FDA says 3 coronavirus vaccine makers yet to file emergency use application

MANILA - The country's health regulator has yet to receive official application for emergency use authorization of COVID-19 vaccines developed by Johnson & Johnson, Moderna and Sinopharm, its chief said Friday.

The Food and Drug Administration has previously held talks with American companies Johnson & Johnson and Moderna on the requirements for obtaining regulatory approval in the Philippines, FDA director-general Eric Domingo said in a press briefing.

"As of this date, we have not received an application for an EUA from Moderna," he said. " Similar to Moderna... there's no filing of EUA application from J&J." 

Domingo also said China's Sinopharm had also yet to submit its application for EUA.

"As of now, wala pa talagang (there's no) officially filed application with documents and requirements with the FDA when it comes to Sinopharm," he said.

Domingo noted the FDA received 2 letters from different companies expressing intent to apply for EUA in the country.

The agency has since responded to the letters, informing them of the requirements. Both firms have yet to respond.

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In February, President Rodrigo Duterte said he preferred to use COVID-19 shots from the Chinese state firm. Some members of his security detail also took unauthorized Sinopharm jabs last year. 

The FDA reiterated that an EUA would only be issued if the following circumstances are present:

• Based on the totality of evidence available, including data from adequate and well-known controlled trials, it is reasonable to believe that the drug or vaccine may be effective to prevent, diagnose or treat COVID-19.
• The known and potential benefits of the drug or vaccine when used to diagnose, prevent or treat COVID-19 outweigh the known and potential risks of the drug or vaccine, if any; and
• There is no adequate, approved and available alternative to the drug or vaccine for diagnosing, preventing or treating COVID-19.

To date, only COVID-19 vaccines developed by Pfizer/BioNTech, AstraZeneca/Oxford, Sinovac and Gamaleya Institute have been approved in the Philippines for emergency use.

Based on Phase 3 clinical trials, Johnson & Johnson's vaccine was 66 percent effective against the disease while Moderna had an efficacy rate of 94 percent against symptomatic COVID-19.

For Sinopharm, the company said its vaccine was found 72.5 percent effective against COVID-19, according to interim analysis.

The country began its inoculation drive on March 1, with priority given to health care workers a day after it received COVID-19 doses donated by Sinovac. It later received jabs from AstraZeneca through vaccine-sharing scheme COVAX facility.

As of Tuesday, nearly 241,000 out of 1.7 million medical frontliners have been inoculated against the disease.

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