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Pfizer requested on Tuesday that the US Food and Drug Administration approve extra-low dosages of its COVID-19 vaccine for children under the age of five, potentially allowing vaccinations to begin as early as March.
The Food and Drug Administration had pressed Pfizer and its partner BioNTech to apply faster than intended — and before it was determined whether the children would require two or three doses.
The country’s 19 million youngsters under the age of five are the only ones who have not yet been vaccinated against the coronavirus. Many parents have pushed for the vaccinations to be extended to toddlers and preschoolers, especially after the omicron variant sent an unprecedented number of children to the hospital.
Dr. Dyan Hes, who operates a paediatrics clinic in New York City, stated, “I would say the parents in my office are desperate” to get their young children vaccinated. “When they walk through the door, that’s the first question they ask: ‘When do you think the shot will come out?” says one.
Pfizer wants to offer shots to youngsters as early as six months old that are one-tenth the amount provided to adults. The company stated that it has begun submitting data to the FDA and intends to finish the process within a few days.
How many injections those kids will require is an open issue. Early research revealed that two of the extra-low doses were effective for newborns but not for preschoolers. Pfizer is currently evaluating a third shot, with results due in late March.
That implies the FDA may decide to approve two doses for the time being, with a third shot being approved later if the study supports it.
In a statement, Pfizer CEO Albert Bourla said that company experts estimate this age group would eventually require three of the extra low-dose doses, but that FDA action now might allow parents to begin the vaccination procedure while waiting for a final decision.
In mid-February, the FDA announced that it will convene a panel of independent researchers and clinicians to assess the Pfizer data. Although the agency is not obligated to take their advice, it is an important step in publicly assessing vaccination safety and efficacy.
FDA officials are concerned about how long to wait for new vaccine evidence — and how much to demand — since they are under pressure to be more proactive against a virus that has repeatedly puzzled health experts.
Because of omicron’s “higher toll on children,” the FDA has ordered Pfizer to start submitting its application now, according to an FDA spokeswoman, citing a spike in cases among children under the age of five.
The FDA’s final judgement might be made within a month, but that’s not the only roadblock. The Centers for Disease Control and Prevention (CDC) must also approve the plan.
Vaccination rates among children, on the other hand, have been lower than in other age groups. According to the American Academy of Pediatrics, only 20% of children aged 5 to 11 were fully vaccinated as of last week, while just over half of those aged 12 to 17 were. Almost all adults have been properly immunised.
Although young children are significantly less likely than adults to become seriously ill as a result of the coronavirus, it can happen, and paediatric COVID-19 infections are at an all-time high.
“What we’re seeing right now in this age range is still a lot of hospitalizations and tragically some deaths,” said Dr. Sean O’Leary of the University of Colorado, who serves on the AAP’s infectious disease committee. “That’s going to be incredibly crucial because all of those hospitalizations and fatalities are practically preventable,” she says, if the FDA approves immunizations for these children.
Pfizer’s trial gives children under the age of five two shots three weeks apart, followed by a third dosage at least two months later. The company is looking to see if the kids create antibodies that are similar to those that defend teenagers and young adults.
Pfizer added a third dose to the experiment in the hopes of increasing protection after preliminary results suggested the shots were safe.
Only 3 out of 10 parents of children under the age of 5 indicated they would get their child vaccinated as soon as injections were approved, according to a Kaiser Family Foundation poll, while nearly a quarter said they would not. The findings of a mid-January survey of 1,536 persons were announced on Tuesday.
Dr. Nimmi Rajagopal, a family medicine physician for Cook County Health, which controls the public hospital system, said Chicago health officials have been attempting to prepare parents for months for the day the vaccinations are available. Some parents are concerned about how thoroughly the vaccinations will be assessed, or they have other concerns, which she believes must be addressed.
If the FDA approves, Rajagopal plans to have her 2-year-old son vaccinated, making it safer for him to play with other children.
“I’ve been waiting for a long time,” she explained.
