Pfizer's newest bivalent COVID-19 omicron booster vaccine has been approved by the U.S. Food and Drug Administration for kids ages six months through four years old.
The FDA Center for Biologics Evaluation and Research has recently authorized children between six months and four years old who have completed their three-dose primary series with Pfizer-BioNTech's original monovalent shots over two months ago.
FDA grants Pfizer's new COVID-19 booster for kids under five
These children are now eligible to receive a single booster dose of the updated shot, which is bivalent and targets both the original COVID strain and the omicron BA.4 and BA.5 variants.
According to CNBC, Peter Marks, the director of the FDA's Center for Biologics Evaluation and Research, reportedly said in a press release that this authorization offers caregivers and parents the chance to strengthen their kids' COVID-19 protection.
The updated shot offers increased immunity against the newly emerging COVID variants and reduces the risk of severe illness.
It's important to note that children who completed two doses of Pfizer's original vaccine have been eligible for the omicron booster since December, but those who received the omicron shot as their third dose are not currently eligible for the bivalent booster.
Nevertheless, they should still be protected against severe COVID-19 cases. This authorization is a significant step in protecting young children against COVID, as they are among the most vulnerable to the virus.
By getting vaccinated and receiving booster shots, caregivers and parents can help ensure the safety and well-being of the children under their care.
Furthermore, to ensure that children receive the appropriate vaccination for their unique circumstances, it is advised that parents seek guidance from a healthcare professional.
They can offer expert advice on each child's best course of action, considering factors such as age, medical history, and any preexisting conditions.
Emergency use authorization for the COVID-19 omicron booster vaccine for kids
As per Pfizer, the bivalent COVID-19 omicron booster vaccine for kids has not been approved or licensed by the FDA. However, it has been approved for use in emergencies to prevent COVID-19 in people under the age of five and those six months old.
The FDA's approval is only valid for the period specified in the declaration that the use of the medical product is justified as an emergency only.
However, this declaration can also be canceled, or the permission to vaccinate with this specific formula will be withdrawn.
Based on safety information previously assessed by the FDA, the Pfizer-BioNTech COVID-19 vaccine and its bivalent booster dose are both considered safe.
According to data gathered from September to December 2022, individuals who received an mRNA-based bivalent booster showed greater protection against COVID-19 hospitalization than those who received two or more doses of the original wild-type vaccine from the same company, given two months prior.
According to the FDA, clinical studies were conducted to evaluate a booster dose with Pfizer-BioNTech's investigational bivalent COVID-19 vaccine, which targeted the original Covid strain and the omicron BA.1 variant in individuals over 55 years of age.
It is important to note that emergency use authorizations are temporary measures authorized during public health emergencies, as determined by the FDA.
The Pfizer-BioNTech bivalent COVID-19 omicron booster vaccine for children will continue to be under FDA observation for safety and efficacy, and if necessary, appropriate action will be taken.
Parents and caregivers should consult a healthcare professional to decide the best course of action for each child's unique situation.
