The Food and Drug Administration (FDA) has issued emergency use authorization (EUA) for the Sinovac Covid-19 vaccine of China but due to its low efficacy rate of only 50.4 percent it is “not” recommended to be used for healthcare workers (HCWs).
However, FDA director general Eric Domingo said Sinovac could be used among clinically healthy individuals aged 18 to 59 years.
“The interim data from the ongoing Phase 3 [clinical] trials showed that when the vaccine is used on clinically healthy members of the community aged 18-59 it has an efficacy rate of 65. 3 percent to 91.2 percent,” Domingo said during the Laging Handa press briefing.
The 65.3 percent was based on a clinical trial in Indonesia while the 91.2 percent efficacy was the result of the trial in Turkey.
“However, it has a lower efficacy rate of 50.4 percent for healthcare workers exposed to Covid-19. Therefore, it is not recommended to use in this group,” Domingo stressed.
China’s Sinovac had applied for EUA for its Covid-19 vaccine on January 13, 2021.
Other vaccines with EUA are Pfizer -BioNTech and AstraZeneca Pharmaceuticals Covid-19 vaccine.
Domingo reiterated that the granting of the EUA is not a marketing authorization or a Certificate of Product Registration, “therefore it cannot be sold to market commercially.”
Domingo assured that FDA is committed to continue its job to ensure that Filipinos can have access to vaccines that hold greater benefits and outweighs the risk and possible adverse effects during this time of pandemic.
Read full article on BusinessMirror
