Moderna gets FDA nod for ages 12-17

MANILA, Philippines — The Food and Drug Administration (FDA) yesterday approved the use of Moderna’s COVID-19 vaccine for minors aged 12 to 17 years in the country.

At a public briefing, FDA director general Eric Domingo said they have granted the application of Moderna for the amendment of its emergency use authorization (EUA) to include this age group. Previously, its EUA was only for those aged 18 years and above.

He stressed though that this approval includes a warning for vaccinators and doctors to “watch out” for “very rare cases of myocarditis.”

“It’s like inflammation of the heart that was seen in very few, very rarely – one in every million maybe – who have been vaccinated. It was seen more among the young males,” he added.

Despite this, Domingo gave assurance that the benefits of vaccination “outweigh the risk,” especially now that the highly transmissible Delta variant is circulating.

Senate Majority Leader Miguel Zubiri thanked the FDA for its quick action in granting the EUA for Moderna vaccines for adolescents, saying this meant that the country now has both Moderna and Pfizer vaccines to tap when the vaccination program for the age group starts.

“It’s been so terrifying, seeing the newer strains of the virus striking more and more children, so this approval is fantastic news. We will be able to have one more layer of protection for our kids, apart from the current health protocols that we are enforcing,” Zubiri said in a statement.

He said the move will not just protect children, but also help the country reach herd immunity more quickly.

The country is on track to achieving population protection by yearend, said National Task Force against COVID-19 chief implementer Carlito Galvez Jr. yesterday as he cited the arrivals in the country of larger vaccine shipments from various manufacturers.

Over four million doses of Pfizer vaccines are expected to arrive this month as part of the 40 million doses procured by the government.

As of Sept. 1, the country has received a total of 52,603,760 vaccine doses from various manufacturers.

On Wednesday, the Philippines received 188,370 doses of Pfizer vaccines and another 651,500 doses Thursday evening through the World Health Organization’s COVAX Facility.

US embassy Chargé d’Affaires John Law noted that the shipment of Pfizer vaccines will enable the national government to ramp up its inoculation rate and provide more people with an extra layer of protection against COVID-19.

“Every time we see a delivery of these vaccines, with hundreds of thousands, or millions of vaccines coming in, that means hundreds of thousands of Filipinos in a few days are going to be better protected against this pandemic,” Law said.

According to the embassy, the US government is working closely with Philippine stakeholders to protect public health and support the local response to COVID-19. It has provided over P1.38 billion worth of assistance to the Philippines since the start of the pandemic.

The United Nations International Children’s Fund (UNICEF) lauded the Philippine government’s sustained efforts to ramp up the country’s vaccination rollout, which aims to achieve population protection by yearend.

“Let me thank the Philippine government for all the efforts to get the population vaccinated,” said UNICEF Philippines health and nutrition chief Malalay Ahmadzai during the arrival of 188,370 doses of Pfizer-BioNTech vaccines Thursday.

“The vaccines are safe and people need to make an effort to get vaccinated so we can break the cycle of the pandemic. There has been a lot of efforts going on in the vaccines to make sure that every person in the Philippines receives vaccines,” Ahmadzai added.  – Paolo Romero, Janvic Mateo, Jose Rodel Clapano, Rudy Santos

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