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Task Group on Vaccine Evaluation and Selection justifies government's vaccination under EUA: 'Benefits outweigh the risks'
Task Group on Vaccine Evaluation and Selection justifies government's vaccination under EUA: 'Benefits outweigh the risks'
“The benefits outweigh the risks.”
This was the reason cited by the Task Group on Vaccine Evaluation and Selection (TG-VES) behind the Philippine government’s decision to conduct coronavirus disease (COVID-19) vaccination this month, even though vaccine developers have yet to complete their Phase 3 vaccine clinical trials.
Department of Science and Technology Undersecretary Rowena Cristina Guevara, who leads the task group, also clarified that the government’s vaccination should not be called as mass vaccination because the Food and Drug Administration (FDA) only granted an emergency use authorisation (EUA), and not certificate of product registration (CPR) for the COVID-19 vaccines developed by foreign pharmaceutical companies.
"Only the government is allowed to buy right now because it’s EUA. Kailangan mapaintindi natin sa kababayan dahil EUA, it is an investigational drug or vaccine. Hindi pa kasi sya tapos ng clinical trials nya (We should let our people understand that because it’s EUA, it is an investigational drug or vaccine. The clinical trials have yet to be completed),” she told the Manila Bulletin in an interview.
She explained that once the vaccine developers complete their Phase 3 clinical trials, they can apply for the CPR.
“Pag natapos mo 50 percent ng iyong Stage 3 clinical trial at mayroon kang interim results, you can apply for EUA, ibig sabihin hindi pa tapos. Pero dahil pandemic ngayon, the benefit outweighs the risks, 'yun ang reason kung bakit gagawin natin itong vaccination even though hindi pa tapos ang clinical trials. Wala pang nakakatapos ng Phase 3 (When you complete 50 percent of your State 3 clinical trial and you have your interim results, you can apply for EUA, which means it is not yet completed. But because we are in a pandemic, the benefit outweighs the risks, that is the reason why we have to do this even though the clinical trials are not yet done) ,” Guevara noted.
"It is important to do this because the benefits outweigh the risks.”
She maintained that the Philippines is ready to roll out its vaccination program this month.