The European Medicines Agency (EMA) on Thursday gave its official recommendation to approve the BioNTech-Pfizer vaccine, Comirnaty, for children aged 5 to 11. In its statement, it said that the dose of Comirnaty will be lower than that used in people aged 12 and above (10 micrograms compared with 30 micrograms).

Currently, EMA's Committee for Medicinal Products for Human Use is evaluating the possible authorization of Moderna's Spikevax vaccine for children aged 6 to 11.

What are the concerns about children getting COVID vaccines?

The recent case of a 12-year-old boy from the northern German city of Cuxhaven, who died shortly after receiving the second shot of the BioNTech-Pfizer vaccine, has led to much speculation about the safety of the vaccine for children and adolescents.

A claim being made is that the boy died from the jab.

This is, at the very least, misleading. The district administration in Cuxhaven has now provided further information on the case following the final results of the autopsy, which were submitted to the Paul Ehrlich Institute (PEI), Germany's federal body for vaccines and biomedicines. According to a PEI statement, the boy had a particularly severe previous heart condition. "Taking into account the extensive medical findings, the vaccination cannot be regarded as the sole cause of the fatal outcome," it said.

In its latest security report, the PEI lists five such suspected cases through September 30 in adolescents aged 12-17 in relation to vaccination with the BioNTech-Pfizer vaccine. At least three of them had serious preexisting conditions, according to the PEI evaluation.

Professor Jörg Dötsch, director of the Clinic for Pediatrics and Adolescent Medicine of the University Hospital Cologne, told DW via email: "There is no evidence that vaccines can kill children. In fact, in Germany, four children have died in a temporal association, but none of the deaths had been associated to the vaccination itself."

Are children 'not at risk' of being infected?

The tweet above goes on to claim that "children are not at risk" from the disease itself.

This is false. In its recent Morbidity and Mortality Weekly Report, the US Centers for Disease Control and Prevention (CDC) states that "COVID-19 can also lead to severe outcomes in children and adolescents."

A CDC science brief asserts that children and adolescents can contract COVID-19, get sick and spread the virus. Looking at figures through March this year, the CDC found that the aggregate rates of a COVID infection and symptomatic illness in children from the ages of 5 to 17 were comparable to infection and illness rates in adults between the ages of 18 and 49, and higher than rates in adults aged 50 and older.

The evidence notwithstanding, there are widespread claims that the risk of children in the age group contracting the virus is negligible and that they don't need to be vaccinated.

In a briefing earlier this week, the CDC outlined that as of mid-October there were more than 8,300 COVID-19 related hospitalizations in the age group 5-11, and nearly 100 deaths. The CDC stressed that COVID-19 is one of the top 10 causes of death for children in that age group.

That's backed up by Sean O'Leary, vice chair of the American Academy of Pediatrics (AAP) and a pediatric infectious diseases specialist at the University of Colorado. 

"More than 6.6 million children have been infected with this virus since the beginning of the pandemic, and children have suffered in numerous other ways. Children can get sick from COVID, and some get very sick," he told DW via email.

According to a Harvard Medical School publication, young children are at risk of contracting the disease, even if many of them display few or even no symptoms. Those with preexisting health conditions can be at a greater risk of a serious case of COVID-19.

Another example of disinformation in this context that has resurfaced again is the claim that 13 children in South Africa died earlier this month after a COVID-19 vaccination.

This is false. A reverse video search shows that the children shown in the video were in fact killed in a stampede in Kenya in 2020.

Can a vaccine shot for children cause heart muscle inflammation?

Another claim making the rounds is that giving young children a vaccine shot can cause severe myocarditis — inflammation of the heart muscle — and blood clots.

At this stage, that assertion is misleading, O'Leary said.

"The COVID vaccines have undergone a rigorous testing and review process and have been found to be safe. They are over 90% effective with minimal rare side effects. The common ones are pain at the injection site, some local swelling and redness, and in some, headache, muscle aches and fever.

"The child who is infected with COVID is much more likely to get myocarditis than the child who is vaccinated. The myocarditis is also more likely to be severe with infection and very mild and self-limited after the vaccine," he added.

While there have been some cases of myocarditis, it's crucial to put these occurrences into context. "They are about one in 16,000 children," said Dötsch of the University Hospital Cologne. "In relation to this, the risk of myocarditis with a COVID-19 infection is about sixfold as high. The risk of blood clots has predominantly been associated with the vector vaccination by AstraZeneca and is not commonly seen in mRNA vaccinations."

Should kids be vaccinated?

This week, Israel rolled out its BioNTech-Pfizer vaccination program for children aged 5 to 11, and joined a long list of countries that have approved vaccines for that age group.

Earlier this month in the United States, the CDC gave its backing for the use of the BioNTech-Pfizer vaccine following the authorization by the US Food and Drug Administration (FDA).

Their assessments followed the announcement in September by BioNTech-Pfizer of a successful trial of administering a COVID vaccine to children in that age group.

The vaccine was found to be safe and well-tolerated and displayed solid neutralizing antibody responses, according to the companies.

Are children more likely to die of the vaccine than the virus?

Another claim that has resurfaced recently is that "children are 50 times more likely to be killed by COVID vaccines than the virus itself." That assertion was made by Michael Yeadon, a former-Pfizer scientist-turned-anti-vaccination activist who has made unfounded claims about the pandemic in an interview with longtime Trump ally Steve Bannon on his War Room channel.

"There is no factual evidence to support the claim that children are more likely to be killed by COVID vaccines than the virus itself. We know that children can get very sick and die from a COVID-19 infection," said O'Leary.

The AAP reports that, as of November 18, at least 636 children have died in the US since the start of the pandemic based on information provided by 45 US states, Puerto Rico and Guam.

To date, there have been zero deaths of children from the COVID-19 vaccine, according to the report.

"Many people base false information on reports made to the Vaccine Adverse Event Reporting System (VAERS), which is an early-warning system that detects problems possibly related to vaccines. Anyone can submit a report to VAERS, but until the report is investigated and confirmed, it does not prove that a vaccine caused the adverse effect," O'Leary said.

Conclusion

At this point, there is no evidence to suggest that a COVID-19 vaccine is dangerous for young children. It's still too early to assess whether serious adverse health effects will manifest themselves, as many countries have only recently rolled out the vaccination program for the 5-11 age group. In terms of long-term effects, University Hospital Cologne's Dötsch said they are not expected "since the mRNA is decayed within hours or days. It cannot affect the DNA structure."

As things stand, the advantages clearly outweigh the risks. Parents will have to decide what they deem best for their children, but the advice is clear. 

"Vaccinating children will protect their health and also allow them to fully engage in all of the activities that are so important to their health and development. It will also enable children to safely visit with friends and family during winter holiday celebrations," said the AAP's O'Leary.

Edited by: Fabian Schmidt