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

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

Although this may be surprising, other survey results shed light on the reasons for this reluctance: fear of side effects.

Two-thirds of parents of children this age said they feared the COVID-19 vaccine could affect their children’s future fertility. These concerns are so significant that the American Academy of Pediatrics recently released a video contesting any potential impact of the vaccine on puberty or fertility.

However, the reluctance to vaccinate is not only due to fears of an impact on fertility. More than three-quarters of parents said they were “very” or “somewhat” concerned that their child might experience serious side effects or that not enough was known about the long-term effects of the drug. COVID-19 vaccine.

So what are the possible side effects?
What are the kids going to get?
In the same way that pharmaceutical companies have rushed to get the vaccine approved for adults, these companies have conducted trials to see if their vaccines are safe and effective in adolescents and children.

Speaking at an independent SAGE briefing on November 5, 2021, Professor Deenan Pillay – professor of virology at University College London (UCL) in the UK – said:

“There have been several trials. We are always concerned about the side effects of all drugs in children and of course we cannot just extrapolate from data that [comes] from adults to children. We have to wait to keep the children safe. And now it has happened.

So far, mRNA vaccines from Pfizer and Moderna have been approved in the United States for children over 12 years of age, with the Pfizer vaccine approved for ages 5 to 12 at the end of October 2021.

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

Most countries offering vaccination to people over 12 offer the Pfizer or Moderna vaccine, Reuters recently reported. A single dose of the Pfizer vaccine is available for people over 12 in the UK, where the Moderna vaccine is also approved for this age group.
Pfizer intends to try the vaccine in children aged 6 months to 5 years, and Moderna has ongoing trials to test the safety and effectiveness of the vaccines in children under 12 years of age.

Novavax is about to launch a study involving up to 3,000 adolescents aged 12 to 17 at 75 sites in the United States. Johnson & Johnson has enrolled children as young as 12 in existing trials, and AstraZeneca plans to conduct trials of its vaccine in children as young as 6.

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

However, the doses of the vaccine given to children over 12 years old and those under 12 years old differ. Pfizer released data from its Phase 2 and 3 trials in late September 2021. The data suggested the vaccine was safe in children aged 5 to 11.

Children under 12 will be offered 10 micrograms (mcg) of the vaccine. This is compared to 30 mcg of the vaccine, which is the amount given to children over 12 and adults. Experts hope that this lower dose might lead to fewer side effects, as lower doses generally should.
Minor side effects
Pfizer’s Senior Vice President of Clinical Vaccine Research and Development Dr Bill Gruber broke down the drug company’s data on its Phase 2 and 3 trials at the Vaccine Advisory Board meeting and related biologics from the FDA on October 26, 2021.

It found that there were very few serious adverse events and no deaths during the phase 2 and 3 trials in children aged 5 to 12. He also explained that the side effects were similar to those experienced by adults.

The most common side effects in children after their second dose of the vaccine – reactions to the first dose were less common – were fatigue and headache, 39.4% and 28% of children 5 to 12 years old with these symptoms, respectively.

This is compared to 65.6% and 60.9% of adults. It should be noted that the data showing that the fever and chills experienced after the vaccine were lower in 5 to 12 year olds than in 12 to 65 year olds.

Only 6.5% of children aged 5 to 12 developed fever after vaccination, compared to 17.2% of those over 12 years old. In addition, only 9.8% of people aged 5 to 12 experienced chills, compared to 40% of those over 12.

Due to existing concerns about the risk of myocarditis and pericarditis in adolescent and young adult males, scientists took specific precautions during this trial, Dr Gruber told the committee.

He said: “To improve the possible detection of rare myocarditis events in adolescents and young adults, should they occur, specific instructions have been provided to be alert for symptoms and signs of myocarditis […] . No anaphylaxis, myocarditis and no appendicitis have been reported.
The Centers for Disease Control and Prevention (CDC) and others are currently monitoring levels of myocarditis, which is inflammation of the heart muscle. This follows reports in July 2021 that some adolescents were diagnosed with the disease after receiving the Pfizer vaccine, which people over 12 can receive since May 2021.

The CDCTrusted Source reports that men aged 12 to 29 are most at risk of developing myocarditis.

It also states that although 687 cases of post-vaccination myocarditis were reported in people under the age of 30 in the United States between December 29, 2020 and June 11, 2021, healthcare professionals administered more than 52 million doses of vaccine for people aged 12 to 12 years. 30 years in all. So this represents a very small risk.

However, there was still a discussion to be had as to whether the risks of the vaccine, which were very low, outweighed the risks of developing COVID-19, which were also lower for this part of the population than people. elderly.

One study, which has not yet been peer reviewed, claimed that the risk of experiencing an adverse cardiac event after mRNA vaccination in men aged 16 to 17 without any Comorbidity was actually 3.5 times higher than the risk of hospitalization due to COVID-19. This was widely reported in August 2021.

Conversely, a study published in the New England Journal of Medicine on October 6, 2021 reported results from monitoring of the problem by the Israeli Ministry of Health that appeared to prove a link between receipt of the Pfizer vaccine and myocarditis.

Data collected between December 20, 2020 and May 31, 2021 confirmed 136 cases of myocarditis after receiving Pfizer vaccine out of 5.12 million Israelis who had received two doses. The analysis suggests that the risk is highest after the second dose in male recipients aged 16 to 19, with a relative risk of 1 in 6,637.

Study co-author Professor Manfred Green, from the Epidemiology Department at the University of Haifa in Israel, told Medical News Today in an interview:
Medically vulnerable children
Much of the concern expressed about the side effects of COVID-19 vaccines relates to the risk they may pose to healthy children.

Meanwhile, children who have pre-existing conditions will be particularly vulnerable to COVID-19 and will benefit more from the vaccination. So what about them?

There have been few studies on these children because the children in these groups are few. However, a study published in the journal Archives of Disease in Childhood found no problematic side effects in a group of 20 adolescents aged 12 to 15 with neurological disorders.

Risk-benefit analysis
When assessing the risks posed by the possible side effects of the COVID-19 vaccine, it is impossible to do so without considering the possible benefits – although these may be difficult for the individual to discern.

Analysis published in the Journal of the Royal Society of Medicine on November 1, 2021, suggests that vaccinating 12-17 year olds is most beneficial while infection rates remain high – which they do, of course, in many regions. of the world.

The analysis suggests that if SARS-CoV-2 infections reach 1,000 per 100,000 people per week for 16 weeks, vaccination could prevent 4,430 hospitalizations and 36 deaths over 16 weeks. It also suggests that thousands of cases of long COVID could be prevented, even if the rate of long COVID were as low as 4% among adolescents.

Speaking at an independent SAGE briefing on November 5, 2021, the author, Professor Christina Pagel, professor of operations research at UCL, said:

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