The vaccine was completely cleared for use in people aged 16 and up on Monday. It is also approved for emergency use in children as young as 12, but it is not yet approved for usage in younger children.
Pfizer Vaccine Should Not Be Used ‘Off-Label’ In Younger Children, According To The Fda
On Tuesday, Acting FDA Commissioner Dr. Janet Woodcock said, “We don’t have data on the right dose, and we don’t have full evidence on the safety in children younger than what is in the EUA [emergency use authorization].”
“So, it would be a tremendous concern that people will vaccinate their children because we don’t have the correct dose, we don’t have the safety data, and we don’t have all of the efficacy evidence,” Woodcock said. “We do not suggest vaccination of children under the age of 12 with this vaccine. It would be impolite to do so.”
“Before suggesting that children be vaccinated, we would need to know the facts and the proper dose,” she stated.
“We need to see the data from those studies before we give this vaccine to younger children,” AAP President Dr. Lee Savio Beers said in a statement Monday. “The clinical trials for the COVID-19 vaccine in children ages 11 years old and younger are underway, and we need to see the data from those studies before we give this vaccine to younger children.”
The adult vaccine dose is substantially higher than those being evaluated in younger children, according to the statement, and the AAP “highly discourages” off-label use of the vaccine in children under the age of 12.
Among the top vaccine providers for Covid-19 Pfizer is one of the players and also a known name in the world of medicine manufacturers. The FDA has to issue such notice to keep the expert away from using the vaccine for children who are below 12 as in many cases it has been noticed by the authorities that such age children are also given this vaccine and there is no clinical data yet that proves the vaccine safe for kids of this age said an expert while speaking about the vaccine usage.
Pfizer plans to obtain vaccine trial data on children ages 5 to 11 by the end of September, with data on children ages 2 to 5 coming soon after.
Both Moderna and Johnson & Johnson are testing their vaccines in youngsters. The AAP has documented 180,000 new cases of COVID-19 among children and adolescents as of last week. Approximately 8.5 million adolescents, or 34% of all adolescents, have been fully vaccinated so far.
According to the CDC, the highly transmissible delta variation is driving a spike in infections across the country, with an average of 133,056 new cases every day. According to a report from the American Academy of Pediatrics and the Children’s Hospital Association, more than 180,000 new pediatric COVID-19 cases were recorded in the week ending August 19, about 50 percent more than the week before. Since the week ending July 22, there has been a fourfold surge from roughly 38,000 new cases. Last week, children accounted for almost 22% of all new cases.
During a recent FDA stakeholder call, Rachel L. Levine, M.D., FAAP, assistant secretary for health at the Department of Health and Human Services, said, “We know that with the spread of the delta variant, how contagious it is, more children and more adolescents are getting infected, and certainly because more are getting infected, more are becoming significantly ill and becoming hospitalized.” “Moreover, these children and adolescents have the ability to transmit the disease in their homes and communities.”
