The Food and Drug Administration said Thursday that Sinovac COVID-19 vaccine is found to be at least 51% effective among senior citizens, noting that the vaccine from China should not be given to elderly with acute illness and uncontrolled hypertension.
“Based on what we saw on Phase 1 and Phase 2 and some Phase 3 (human trial) clinical trials in other countries, the efficacy rate [of Sinovac on seniors] is at 51% to 52%,” Domingo said.
We [also] have 700 health workers aged 60 and above who got Sinovac because they signed a waiver, and the adverse events we saw were the usual,” he added.
“We can say the benefits outweigh the risk. That is why the DOH requested us to revise our recommendation, and also because we do not have other available vaccine brands alongside the high transmission rate,” Domingo noted.
However, Domingo said that the use of Sinovac COVID-19 vaccine on elderly still has limitations. “This is not for those who have acute illness, uncontrolled hypertension, or hypertensive emergency.”
According to the evaluation of FDA, Sinovac’s efficacy rate on clinically healthy individuals ranges from 65% to 91%.
However, Sinovac’s efficacy rate on health workers is only at 50.4%, but he said 50% is a good enough threshold.
Sinovac COVID-19 vaccine 51% effective among elderly: FDA
“The acceptable level for the World Health Organization (WHO) is 50%,” Domingo pointed out.
FDA earlier announced that it approved the use of the Sinovac vaccine from China in senior citizens.
“After considering the recommendation of the experts and the current situation of high COVID-19 transmission and limited available vaccines, the FDA is allowing the use of Sinovac on senior citizens,” Domingo said.
But the FDA stressed that the health status and exposure risk of vaccinated seniors should first be evaluated.
The use of Sinovac COVID-19 vaccine was previously only allowed in the ages of 18 to 59 years.
But according to the FDA, they had to re-evaluate Sinovac’s data now that the supply of AstraZeneca vaccines is running out.