WHO: Gov’t may know something about Sinovac that we don’t
MANILA, Philippines — The representative of the World Health Organization (WHO) to the Philippines on Tuesday said the limitations the Food and Drug Administration (FDA) had set on the use of Sinovac Biotech’s COVID-19 vaccine were likely due to some disclosure the Chinese pharmaceutical company had made to the Philippine government.
“There may have been some information that was shared with the FDA in the Philippines that made it necessary for the [regulator] to decide on this limited use of [the vaccine] in the 18-to-59-year age group,” Dr. Rabindra Abeyasinghe said in a news briefing at the Department of Health (DOH).
The FDA on Monday granted emergency use authorization to CoronaVac, the COVID-19 vaccine of Sinovac, but did not recommend it for health workers at high risk of exposure to the coronavirus and for elderly people due to its varying levels of efficacy.
It’s up to gov’t
Citing late-stage trial data of CoronaVac, Eric Domingo, the FDA chief, said it was only 50.4 percent effective in the high-risk group compared with healthy people age 18-59.
“According to our experts, [Sinovac’s] vaccine is not the best vaccine for them,” Domingo said.
Asked if the WHO believed it was appropriate for the FDA to limit the use of CoronaVac, Abeyasinghe said the world body would leave the matter to be decided by Philippine authorities.
“In the absence of clear information that the WHO can access, we would leave it to the Philippines’ FDA and the Philippine government to prioritize [who they feel should get the vaccine],” Abeyasinghe said.
But when the WHO has completed its emergency use listing process, it will have clearer evidence of CoronaVac’s efficacy for different age groups, and will make appropriate recommendations, he added.
“We believe that using vaccines with higher efficacy to protect the most at-risk, who will be naturally more exposed to COVID-19 infections, will be a better solution, especially if that process can be accomplished without too much delay,” Abeyasinghe said.
The WHO, he said, is also reviewing the emergency use application of China National Pharmaceutical Group (Sinopharm) for its COVID-19 vaccine, and the world body will have a decision by March.
“We are not privy to all 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,” Abeyasinghe said.
‘Half-baked’ authorization
Lawmakers slammed the FDA on Tuesday for the “half-baked” authorization it had given to the Sinovac vaccine.
House Minority Leader Joseph Stephen Paduano called the FDA action “a case of self-contradiction”—
authorizing CoronaVac for emergency use but not recommending it for health workers and elderly people.
“This development only indicated that the [authorization] issued to Sinovac was half-baked,” Paduano said in a statement. He criticized the FDA for “putting the image of [the] Sinovac vaccine in a bad light, which, in effect, cast[s] doubt on its efficacy.”
He said the FDA action had “further eroded public trust and confidence in inoculation.”
Bayan Muna Rep. Carlos Zarate also expressed concern over the authorization of CoronaVac, and asked why the government’s vaccination program seemed to be dependent on Sinovac and Sinopharm.
Zarate said the FDA had authorized the Pfizer and AstraZeneca vaccines way ahead of CoronaVac, but the health and vaccine procurement officials did not work immediately on the indemnification agreements required by the manufacturers, which “certainly they knew very well since other countries also complied with it.”
Also on Tuesday, BHW Rep. Angelica Natasha Co urged the Philippine Health Insurance Corp. (PhilHealth) to approve coverage of hospitalization due to adverse effects of COVID-19 vaccines.
On Monday, the House of Representatives passed on third and final reading a bill creating a P500-million indemnification fund for people who would suffer vaccine injury.
