Pfizer Requests Clearance for Children’s Covid-19 Booster

A decision by the Food and Drug Administration on the request could come before the end of the year. The Centers for Disease Control and Prevention would then convene a meeting of its outside advisers, made up of pediatricians, public-health experts and other vaccine specialists, before issuing a recommendation.

Moderna last week asked the FDA to authorize the use of its updated booster shot in children ages 6 to 17. The company expects to complete a request for use of the booster in children 6 months through 5 years later this year.

The new so-called bivalent vaccine targets the ancestral strain of the virus as well as two substrains of the Omicron strain. Vaccine manufacturers retooled their vaccines at the direction of regulators earlier this year, after studies found that the original Covid-19 vaccines weren’t as effective against Omicron as they were against earlier strains of the virus.

Pfizer and BioNTech said they have begun testing the vaccine in youngsters in a clinical trial but didn’t provide any data from the study. The study began Friday, a spokeswoman said. The request was based on other information, including trial data from a shot targeting the original Omicron variant that hasn’t been cleared for use, as well as manufacturing data and animal testing, the companies said.

Children 5 to 11 years old became eligible for Covid-19 shots nearly a year ago, although their pace of vaccination has been slower than health experts and physicians hoped. More than 10 million children in this group, or roughly 38%, have received at least one dose, according to the American Academy of Pediatrics.

Boosters for these children were cleared by regulators in May. Roughly 15% of fully vaccinated 5 to 11 year old children have received a booster, according to the CDC.

Opinion surveys have found limited support among parents for vaccinating their children. Health authorities and pediatricians have urged parents to vaccinate their children to protect themselves and others against severe Covid-19.

Overall, children are less likely than adults to become infected with Covid-19 or develop severe disease, and many who develop cases experience mild or no symptoms, according to health experts and studies.

The hospitalization rate in children, however, increased during the Omicron wave, especially among those who weren’t vaccinated.

Retooled boosters for people at least 12 years old became available earlier this month, with about 4.4. million people receiving the shot so far, according to federal figures.

The vaccines were cleared by U.S. health regulators without human trial data showing they are effective, and instead used other sources of data, such as the performance of earlier iterations of boosters.

Pfizer and BioNTech said they expect to ask European regulators to authorize the shots in the next few days.

Write to Jared S. Hopkins at [email protected] and Dean Seal at [email protected]

A decision by the Food and Drug Administration on the request could come before the end of the year. The Centers for Disease Control and Prevention would then convene a meeting of its outside advisers, made up of pediatricians, public-health experts and other vaccine specialists, before issuing a recommendation.

Moderna last week asked the FDA to authorize the use of its updated booster shot in children ages 6 to 17. The company expects to complete a request for use of the booster in children 6 months through 5 years later this year.

The new so-called bivalent vaccine targets the ancestral strain of the virus as well as two substrains of the Omicron strain. Vaccine manufacturers retooled their vaccines at the direction of regulators earlier this year, after studies found that the original Covid-19 vaccines weren’t as effective against Omicron as they were against earlier strains of the virus.

Pfizer and BioNTech said they have begun testing the vaccine in youngsters in a clinical trial but didn’t provide any data from the study. The study began Friday, a spokeswoman said. The request was based on other information, including trial data from a shot targeting the original Omicron variant that hasn’t been cleared for use, as well as manufacturing data and animal testing, the companies said.

Children 5 to 11 years old became eligible for Covid-19 shots nearly a year ago, although their pace of vaccination has been slower than health experts and physicians hoped. More than 10 million children in this group, or roughly 38%, have received at least one dose, according to the American Academy of Pediatrics.

Boosters for these children were cleared by regulators in May. Roughly 15% of fully vaccinated 5 to 11 year old children have received a booster, according to the CDC.

Opinion surveys have found limited support among parents for vaccinating their children. Health authorities and pediatricians have urged parents to vaccinate their children to protect themselves and others against severe Covid-19.

Overall, children are less likely than adults to become infected with Covid-19 or develop severe disease, and many who develop cases experience mild or no symptoms, according to health experts and studies.

The hospitalization rate in children, however, increased during the Omicron wave, especially among those who weren’t vaccinated.

Retooled boosters for people at least 12 years old became available earlier this month, with about 4.4. million people receiving the shot so far, according to federal figures.

The vaccines were cleared by U.S. health regulators without human trial data showing they are effective, and instead used other sources of data, such as the performance of earlier iterations of boosters.

Pfizer and BioNTech said they expect to ask European regulators to authorize the shots in the next few days.

Write to Jared S. Hopkins at [email protected] and Dean Seal at [email protected]