THE Food and Drug Administration (FDA) yesterday has allowed the use of Pfizer Inc’s COVID-19 vaccine on children aged 5 to 11 years, Director General Eric Domingo said yesterday.
Pfizer is the first in the country to get an emergency use authorization (EUA) for the 5-11 age group. Pfizer submitted its application for an EUA last month.
The FDA also granted an EUA to the COVID-19 drug of pharmaceutical giant, MSD, known as molnupiravir with brand name Molnarz®.
The EUA grant means only the brand Molnarz® will be allowed to be used in the country among molnupiravir drugs, and the FDA will stop issuing compassionate special permits (CSPs) for the use of other brands.
Domingo said hospitals that have been issued CSPs for other brands of molnupiravir will be allowed to use up their remaining stocks.
Domingo said Molnarz may be given only to COVID patients who are that 18 years old and older, and are considered as mild to moderate cases.
He said molnupiravir is given two times a day for five days from the onset of the symptoms. “Otherwise, it won’t be useful.”
On the EUA for the 5-11 age group, Domingo said, “It is reasonable to believe that the vaccine may be effective to prevent COVID-19, and that the benefits of vaccination outweigh the known and potential risks,” Domingo said in a public briefing.
“We didn’t find anything unusual or important safety signals that will prevent us from granting the EUA,” he added.
Domingo said the vaccine has a “high efficacy rate of above 90 percent for children 5 to 11 years old” while adverse effects following immunization were mostly mild.
“In the clinical trials, there were only very mild side effects on children, like mild fever and pain in the injection site,” he said.
Pfizer vaccines available in the country will not be the ones used for children because there is a different dosage for the 5-11 age group.
“It has lower dosage and lower concentration compared to the vaccines used for adults,” Domingo said.
He said the government will roll out the vaccination of children as soon as supplies are available.
“The plan is to rollout as early as January,” he said Domingo.
Vaccine czar Carlito Galvez Jr. said government is fast tracking the purchase of vaccines for the 5-11 age group. He earlier said the government is buying 15 million doses of Pfizer vaccines for that group, with the goal of starting vaccination in the first quarter of 2022.
Some 3.7 million doses of government-procured and donated Pfizer and Moderna vaccines arrived yesterday, bringing to about 195 million doses the total delivered to the country since February. Another 1.2 million doses of vaccines were set delivery Thursday night. On Wednesday night, the country received 810,810 doses of Pfizer vaccines donated by France.
As of December 22, the Philippines has administered about 104.4 million doses of vaccines nationwide, including 1.267 million booster shots. — With Jocelyn Montemayor
