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FDA okays Monderna vax for children 6-11 years old

The Food and Drug Administration has approved the emergency use authorization (EUA) of Moderna’s COVID-19 vaccine for children aged 6 to 11 years old, the Department of Health (DOH) announced on Tuesday.

This developed as the DOH reported five additional cases of the Omicron subvariant BA.2.12.1 in the Western Visayas region.

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Meanwhile, independent monitoring OCTA Research Group said it is “too early to tell” if the increase in COVID-19 cases in some areas of the Philippines will be sustained.

Health Promotion and Communication Service director Dr. Beverly Ho, during her regular briefing, said the Philippine FDA granted the amendment to the EUA of Moderna last May 20 for use as a primary vaccine series for children.

However, the DOH still awaits the recommendation of the World Health Organization for the use of Moderna for children six to 11 years old. This will be the guide of the Health Technology Assessment Council (HTAC) for its independent evaluation.

Zuellig Pharma Corp.’s ZP Therapeutics, citing published and peer-reviewed clinical data, said in a statement that two doses of the Moderna’s Spikevax vaccine have “an acceptable safety profile and elicits a strong immune response for children aged 6 to 11.”

Zuellig also pointed out that the efficacy of Spikevax among the younger age group is similar to those in adults.
“This is a welcome development in expanding COVID-19 vaccine access within our pediatric population,” said Zuellig medical doctor Dr. Philip Nakpil.

“The Spikevax COVID-19 Vaccine Moderna boosts opportunities in ensuring more children are protected against the virus,” he added.

In late December last year, the FDA approved the EUA for the Pfizer COVID-19 vaccine for ages 5 to 11 years old.
Based on the DOH’s national COVID-19 vaccination dashboard, at least 151 million vaccine doses have already been administered in the country as of May 29.

Of this number, 70.8 million Filipinos are already fully vaccinated against COVID-19, while 66.7 million have received one dose. Some 14 million individuals have also received booster shots.

As this developed, Ho said the new Omicron subvariant cases were found among three fully-vaccinated returning overseas Filipinos (ROFs) coming from the United States.

The Omicron subvariant was also detected in two local cases, who are also both fully vaccinated.

These five new cases of the Omicron subvariant BA.2.12.1 brought the total number of cases to 22. Eighteen of these were locally-acquired — two from the National Capital Region, 12 from Puerto Princesa in Palawan, and four from Western Visayas.

The four infections were from ROFs residing in Western Visayas.

The virus’ reproduction rate in Metro Manila slightly increased to 1.08 following a rise in its average daily cases to 74 in the past 7 days from 72 during the previous week, according to OCTA fellow Guido David.

“So far, we’re just seeing an uptick. It’s unclear whether it will continue, if cases will continue to rise or whether we’ll maintain a low risk situation,” David said in a televised press briefing.

“It’s too early to determine the trajectory. It’s still possible the uptick will decline…possible also the uptick will continue but only very slightly. Right now it’s too early to tell what will be the effect,” he added.

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