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FDA: COVID-19 vaccine must be 60% to 70% effective at minimum


A COVID-19 vaccine must be 60% to 70% effective to be able to secure approval from the Philippines’ Food and Drug Administration (FDA), Director General Eric Domingo of FDA said. 

“Generally, it should be 60% to 70% effective. That is the minimum requirement,” Domingo said in an ANC interview.

“Most vaccines pass [FDA regulation] if they have 60% to 70% efficacy rate. But of course, the higher [percentage of efficacy rate], the better,” Domingo added.

President Rodrigo Duterte has already issued an executive order allowing FDA to issue emergency use authorization for COVID-19 vaccines which it will find safe and effective. 

Only COVID-19 vaccines developed by Pfizer-BioNTech, Moderna and AstraZeneca-Oxford have been proven at least 80% effective after human trials. 

However, only the COVID-19 vaccine developed by Pfizer-BioNTech have secured EUA from regulatory bodies of the United States, United Kingdom and Canada. 

With EUA issuance of reputable regulatory bodies limited to Pfizer, Domingo said that it is understandable that the supply is scarce. 

“It takes some time kasi wala pa ring EUA ang iba, so the production is not yet enough to be able to supply it here immediately,” Domingo pointed out. 

Vaccine czar Carlito Galvez, Jr. earlier said that COVID-19 vaccine supply from Western companies like American firm Pfizer are only due to arrive in the Philippines by third quarter of 2021. This is because most of the supply were already secured by Western countries like the United States, United Kingdom and European Union. 

Galvez said the Philippines is eyeing to secure 25 million doses of COVID-19 vaccine from Chinese firm Sinovac by March 2021.

Sinovac, however, has yet to release the results of the Phase 3 of its clinical trials or the human trials. 

Domingo, however, assured the public that no COVID-19 vaccine will be administered in the country unless it passes FDA scrutiny which includes evaluation of results on human clinical trials. 

“Hindi sila makakapasok unless ito ay safe and effective,” Domingo said.

The Philippines has already secured 2.6 million doses of COVID-19 vaccine developed by AstraZeneca-Oxford—an initiative funded by the private sector for donation to the Philippines government. 

The 2.6 million doses is good for one million people. —KG, GMA News

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