DOH: No FDA-EUA application yet from manufacturers of COVID-19 vaccine for kids below 5
Metro Manila (CNN Philippines, July 2) — Manufacturers of COVID-19 vaccines to be used for children before 5 years old have not yet applied for Emergency Use Authorization (EUA) before the Food and Drug Administration (FDA), the Department of Health said.
“This initiative will still have to be stringently reviewed and studied by regulatory institutions and our panel of experts before consideration for implementation,” the DOH said in a statement on Saturday.
In mid-June, vaccine expert Dr. Nina Gloriani expressed support for the move to inoculate children aged 5 and below amid rising cases of COVID-19 in the country.
“Yes, kasi bubuuin 'yan, makukumpleto ‘yung ating [because that will complete our] immunization coverage,” she pointed out.
“Pero [But] of course, we have to consult the pediatricians also," she added. "Titingnan natin kung sino yung mga bata na talagang pwedeng-pwede diyan. Normally, we’re looking at the more healthy children pero sa totoo lang, ang binibigyan din natin ng bakuna against COVID ay mas ‘yung may mga maysakit, kasi sila ‘yung mas makaka-experience ng more severe form of COVID-19.”
[Translation: We will see who among the children are eligible for that. Normally, we’re looking at the healthier ones but actually, we are giving more priority to those who are sick because they are the ones who will experience a more severe form of COVID-19.]
The vaccine expert also shared that upon application of EAU, evaluation and approval process may take three to four months.
“Pero isipin natin na meron pang second layer of approval, ‘yan po ‘yung sa DOH-HTAC (Health Technology Assessment Council)," she noted. "Kasi kung bibilhin ng gobyerno ‘yung bakuna, kailangan pong dumaan sa HTAC tapos 'yung procurement process, so baka mga 6 months before children below 5 can be vaccinated."
[Translation: But let’s take note that there’s a second layer of approval from the DOH-HTAC. If the government will buy the vaccine, it should go through HTAC. Then there’s the procurement process, so it may probably take six months before children below 5 can be vaccinated.]
Meanwhile, the DOH said the department and the National Vaccination Operations Center (NVOC) are currently focusing their efforts to ramp-up the vaccine rollout to current priority groups, to areas and age groups with a high number of unvaccinated individuals, and to those yet to receive their first booster.
“The country’s COVID-19 response actions, along with actions for all other non-COVID health matters, continue through senior DOH officials supervising specific bureaus, offices, and units,” it added.
President Ferdinand “Bongbong” Marcos, Jr., who assumed office on June 30, has yet to appoint a new health secretary.
CNN Philippines' correspondent Carolyn Bonquin contributed to this report.