Moderna seeks approval for coronavirus vaccine for infants

Moderna’s announcement was made by parents, pediatricians, and politician I’m becoming more and more impatient about the lack of vaccines and treatments to protect infants.

Politico Last week, authorities reported that they may not make a vaccine decision until June and are devoted to reviewing Moderna shots for children under the age of 6 with a triple-dose regimen by Pfizer and German partner BioNTech. Did. It caused anger and suspicion among some parents who claimed that the authorities had postponed the vaccine. The FDA has not answered questions about timelines or strategies for pediatric vaccines and has not announced a date for external advisors to meet to review Moderna vaccine data.

“It’s difficult to have an accurate timeline, but I think they realize that there are unmet needs here,” Moderna Chief Medical Officer Paul Burton said in an interview. rice field. “I think they will try to move soon.”

The findings on the Moderna pediatric vaccine are not the slam dunks that the general public was accustomed to when the results were published. coronavirus Vaccine research. This mainly reflects the emergence of Omicron variants.

Vaccine trials for young children are designed to show whether laboratory tests produce an army of antibodies that fight disease equal to or greater than the reaction that protected young adults in the early stages of a pandemic. .. According to a Moderna study, the two-shot vaccine regimen (each shot is a quarter of the dose given to an adult) provides an immune response to children under 6 years of age, similar to that found in the blood of young adults. I succeeded in evoking it.

However, there is a difference between showing success in lab tests and protecting people in the outside world, especially when Omicron variants rampage.

In the midst of Omicron’s surge, the two injections were reasonably effective in preventing the disease caused by the mutant, reflecting the performance of the adult vaccine. According to the latest analysis by Moderna, it was 51% effective in preventing illness in children aged 6 months to 2 years and 37% in children aged 2 to 5 years. Doctors expect more protection against serious illnesses, but hospitalization and death are rare results for children, so there are no cases in the trial and vaccines are available against serious illnesses. No conclusions could be drawn about the protection provided.

Moderna said a study involving 6,700 children under the age of 6 proved that the vaccine was safe and well tolerated. Fever occurred in about 15% of children aged 2-5 years under study and 17% of children in between 6 months and 2 years.

The FDA then scrutinizes the data.

The presence of Omicron variants is likely to constitute a debate about vaccines, with experts agreeing on what constitutes a successful shot, especially in infants who rarely get serious illness after infection. Make it difficult. Success benchmarks are in many ways obsolete, as the levels of antibodies protected from the original coronavirus strain no longer provide substantial protection.

“This was not an easy task,” said Catherine M. Edwards, a professor of pediatrics at Vanderbilt University Medical Center. “When the vaccine seemed to be 95% effective, we all said” Hallelujah. ” But we have varieties, vaccines are not very effective for them, and decline is a real problem. And Covid is declining faster than other vaccines. It’s not an easy problem. “

Many experts agree that Omicron variants, including infants, have shown that they need booster immunity. The third dose improves and expands the immune response to the mutant. However, some argue that even if the Pfizer-BioNTech 3-shot regimen is approved immediately behind, the 2-shot course should be approved.

“The sooner my heart is, the better. It doesn’t matter if it’s Moderna, Pfizer, or both,” said Sunanda Gaul, a pediatric professor at Rutgers Robert Wood Johnson Medical College. “Let these kids get vaccinated. Let’s get started. If you need a booster, get one later.”

The finding that most children are already infected may also be part of the debate. Many doctors support the additional protection provided by vaccination because it is not known how long immunity to the infection will last and it is clear that reinfection can occur. Still, most children are at low risk of serious illness, and given the vast resources needed to vaccinate all children, among some parents and even experts on how to use the vaccine. It is unlikely to be resolved because it raises questions.

“Is a universal campaign to vaccinate all children still meaningful?” Richard Malley, an infectious disease doctor at Boston Children’s Hospital, vaccinated children at risk of infection complications. Asked, emphasizing the importance of doing. She said, “The UK has fallen and vaccines are available, but that’s not a strong impetus. Conversations need to take place here.”

Peter Marks, director of the FDA’s Center for Biopharmaceutical Evaluation and Research, told the Senate at a hearing Tuesday that “to sacrifice criteria to complete the evaluation of the covid-19 vaccine for children under the age of five. Act quickly without any. ” It is one of our top priorities. “

However, he added, “You can’t actually finish the review until the full application is complete.”

Biden administration officials said they were anonymous because they were not authorized to discuss the issue publicly, saying Moderna plans to submit all raw data by the beginning of the second week of May. ..

Burton said this week’s submission “should provide basic data at every core the FDA needs.” … This should be enough for the FDA to start a review. “

It is unclear whether the agency will review all Moderna data submissions at once, including findings on children up to the age of 17, many of whom already have access to the Pfizer-BioNTech vaccine.Moderna’s pediatric vaccine program stall Almost a year due to concerns about rare cases of heart inflammation in adolescence. Some parents are calling on agencies to prioritize younger children because they cannot receive protection.

However, the FDA has made a good start by reviewing some of the data for the senior group, so it’s unclear if it will be slow to review the entire package at once. Last year, Moderna submitted approval for adolescents aged 12 to 18, and asked for approval for shots for children aged 6 to 11 a few weeks ago, Burton said.

Even if the FDA is scrutinizing Moderna’s data, the situation could be further complicated in the coming weeks as the results of the Pfizer-BioNTech pediatric vaccine may be reported.

The Pfizer-BioNTech vaccine was initially expected to be rolled out earlier this year. But in December, the company announced that a lower-dose two-shot regimen than Moderna did not meet the laboratory benchmarks of achieving an immune response comparable to that reported in young adults. The company has added a third dose, and executives expect a three-dose regimen to be available in June.

Some parents and pediatricians are pressured agents to act swiftly, but Edwards of Vanderbild warned that steps should not be skipped.

“I want to make sure the vaccine is safe,” she said. “We are not paying close attention and we are not using the usual careful methods, so making one mistake with one vaccine will hurt everything.”

Leonard Bernstein and Francis Sted Cellars contributed to this report.