WASHINGTON: Pfizer on Wednesday asked the US to ratify the extra-low dose of Covid-19 vaccine for children under 5 years, potentially paving the way for the youngest Americans to start receiving shots in March.
In extraordinary steps, feeding food and medicine has urged Pfizer and his partner Bionech to register earlier than the company has planned.
19 million under 5 years of state children are the only groups that have not qualified for vaccination against the Coronavirus.
Many parents have prompted expansion of shots to toddlers and preschoolers, especially as the omicron wave sent a record number of children to the hospital.
If the FDA agrees, pfizer shots that contain only one tenth of the doses given to adults can be distributed to children as young as 6 months.
Pfizer said on Wednesday it began to hand over the data to the FDA and expect to complete the process in a few days.
Open questions are how many shots needed by children.
Pfizer is testing three shots after two extra-low doses turned out to be strong enough for babies but not for preschoolers, and the final data from the study was not expected until the end of March.
That means the FDA can consider whether it will authorize two shots for now, with the potential third shot being cleaned later if the research supports it.
The FDA said Tuesday the researcher would hold a research panel and independent doctor in mid-February to help review Pfizer data.
The agency is not required to follow panelist advice but their input is a key step in the security and effectiveness of the public vetting vaccine.
The final decision of the FDA can come in a month but it’s not the only obstacle.
Control centers and prevention of disease must also sign.
Biden administration has tried to accelerate the authorization of Covid-19 shots for children, who argue that vaccination is very important to open school and child care centers and keep them open, and to free parents from child care tasks so they can return to work.
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But the level of vaccination is lower among children than in other age groups.
Last week, only 20 percent of children aged 5 to 11 and were only half of 12 to 17 years vaccinated, according to the American Academy of Pediatrics.
Nearly three quarters of adults are fully vaccinated.
While small children are much less likely than adults for severe pain from Coronavirus, it can occur, and Covid-19 pediatric infection is higher than at other points in a pandemic.
“What we see is still a lot of hospitalization and unfortunately some deaths in this age group,” said Drs Ean O’Leary from the University of Colorado, who was in the AAP infectious disease committee.
If the FDA clears vaccination for these children, “it will be very important because all hospitalization and death can basically be prevented.” For children under 5 years, the Pfizer study gave participants of two separate shots three weeks, followed by the third dose at least two months later.
Companies are testing whether children produce the level of antibodies similar to those known to protect teenagers and young adults.
In December, Pfizer announced that children under 2 appeared to be protected but that antibody responses were too low at the age of 2 to 4 years.
It is not clear why, but one possibility is that extra-low doses are somewhat too low for preschoolers.
Because the preliminary results show safe shooting, Pfizer added the third dose to testing in the hope of increasing protection.
Given how the booster works for the older age group, “it makes sense” that younger children can benefit from the third shot, said O’Leary.
“I certainly can understand where the company and the FDA come in terms of the desire to move this, anticipate that there will be a third dose on the phone.”
Pfizer asked the FDA to allow Covid-19 vaccine for children under 5 years
