FDA: Sinovac can't be used on elderly until proven safe for them
MANILA, Philippines — Chinese drugmaker Sinovac Biotech must prove its COVID-19 vaccine is safe and effective for the elderly before the jab can be administered to them, the country’s Food and Drug Administration said Friday.
FDA Director General Eric Domingo said Sinovac and its local distributor need to present evidence to the agency that senior citizens can receive its CoronaVac vaccines before the Emergency Use Authorization for it can be revised to cover people aged 60 and above.
“Once they submit all the scientific data and evidence, then we can always revise the EUA. But at this time, we have not received this evidence, so the approved indication is for people who are 18 to 59 years old,” Domingo said.
While most studies have shown adverse effects of COVID-19 vaccines are less likely among the elderly, the FDA chief said “we still need the actual data.”
The EUA issued to CoronaVac clears the jab for use only on “clinically healthy” individuals between 18 to 59 years old. The government’s coronavirus task force eventually approved the recommendation to give CoronaVac to medical frontliners as it is 100% effective in staving off moderate to severe cases.
Domingo said the vaccines developed by Pfizer-BioNTech, AstraZeneca and Sputnik V can be administered to senior citizens. However, only AstraZeneca shots are currently available in the country.
Vaccine czar Carlito Galvez said Wednesday the government is eyeing the use of CoronaVac on senior citizens, a recommendation that Malacañang supported. President Rodrigo Duterte, himself a senior citizen, has not been cleared to use Sinovac. Elderly Cabinet officials have also begged off from the vaccine.
Senior citizens are next in line for inoculation once 1.7 million healthcare workers get vaccinated.
Sen. Risa Hontiveros said giving the vaccine to senior citizens would be “intentional malpractice.”
Lack of FDA authorization did not stop members of the Presidential Security Group from using smuggled Sinopharm vaccines last year. According to columnist Mon Tulfo, who has also admitted to receiving the smuggled vaccines, Cabinet officials and a senator have also been inoculated with the smuggled vaccines.
Nobody has been held to account for the smuggling nor for the unauthorized vaccinations, which the Palace and the president excused.
The Philippines launched its vaccination drive against COVID-19 on March 1 with 600,000 doses of Sinovac, which were donated by Beijing. AstraZeneca shots supplied by the World Health Organization-led COVAX Facility came days later.
Galvez said 1.4 million more doses of CoronaVac will arrive next month.
A total of 240,297 people have so far received first doses of the Sinovac and AstraZeneca jabs.
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