Pfizer asked the FDA for an exemption from its COVID-19 vaccine to be approved for children aged 6 months to 4 years.
Parents who believed their children below 5 years old would need to wait for COVID-19 vaccines might be wrong. They could get them as soon as March. These are the first steps and what to expect when they become available in the U.S.
Pfizer asked the Food and Drug Administration for an authorization to allow extra-low doses its COVID-19 vaccine in children aged 6 months to 4 years. The FDA will review the request and convene an outside panel to discuss the data in February. That advice will be used by the FDA to determine if the new doses of the drug are safe and effective for children under five years old.
This is not the end. The Centers for Disease Control and Prevention will convene an expert panel to decide whether the shots should be recommended for this age bracket.
The doses for children aged are only one-tenth as large as the adult doses. This is even less than the doses for children aged 5 to 11 years old, which are only one-third of the adult doses. Pfizer will need to bottle these extra-low doses in special containers so that they don’t get mixed up with other vaccines.
DO YOU WANT TWO OR THREE DOSES?
This is where things get complicated. Pfizer released a setback in December. Preliminary results from a study showed that two extra-low doses were strong enough to protect babies, but not strong enough to be safe for children aged 2 to 4. Pfizer added another shot to the study but it is not expected to have any results until late March.
The FDA did take the unusual step of asking Pfizer to apply for a two-dose combination with the possibility of an additional shot later. The FDA advisory committee meeting will be the first opportunity for the public to see any evidence that two extra-low doses of the drug are more effective than originally thought among preschoolers.
If CLEARED WHERE WOULD SHOTS BENEFIT?
The government increased the ability of pharmacists to administer vaccines during the pandemic. However, shots for children younger than 5 years old are primarily administered in the offices of pediatricians.
WHAT ABOUT KIDS OLDER THAN 6 MONTHS?
It is not planned to give shots to newborns.
WILL THERE BE A HIGH DEMAND FOR SHOTS?
Vaccinations were lower in children than other age groups. This trend is likely to continue for children under 5. According to the American Academy of Pediatrics, only 20% of children aged 5-11 years old and half of those aged 12–17 years old were fully vaccinated as of last week. Nearly three quarters of all adults have been fully vaccinated. COVID-19 is less severe in children than it is in adults. However, record numbers of children have been admitted due to the omicron waves.