4 vaccine makers submit EUA application for COVID-19 vaccine booster shot—PH FDA

November 4 ------ Four vaccine developers have already submitted their application to the Food and Drug Administration (FDA) for the approval of their COVID-19 vaccine booster shot or third dose for emergency use. FDA Director-General Rolando Enrique Domingo said the vaccine makers that submitted the application were Pfizer-BioNTech, AstraZeneca, Sinovac, and the developer of the Sputnik V vaccine.

“Nakatanggap na po kami nitong bago po mag-Undas ng applications for product variation or modification po, amendment ng EUA galing po sa Pfizer, sa AstraZeneca, sa Sinovac, at saka Sputnik,” said Domingo during President Duterte’s Talk to the People program aired on Wednesday, Nov. 3. “Nag-request po sila na ma-include ang third dose sa kanilang regimen or booster dose. At ipinadala po nila yung kanilang scientific data available at ito po yung ina-aral ngayon ng ating mga experts,” he added.

The Department of Health (DOH) said that there is a difference between a booster shot and a third dose. DOH Undersecretary Maria Rosario Vergeire previously explained that a third dose is for people who “cannot mount appropriate immunity” against COVID-19. A booster shot, meanwhile, is being given because of waning immunity “several months” after vaccination. Domingo said that the DOH is already preparing the necessary guidelines for the administration of booster doses and third shots.

“Hinihintay po din natin yung final WHO (World Health Organization) recommendation which we expect to come out within the next two weeks, and at the same time, the DOH is preparing guidelines for rollout,” he said. “Mga two or three weeks ay magkakaroon na rin po tayo ng guidelines para po dito sa ating booster or third shot po ng ating bakuna,” he added.

This was also bared by DOH Undersecretary Myrna Cabotaje during a separate press briefing—as they are now conducting a profiling for the groups eligible to receive booster shots and third doses. “Nagta-tally na kami. Nagiimbentaryo na kami ng mga healthcare workers na vaccinate, kailan, ano ang mga naibakuna sa kanila,” she said.

“Sa mga immunocompromised, there is a certain group of patients….we are starting to track them. Yung mga operational details lang ang pina-finalize,” she added. The FDA chief, meanwhile, urged the local government units (LGUs) to urge eligible people to get vaccinated. “In the meantime, of course, ang ine-encourage pa po rin natin lahat ng LGUs na priority pa rin po natin talagang bakunahan muna lahat ng unvaccinated,” said Domingo.

Source: mb.com.ph