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Covid Healthline

COVID-19 vaccines for children: What are the side effects?

Vaccines undergo particularly rigorous safety tests before receiving approval for use in the general population. However, no drug is guaranteed to be free from side effects, so what are the side effects that children receiving the COVID-19 vaccine may face?

The Food and Drug Administration (FDA)Trusted Source approved the Pfizer vaccine for children aged 5–11 years on October 29, 2021. According to a recent survey by KFF COVID-19 Vaccine Monitor, just over one-quarter of parents of children in this age group are eager for their child to be vaccinated as soon as possible.

Although this may be surprising, other survey findings shed some light on the reasons behind this hesitancy: a fear of side effects.

Two-thirds of parents of children of this age said that they were worried that the COVID-19 vaccine would affect their children’s future fertility. So significant are these concerns that the American Academy of Pediatrics recently put out a video disputing any potential impact of the vaccine on puberty or fertility.

Vaccine hesitancy is not just over fears of an impact on fertility, however. Over three-quarters of parents reported that they were “very” or “somewhat” concerned that their child might experience serious side effects or that not enough is known about long-term effects from the COVID-19 vaccine.

So, what are the possible side effects?

What are children going to get?

In the same way that pharmaceutical companies raced to get the vaccine approved for adults, those companies have carried out trials to see if their vaccines are safe and effective in adolescents and children.

Speaking at an Independent SAGE briefing on November 5, 2021, Prof. Deenan Pillay — a professor of virology at University College London (UCL) in the United Kingdom — said:

“There have been a number of trials. We are always concerned about the untoward effect of all medicines in children, and, of course, we can’t just extrapolate from data that [come] from adults to children. We have got to wait to ensure there is safety in children. And now that has happened.”

So far, mRNA vaccines from Pfizer and Moderna have received approval in the U.S. for children over 12 years of age, with the Pfizer vaccine approved for 5–12-year-olds at the end of October 2021.

The European Medicines Agency announced that it would start investigating the safety of the vaccine in that age group on October 18, 2021.

Most countries offering vaccination to those over 12 years of age are offering the Pfizer or Moderna vaccine, Reuters recently reported. A single dose of the Pfizer vaccine is available for those over 12 years old in the U.K., where the Moderna vaccine also has approval for this age group.

Pfizer has plans to trial the vaccine in children aged 6 months to 5 years, and Moderna has ongoing trials to test the safety and efficacy of vaccines in children under 12 years old.

Novavax is about to start a study of up to 3,000 adolescents aged 12–17 years across up to 75 sites in the United States. Johnson & Johnson has enrolled children as young as 12 years into existing trials, and AstraZeneca is planning on conducting trials of its vaccine in children as young as 6 years.

The vaccine with the most evidence to support its use so far is Pfizer’s mRNA vaccine against SARS-CoV-2, which is the virus that causes COVID-19.

However, the vaccine doses given to children over the age of 12 years and those under the age of 12 years differ. Pfizer released data from its phase 2 and 3 trials at the end of September 2021. The data suggest that the vaccine was safe in children aged 5–11 years.

Children under the age of 12 years will be offered 10 micrograms (mcg) of the vaccine. This is compared with 30 mcg of the vaccine, which is the amount given to children over the age of 12 years and adults. Experts hope that this lower dose could result in fewer side effects, as lower doses generally should.

Minor adverse reactions

Senior vice president of Pfizer Vaccine Clinical Research and Development, Dr. Bill Gruber, broke down the drug company’s data from its phase 2 and 3 trials at the FDA’s Vaccines and Related Biological Products Advisory Committee Meeting on October 26, 2021.
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