic. The newly reported deaths are also a record-high at 401.

The surge in cases is happening as the government struggles to speed up its vaccine rollout amid a global shortage.