DOH advisory council says 2nd booster for all Filipinos has no FDA approval yet

June 30, 2022 - 8:01 PM
Booster shot in PH
Health Secretary Francisco Duque inoculates a health worker with a booster shot of COVID-19 Pfizer vaccine during a program launching the government's vaccination drive to provide booster shots to front-liners, at the National Kidney and Transplant Institute in Quezon City, Metro Manila, Philippines, November 17, 2021. (Reuters/Eloisa Lopez)

An advisory body announced that it has yet to receive authorization from state regulators for the rollout of second booster shots or the fourth dose of COVID-19 vaccines.

The Health Technology Assessment Council (HTAC), an independent advisory body of the Department of Health, made this announcement following calls for the additional shots for the following people:

  • All adults from 18 to 59 years old
  • Overseas Filipino workers
  • Seafarers
  • Economic sector

The council emphasized that it has not yet received an emergency use authorization from the Food and Drug Administration for the distribution of second booster shots.

“HTAC has not yet received an EUA from the FDA. Neither has there been a WHO recommendation,” HTAC said.

Clarification of the Health Technology Assessment Council (HTAC) on its role in COVID-19 vaccination (Facebook/HTAC Philippines)

It also cited a statement from the World Health Organization last May 17 regarding the benefits of second booster shots to other individuals.

“Studies show some short-term benefit of an additional booster dose of mRNA vaccine in health workers, those over 60 years of age or with immunocompromising conditions. Data to support an additional dose for healthy younger populations are limited; preliminary data suggest that in younger people, the benefit is minimal,” HTAC quoted WHO as saying.

Last May, DOH has so far approved the second dose for the following groups:

  • Health care workers
  • Senior citizens
  • Immunocompromised individuals

The health department, however, stressed that there should be a three-month waiting period after they received their first booster shows.

HTAC also recalled that it only recommended the first booster shot or third dose of the Pfizer-BioNTech to the adolescent population ages 12 to 17 years old after it received FDA’s EUA.

The prerequisite is still priority groups A1 (frontline workers in health facilities), A2 (senior citizens) and A3 (persons with comorbidities).

“HTAC only mentioned the prerequisite of a 40-70% booster coverage among the Priority Groups A1 to A3 in line with the need to first protect the most vulnerable: healthcare workers, senior citizens, and adults with comorbidities,” HTAC said.

The council further noted it leaves the role of deploying the vaccines to the National COVID-19 Vaccination Operations Center (NVOC).

Process of gov’t COVID-19 vaccination program

In its statement, HTAC shared the following basic steps in the government’s vaccination program:

  1. Emergency Use Authorization (EUA) from the FDA
  2. A positive recommendation by HTAC based on a WHO recommendation
  3. NVOC implementation guidelines.

This process is in accordance with the following laws:

  • RA 9711 (Food and Drug Administration Act of 2009)
  • RA 11223 (Universal Healthcare Act)
  • RA 11525 (COVID-19 Vaccination Program Act of 2021)

Despite the standing limits for second booster coverage, the council is still working to expand the number of people receiving these shots across the country.

“This will have a more substantial impact in preventing infection, hospitalization and deaths; preserving the health system; and keeping the economy open,” HTAC said.