TThe Food and Drug Administration on Friday approved the Pfizer-BioNTech and Moderna Covid vaccines for use in children as young as 6 months of age, setting the stage for a government push to make the vaccines available to the youngest children.
The decision comes less than two days after a panel advising the FDA voted unanimously to recommend approval, saying its benefits outweigh any risks to young children.
The FDA has also approved the Moderna vaccine, previously approved for adults over the age of 18, for older children and adolescents, meaning both vaccines are approved for all age groups over 6 months.
“Those entrusted with the care of children can have confidence in the safety and effectiveness of these Covid-19 vaccines and that the agency has thoroughly evaluated the data,” FDA Commissioner Robert Califf said in a statement.
However, before families can begin claiming the vaccines, an advisory committee from the Centers for Disease Control and Prevention must also recommend the shots, and CDC Director Rochelle Walensky must accept the recommendation. The group meets on Friday and Saturday when the votes take place.
The Biden administration is already poised to roll out the vaccine. On June 9, the government said that should the vaccines be approved and recommended by the CDC, it would be done with 10 million doses available, and millions more were on the way.
Administrators said they were working to ensure a wide range of pediatricians received the recordings, including those in smaller practices and in rural settings. The vaccines will be available in pack sizes of 100 doses and will come with all the supplies needed to administer them, including small needles.
“We know there are many parents who have been eagerly awaiting the opportunity to vaccinate their youngest children and we share their zeal,” said a senior administration official. “So every day, all day, right now, our focus is preparing to make this as accessible as possible for as many families as possible.”
The introduction of the vaccines will bring new logistical challenges as they have different doses, dosing regimens, and efficacy and safety profiles compared to the vaccines for older children and adults.
The Pfizer syringe developed with partner BioNTech is administered in 3 microgram doses in this age group. The first two are given three weeks apart, and the third is given eight weeks after the second dose.
The Moderna vaccine is given in two 25-mcg doses a month apart. However, most experts believe that children who receive the Moderna vaccine should also receive a booster shot with either the original Moderna vaccine, which has not yet been approved, or with a yet-to-be-launched Moderna vaccine more specific to the Omicron variant aims
Both vaccines were approved on the basis of clinical studies showing that they produced antibodies at levels similar to those seen in adults. The Pfizer-BioNTech shot was originally developed as a two-dose vaccine, but results prompted the companies to add a third dose to their vaccination schedule. The FDA said that an analysis of the effectiveness of the Pfizer/BioNTech vaccine in this age group was not reliable due to the low overall number of Covid cases.
“I think we’ll have to wait a little longer for Pfizer to have more mature efficacy data to be confident that we want to release numbers, although we have no concerns that there will be significant concerns about efficacy here,” said Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research, at a press conference.
In clinical trials involving children ages 6 to 23 months, the Moderna vaccine was 50.6% effective in preventing symptomatic COVID-19, according to the FDA. In participants aged 2 to 5 years, it was 36.8% effective.
Both vaccines can cause symptoms such as fever, tiredness, pain, irritability and decreased appetite. The Pfizer vaccine appeared to be slightly less likely to cause fever than the Moderna vaccine, although an indirect comparison of clinical trials can be misleading and the FDA did not claim a direct comparison of the tolerability of the two vaccines in its announcement.
“I think with two vaccines with different dosing regimens, it becomes even more important that public health education, provider education, is done very, very carefully,” said Archana Chatterjee, vice president of medical affairs at Rosalind Franklin University of Medicine and Science, at the FDA Advisory Panel meeting earlier this week. “We are making a choice between two different vaccines that have slightly different profiles.”
Both vaccines have been linked to inflammation of the heart or lining of the heart, conditions known as myocarditis or pericarditis, in adolescent males. In 16- to 17-year-old men, who are most at risk, myocarditis is reported in about 1 in 13,000 with the second dose of Pfizer’s vaccine; Some analysis has shown that the risk for the Moderna vaccine may be higher, but the FDA presented other data at its Advisory Committee meeting suggesting the risk was similar for both vaccines.
The FDA said that in analyzes it performed with the CDC, most cases of myocarditis and pericarditis due to the vaccine resolve quickly with no impact on quality of life 90 days or more after reporting the case. No increased rates of the condition have been identified in younger children.
Uptake of Covid vaccines was much lower among children than adults. According to the CDC, as of June 1, only 29.2% of 5- to 11-year-olds were fully vaccinated, compared to 74.8% of 40- to 49-year-olds and 87.8% of those over 75.
The CDC stressed at the FDA meeting that the risk to children from Covid is very real, although the risk of hospitalization or death is lower than adults. In children aged 1 to 4 years, Covid is the fifth leading cause of death. From January 2020 to May 2022, 202 children in this age group died from Covid. “Every child death is tragic and should be avoided whenever possible,” Califf said at the FDA press conference.
Hospital admissions of children in this age group who tested positive for Covid increased as the Omicron variant became more prevalent. Hospitalization rates in this age group were initially lower than for influenza, the CDC said at the FDA meeting, but as of October 2021 they are substantially higher. Califf said hospitalization rates for children with Covid were five times higher during the latest wave than at the worst earlier points in the pandemic.
“We’ve been planning this moment for months, and once the FDA approves these vaccines, we will be distributing them across the country,” said Ashish Jha, the White House coordinator of Covid-19 response said in a video released on Wednesday. “And as soon as the CDC approves that, we’re going to start seeing these vaccines take up arms.”