Pfizer says vaccine safe for ages 5 to 11, will seek approval soon

On Monday, Pfizer announced that its testing showed that its vaccine against the coronavirus is safe and effective for children ages 5 to 11, and that it would be seeking FDA approval to administer the vaccine to those age groups soon.

The company said that a “favorable safety profile” was observed in a trial of the targeted age group, at a dosage one-third the amount given to those ages 12 and up.

“Over the past nine months, hundreds of millions of people ages 12 and older from around the world have received our COVID-19 vaccine. We are eager to extend the protection afforded by the vaccine to this younger population, subject to regulatory authorization, especially as we track the spread of the Delta variant and the substantial threat it poses to children,” Pfizer CEO Albert Bourla said.

“Since July, pediatric cases of COVID-19 have risen by about 240 percent in the U.S. – underscoring the public health need for vaccination. These trial results provide a strong foundation for seeking authorization of our vaccine for children 5 to 11 years old, and we plan to submit them to the [Food and Drug Administration (FDA)] and other regulators with urgency,” he added.

Would be first vaccine for younger children

The trial included 2,268 participants in the 5 to 11 age group, and found that side effects were similar to those in the 16 to 25 age group.

If approved, Pfizer would be the first vaccine available to the 5 to 11 age group, and would give a measure of protection to parents and teachers who could be exposed to COVID-19 from unvaccinated children, at least theoretically.

Although children have low levels of severe disease and hospitalization, the numbers of both mild and severe cases among children have increased with the delta variant. Future variants may put children even more at risk for infection.

Currently, around 64% of children ages 12 to 17 have been fully vaccinated using the Pfizer vaccine, which is the only one approved in the U.S. for that age group.

Evaluating myocarditis risk

However, at least one study found that the risk of myocarditis in males ages 12 to 15 after vaccination, while small, was more than six times as high as their risk of hospitalization and severe disease from COVID-19.

If this risk is similar in the 5 to 11 age group, it may give parents pause about vaccinating their younger children.

The main attraction for people to get vaccines is that they reduce the risk from COVID. For at least some younger people, it appears that may not be the case.

Officials are pushing vaccination for all eligible people in order to lower the number of new infections and severe infections, which have been filling some hospitals to capacity during delta.

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