American biotech company modern said on Thursday that it had filed an emergency use authorization application in the United States for its COVID-19 vaccine for children six months to under six years of age.
Very young children are the only group not yet eligible for the COVID-19 vaccine in the US and most countries, a source of concern for many parents.
“We believe [this vaccine] will be able to safely protect these children against SARS-CoV-2, which is so important in our ongoing fight against covid-19 and will be especially welcomed by parents and caregivers,” said company CEO Stephane Bancel, in a statement.
In March, the company announced the results of a trial that showed the two-shot regimen was safe and produced a strong immune response.
Specifically, two 25-microgram doses given to infants, toddlers, and preschool children elicited similar levels of antibodies as two 100-microgram doses given to 18- to 25-year-olds, indicating similar levels of protection against severe cases of the virus.
“Children under the age of six are now the largest unvaccinated group in the US population,” Dr. Phil Landrigan of Boston College told The Associated Press. “They are a group where the virus can continue to spread and then infect older people who are most at risk. So it’s very important.”
Side effects in the trial were generally mild and consistent with those seen in older age groups. However, the company found relatively low efficacy, as its trial was conducted during the Omicron variant vibe.
Vaccine efficacy in children six months to two years was 51 percent, and efficacy was 37 percent in the two to five year age group, limiting the analysis to only confirmed cases positive in one test positive PCR.
Moderna said these were similar to estimates of vaccine efficacy in adults during Omicron, and is currently studying booster doses for all pediatric cohorts as well.
In February, the Food and Drug Administration (FDA) postponed a meeting from a panel to consider the Pfizer-BioNTech COVID vaccine for children under five, saying he wanted to see data on how three doses worked before considering the matter.
Pfizer’s vaccine, when given in two 3-microgram doses to children six months to two years old, elicited a level of antibodies similar to the full 30 micrograms given to 16- to 25-year-olds, but not in children between two and four years old. .
This week, Pfizer CEO Albert Bourla said in an interview that his company aimed to get the vaccines out by June if regulators agree.
The picture is further complicated by the fact that Moderna’s vaccine is currently licensed only for adults 18 and older in the US, while Pfizer is available at five and up. Moderna is seeking separate authorization for older children.
In an interview with CNN+ this week, Anthony Fauci, the White House’s top medical adviser, suggested that the FDA could review both companies’ data for young children simultaneously so as not to “confuse people.”
Scientists evaluating a vaccine for infants must closely consider the risk-benefit balance.
Even when they are not vaccinated, children under the age of five have a very low risk of serious illness. There have been 476 deaths in the US in this age group since the start of the pandemic, according to official data.
Among all American children, there have also been nearly 8,000 MIS-C casesa postviral inflammatory condition, which caused 66 deaths.
Emergency physician Jeremy Faust of Brigham and Women’s Hospital tweeted that Moderna’s results were very positive news, despite lackluster-sounding efficacy estimates.
“What these vaccines have really been shown to do, over and over again, is protect against serious illness and hospitalizations, long-term consequences,” he said, adding that the results of the immune response predicted the success of these measures.
“I will feel quite comfortable vaccinating my four-year-old son with Moderna.”