FDA grants EUA to Sinovac but…

The Food and Drugs Administration FDA has approved the emergency use authorization (EUA) of the Sinovac Covid-19 vaccine.

FDA Director General Rolando Domingo said interim data from the ongoing Phase 3 trials shows that when the vaccine is used on clinically healthy members of the community aged 18 to 59 it has an efficacy rate of 65.3% (Indonesia) to 91.2%

However, Sinovac has a lower efficacy rate of 50.4% in Brazil when used on health care workers exposed to Covid-19. Therefore, it is not recommended for use in this group.

“The vaccine regimen recommended by experts consist of 2 standard doses of 0.5ml each given 4 weeks apart. The adverse events reported were transient and mostly mild to moderate similar to common vaccine reactions,” Domingo said.

Domingo added that no specific safety concerns were identified “but it must be noted that this only reflects limited follow up and more adverse effects may emerge that’s why close surveillance and monitoring is needed after the immunization.”

The vaccine produced by Sinovac is also certified Halal by the Indonesian authorities.

“The (Sinovac) vaccine is a good option for individuals who have allergies to components of other vaccines such as the polyethylene glycol and polysorbate. Hindi s’ya nagco-contain nitong mga chemicals that usually cause anaphylaxis and severe allergies,” Domingo said.

 

Via ABS-CBN