The Food and Drug Administration (FDA) granted emergency use authorization (EUA) to China’s Sinovac’s COVID-19 vaccine after a “thorough and rigorous review” by regulatory and medical experts.
Sinovac is the third company that has been granted EUA following Pfizer-BioNTech (Jan. 14) and AstraZeneca (Jan. 28).
(Emergency use authorization allows the use of vaccines and therapeutics that are still under development during public health emergencies of international concern.)
In a Laging Handa virtual press briefing Monday, FDA director general Dr. Eric Domingo said, “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. The interim data from the ongoing Phase 3 trial 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 to 91.2 percent after the first dose.”
Domingo said the 65.3 percent efficacy rate was seen in Indonesia, and the 91.2 percent efficacy rate was seen in Turkey.
Sinovac may have a higher efficacy rate on clinically healthy individuals between the said age groups, but Domingo noted that it has a 50.4 percent efficacy rate when used on healthcare workers exposed to COVID-19. “Therefore, it is not recommended for use in this group.”
The vaccine consists of two standard doses of 0.5ml each, which will be given four weeks apart.
Domingo also noted that the adverse events reported were “transient and mostly mild to moderate,” which are similar to common vaccine reactions and specific safety concerns were not identified.
However, Domingo said, “It must be noted that this only reflects the limited follow up and more adverse effects may emerge, that’s why close surveillance and monitoring is needed after the immunization.”
In addition, the Sinovac vaccine, according to Domingo, is “a good option for individuals who have allergies to components of other available vaccines, which cause anaphylaxis and other severe allergies.” The vaccine is also certified Halal by the Indonesian authorities.
China, Indonesia, Turkey and Brazil have also granted an emergency use authorization for the Sinovac vaccine.
In an online press briefing Monday, Presidential Spokesperson said the government may revise the priority list after the FDA did not recommend the Sinovac vaccine to healthcare workers, even though it has already been granted an EUA. Roque said the military maybe first, followed by frontline and healthcare workers.
Roque, who said that Sinovac is “not a low-quality vaccine,” added that the “economic frontliners” might also be the first ones on the list to get the jab. “Ito po ay mga manggagaling sa mga industriya na hindi natin pinasara. You’re talking of farmers, miners, fishermen, transport workers, BPOs.”
Roque recently said that 600,000 doses of Sinovac vaccine are set to arrive on Feb. 23.
Of the initial batch, 100,00 will be donated by Beijing to the Philippine military according to Roque.