COVID-19 Vaccines for Children: Are They Safe? – Community News
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COVID-19 Vaccines for Children: Are They Safe?

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

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A nurse gives a boy a dose of the Pfizer vaccine at a COVID-19 vaccine clinic at Lyman High School in Longwood, FL, the day before classes begin for the 2021-2022 school year. SOPA images/Getty images

The Food and Drug Administration (FDA) approved the Pfizer vaccine for children ages 5-11 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 would like their child to be vaccinated as soon as possible.

While this may be surprising, other research findings shed some light on the reasons behind this hesitation: a fear of side effects.

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

However, the hesitation in vaccinating isn’t just about the fear of an impact on fertility. More than three quarters of parents said they were “very” or “somewhat” concerned that their child could develop serious side effects or that not enough is known about the long-term effects of the COVID-19 vaccine.

So, what are the possible side effects?

In the same way that drug companies rushed to get the adult vaccine approved, those companies have been conducting 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 tests. We are always concerned about the adverse effects of all drugs in children, and of course we cannot just extrapolate from data that [come] from adults to children. We have to wait to make sure children are safe. And that has now happened.”

So far, Pfizer and Moderna mRNA vaccines have received approval in the US for children over the age of 12, and the Pfizer vaccine was approved for 5-12 year olds at the end of October 2021.

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

Most countries that offer vaccination to individuals over the age of 12 offer the Pfizer or Moderna vaccine, Reuters recently reported. A single dose of the Pfizer vaccine is available to individuals over the age of 12 in the UK, where the Moderna vaccine is also approved for this age group.

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

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

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

However, the vaccine doses given to children over 12 years of age and children under 12 years of age differ. Pfizer released data from its Phase 2 and 3 studies in late September 2021. The data suggest that the vaccine was safe in children ages 5-11.

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

Senior Vice President of Pfizer Vaccine Clinical Research and Development, Dr. Bill Gruber, broke through the drug company’s data from its Phase 2 and 3 trials at the FDA’s Advisory Committee on Vaccines and Related Biological Products meeting on Oct. 26, 2021.

He revealed that there were very few serious side effects and no deaths during the Phase 2 and 3 trials in children aged 5-12 years. He also explained that the side effects were similar to those seen in 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, with 39.4% and 28% of 5-12 year olds experiencing those symptoms, respectively.

This is compared to 65.6% and 60.9% of adults. Notable were data showing that post-vaccine fever and chills were lower in 5-12 year olds than in 12-65 year olds.

Only 6.5% of children aged 5-12 years developed a fever after vaccination, compared to 17.2% of children older than 12 years. Also, only 9.8% of 5-12 year olds experienced chills, compared to 40% of those over the age of 12.

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

He said: “To improve the potential detection of the rare cases of myocarditis in adolescents and young adults, [they] occur, specific instructions were given to be vigilant with symptoms and signs of myocarditis […]. No anaphylaxis, no myocarditis, and no appendicitis were reported.”

The Centers for Disease Control and Prevention (CDC) and others are currently tracking rates of myocarditis, an inflammation of the heart muscle. This comes in response to reports in July 2021 that some teenage boys had been diagnosed with this condition after receiving the Pfizer vaccine, which individuals over the age of 12 have been able to receive since May 2021.

The CDC reports that men between the ages of 12-29 are most at risk for developing myocarditis.

It also states that although between December 29, 2020 and June 11, 2021, 687 cases of post-vaccination myocarditis had been reported in youth under the age of 30 in the U.S., healthcare professionals had given more than 52 million doses of the vaccine to 12-year-olds. – 30 years in total. This therefore represents a very small risk.

However, it had yet to be debated whether the vaccine’s risks, which were very small, outweighed the risks of developing COVID-19, which were also smaller for this segment of the population than for older adults.

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

Conversely, a study in the New England Journal of Medicine of October 6, 2021, Israel’s Ministry of Health reported findings on the matter that appeared to prove a link between Pfizer vaccine reception and myocarditis.

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

Study co-author Prof. dr. Manfred Green, of the Department of Epidemiology at the University of Haifa in Israel, told Medical news today in an interview:

“Myocarditis is more common in men and women, [and] there are all kinds of theories why […]. [In the study, we found that] it was generally a mild illness, a mild infection, and a minor event requiring hospitalization, as people with myocarditis are almost always hospitalized for observation. They demanded […] very basic anti-inflammatory treatment to treat the inflammation. Everything was fine, they recovered well.”

dr. Green is on the committee to decide on November 10, 2021 whether or not to license vaccines for 5-12 year olds in Israel. He pointed out that if the dose given to 5-12 year olds is one-third the dose given to older children and adults, “expected” [that] there will be [fewer] side effects and [fewer] effects.”

Much of the concern about side effects of COVID-19 vaccines revolves around the risk they can pose to healthy children.

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

Little research has been done on these children because there are very few children in these groups. However, a study appearing in the journal Archives of childhood illness found no problematic side effects in a group of 20 adolescents aged 12-15 years with neurological disorders.

When evaluating the risks of potential side effects of the COVID-19 vaccine, it is impossible to do so without considering the potential benefits, although these may be difficult for the individual to discern.

An analysis that appeared in the Journal of the Royal Society of Medicine on November 1, 2021, suggests that the vaccination of 12-17-year-olds is most beneficial, while the infection rate remains high – which, of course, they do in many parts of the world.

The analysis suggests that if SARS-CoV-2 infections are as high as 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-term COVID could be avoided, even if the percentage of long-term COVID in teens was only 4%.

Speaking at an Independent SAGE briefing on November 5, 2021, author Prof. Christina Pagel – a professor of operations research at UCL -:

“It became really clear that if you get really high rates of disease, it’s hugely beneficial, and so although children aged 5-11 are less likely than adolescents to get really sick at the current infection rates, at 6% [with the infection] the end of October [in the U.K.], it is almost certain that it will be beneficial … I would be really surprised if there [weren’t] a benefit to vaccinating 5-11 year olds, and I’m a little concerned that some members of [Joint Committee on Vaccination and Immunisation] already say ‘it’s too early.’”

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