Infectious Disease
The Pfizer approval enables a “more thorough review” of the Moderna vaccine for adolescents
December 21, 2021
3 minutes read
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Source:
Healio interview.
Disclosure:
Bernstein and Kemna do not report any relevant financial information.
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There have been rare reports of myocarditis and pericarditis in people who received a COVID-19 messenger RNA vaccine, with the cases particularly occurring in adolescent males and young adults, according to the CDC.
Researchers reported in the BMJ last week that the rate of myocarditis in nearly 5 million vaccinated people in Denmark among those who received the Moderna vaccine was higher than Pfizer-BioNTech’s, but that the absolute number of cases was low.
Scientists are trying to understand the potential risk of myocarditis from COVID-19 vaccination. Source: Adobe Stock
“I know a lot of parents have questions about myocarditis. Fortunately it was mild and self-limiting. ” Henry H. Bernstein, DO, a pediatrician at North Shore University Hospital in Manhasset, New York, said Healio.
In fact, the problem only became apparent after the Pfizer BioNTech vaccine received an Emergency Authorization (EUA) from the FDA, so Mariska S. Kemna, MD, Pediatric Cardiologist and Professor of Pediatrics at Seattle Children’s Hospital.
“Because vaccine-related myocarditis is so rare, affecting 1 in 5,000 to 10,000 young men, it was not shown as a side effect in the initial studies,” Kemna told Healio.
Still, the issue resulted in the FDA delaying its decision on Moderna’s application for an EEA that would make the vaccine available to children ages 12-17 in the United States. Due to the delay, Moderna said it would consider filing another EEA application for a 50 µg half dose of the vaccine for children ages 6-11.
Kenma said the fact that the Pfizer vaccine is already approved for children allows for a “more careful review” of Moderna’s formula.
“With a similar vaccine for the adolescent population already in place, the FDA can spend more time reviewing it carefully as there is less sense of pandemic urgency,” said Kemna.
She added that although Moderna’s pediatric vaccine is used in Europe, a higher rate of myocarditis compared to Pfizer’s vaccine “may have caused some reluctance”. [for] the FDA. “
“It has also resulted in a situation in which some European countries like Norway and Sweden no longer offer Moderna to men under 30,” said Kemna.
Although no conclusive evidence was found as to why the vaccines can cause myocarditis, Kemna suggested that the researchers investigate the dose of Moderna.
“While we don’t fully understand why the Moderna vaccine carries a higher risk of myocarditis, it may be dose-dependent as the Moderna vaccine dose (100 µg) is significantly higher than Pfizer’s (30 µg),” said Kemna.
She suggested that young men could potentially benefit from lower doses of both vaccines or a vaccination schedule with a longer interval between the first and second dose to lower their risk of vaccine-associated myocarditis.
“For example, a teenager’s immune system is very different from a 70-year-old’s immune system, yet they are both currently receiving the same vaccination dose and schedule,” said Kemna. “On the other hand, children between the ages of 5 and 11 are given 10 µg of the Pfizer vaccine while 12 to 18 year olds are given 30 µg, although their immune systems are likely to be equally responsive.
“The coming months will show whether the pediatric age group between 5 and 11 years of age who are currently being vaccinated with the lower vaccine dose are at the same risk of myocarditis as teenagers. If not, a strong argument can be made to lower vaccine doses in teenagers to protect them from both COVID-19 and vaccine-related myocarditis. ”
Even so, it was of vital importance for all eligible children to receive the vaccine, regardless of the risks.
“It remains important to recognize that the risk of cardiovascular complications, even myocarditis, is much higher with COVID-19 than with vaccination with an mRNA COVID vaccine,” said Kemna.
References:
CDC. Myocarditis and pericarditis after mRNA COVID-19 vaccination. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/myocarditis.html. Accessed December 21, 2021.
Husby A, et al. BMJ. 2021; doi: 10.1136 / bmj-2021-068665.
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