Pharmaceutical giant Pfizer is looking to secure an emergency use authorization (EUA) for its coronavirus disease (COVID-19) vaccines for children aged 5 to 11 years, according to the Food and Drug Administration (FDA).
FDA Director General Eric Domingo yesterday said Pfizer applied for an EUA last week, and the application is undergoing evaluation by vaccine experts.
“I’m quite confident that once they are able to submit all their data, our experts will be satisfied,” Domingo said in a radio interview, noting the Pfizer vaccine is already being used in several countries.
The US Food and Drug Administration, in October, authorized the emergency use of the Pfizer vaccine for minors aged 5 to 11 years.
“We have real world data, and not just clinical trials. We can already see their safety and efficacy,” he said.
Domingo said Pfizer might get the EUA by the end of the year,
“If I am not mistaken, we will be expanding to the 5-to-11-year old (group) by January next year,” said Domingo.
About 12 million children aged 5 to 11 years are expected to benefit once Pfizer gets an EUA for its vaccine.
Currently, the Philippines is vaccinating only those aged 12 years and older.
Pfizer is the first COVID-10 vaccine that secured approval from the FDA. The EUA which was granted in January was later amended, allowing its use for adolescents aged 12 to 15 years.
