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What are the risks of COVID-19 vaccinations for children?

Before being approved for use in the general public, vaccines must pass stringent safety tests. However, no medicine can be guaranteed to be without adverse effects, so what are the potential negative effects for children who get the COVID-19 vaccine?

A nurse gives a boy a dose of the Pfizer vaccine

On October 29, 2021, the Food and Drug Administration (FDA)Trusted Source authorized the Pfizer vaccination for children aged 5–11 years. According to a recent KFF COVID-19 Vaccine Monitor study, slightly more than one-quarter of parents of children in this age range want their kid to get vaccinated as soon as feasible.

Although this may come as a surprise, other poll results provide some insight on the reasons behind this hesitance: a fear of negative effects.

Two-thirds of parents with children this age were concerned that the COVID-19 vaccination will have an impact on their children’s fertility in the future. These worries are so serious that the American Academy of Pediatrics has released a video refuting the vaccine’s possible influence on puberty or fertility.

Vaccine apprehension stems from more than just concerns about the influence on fertility. Over three-quarters of parents reported being “extremely” or “very” concerned that their kid would have major side effects from the COVID-19 vaccination or that not enough is known about long-term implications.

So, what are some of the potential adverse effects?

What are children going to get?

Pharmaceutical firms, in the same way that they rushed to get the vaccine authorized for adults, have conducted trials to evaluate if their vaccinations are safe and effective in adolescents and children.

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

“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 been licensed in the United States for children over the age of 12, with the Pfizer vaccine expected to be approved for 5–12-year-olds by the end of October 2021.

On October 18, 2021, the European Medicines Agency stated that it will begin examining the vaccine’s safety in that age range.

According to Reuters, most nations that give immunization to those above the age of 12 use the Pfizer or Moderna vaccine. In the United Kingdom, a single dose of the Pfizer vaccine is available for people above the age of 12, and the Moderna vaccine is also approved for this age range.

Pfizer intends to test the vaccine in children aged 6 months to 5 years, while Moderna is already testing the safety and efficacy of vaccinations in children under the age of 12.

Novavax is preparing to begin a research involving up to 3,000 teenagers aged 12–17 years at up to 75 sites across the United States. Johnson & Johnson has included children as young as 12 years old in current trials, while AstraZeneca plans to undertake vaccination trials in children as young as 6 years old.

Pfizer’s mRNA vaccine against SARS-CoV-2, the virus that causes COVID-19, has received the greatest evidence to far to justify its use.

However, vaccination dosages for children over the age of 12 and those under the age of 12 differ. At the end of September 2021, Pfizer will share findings from its phase 2 and 3 studies. According to the findings, the vaccination proved safe in children aged 5–11 years.

Children under the age of 12 will be given a dose of 10 micrograms (mcg) of the vaccination. This compares to 30 mcg of the vaccine, which is administered to children over the age of 12 and adults. Experts believe that the reduced dose will result in fewer negative effects, as smaller doses should in general.

Minor negative responses

Dr. Bill Gruber, senior vice president of Pfizer Vaccine Clinical Research and Development, presented findings from the pharma company’s phase 2 and 3 studies at the FDA’s Vaccines and Related Biological Products Advisory Committee Meeting on October 26, 2021.

During the phase 2 and 3 studies of children aged 5–12 years, he reported that there were extremely few significant adverse events and no deaths. He also stated that the adverse effects were identical to those seen by adults.

Fatigue and headache were the most prevalent adverse effects in children following their second dosage of the vaccine (first dose responses were less common), with 39.4 percent and 28 percent of 5–12-year-olds suffering such symptoms, respectively.

This compares to 65.6 percent and 60.9 percent of adults, respectively. Data indicating that fever and chills reported after the immunization were lower among 5–12-year-olds than among 12–65-year-olds were noteworthy.

Only 6.5 percent of children between 5–12 years developed fever following immunization, compared to 17.2 percent of those above the age of 12. In addition, just 9.8 percent of individuals aged 5–12 years had chills, compared to 40 percent of those over the age of 12.

