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

A COVID-19 vaccine must be proven to be at least 60% to 70% effective before the Philippines’ Food and Drug Administration (FDA) approves its use in the country, FDA Director-General Eric Domingo 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.

Today, only COVID-19 vaccines manufactured by Pfizer-BioNTech, Moderna, and AstraZeneca-Oxford have been proven at least 80% effective after the final stages of human trials.

However, only the Pfizer-BioNTech’s COVID-19 vaccine acquired emergency use authorization (EUA) from the United States, United Kingdom, and Canada regulatory bodies.

With this, Domingo said that it is understandable that Pfizer vaccine supplies are limited.

“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.

Malacañang explained Tuesday why the government opted to buy China-made CoronaVac COVID-19 vaccine over other candidate vaccines, saying other manufacturers have not committed supplies to the Philippines.

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

Presidential spokesperson Harry Roque stressed out that there is a global competition on early access for COVID-19 vaccines.

“As of now, the market is really demand-driven, and we will get what we can procure. We have no favorites,” Roque said at a press briefing.

He said China has committed to supply CoronaVac to the Philippines. He added other vaccine manufacturers like Pfizer, AstraZeneca or Moderna has not made a similar commitment.

Roque said the government plans to purchase Pfizer vaccine. However, this could arrive in the second and third quarter of 2021, and “It’s not acceptable to the President to wait that long.”

However, Sinovac has yet to release the results of its Phase 3 trials, unlike Pfizer and Moderna.

However, Domingo assured the public that no COVID-19 vaccine would be given to Filipinos unless it secures approval from the FDA.

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