FDA unsure of Sinovac effect

Duterte asks agency to explain ‘colatilla’ on vaccine use for frontliners

The Food and Drug Administration has expressed reservations on the efficacy of the Sinovac COVID-19 vaccine for medical frontliners and senior citizens even as President Rodrigo Duterte summoned the head of the agency to explain its position.

The FDA issued an emergency use authorization to Sinovac but recommended that it be used only for clinically healthy individuals aged 18 to 59 years.

In a television interview yesterday, FDA director general Eric Domingo said there was not enough data to remove the colatilla since Sinovac’s own Phase 3 clinical trials had participants mostly aged 18 to 59 years old.

“So since there is not enough clinical data for use on 60 and above, we cannot allow it for use on them. But if they give us clinical data on that, then we can expand the allowed indication age,” he said.

“As for medical workers, we did not recommend it for frontline workers dealing with COVID-19, a very specific sub-group, because the efficacy there is about 50.4 percent, compared to 63 percent to 91 percent on healthy 18 to 59 year olds where the vaccine would be very, very good. All vaccines have certain people that it reacts well to and those that it does not,” Domingo added.

Presidential spokesman Harry Roque said Duterte wanted a more in-depth explanation from the FDA even as he respected the decision of the agency.

“FDA director general Eric Domingo has been summoned, and the President has relayed his concern as to why there was that kind of colatilla,” Roque said.

“The President respects the opinion of experts, so we let that colatilla remain. But his question is this: the World Health Organization said 50 percent efficacy is acceptable, so why is there a need for such a colatilla,” he added.

Domingo said the FDA would rather err on the side of caution given that the data of Sinovac has not yet been published in a peer-review journal.

“What we got are the raw reports that we had to analyze ourselves. We can only allow indications that we can be sure of. We can see that for 18 to 59, it has very good clinical efficacy. But for others, we cannot prove yet without necessary information.”

“If you look at the vaccination in Indonesia and Brazil, they did clinical trials there and they have results. Second, if you look at their phased programs, they started with 18 to 59 first. And once they were done with that, they expanded to 60 and above. So they already have real world experience. But let me tell you that in China, until now, they only used it for 18 to 59. We received that information from the Chinese embassy,” he added.

But at the House of Representatives, former health secretary and Iloilo Rep. Janette Garin said the FDA’s colatilla should be reviewed.

“FDA’s decision on Sinovac should be reviewed and revisited. For the nth time, we have heard our experts say, vaccination has three goals: to prevent severe disease and death, to prevent clinical disease, and to prevent transmission,” Garin said.

“While I agree that everybody is careful about vaccines being given to seniors, it’s untenable to restrict the vaccine among healthcare workers,” she added.

Aside from Sinovac, the FDA also issued emergency use authorization to Pfizer-BioNTech and AstraZeneca.

Domingo said Russia’s Sputnik vaccine and India’s Bharat Biotech have pending applications, while other potential candidates include Moderna, Novovax and Covovax.

Beijing has donated 600,000 Sinovac doses that are set to arrive either before the end of February or early March.

“The products are already there. We are managing the procedures of making the delivery and we will expect that the Philippines will be one of the important countries where we’re going to supply the products,” Sinovac general manager Helen Yang said in an interview on ANC.

Roque said Duterte wants to personally witness the arrival of the Sinovac doses.

“We are Filipinos. We honor our debt of gratitude. In our time of need, our friend China is sending our first vaccines,” he said.

The country was supposed to receive 117,000 Pfizer vaccines in mid-February, but the lack of an indemnity agreement pushed back the delivery.

Topics: Food and Drug Administration , Sinovac vaccine , COVID-19 , medical frontliners
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