On Tuesday, Pfizer and its partner BioNTech announced that it has submitted data to seek an emergency authorization for the use of the Pfizer-BioNTech COVID-19 Vaccine in children ages six months to five years, that's babies and toddlers.
They said the submission came following a request from the US Food and Drug Administration, "in response to the urgent public health need in this population."
They expect to complete the EUA submission in the coming days.
"This application is for authorization of the first two 3 µg doses of a planned three-dose primary series in this age group. Data on a third dose given at least 8 weeks after completion of the second dose are expected in the coming months and will be submitted to the FDA to support a potential expansion of this requested EUA," Pfizer wrote in a press release.
If the authorization is granted, the vaccine would become the first globally to be available for young children.
"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," said Albert Bourla, Chairman and Chief Executive Officer, Pfizer.
"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. If two doses are authorized, parents will have the opportunity to begin a COVID-19 vaccination series for their children while awaiting potential authorization of a third dose," he added.
Pfizer noted that of the current 75.6 million recorded COVID-19 cases in the US, 10.6 million children have tested positive for the virus, and 1.6 million of those cases came from children under the age of five. They also noted that for the week ending January 22, children under 4 accounted for 3.2 percent of the total hospitalizations due to COVID-19.
Trials included 4,500 children aged six months old to five, which was nearly a tenth the size of the 43,000 participant trial used for getting the vaccine authorized for adults in late-2020, according to the Daily Mail.
Experts have expressed concerns though about giving the shots to these young children.
Dr. Cody Meissner, the chief of pediatrics at Tufts Children's Hospital in Boston and a member of the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC), questioned the necessity of a shot for a population which already records such low risk of hospitalization or death from COVID-19.
"I think we're rethinking the way we looked at this question, because even though people are appropriately vaccinated they are still able to become infected and transmit the virus to susceptible people around them," Meissner told the Daily Mail.
"So this is a little bit different than many other infectious diseases such as measles, or mumps, or rubella. If you're protected from infection with the vaccine, then you're not going to transmit it to other people," he added. "But that's not the same setting with [this virus]."
Meissner noted that deaths among young children from the virus remain extremely low, with data from the Centers for Disease Control and Prevention stating that young children make up less than 0.1 percent of COVID-19 deaths in the US.
He noted though that he would be open to a vaccination system for young children similar to those implemented in countries like the UK or Sweden, where children in the five to 11 age group must have a condition that puts them at serious risk from the virus.
"Outside of children with serious comorbidities, he does not think there is a basis to approve the jab in the younger age group, and he especially fears green-lighting the shot will open the door for preschools and other facilities to institute vaccine mandates for young kids," the Daily Mail wrote.
"If people are really going to follow the facts, and follow the science, which everybody claims they're doing ... they come to the opposite conclusion," he said. "The burden of disease in children under five years of age is so low."
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