The new data on Pfizer and Moderna's Covid vaccines for infants and toddlers will be reviewed by the Food and Drug Administration's expert committee on June 15.
The FDA said in a post on Monday that they are working as quickly as possible to carefully review all the vaccines.
The safety and efficacy data of the vaccines will be reviewed by the FDA's committee of independent experts, who will make a recommendation on whether the agency should authorize the shots. The committee's recommendation is usually followed by the FDA.
Pfizer and BioNTech said their three-dose vaccine for children ages six months to five years-old was 80% effective at preventing illness from the omicron Covid variant based on preliminary data from a clinical trial.
The FDA and Pfizer wanted to fast-track authorization of the first two doses in February. After the first two shots only had a 30% to 40% effectiveness against omicron, Pfizer decided to wait on the data from the third shot.
Moderna asked the FDA to approve the vaccine for children under the age of 6. The two-shot vaccine was effective against infections from omicron in children under two years old, and in children 2 to 5 years old. Moderna Chief Medical Officer Dr. Paul Burton said that the children's levels of antibody should translate to high levels of protection against severe illness.
Pfizer and Moderna's applications will be reviewed by the FDA within days of each other, so if the agency believes the data supports a decision, both vaccines will be authorized at the same time.
Pfizer uses a triple course of 3-microgram shots while Moderna uses two 25-microgram shots for infants and toddlers. The companies use larger amounts of vaccine for adults.
Only children under the age of 5 are eligible for the vaccine against Covid. The FDA has been asked to authorize the shots for months. Large numbers of children were affected by omicron during the winter. The Centers for Disease Control and Prevention estimates that 75% of children under the age of 11 have been exposed to Covid.
Children under the age of 5 were five times more likely to be hospitalized for Covid during the omicron wave than during the previous delta surge, according to the CDC. Public health experts are concerned about children developing long Covid and multisystem inflammatory syndrome, or MIS-C, a condition associated with viral infections.
Covid infections are rising again in the U.S. as more transmissible omicron subvariants sweep the country. According to CDC data, the US is reporting more than 105,000 Covid cases per day on average as of Friday, a 16% increase over the week prior. Over the past week, there have been more than 3,300 patients admitted with Covid per day on average, according to the data.
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