In vaccine trials, Shot met key criteria defined by the company and regulatory agencies for success, producing immune defenses equal to or better than those that protected young adults before the emergence of Omicron variants. .. According to the Moderna news release.
However, in the face of Omicron, the immune defenses gathered by the two doses in adults were not very strong, especially in the prevention of infection. The same pattern was seen in children, with a vaccine efficacy of about 40%.
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Two years after the coronavirus pandemic, parents and pediatricians have longed for progress towards pediatric vaccines, as children under the age of five are the last group to be vaccinated. In the United States, there are about 19 million children in this age group.
Moderna said it plans to submit data on children aged 6 months to 5 years to the Food and Drug Administration within the next few weeks. At a briefing on Tuesday, a company representative told government officials that he would apply for an emergency permit in mid-April.
The data has not been published or peer-reviewed, and regulators will carefully review the details in the coming weeks. It is expected that a panel of outside experts will be convened to advise authorities on whether to approve the vaccine. Jacqueline Miller, Senior Vice President of Infectious Diseases at Moderna, refused to provide a possible timeline for when shots will be available, saying those decisions depend on discussions with the FDA. ..
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“We are optimistic that we can move the vaccine forward, preferably reasonably quickly,” Miller said.
Children received two doses of 25 micrograms, a quarter of adults. The findings reflect the complex and changing landscape of the pandemic.
“I think we have to remember that there are some goals at this stage of the pandemic,” said Clarence Buddy, a pediatric professor and exam leader at Vanderbilt University Medical Center. Creech says. “The first is still the protection of the most vulnerable people, and while it’s easy to see grandparents and older people in their high-risk groups, the underlying medical condition, recent heart surgery, or medically children. You must be aware that there is a risk of this virus in fragile children. “
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Although the vaccine did not stop all Omicron infections — it was not expected to be possible — Kulich said it was encouraged to maintain some protection against mild infections.
“Being able to provide a vaccine that not only prevents severe illnesses, but also prevents mild or moderate illnesses to a reasonable degree, is a major step forward for us as pediatricians,” said Kulich.
Tens of thousands of participants participated in the first vaccine trial, waiting to see if vaccinated participants were less likely to get sick than those who received placebo. These studies have shown that the Moderna vaccine is more than 90% effective in preventing disease in adults against previous versions of the virus.
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To rapidly extend vaccine eligibility beyond adults, children’s trials were designed primarily to measure safety and whether the vaccine is reminiscent of antibodies that fight the same level of virus. rice field. When the Moderna vaccine trial was initiated, success was defined as an immune response equivalent to that reported among young adults during the pre-Omicron period.
The Moderna exam reached that benchmark in young children. However, two doses have been found to be much less effective against the highly contagious Omicron mutants in adults, which is also true for children. The overall defense against infection in infants was about 40%, but slightly lower in children under 2 years of age.
Children’s trials were primarily not designed to measure vaccine efficacy, so there is statistical uncertainty about efficacy findings, but the company’s statistical analysis shows that it is above zero. Shown.
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In this study, there were no cases of serious illness or hospitalization involving nearly 7,000 children between the ages of 6 months and 5 years, and it was not possible to detect the possible protective effect of the vaccine against the worst outcomes.
Miller, Senior Vice President of Infectious Diseases at Moderna, admitted that the data were more difficult to interpret than in the early days of the pandemic, but the immune response evoked by children was similar to that of adults, with protection against Omicron variants. Said the same.
She plans to test the booster doses for her children and submits to the regulatory agency a proposal to test them four months after the children complete the first series of two shots. I added that there is.
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In contrast to the easy path of the first vaccine, children’s vaccines have a stop and start, lack a predicted timeline, and disperse frustration, confusion, and impatience between parents and pediatricians. increase.
In December, Pfizer and BioNTech announced that at ages 2-4, the double-dose regimen failed to elicit the same immune response that would protect young adults. Both companies have added a third shot (and a few months of waiting) to the trial.
Then, in a look in late January, federal officials showed that there could be a path towards a double dose of the Pfizer-BioNTech vaccine. This is a strategy aimed at starting to boost children’s immunity as authorities have been waiting for data on the third vaccination. However, the FDA has since stated that no decision will be made until the results of the third dose are available.
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This failure has led some experts to question whether the dose of Pfizer-BioNTech is too low, but Pfizer scientists say that the youngest child has less severe fever. States that they chose a low dose.
Moderna’s pediatric vaccine caused a fever of over 100.4 degrees in 1 in 6 youngest people. Children under 2 years old. Fever rates were slightly lower between the ages of 2 and 5. According to the company, fever above 104 degrees was rare and was reported in only a few children. There were no cases of myocarditis, pericarditis, or heart inflammation that rarely occurred after messenger RNA vaccination.
James Campbell, a pediatric infectious disease doctor at the University of Maryland School of Medicine, said he was excited about the results when he attended the trial but only learned the findings when they were published Wednesday morning. According to him and others, the safety profile of the two doses appears to be similar to other pediatric vaccines, but further scrutiny is important.
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Because children are less prone to the serious symptoms of covid, the trial had to be much larger and longer to detect whether the vaccine was protected from hospitalization or death. Studies show that adults who have an immune response similar to that found in infants have the greatest protection against severe symptoms and the most protection against very mild or asymptomatic cases. It has been shown to be low. That should also apply to younger children, Campbell said.
“If you do, there was some backlash that this might not change the course of the pandemic, or that it might be such a mild illness in children, they are vaccinated. You don’t have to, “Campbell said. “If people stop comparing it to adult Covid and start comparing it to other childhood diseases, I would say this is very serious. The number of children dying from Covid is any other infection. More than. “
Moderna faces a delay in pediatric vaccines. The shots are only allowed in the United States for people over the age of 18, while Pfizer shots are only allowed for children up to the age of five.
Moderna filed for teenager approval last June, but regulatory decisions have been postponed due to concerns that high doses of Moderna may increase the risk of myocarditis in that age group. The company is assessing the potential for half doses in these teens.
The company announced on Wednesday that it would submit updated data for all younger age groups and seek approval from children aged 6 to 11 years. Pfizer-BioNTech shots have already been approved for that age group, so there is less chance of increased interest among family members.
Even in the midst of the Omicron surge this winter, disappointing uptake among older children leaves the question of whether parents are enthusiastic about the vaccine. A recent Kaiser Family Foundation survey of parents of children in this age group found that nearly one-third immediately vaccinated their children and about one-third were waiting. I’m answering. The remaining parents were never vaccinated for their children or were split between parents who were vaccinated only when needed.
Children escape the worst pandemics and have a lower incidence of severe illness and death than older people. However, according to a recent study by the Centers for Disease Control and Prevention, their hospitalization rates soared to the highest levels of pandemics during the winter Omicron surge.
During the peak of the Omicron variant surge in January, children under the age of 5 were hospitalized five times as often as the peak of the delta surge in early September. Also, because nearly two-thirds of hospitalized children had no underlying medical condition, there was no reliable way to predict which infant would be hospitalized.