CoronaVac’s side effects on senior citizens ‘within usual limits,’ says FDA

FILE PHOTO: A booth displaying a coronavirus vaccine candidate from Sinovac Biotech Ltd is seen at the 2020 China International Fair for Trade in Services (CIFTIS), following the COVID-19 outbreak, in Beijing, China September 4, 2020. REUTERS/Tingshu Wang

MANILA, Philippines — Side effects reported by health care workers who are senior citizens vaccinated with CoronaVac vaccines developed by China’s Sinovac BioTech are “within the usual limits,” the Food and Drug Administration (FDA) said Thursday.

This is one of the factors the agency considered in deciding to allow the use of CoronaVac shots to senior citizens, when it was only previously recommended to be administered on clinically healthy individuals aged 18 to 59 years old, FDA Director General Eric Domingo said.

Domingo said there are about 700 healthcare workers who are senior citizens who received CoronaVac jabs upon signing waivers with their respective hospitals.

“Noong tiningnan natin ‘yung datos, ‘yung kanilang mga adverse events ay within the usual limits ng adverse effects na nakikita sa ating mga bakuna,” he said in a Laging Handa public briefing.

(When we looked at their data, we found that the adverse events they reported are within the usual limits of adverse events usually experienced in vaccination.)

The FDA also allowed the use of CoronaVac on senior citizens considering the limited available supply of vaccines for them. At present, the government has been administering AstraZeneca vaccines to senior citizens, which Domingo said,  has already run out of supply.

Citing early reports on the efficacy of the vaccine, Domingo said its efficacy rate among senior citizens is around 51% to 52% “at the least.”

The safety data from Phase 1 and Phase 2 trials of the vaccine is also good, he added.

“Kaya noong nakita natin lahat ito, at ‘yung pangangailangan ng ating bansa na protektahan ang mga senior citizen ay binigyan na natin ng go signal na gamitin ang mga bakuna na ito sa mga senior citizen knowing that the benefit outweighs the risk when it comes to the situation right now dito sa ating bansa,” Domingo said.

(So when we saw all this, and considering the need to protect senior citizens, we gave the go signal for the use of the vaccine on senior citizens, knowing the benefit outweighs the risk when it comes to the situation right now in the country.)

Domingo said senior citizens with acute and severe illnesses, like those with uncontrolled hypertension, are excluded from receiving CoronaVac.

EDV