The Philippine Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to China’s Sinovac Covid-19 vaccines but with a catch—the vaccines were not recommended for senior citizens and health workers.
FDA chief Eric Domingo said that the agency granted Sinovac an EUA after a “thorough and rigorous review of the currently available published and unpublished data by our regulatory and medical experts.”
“It is decided that all conditions for an EUA are present and that the benefit of using the vaccine outweighs the known and potential risks,” Domingo said in a Laging Handa briefing.
Domingo said interim data from the ongoing Phase 3 trials of Sinovac in India and Turkey showed that when the vaccine was used on clinically healthy members of the community aged 18 to 59, it had an efficacy rate of 65.3 to 91.2 percent.
However, the vaccines were found to have a lower efficacy rate—50.4 percent—when used on healthcare workers exposed to Covid-19.
“Therefore, it is not recommended for use in this group,” Domingo said.
Domingo added that the Sinovac vaccine should be a “good option” for individuals allergic to Polyethylene glycol and polysorbate.
“Hindi po siya nagko-contain nitong mga chemicals that are usually the ones that cause an anaphylaxis and severe allergies. The vaccine produced by Sinovac is also certified halal by the Indonesian authorities,” he said.
The FDA earlier authorized vaccines produced by Pfizer-BioNTech and AstraZeneca for emergency use. John Ezekiel J. Hirro