Dr. Gruber revealed to the committee that due to current concerns regarding the danger of myocarditis and pericarditis among teenage and young adult males, the scientists took special care during this research.

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

Myocarditis

Myocarditis, or inflammation of the heart muscle, is now being monitored by the Centers for Disease Control and Prevention (CDC) and others. This follows news in July 2021 that some adolescent males were diagnosed with this disease after getting the Pfizer vaccination, which people over the age of 12 have been eligible to obtain since May 2021.

According to the CDC, males aged 12–29 years are the most at risk of acquiring myocarditis.

It further notes that, while 687 occurrences of myocarditis following immunization were documented in under-30s in the United States between December 29, 2020, and June 11, 2021, healthcare practitioners administered more than 52 million doses of the vaccine to persons aged 12–30 years. As a result, this is a very low danger.

However, there was still debate on whether the vaccine’s hazards, which were extremely low, exceeded the chances of acquiring COVID-19, which were likewise lower for this age group than for older individuals.

One unreview study reported that the risk of an adverse cardiac event following mRNA immunization in boys aged 16–17 years with no comorbidities was actually 3.5 times higher than the risk of hospitalization due to COVID-19. In August 2021, this was widely publicized.

On the other hand, a research published in the New England Journal of Medicine on October 6, 2021, highlighted data from the Israeli Ministry of Health’s tracking of the issue that appeared to indicate a relationship between receiving the Pfizer vaccination and myocarditis.

Data obtained between December 20, 2020, and May 31, 2021 revealed 136 occurrences of myocarditis after receiving the Pfizer vaccination, out of 5.12 million Israelis who received two doses. The danger appears to be greatest after the second dosage in male recipients aged 16–19 years, with a risk ratio of 1 in 6,637.

Prof. Manfred Green of the Department of Epidemiology at Israel’s University of Haifa told Medical News Today in an interview:

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

Dr. Green sits on the committee due to decide whether or not to proceed with licensing vaccines for 5–12-year-olds in Israel on November 10, 2021. “It is predicted [that] there would be [fewer] side effects and [fewer] adverse occurrences,” he said, noting that the dose given to 5–12-year-olds is one-third that given to older children and adults.

Children who are medically susceptible

Much of the worry expressed concerning COVID-19 vaccination adverse effects is about the harm they may pose to healthy youngsters.

Meanwhile, children with certain preexisting disorders will be most sensitive to COVID-19 and will benefit the most from immunization. So, how do they fare?

Few research have been conducted on these youngsters due to the small number of children in these categories. However, one research published in the journal Archives of Disease in Childhood reported no serious side effects in a sample of 20 teenagers with neurological problems aged 12–15 years.

Risk-benefit analysis

When assessing the dangers posed by potential COVID-19 vaccination side effects, it is impossible to ignore the potential advantages – which may be difficult to determine for the individual.

An research published on November 1, 2021 in the Journal of the Royal Society of Medicine reveals that vaccination of 12–17-year-olds is most useful while illness rates stay high — which they are in many places of the world.

According to the estimate, if SARS-CoV-2 infections reach 1,000 per 100,000 people per week for 16 weeks, immunization might save 4,430 hospitalizations and 36 fatalities. It also implies that thousands of cases of long COVID might be averted, even if the rate of long COVID in teens was as low as 4%.

Author Prof. Christina Pagel, a UCL professor of operational research, stated during an Independent SAGE briefing on November 5, 2021:

“It became really clear that if you got to really high case rates, then it is massively beneficial, and so even though children of 5–11 are less likely than adolescents to get really sick at the current rates of infection, with 6% [with the infection] at the end of October [in the U.K.], it is almost certain to be beneficial… I would be really surprised if there [weren’t] a benefit to vaccinating 5–11-year-olds, and I am a bit concerned that some members of [Joint Committee on Vaccination and Immunisation] are already saying ‘it’s too soon.’”

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