Vaccine developers need to secure EUA from PH FDA for COVID-19 booster doses

Manufacturers of coronavirus disease (COVID-19) vaccines need to secure an emergency use authorization (EUA) from the Philippine Food and Drug Administration (FDA) to allow the use of booster shots of their vaccines in the country, an official of the Department of Health (DOH) said.

“Kailangan ng emergency use authorization from FDA for a booster shot. Kasi yung inaplayan ng mga companies ngayon doon sa kanilang application ay two doses lang yan (Emergency use authorization from FDA is needed for the use of booster shots. What the companies applied previously is only for two doses),” said DOH Undersecretary Myrna Cabotaje in a radio interview on Saturday, Oct. 16.

“So, if you are going to give a booster, dapat mag-apply din sila na pwedeng pang-booster yung kanilang current vaccine na supply sa atin (they should also apply for an EUA for that),” she added.

So far, the FDA has yet to receive an application from vaccine developers on booster doses.

“We are reaching out, the FDA and DOH are reaching out para maka apply sila. Kasi alam naman natin emergency use authorization iyan (so that they can apply. Because we know that these vaccines are still under emergency use authorization),” said Cabotaje.

“So, we are after safety na may mga pag-aaral na ipapakita sa ating FDA para masabi natin the benefit outweighs the risks of giving a booster (So, we are after safety -- with studies that will be shown to our FDA -- so we can say the benefit outweighs the risks of giving a booster dose),” she added.

At present, Cabotaje said there is still no official recommendation from local experts if the use of booster shots will be allowed in the country.

“Hati yung ating mga eksperto dahil ang kanilang majority decision hangga’t maaari, i-push yung ating mga senior citizens at mabakunahan yung marami pang hindi pa nababakunahan (Our experts are still divided about this because their majority decision is as much as possible, we need to push the vaccination on our senior citizens and vaccinate those who have not been inoculated yet),” she said.

As of Oct. 13, Malacanang said 23 million individuals were already fully vaccinated in the Philippines--which was equivalent to 30.8 percent of the target population for COVID-19 vaccination.

Booster shot vs. 3rd dose

Cabotaje also noted that there is a difference between booster shots and the third dose of COVID-19 vaccine.

“Yung booster binibigay mo pag bumababa na yung immunity after several months ng primary dose. Yung third dose, ayun yung binibigay natin para sa mga groups of population na hindi naka mount ng sufficient immunity (You give the booster when the immunity is already waning after several months of receiving the primary dose. The third dose, that's what we provide for groups of the population that cannot mount sufficient immunity),” she explained.

“Pag sinabing third dose, ito yung recommendation ng WHO (World Health Organization) para sa ating mga senior citizens, para immunocompromised, at sinusuggest din para sa healthcare workers kasi mataas yung kanilang risk of infection (When we say third dose, this is the recommendation of the WHO for our senior citizens, for immunocompromised, and also recommended for healthcare workers because their risk of infection is high),” she added.

How would a person know if his or her immunity is already waning? Cabotaje said that experts around the world as well as the vaccine developers are still studying this.

“Inaaral iyan. Iyon ang studies abroad. Very sensitive kasi yung pag measure (That is still being studied abroad. The measurement is very sensitive),” she said.

“So inaaral pa rin ng mga kumpanya at eksperto. Kaya nga meron kang efficacy study (So companies and experts are still studying that. That is why they have efficacy studies),” she added.