FDA Approves Pfizer/BioNTech COVID-19 Vaccine for 12-15 Age Group

But how safe is the vaccine for kids?
Fabienne Lang

The U.S. Food and Drug Administration (FDA) said on Monday, May 10 that it's expanded its approval of the Pfizer/BioNTech COVID-19 vaccine to be administered to adolescents from 12 to 15 years old in emergency cases. 

Teens could start receiving the vaccine dose as early as Thursday, May 13, read the FDA's statement. Since late 2020 and up until yesterday, teenagers only 16 years of age and above could receive the Pfizer/BioNTech vaccine for emergency uses.

Acting FDA Commissioner Janet Woodcock, said "Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic"

"Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations," she continued. 

Given the Pfizer/BioNTech vaccine proved to be 100 percent effective in children aged 12 to 15, it's easy to see why some people might be pushing for it.

Do kids catch COVID-19, and is it safe to give young teens and kids COVID-19 vaccines?

The U.S. Centers for Disease Control and Prevention (CDC) reported approximately 1.5 million COVID-19 cases in adolescents aged between 11 and 17 years old between March 2020 and April 2021. 

It has been noted that children undergo milder COVID-19 side effects than adults, and deaths are very rare. However, as a study published in the journal Nature in April explained, some adolescents who have mild COVID-19 symptoms can sometimes develop a condition that can be deadly called multi-system inflammatory syndrome in children (MIS-C) later down the line.

On top of that, children have been known to sometimes pass COVID-19 on to adults or other children. As the Nature study said, children are most likely not super-spreaders, but with stronger variants developing, they might end up spreading the virus more and more. This argument is enough for parents and medical workers to believe children and teenagers should be inoculated, too.

COVID-19 vaccine trials on teenagers

To try and see the effects of COVID-19 vaccines in young adolescents, rigorous and safe vaccine trials have taken place over the past few months.

In Pfizer/BioNTech's case, 2,260 voluntary participants aged between 12 and 15 years old participated in its randomized, placebo-controlled vaccine trial in the U.S. Roughly half of the teenagers received a dose of the vaccine, and the other half was administered a saline placebo. 

The same side-effects that adults typically feel after receiving the jab were reported, such as an ache where the vaccine was administered, fatigue, headache, chill, muscle pain, fever, and joint paint. 

Other U.S.-authorized vaccines, like Johnson & Johnson and Moderna, are also looking into the safety and effectiveness of vaccinating young children and teenagers. Johnson & Johnson has already begun vaccine trials in adolescents aged 12 - 17 years old, and Moderna is also carrying out clinical trials on those aged 12 to 17 years old, and enrolling candidates aged six months to 11 years old.

There's still some work to be done before all children are able to receive COVID-19 vaccines, but the path is being paved.

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