Sinovac COVID-19 vaccine being evaluated by FDA —DOH

Chinese firm Sinovac’s COVID-19 vaccine is being evaluated by the Food and Drug Administration even if it has yet to be approved by the Ethics Review Board, the Department of Health (DOH) said Monday. 

Health Undersecretary Maria Rosario Vergeire noted that this evaluation was above board and preliminary, considering that Sinovac has already secured the approval of the Vaccine Experts Panel (VEP) under the Department of Science and Technology (DOST).

“ON FDA evaluating Sinovac, that is an internal agreement between the Task Group composed of the FDA, DOST and DOH. Sistema ito na kapag na-approve na ng VEP ang produkto, FDA can initially evaluate iyong mga dokumento para hindi makatagal [sa proseso], while we wait for the Ethics Board [approval],” Vergeire said. 

The VEP under DOST reviews the Phase 1 and 2 clinical trials of the candidate vaccine, while the Ethics Board evaluates the selection of participants for human clinical trials, among other safeguards that the vaccine manufacturer provided for participants. 

The evaluation of VEP and Ethics Board are done simultaneously.

Vergeire, however, stressed that Sinovac will not be approved by FDA without an approval from the Ethics Board. 

“Hindi po magkakaroon ng FDA approval if the regulatory process is not complied with,” Vergeire added.

Malacanang said last week Sinovac’s COVID-19 vaccine remains the country’s top pick for its immunisation program despite bribery claims hounding the Beijing-based firm.

The Palace expressed confidence in the vaccine review process to be conducted by the FDA, whose chief, Eric Domingo, enjoys the full trust of President Rodrigo Duterte, according to presidential spokesperson Harry Roque.

Earlier this month, Indonesia received its first shipment of Sinovac’s COVID-19 vaccine as its government prepares a mass inoculation program.

Only COVID-19 vaccines made by American companies Pfizer-BioNTech, Moderna and British firm AstraZeneca have been proven to be at least 90% effective after human trials so far.

United Kingdom has started its national vaccination against COVID-19 last week with a vaccine Pfizer-BioNTech, while the United States and Canada are due to follow suit this week. 

The Philippines, on the other hand, has secured only 2.6 million doses of the COVID-19 vaccine of AstraZeneca so far, courtesy of funding from the private sector. 

AstraZeneca, however, has only secured Ethics Review Board approval thus far. 

The Philippines has recorded 449,400 COVID-19 cases so far. Of this number, 418,687 recovered while 8,733 died. 

The number of active COVID-19 cases is 21,980. —KG, GMA News