MANILA – The Food and Drug Administration (FDA) has granted an emergency use authorization (EUA) to China’s Sinovac Biotech coronavirus disease 2019 vaccine.
“The FDA is granting an emergency use authorization to the COVID-19 vaccine of Sinovac Life Sciences Company, known as SARS-CoV-2 vaccine Vero Cell Inactivated, o ‘yung trade name nya ay CoronaVac,” FDA Director General Eric Domingo said on Monday.
Domingo said the COVID-19 vaccine from China was given EUA “after a thorough and rigorous review of the currently available published and unpublished data” by regulatory and medical experts.
The FDA official further said that experts recommended two equal and standard doses of 0.5 milliliters each, given four weeks apart, for patients who will be inoculated with Sinovac’s vaccine. Its adverse effects were “transient and mostly mild to moderate” which are similar to common vaccine reactions.
“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,” said Domingo.
The interim data from Sinovac according to Domingo has an efficacy rate of 65.3 percent on patients aged 18 to 59 years old, based on trials done in Indonesia and around 91.2 percent on trials done in Turkey.
The China-based vaccine, however, is not recommended to be inoculated to health care workers because it showed a lower efficacy rate of 50.4 percent.
Besides being certified Halal by Indonesia, Sinovac is a “good option for individuals who have allergies to components of other available vaccines such as the polyethylene glycol and polysorbate,” said Domingo.
Presidential spokesman Harry Roque previously said 600,000 Beijing-donated Sinovac shots, including 100,000 doses donated to the military and health workers, will reach the country this month.
Roque added that it will only take three to five days for the Chinese Embassy to prepare shipment of the vaccines once FDA issues an EUA./PN
