Philippines' Health Regulator Awaits EUA Applications from COVID-19 Vaccine Makers

Strategic Insights -

The Philippine Food and Drug Administration (FDA) has yet to receive official applications for emergency use authorization (EUA) from three COVID-19 vaccine manufacturers: Johnson & Johnson, Moderna, and Sinopharm. Despite holding talks with American companies Johnson & Johnson and Moderna on the requirements for obtaining regulatory approval, no applications have been submitted. The FDA has reiterated its criteria for issuing EUA, which includes evidence of vaccine efficacy, benefits over risks, and the absence of approved alternatives. Meanwhile, the country has approved EUA for vaccines developed by Pfizer/BioNTech, AstraZeneca/Oxford, Sinovac, and Gamaleya Institute. The inoculation drive, which began on March 1, has prioritized healthcare workers, with nearly 241,000 out of 1.7 million medical frontliners vaccinated against COVID-19 as of Tuesday.

Key Takeaways:

  • The Philippine FDA has not received EUA applications from Johnson & Johnson, Moderna, and Sinopharm, despite holding talks with American companies.
  • The FDA has reiterated its criteria for issuing EUA, which includes evidence of vaccine efficacy, benefits over risks, and the absence of approved alternatives.
  • The country has approved EUA for vaccines developed by Pfizer/BioNTech, AstraZeneca/Oxford, Sinovac, and Gamaleya Institute.
  • The inoculation drive, which began on March 1, has prioritized healthcare workers, with nearly 241,000 out of 1.7 million medical frontliners vaccinated against COVID-19 as of Tuesday.
  • President Rodrigo Duterte has expressed a preference for COVID-19 shots from Chinese state firm Sinopharm, and some members of his security detail have taken unauthorized Sinopharm jabs.
  • The FDA received 2 letters from different companies expressing their intent to apply for EUA in the country.

Statistics:

  • 241,000 medical frontliners have been vaccinated against COVID-19 as of Tuesday, out of 1.7 million (14.2%).
  • 66% efficacy rate for Johnson & Johnson's vaccine against COVID-19 in Phase 3 clinical trials.
  • 94% efficacy rate for Moderna's vaccine against symptomatic COVID-19 in Phase 3 clinical trials.
  • 72.5% efficacy rate for Sinopharm's vaccine against COVID-19, according to interim analysis.

Sources:

  • FDA director-general Eric Domingo, press briefing
  • President Rodrigo Duterte, statement on preferred COVID-19 shots
  • Chinese state firm Sinopharm, vaccine efficacy data
  • COVID-19 vaccine manufacturers (Johnson & Johnson, Moderna, Sinopharm), EUA applications
  • Philippine FDA, EUA criteria and approved vaccines
  • SyndiGate Media Inc. (Syndigate.info), news article (2021)