Philippines approves Pfizer COVID shot for 5- to 11-year-olds
Benefits of vaccination outweigh risks, says drug regulator
Manila: The government here has given an “emergency use authorisation” (EUA) for Pfizer’s COVID-19 vaccine for children ages 5 to 11 on Thursday (December 23, 2021) as well as the COVID drug molnupiravir.
“Upon review of technical documents and evaluation of the US (United States) FDA recommendations, our experts have found that the data submitted is sufficient for the EUA approval,” said Eric Domingo, director-general the Philippines’ Food and Drug Administration (FDA) in a media briefing.
“We observed it is reasonable to believe that the vaccine may be effective to prevent COVID-19 and the benefits of vaccination outweigh the known and potential risks,” he added.
Domingo also pointed out that Pfizer has a 90.7% efficacy for the said age group. Adverse events observed during the clinical trials are mild, he said.
“The adverse events we saw during the clinical trials were very mild, like other vaccines administered to children. Some may experience fever, slight pain in the injection site. But there are no unusual or important safety signals for us not to give this EUA. So, this is being granted today,” Domingo in a mix of Tagalog and English.
The vaccine dosage for children will be different from adults, the official clarified. He asked concerned authorities to procure it separately.
“The shots for children have a lower dosage and concentration compared to what is being administered to adults now,” he explained.
"Last week, we already told our task force, Secretary Carlito Galvez Jr., and Department of Health Secretary Francisco Duque III that the vaccine for children 5 to 11 years old would be different. So, they will have to order and procure these separately."
Molnupiravir gets EUA
Also on Thursday, the drug regulator has granted EUA to Molnarz’s molnupiravir, a capsule to treat mild COVID-19 for use in the Asian country.
“As of now, we granted a EUA to molnupiravir with the brand name Molnarz,” added Dr. Domingo in Filipino. “Molnarz is the first to apply and so far, they complied with our requirements of safety, efficacy, and quality.”
It is to be taken twice a day for five days and should be given as soon as possible after diagnosis and within the first five days since the onset of symptoms, Domingo said.
It is not recommended for women with childbearing potential, pregnant, and lactating.
The drug comes in a 200-milligram capsule. Four capsules should be given every 12 hours for five days to an eligible COVID-19 patient.
“It should be given as soon as possible after diagnosis and should be within the first five days after the onset of symptoms,” said Domingo.