IMPORTANT CARGO A container of the first batch of Sinovac Biotech’s CoronaVac vaccine for COVID-19 from mainland China arrives at a cargo terminal in Hong Kong, as the Chinese special administrative region launches its mass vaccination drive this week. —REUTERS
MANILA, Philippines — The Food and Drug Administration (FDA) on Monday granted emergency use authorization to the COVID-19 vaccine made by the Chinese pharmaceutical company Sinovac Biotech, but did not recommend it for front-line health workers at high risk of exposure to the coronavirus and for elderly people due to its varying levels of efficacy.
The FDA decision put economic frontline workers and military personnel at the top of the government’s priority list for inoculation with the vaccine donated by China. Soldiers will get 100,000 doses of the 600,000-dose donation expected to arrive this week.
Staff at government-run hospitals in Metro Manila and other cities were originally at the top of the priority list, but FDA chief Eric Domingo on Monday said late-stage trial data of the Sinovac vaccine, known by its trade name CoronaVac, showed it had a lower efficacy rate when used for health-care workers exposed to the coronavirus compared with healthy people age 18-59.
The Philippines has about 1.4 million health workers.
Not best for health workers
“According to our experts, [Sinovac’s] vaccine is not the best vaccine for them,” Domingo said in a news briefing, referring to the health workers. He said the data showed CoronaVac was only 50.4 percent effective in the high-risk group.
“Therefore, it is not recommended for use in this group,” Domingo said. “That’s better than nothing, but the recommendation of our experts is this is not the best vaccine for [health-care workers],” he added.
CoronaVac showed a higher efficacy rate of 65.3 percent among “clinically healthy” people 18 to 59 years old based on clinical trials in Indonesia, and 91.2 percent based on clinical trials in Turkey, Domingo said.
CoronaVac, according to the FDA, is safe for use and the adverse events reported after immunization were “transient and mostly mild to moderate, similar to common vaccine reactions.”
“The rating for allergy and anaphylaxis is good. There is a low possibility of having allergy or severe allergic reaction,” Domingo said.
CoronaVac will be administered in two doses, four weeks apart.
Third to be approved
It is the third COVID-19 vaccine to get FDA emergency use permit. The first was the Pfizer-BioNTech vaccine, issued a permit on Jan. 14, and the second was the AstraZeneca vaccine, authorized on Jan. 28.
The FDA is reviewing the applications for emergency use permit of Gamaleya Research Institute of Russia and Bharat Biotech of India.
Vaccines approved for emergency use cannot be sold locally and the manufacturers or their local representatives can sell them only to the Department of Health (DOH) and the National Task Force Against COVID-19 or their designated organizations.
Asked how the FDA decision would affect the government’s vaccine rollout plan, which was supposed to start with hospital staff, Vivencio Dizon, deputy program implementer, said the matter had to wait for the
recommendation of the National Immunization Technical Advisory Group.
Dizon said the group would discuss the matter during a meeting on Tuesday.
Presidential spokesperson Harry Roque said the group would probably revise the priority list for the Sinovac vaccine given the limitations on the drug’s use.
“Since the first priority are the health-care workers followed by seniors, they cannot use [the vaccine]. The economic front-liners may be the first along with the soldiers. These are the ones working in industries that were open during the [lockdown],” Roque told a news briefing.
He said the group included farmers, fishermen, miners and workers in the transportation sector, export industries and business process outsourcing.
The priority areas, he said, will be Metro Manila, Cebu and Davao.
Roque said China would need three days from the grant of authorization to deliver the vaccines, which means these could arrive this week.
The vaccines would need only ordinary refrigeration, he said.
Roque said President Duterte, who had expressed preference for a China-made vaccine, would get the vaccine made by China National Pharmaceutical Group (Sinopharm).
Mr. Duterte is 75 and not eligible for CoronaVac.
Infectious disease expert Edsel Salvana of the National Institutes of Health found the FDA decision “interesting.”
“Sinovac got [the authorization], but [it] states that it should not be used for front-line health-care workers, seniors or those with comorbid conditions,” Salvana said. “I would have preferred [health workers get it first], but it depends on what vaccines are available and can be used.”
Indonesian model
In a series of text messages, Salvana said the Philippines may consider following the Indonesian model, where the government vaccinated economic workers ahead of the medical workforce.
Dr. Lulu Bravo, executive director of the Philippine Foundation for Vaccination, said she won’t question the FDA’s decision, but found it “ironic” that health workers won’t get vaccinated first after all.
Sen. Joel Villanueva said the government might be practicing “class vaccination” if it went ahead and use CoronaVac on ordinary citizens after declaring it unfit for health workers.
Villanueva asked the FDA to explain why it was not recommending the vaccine for health workers, but allowing it to be used on other groups.
“If Sinovac is not recommended for health workers, are we not practicing class vaccination by giving it to others?” he said in a statement.
Under the law, he said, patients have the right to full access to information, such as scientific explanation on why they are or are not getting a certain type of vaccine.
Lacson’s analogy
Sen. Panfilo Lacson expressed dismay at the FDA declaration.
“For lack of a better analogy, it’s like a chef who refuses to eat the food that he just cooked because it is not good but he serves to customers,” Lacson said.
In his defense of the proposed COVID-19 Vaccination Act, Sen. Juan Edgardo Angara clarified that the FDA restriction applied only to health workers handling COVID-19 patients.
Senate Majority Leader Juan Miguel Zubiri also clarified that CoronaVac was not recommended for health workers handling COVID-19 cases because of the “higher viral load” that they were exposed to.
“Because they are more exposed to the COVID-19 disease, they need higher efficacy rate. But for normal population, efficacy rate of Sinovac is good enough,” Zubiri said.
Health Secretary Francisco Duque III said the DOH was planning to use its savings to buy 50,000 doses of the Sinovac vaccine, on the suggestion of the COVID-19 task force.
The Philippines had expected to receive 117,000 doses of the Pfizer vaccine from the global procurement pool COVAX by mid-February, but the delivery was delayed due to the need to sign an indemnification agreement to free the manufacturer from liability in case of adverse side effects.
Roque said the Philippines was not required to sign such an agreement for the donated Sinovac vaccines.
Injury from CoronaVac use will be covered by the indemnification fund to be created under the proposed vaccination law, he said.
—With reports from Leila B. Salaverria, Melvin Gascon and Reuters