Good News, Experts Support The Provision Of Pfizer's COVID-19 Vaccine For Children 5-11 Years Old

JAKARTA - The expert panel team provided support for recommendations for the use of Pfizer's COVID-19 vaccine for children aged 5-11 years, saying the benefits of the vaccine outweigh the risks.

The authorization of a COVID-19 vaccine for this age group is an important regulatory step, as children return to school for hands-on learning.

This endorsement was issued by a panel of experts for the United States Food and Drug Administration (FDA), Tuesday. A meaningful step, considering this will reach 28 million children in that age range to receive the COVID-19 vaccine.

Vaccines could be available for younger age groups as early as next week. The FDA is under no obligation to follow the advice of outside experts, but it usually does. The vote was 17 in favor with one abstention.

If the FDA allows injections for this age group, the US Centers for Disease Control and Prevention (CDC) advisory panel will meet next week to make recommendations about administering the vaccine. The CDC director will make the final call.

While children who become seriously ill or die from COVID-19 are relatively rare compared to adults, some develop complications, and infections in unvaccinated children have increased due to the highly contagious Delta variant of the Coronavirus. Data from the American Academy of Pediatrics shows that more than 500 US children have died from COVID-19.

"This is the eighth highest killer of children in this age group over the past year," said Dr. Amanda Cohn, a pediatric vaccine expert at the CDC and a member of the voting panel.

"Use of this vaccine will prevent death, will prevent ICU admission and will prevent significant long-term adverse outcomes in children".

To date, only a few countries have allowed COVID-19 vaccination for children in this age range, including China, Cuba, and the United Arab Emirates.

In the United States, only about 57 percent of the population is fully vaccinated, lagging behind other countries such as the UK and France. Meanwhile, the percentage of young children receiving injections may be low. The US vaccination rate for 12 to 15-year-olds follows other age groups at around 47 percent.

Pfizer is seeking approval for a lower dose of 10 micrograms for young children, compared to 30 micrograms for those 12 years and older.

The company said their vaccine showed 90.7% efficacy against the coronavirus in clinical trials of children aged 5-11 years.

Advisors are paying close attention to levels of heart inflammation called myocarditis that has been linked to Pfizer/BioNTech and Moderna vaccines, especially in young men.

Several panel members suggested, because of the risk of myocarditis, the vaccine should be given to a narrower group of children, such as those with conditions that make them more likely to be hospitalized.

"There are certain children who should be vaccinated. The question of how widely it is used, I think is important," said Eric Rubin, Editor-in-Chief of the 'New England Journal of Medicine'.

If permitted, the Pfizer/BioNTech vaccine will likely be the only one available to this age group in the United States for some time.

Meanwhile, Pfizer said it could have data from its clinical trials on even younger children ages 2 to 4 by the end of the year.

To note, the World Health Organization (WHO) since May has been urging rich countries to reconsider plans to vaccinate children. Instead, donate COVID-19 injections to the COVAX program for distribution to poor countries.