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Pfizer asks FDA to allow COVID-19 vaccine for children under 5 – San Bernardino Sun

By LAURAN NEERGAARD ​​and MATTHEW PERRONE

WASHINGTON (AP) – Pfizer on Tuesday asked the United States to license an ultra-low-dose COVID-19 vaccine for children under the age of 5, potentially paving the way for the youngest Americans to begin getting the vaccine. please as early as March.

In an unusual move, the Food and Drug Administration urged Pfizer and its partner BioNTech to file earlier than the companies planned.

The country’s 19 million children under the age of 5 are the only group not yet eligible for a vaccine against the coronavirus. Many parents have pushed for the expansion of shots to toddlers and preschoolers, especially as the omicron wave has sent record numbers of babies to hospitals.

“I can tell the parents in my office are desperate,” said Dr. Dyan Hes, who runs a pediatric clinic in New York City that has high vaccination rates. get their youngest children vaccinated. For many people, “that’s the first thing they ask when they walk through the door: ‘When do you think the footage will come out?'”

With FDA approval, Pfizer injections containing 1/10 of the adult dose could be dispensed to children under 6 months. Pfizer said Tuesday that it has begun submitting its data to the FDA and expects to complete the process within the next few days.

An open question is how many noses will those children need. Two of the extremely low doses turned out to be potent enough for infants but not for preschoolers in the initial trial. Pfizer is testing three injections and final data is expected by the end of March.

That means the FDA could consider whether to allow two shots now, with the possibility of a third shot later if research backs it up.

The FDA said Tuesday it will convene a panel of independent researchers and physicians in mid-February to help review the Pfizer data. The agency is not required to follow their advice, but their input is an important step in publicly testing the safety and effectiveness of vaccines.

The question of how long to wait for new vaccine data — and how much to ask for — is a concern for FDA regulators, who face pressure to be more proactive against a new virus. Withdrawal has repeatedly confounded medical professionals.

The FDA has asked Pfizer to start filing its applications now due to “greater numbers of children causing it,” an agency spokesman said, citing record cases in children under 5. age.

“In light of these new data and the increase in morbidity and hospitalizations in this youngest age group, the FDA considers it prudent to ask Pfizer to submit the data it has,” agency spokeswoman Stephanie Cacomo said. available”.

The FDA’s final decision could be made within a month, but that’s not the only hurdle. The Centers for Disease Control and Prevention was also closed.

The Biden administration has been trying to accelerate the licensing of children’s COVID-19 vaccines, arguing that vaccinations are crucial to opening schools and day care centers and keeping them open. while also freeing parents from childcare duties so they can go back to work. .

However, vaccination rates among children are lower than in other age groups. As of last week, just 20% of children ages 5 to 11 and just over half of 12 to 17 years old had been fully immunized, according to the American Academy of Pediatrics, according to the American Academy of Pediatrics. Nearly three-quarters of adults are fully immunized.

Although young children are at much lower risk of severe illness from coronavirus than adults, it can happen, and COVID-19 infections in children are higher than at any other point in the pandemic.

Dr Sean O’Leary of the University of Colorado, who is on the AAP’s infectious diseases committee, said: “What we’re seeing right now is still a lot of hospitalizations and unfortunately some deaths. death at this age. If the FDA removed vaccinations for these young people, then “that would be really important because all hospitalizations and deaths are essentially preventable.”

For children younger than 5 years of age, the Pfizer study gave participants two injections three weeks apart, followed by a third dose at least two months later. The company is testing to see if young people produce levels of antibodies similar to those known to protect teenagers and young adults.

In December, Pfizer announced that children under 2 years of age appear to be protected but antibody responses are too low in children aged 2 to 4 years. It’s not clear why, but there is a possibility that the extremely low dose is a bit too low for preschoolers.

Because preliminary results showed the shots were safe, Pfizer added a third dose to the trial, hoping to improve protection.

Nimmi Rajagopal, family medicine physician with Cook County Health, the agency that oversees the public hospital system, said Chicago health officials have been trying to prepare parents for months for the day vaccination. Some parents wonder how rigorously the shots will be evaluated or have other questions she says need to be addressed.

Rajagopal is excited about getting his 2-year-old son vaccinated if the FDA opens the way, so he’ll be safer playing with other kids.

“I waited and waited and waited,” she said.

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Associated Press journalists Emma H. ​​Tobin and Mike Stobbe contributed to this report.

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The Associated Press Health and Science Division receives support from the Howard Hughes Health Institute’s Science Education Department. AP is solely responsible for all content.

https://www.sbsun.com/2022/02/01/pfizer-asks-fda-to-allow-covid-19-vaccine-for-kids-under-5/ Pfizer asks FDA to allow COVID-19 vaccine for children under 5 – San Bernardino Sun

Tom Vazquez

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