Jack Wasserman, 6, receives a Pfizer-BioNTech booster vaccine for coronavirus disease (COVID-19) on May 19, 2022 in Schwenksville, Pennsylvania, United States.
Hannah Beier Reuters
Pfizer on Monday asked the Food and Drug Administration to approve its new Covid booster shots targeting the Omicron BA.5 subvariant for children ages 5 to 11.
Pfizer’s application to the FDA comes ahead of the release of clinical trial results for the new vaccines. The company said in a statement its request was based on human data from a similar vaccine targeting the Omicron BA.1 subvariant and animal test data on the BA.5 shots.
Pfizer’s main competitor in Covid shots, Moderna, asked the FDA on Friday to clear its Omicron shots for children ages 6 to 17. The Centers for Disease Control and Prevention earlier this month cleared Pfizer’s Omicron boosters for people ages 12 and older and Moderna’s new vaccines for adults.
The CDC said in a document released earlier this month that the recordings will likely be available to children ages 5 and older in October. The health agency’s Vaccine Advisory Committee has scheduled meetings for October 19 and 20, which are expected to review the available data on the boosters for this pediatric age group.
FDA and CDC officials expect the omicron BA.5 syringes to provide significantly better protection against infection and disease this fall and winter. But US health officials have conceded that in the absence of human data, it’s unclear how much more protection the new vaccines will offer compared to the old ones.
dr Peter Marks, who heads the FDA’s vaccine review division, said the US uses the same process to switch the Covid vaccines to a new strain that it uses to update flu shots every year. Flu shots are also often released for use without human data.
The new boosters target the dominant subvariant omicron BA.5 as well as the original Covid strain that first emerged in Wuhan, China in 2019. The old shots developed against the original Covid strain no longer offer meaningful protection against contagion and mild illness because the virus has mutated so extensively over the course of the pandemic.
The original vaccines still prevent serious illnesses, although their effectiveness against hospitalization is also declining.