Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) have begun a rolling submission for the BNT162b2 vaccine for children ages 6 months to 4 years.
The FDA requested that Pfizer apply for emergency authorization for that age group, according to media reports.
The agency is awaiting data from a third dose of the vaccine in the age group, which could be available in March.
If authorized, the vaccine would be the first to find use for children under 5.
“As hospitalizations of children under 5 due to COVID-19 have soared, our mutual goal with the FDA is to prepare for future variant surges and provide parents with an option to help protect their children from this virus,” Pfizer CEO Albert Bourla said in a statement.
In December, Pfizer and BioNTech (NSDQ:BNTX) announced that an independent data monitoring committee concluded the study met non-inferiority requirements for the 6- to 24-month-old group but not for the 2- to under 5-year-old group.
The vaccine was well tolerated in the young age group.
Recipients in the trial are receiving 3 µg doses of mRNA, which is one-tenth the amount used in adults.
For 5- to 12-year-olds, the authorized dose is 10 µg.
The first two doses are administered 21 days apart, while the third would be injected two months after the primary series.
A number of parents have signed petitions demanding vaccines be made available for children under 5. A petition on Change.org, for instance, has more than 6,000 signatures.
The omicron surge has caused an uptick in infections in children and a rise in hospitalizations. COVID-19 infections in children can cause a rare disorder known as Multisystem Inflammatory Syndrome in Children (MIS-C). There have been more than 10 million pediatric infections in the U.S.
There are 19 million children between the ages of 6 months and 4 years in the U.S.
FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) plans on meeting on Feb. 15 to consider the request for emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 vaccine for children 6 months through 4 years of age.
If the FDA authorizes the vaccine for that age group, a CDC panel will convene to vote on whether it also approves of the decision. If so, CDC Director Dr. Rochelle P. Walensky would need to finalize the decision before it becomes official.
The companies also plan on seeking authorization in Europe and elsewhere to use the BNT162b2 vaccine in younger children.
PFE shares ticked up 0.70% to $53.07 while BNTX shares were up 4.37% to $179.60.
Pfizer and BioNTech had planned on producing roughly 4 billion doses of the vaccine this year.
The companies’ Phase 1/2/3 study — focused on children between 6 months to under 12 years of age — is taking place in the U.S., Finland, Poland and Spain. It has enrolled roughly 8,300 children.
Pfizer and BioNTech have also announced a study testing an omicron-specific vaccine in adults between 18 and 55.
Moderna is similarly running a Phase 2/3 clinical trial for its vaccine in children between six months and 12 years old.
Filed Under: clinical trials, Infectious Disease