FDA has Authorized Pfizer-BioNTech COVID-19 Vaccine for Kids 5 to 11

The Food and Drug Administration (FDA) authorized the use of the Pfizer-BioNTech pediatric COVID-19 vaccine for 5 to 11 years old. The agency said that the decision was based on data from a clinical trial showing that this lower-dose vaccine was 90.7 percent effective for preventing the COVID-19 in this age group.

In addition, no major side effects were detected in the 3,100 children who received the vaccine during the study.

Children have a lower risk of COVID-19 risk

Yes, children are indeed less prone to COVID-19 risk, but the risk is not zero. The FDA’s decision comes after a panel of independent scientists voted in support of the authorization.

Director of FDA’s Center for Biologics Evaluation and Research, Dr. Peter Marks said that at the FDA advisory group meeting, the children ages 5 to 11 are “far from being spared from the harm of COVID-19.”

There have been more than 8,300 younger children hospitalized due to COVID-19, with about a third of those needing intensive care.

Hospitalization rates among the age group are three times higher for Alaska Native, American Indian, Hispanic, and Black children compared with white children. COVID-19 has impacted certain groups of children more than others, similar to patterns seen in adults.

In addition, COVID-19 has disrupted children’s education throughout the pandemic. CDC data shows that “more than 2,000 schools had unplanned closures [due to COVID-19]. It has made an impact on more than a million students.

The benefits of the vaccine outweigh the risks

The dose for the Pfizer-BioNTech pediatric vaccine would be one-third of the strength of the dose given to people 12 and older, with two doses given 3 weeks apart.

The vaccine gets shipped in vials with different colored caps with clear instructions and labeling to distinguish them from the already authorized vaccine doses for adults and adolescents.

Even with the lower-strength dose, the pediatric vaccine was more than 90 percent effective against infection. Side effects were quite similar to what was seen in adolescents and older children. Headache, fatigue, and pain at the injection site were among the most common side effects.

No severe side effects related to the vaccine indeed occurred in the children who were vaccinated.

At the FDA advisory panel meeting, CDC scientists presented many scenarios that looked at the benefits and risks of the vaccine, based on the varying levels of vaccine effectiveness, rates of possible side effects, and virus transmission.

They found that younger children have more vaccine benefits that outweigh the risk of side effects.

The risk looked at was rare cases of heart inflammation – pericarditis and myocarditis. After vaccination, young male adults and older male adolescents after the second dose. These heart conditions may also occur after coronavirus or any other bacterial or viral infections. Myocarditis after COVID-19 can be more severe compared to after the vaccination.

In the risk-benefit model, CDC scientists based the risk of myocarditis after vaccination on rates seen in adolescents.

Some committee members pointed out that pre-COVID myocarditis rates in younger children are lower than in adolescents. A similar trend may be seen with myocarditis after the vaccination.

Vote to provide parents with choice

Given the real yet low risk of myocarditis in children after several vaccinations, many committee members questioned whether the vaccination needs to be authorized for the entire age group or those most at risk. In the end, the committee voted to let parents in conjunction with their pediatrician – make an informed decision for their child.

Children with underlying medical conditions have a higher risk of ending up in the ICU or hospital with COVID-19. For them, vaccination may make more sense.

In the same way, Alaska Native, American Indian, Hispanic, and Black children are at a higher risk of severe COVID-19. It may factor into the decision of parents about vaccination.

Conclusion

FDA and CDC will monitor the safety of the vaccine with the use of several systems. Few will also provide real-time reporting. It will also give a better understanding of the risk of myocarditis after vaccination in younger children. It helps parents to make the right decision about whether to have their child vaccinated.

As a parent, it is your responsibility to make a wise decision for your child.

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