BREAKING: Pfizer submits application to FDA to receive authorization for COVID-19 booster shots for children aged five to 11
- NYC-based Pfizer is bidding to have its COVID-19 vaccine booster shot approved for children aged five to 11
- It would be the first booster shot available to that age group, as Pfizer’s jab is the only one the FDA has approved for minors in the U.S.
- Some experts disagree that the shots are necessary for children this young, though, as the likelihood of them suffering a severe Covid case is very low
- A CDC study published Tuesday found that 75% of U.S. children have been infected with Covid, more than any other age group
Pfizer, the leading manufacturer of COVID-19 vaccines in America, has submitted a bid to the Food and Drug Administration (FDA) to begin distributing booster shots for children aged five to 11.
The New York City-based company made the announcement Tuesday afternoon, also revealing results of its Phase 2/3 clinical trials which raised Covid antibody levels in the age group 36-fold without any serious complications.
If approved, it would be the first booster dose available to the age group, as the Pfizer-BioNTech shot is the only one available to Americans under the age of 18.
Many experts disagree that the shots are needed in children of this age, though, with some pointing to the lasting immunity the shots have against serious infection – combined with the limited risk children face from the virus anyways.
Earlier on Tuesday, the Centers for Disease Control Prevention (CDC), revealed that around 75 percent of U.S. children and teens had been infected with Covid, with a lowly 1,001 deaths recorded among the age group.
Pfizer, the nation’s leading COVID-19 vaccine manufacturer, has applied for authorization for it booster shot in children aged five to 11 years old. Pictured: A young child in Bowling Green, Kentucky, receives a shot of a COVID-19 vaccine
Trials conducted by Pfizer, and the German company BioNTech which it has partnered with in the development of the shots, included 4,500 children aged six months to 12 years old.
Researchers found that participants in the age group had six times move Covid fighting antibodies one month after receiving the booster dose than they had one month after the second dose.
While the booster is likely to provide further protection against infection from U.S. children, some experts believe that children may be fine without this additional defense.
Deaths from Covid among children have been extremely rare during the pandemic so far.
The CDC reports that 0.01 percent of deaths from the virus over the past two years have been among the under-18 age group, despite 75 percent having been infected with the virus – by far the highest prevalence.
‘The fact that 75 percent of our children and adolescents in the U.S. have now been exposed to Covid and have evidence of [antibodies] is further evidence that booster shots are not needed for this population,’ Dr Monica Ghandi, a top infectious disease expert from the University of California, San Francisco told DailyMail.com on Tuesday.
‘Two shots are sufficient to produce a strong (long-lasting) [immune] response and natural infection generates a long-lasting response.’
A study from the University of Utah last year found that 50 percent of pediatric Covid cases are asymptomatic.
The study was performed before the more-mild Omicron variant emerged, meaning the risk for children to even feel symptoms is likely lower now.
Children may also be less likely to spread the virus when infected, with a German study finding that they release as little as only 25 percent of virus particles as adults do.
Data revealed by New York state officials at the end of February also found that the shot was only 12 percent effective at preventing Covid infection for children aged five to 11.
Pfizer, which is forecasting around $30 billion in revenue this year from sales of the COVID-19 vaccine, also previously made a push to get a three dose vaccine for children six months to four years old earlier this year.
Those plans have since been halted.
Currently, the company’s two-dose vaccine series is available to all Americans five and older. Those 12 and older are eligible for boosters, and a fourth overall dose has been authorized for all Americans 50 and older.