Pfizer Inc and BioNTech SE began the regulatory approval process on Tuesday for COVID 19 vaccines for the only age group not yet eligible for the shots.
Pfizer and its German partner BioNTech announced on Tuesday that they have asking emergency-use authorization of their vaccine for children under age five.
The companies said in a joint statement they began the rolling submission process for an emergency use authorization at the request of the Food and Drug Administration “in response to the urgent public health need in this population.”
While the approval process is underway for the two-dose regimen, the companies will continue researching a third dose that would likely be given at least eight weeks after a child receives the second dose.
Pfizer Chairman and Chief Executive Officer Albert Bourla said in the statement that increasing infections and hospitalizations of young children led the two companies to begin the approval process.
“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,” Bourla said.
“Ultimately, we believe that three doses of the vaccine will be needed for children 6 months through 4 years of age to achieve high levels of protection against current and potential future variants.”
Bourla said that if the FDA authorizes the two doses, that would allow parents to begin vaccinating their young children while waiting on approval of a third dose.
The submission announcement on Tuesday comes sooner than previously expected.
In mid-December, Pfizer and BioNTech announced they were modifying their trial to include a third dose of the vaccine for children between 2 and 4 years old after the two-dose approach didn’t lead to the type of immune response researchers sought. The trial did, however, produce the levels desired in children between six months and 2 years old.
The company said at the time that if the three-dose trial was successful, it would likely submit its emergency use request to the federal government in the first half of 2022.
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, then said last week that parents needed to be patient in waiting for approval of the vaccine for younger children.
“I don’t think we can predict when we will see an [emergency use authorization] with that because the company is still putting the data before the FDA,” Fauci said during a White House briefing on the pandemic.
A poll released Tuesday by the Kaiser Family Foundation indicated about 31 percent of parents would get their small children vaccinated immediately.
Another 29 percent said they would wait and see while 12 percent said only if required and 26 percent of respondents said they definitely would not give their young child the vaccine.
Infants Response and Parents Concerns
The number of people hospitalized and who have died from the coronavirus in children is much lower than in adults, but children’s hospitals are reporting record-high admissions. Children who are not yet vaccinated are most vulnerable to severe illness in the under-five age group.
The companies have not released any new data or updates to its study design. In mid-December, Pfizer/BioNTech announced that two shots of a low dose created strong antibody responses in children between the ages of six months and two years. However, the trial’s second phase, which is expected to start in October, will be extended for a year to include children aged five to nine.
The two-dose regimen could now be approved by regulators for younger children. If the data show an additional shot helps create a protective immune response, they may allow slightly older children to receive the same doses.
According to CDC Children aged five to 11 were given shots in October 2021– only 22% of US children in that age group are fully protected, and only three in 10 children who are eligible have received their first shot.
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