Moderna studies COVID-19 Safety and efficacy of vaccines for children
Modern is studying the side effects that the vaccine can have on children from six months to 11 years. Veuer’s Johana Restrepo has more.
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Millions of adults are vaccinated against COVID-19 every day in the US, but trials are still underway to determine the safety and efficacy of the vaccines in children.
Moderna announced on Tuesday that it has given the first doses of its COVID-19 vaccine to children under 12 years of age. The company launched a trial among 12- to 17-year-olds in December 2020.
“This pediatric study will help us assess the potential safety and immunogenicity of our COVID-19 vaccine candidate in this important younger age population,” said Moderna CEO Stéphane Bancel. Immunogenicity is the ability to elicit a body’s immune response.
A Pfizer spokesman said the company had completed participants for the trial with teens ages 12 to 15.
As countries are put under pressure to send children back to school, parents are wondering when their children can get a COVID-19 vaccine. This is when experts expect it to happen:
When can children get COVID-19 vaccine?
The Moderna and Johnson & Johnson vaccines are cleared for people 18 years and older, and the Pfizer vaccine is approved for ages 16 and older.
Moderna and Pfizer have completed their studies for children 12 years and older and expect to release the data over the summer. If regulators make the results clear, younger teens can start vaccinating as soon as there is enough stock.
“For children 12 years and older, I think we have a vaccine that is licensed before the school year 2021-2022,” said Dr. Robert Frenck, director of the Gamble Vaccine Research Center and principal investigator for the Pfizer COVID-19 vaccine trial at Cincinnati Children’s Hospital Medical Center.
There is growing evidence that teens are more likely to transmit COVID-19. According to a report by the Centers for Disease Control and Prevention, the prevalence of COVID-19 is about twice as high among teenagers aged 12 to 17 as among children aged 5 to 11 from March to September 2020.
Vaccinations are usually tested in adults, then teenagers, before being tried among younger children and infants, who may need lower doses or have different reactions.
Modern has started vaccinating younger children in the trials. A Pfizer spokesman said the company hopes to have data from 12- to 15-year-olds in the first part of this year, and based on the findings, it could start with younger children.
None of the companies confirmed a timeline, but Frenck guessed that a vaccine for younger children would be available in the spring of 2022, or ‘maybe a little earlier’.
According to J&J, the company is in ‘talks with regulators and partners about the inclusion of pediatric populations’, according to a statement sent to the US on Tuesday.
Dr G. Paul Evans, CEO of Velocity Clinical Research, which conducts trials for children aged 6 to 11 for many of the businesses, said in an email that it may be more difficult to recruit younger children than teenagers, “because of the reluctance that parents have it naturally when they consider allowing their children to participate.”
But he added that parents are eager to get their children vaccinated. “Parents do not want to keep children in home schooling and want their children to be sociable again,” he said.
Are COVID-19 vaccines safe for children?
Health experts have said the vaccines are likely to be just as safe for children as they appear for adults.
“It’s going to be a fact,” Frenck said.
More than 109 million doses of COVID-19 vaccines have been administered in the US, reports the CDC. During this time, the agency received 1,913 death reports among people who received the vaccine but found no evidence that the vaccine was contributing.
The vaccines are undoubtedly safe among adults Dr. Cody Meissner, head of infectious diseases in children at Tufts Children’s Hospital, but would like to see robust tests that prove the safety and effectiveness among adolescents and children before making a similar claim.
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“Some reluctance to vaccinate children is proper,” he said. “We need vaccinations for children because we want to produce herd immunity. There is no doubt. But we must do it safely.”
Frenck said trial participants are mostly healthy without underlying medical conditions, but he hopes to extend trials to children who could endanger the immune systems by summer.
Are there any differences between the vaccines given to children versus adults?
Although the composition of the vaccines may not change, the dose can be said according to experts.
Teenagers are likely to receive the same dose as adults, but children under the age of 12 may receive a lower dose.
In younger children, researchers can start with a quarter of the usual dose, Frenck said. If things look good, they may decide to increase the dose in the same age group or move it down to the next age group.
Younger children may receive a lower dose because their immune response works well against COVID-19. This is not the case with all vaccines.
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“If you look at the flu vaccine, we use the same dose of flu vaccine in a 6-month-old as in a 64-year-old,” Frenck said.
He stressed that COVID-19 in children is worse than flu.
Although COVID-19 is generally mild in children, it can in rare cases cause serious illness and even death. According to data from the CDC and the American Academy of Pediatrics, more than 260 children died from the coronavirus compared to 188 children from flu during the 2019-2020 season.
“If you compare (260) to 500,000 deaths, that’s a very small number,” Frenck said. “But these are children who were completely healthy until they became COVID.”
Babies younger than six months are not included in the vaccination trials, because there are usually a few antibodies from their mother that can be protected, but can also act with a vaccine, which can possibly cause problems, said Dr. Sallie Permar, chair of pediatrics said. at Weill Cornell Medicine and the New York Presbyterian Komansky Children’s Hospital.
“It will be interesting to see if there is a hint of the kind of problem with COVID-19 vaccines,” she said. On the other hand, babies may end up needing a lap shot if their mothers’ antibody protection does not last long enough.
She said she also believes that young children should receive a lower dose of the vaccine than older children or adults. In her own research on HIV, Permar said she finds that “children can respond well to low-dose protein-based vaccines.”
Why could not adults and pediatric trials take place at the same time?
Researchers needed data from adult trials to understand some safety and effectiveness before proceeding with teens and younger children, health experts said.
“You need to be more fair about why you test vaccines in children,” Frenck said.
Experts said the adolescent and pediatric trials will not last nearly as long as the adult trials because it does not require as many participants as the phase 3 trials in adults.
Moderna and Pfizer took months to recruit 55,000 adult volunteers for Phase 3 trials. For adolescent trials, the companies will need about 3,000 and 2,600, respectively.
Researchers do not want to wait until trial participants come in contact with someone infected with COVID-19 to determine the efficacy of the vaccine, unlike in adults. Instead, they will measure the immune response of children and compare it with the adults.
“If you get the same immune response, the extrapolation is that you have the same protection,” Frenck said.
Contributions: Karen Weintraub, USA TODAY
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