WHO won’t comment on Sinovac efficacy yet

The World Health Organization (WHO) on Tuesday said it was still evaluating the COVID-19 vaccine developed by the Chinese company Sinovac and could not comment on its efficacy.

“We are not privy to all the information being shared by the manufacturers with our regulations team for the evaluation of the vaccine, and so we cannot comment at this point of time on reported efficacies which have been basically taken out of media articles,” said Dr. Rabindra Abeyasinghe during an online briefing.

The Food and Drug Administration (FDA) on Monday approved the Sinovac vaccine for emergency use but said it is not recommended for health workers due to its lower efficacy rate of 50.4 percent in that group.

Clinical trials show the vaccine’s efficacy rate among healthy individuals aged 18 to 59 ranges from 65.3 percent to 91 percent%.

“Our understanding is that there may have been some information that was shared with the FDA in the Philippines that made it necessary for the Philippines’ FDA to decide on this limited use of vaccines in the 18 to 59 year age group,” Abeyasinghe said.

The Palace said health workers and the elderly will not be the first to get inoculated against COVID-19, even though they are on top of the list of priorities for vaccination, because of the Chinese vaccine’s lower efficacy rates for both groups.

The WHO statement seemed at odds with the Palace spokesman’s assertion that Sinovac had been approved by the UN health agency.

Abeyasinghe said the WHO is also still evaluating China’s Sinopharm vaccine .

The leader of the minority bloc in the House of Representatives on Tuesday called the FDA approval of the Chinese vaccine for emergency use “half-baked.”

House Minority Leader and Abang Lingkod Party-list Rep. Joseph Stephen Paduano said he was puzzled why the FDA granted the emergency use authorization for the vaccine despite being unable to recommend it for use on health workers.

"This a case of self-contradiction," Paduano said, and urged the FDA to issue a clarification.

"It's very complicated because according to FDA director general Eric Domingo, the vaccine is 91 percent effective in Turkey, 65.3 percent in Indonesia but it registered only 50.4 percent efficacy among medical front liners in Brazil," Paduano said.

Paduano said the FDA "has further eroded public trust and confidence" in vaccination. He added that the FDA' contradicting statements on the vaccine is not helping the government’s inoculation program.

In approving the emergency use of the Chinese vaccine, Domingo said it was better to have some protection than none.

A pro-vaccination group, the Philippine Foundation for Vaccination, urged the public to trust the FDA and the experts.

“We have to trust the experts [because] they're the ones looking at the data presented. It’s easy to make a judgment but it is not easy to look and pore over scientific data," Bravo told ANC's Headstart.

"Only the vaccine experts, the FDA have all the paperwork,” she said.

Government needs to speed up the approval of other vaccines as the country's initial supply from Pfizer has yet to arrive, said Dr. Tony Leachon, a former adviser of the National Task Force against COVID-19.

"We need to look at these other brands, because the longer we wait and are unable to reopen the economy, the more likely it is that we will have an economic depression,” he said.

Essential workers are urged to get the Chinese vaccine to jumpstart immunization, Leachon added.

"I would encourage essential workers to go on Sinovac because 50 percent is the threshold given by the WHO. We don’t have any choice considering we need to move to perk up the economy," he said.

The best vaccine is the "one that will be available to you that is approved by the experts," Bravo said.

"You can wait for a year, two years but you cannot predict what would happen," she said.

President Rodrigo Duterte's decision to reject the proposal to place the country under modified general community quarantine (MGCQ) and wait for the arrival of vaccine was "rational and logical," said Leachon.

"If we’re going to look at the health metrics I don’t think we’re ready for a modified GCQ," he said.

The country's COVID-19 cases and fatality rate are "increasing day to day," and the reproduction number is "quite high" at 1.22, he added.

"And then you have a threat of the variant and the vaccines are not yet available," he said.

The government earlier said 50 million to 70 million Filipinos can be immunized against COVID-19 by yearend if vaccine supplies arrive on time.

Vaccine czar Carlito Galvez Jr., on the other hand, said the procurement of the vaccines was delayed over manufacturers’ concerns that the Philippines might sue them, just like it did with Sanofi over the Dengvaxia vaccines.

The government is still assessing who will be given the Sinovac vaccine, the Department of Health (DOH) said Tuesday.

The interim National Immunization Technical Advisory Group (NITAG) i reportedly discussing how the country’s prioritization scheme, whic lists health workers as the top priority, will be followed whil taking into consideration FDA’s recommendation not to use the vaccin on frontline health workers.

The NITAG is looking into the possibility of administering the Sinova vaccine to health workers who are not directly tending to COVID-19 patients.

China is donating 600,000 doses of the said vaccine, of which 100,00 are earmarked for the Department of National Defense (DND).

Abeyasinghe, the WHO representative in the Philippines, said that for high-risk individuals, higher efficacy vaccines would be more appropriate.

Only Pfizer and AstraZeneca have been included in the WHO’s emergency use listing, making it easier for member countries to approve the said companies’ COVID-19 vaccines for emergency use. Both have already been granted EUA in the Philippines.

Unlike Sinovac, which has an efficacy rate of 65.3 percent, based on trials in Indonesia, and up to 91.2 percent based on trials done in Turkey, Pfizer has an efficacy rate of 95 percent.

The WHO is a member of the COVAX Facility, which aims for equitable access to COVID-19 vaccines especially for low and middle-income countries.

The Philippines was supposed to receive its first batch of Pfizer’s COVID-19 vaccines through the COVAX Facility this month. But it was delayed because of the lack of an indemnification agreement that would shield the drug manufacturers from being sued over adverse side effects.

Health workers were supposed to receive the Pfizer vaccines.

Abeyasinghe said they “are making every effort to see how we can accelerate that process” of the COVAX Facility, as it remains unclear when the Philippines could receive supplies from it.

Senate President Pro Tempore Ralph Recto on Tuesday said he trusted the judgement of the FDA.

“Nevertheless, I will wait for a better vaccine to be available,” he said.

Health Secretary Francisco Duque III said the Sinovac vaccines will be the first to arrive in the country.

Meanwhile, Senator Risa Hontiveros s urged the National Taskforce against COVID-19 (NTF) to speed up the procurement of vaccines effective for health workers and high-risk groups after the FDA recommended against using Sinovac for them.

Hontiveros said the NTF should stick to the vaccination prioritization as recommended by the WHO by speeding up procurement of vaccines effective for health workers with high exposure to COVID-19.

She warned that rearranging the priority list might lead to further compromise later in the vaccination program.

Also on Tuesday, a group calling itself the Coalition for People's Right to Health said it was “deeply bothered” by the political underpinnings surrounding the recent decisions of health regulatory agencies.

It called on the FDA to review its decision, based on the lack of peer-reviewed, published, and publicly available evidence—a key part of our 8-point policy calls for a more equitable and transparent COVID-19 vaccine roll-out.

“A vaccine roll-out cannot prosper when there is doubt and distrust in a health system that is supposed to actively safeguard their well-being over false reassurances,” the group said.

Topics: Food and Drug Administration , World Health Organization , Sinovac , Vaccine , COVID-19 , Rodrigo Duterte
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