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9月4日のまにら新聞から

Moderna gets FDA approval for EUA for ages 12-17

[ 444 words|2021.9.4|英字 ]

Amid the suspension of using a batch of Moderna vaccines in Japan, the Food and Drug Administration (FDA) approved the emergency use authorization (EUA) of Moderna vaccine for minors against COVID-19 in the Philippines.

Eric Domingo, FDA director general, said Friday two weeks ago Moderna applied to amend the emergency use authorization of its vaccine for ages 12 to 17.

It is the second vaccine to get EUA approval for minors after Pfizer.

"After a thorough investigation by our vaccine experts and our regulatory experts in FDA, we approved today the use under the emergency use authorization of Moderna vaccines for adolescents aged 12 to 17 years old," he said at the virtual ''Laging Handa'' public forum.

"For Moderna very similar to the other mRNA vaccine like Pfizer, our doctors and vaccinators are watching out for the very rare cases of myocarditis. It's like an inflammation in the heart that is very rare, maybe in a few (for) every million of the vaccinated. It is mostly seen in younger males," he said.

"With the Delta variant affecting a lot of children, our experts see that the benefit of using vaccines outweighs the risk," he added.

Domingo said the use of Moderna and Pfizer vaccines to minors will still depend on the decision of the health department and the National Task Force for vaccination.

"We say that we can now use Pfizer and Moderna to 12 to 17 years old but the prioritization for the vaccination will be determined by the DOH and the task force for vaccination. So when they decide that the prioritization will reach the less than 18 or 12 to 17, that is the time we will start the vaccination of minors," he said.

Despite the recent suspension of the use of some doses of Moderna in Japan due to alleged contamination, Domingo said the use of Moderna vaccines in the country will continue.

He explained that the batches of Moderna vaccines that were placed under investigation following the contamination report in Japan does not affect the supply delivered in the Philippines.

"Fortunately the doses delivered here in the Philippines is not included in the batches under investigation and so far we haven't seen any findings to show its effects in the safety and efficacy even those that they see in Japan. So here in the Philippines, we will continue the use of Moderna vaccine at this time. There is no reason to stop it," he added.

But Domingo reminded health workers they should carefully inspect the vaccine before the inoculation.

"We remind our vaccinators that inspections of the vials prior to aspiration and injection is important ," he said. Robina Asido/DMS