The U.S. Centers for Disease Control and Prevention (CDC) anticipates COVID-19 vaccine booster shots that are said to target Omicron subvariants of the virus will be available for children aged 5 to 11 years within a month.
The CDC said in a vaccination planning guide released Sept. 20 that the shots, if they are authorized by the U.S. Food and Drug Administration (FDA), may be available by the middle of October (pdf).
“It is expected that if bivalent boosters are authorized for individuals aged 5 years and older as a booster, monovalent mRNA COVID-19 vaccines may no longer be authorized as booster doses,” the agency said.
COVID-19 vaccines have come under intense scrutiny following a string of studies pointing to adverse effects such as myocarditis, pericarditis, severe allergic reactions, and in some cases, deaths.
A study published in August found that nearly 3 in 10 children who received Pfizer’s COVID-19 vaccine experienced adverse cardiac side effects afterward.
A separate study published earlier in September found that age played a major factor in the risk of death following a COVID-19 shot, with individuals over 80 at higher risk.
Demand for new booster shots has dropped, with just over 109 million people in the United States having received their first booster shot, according to CDC data.
Lack of Data to Support Boosters
Pfizer-BioNTech is developing a bivalent vaccine for children aged 5 to 11 years, while Moderna’s bivalent vaccine would be eligible for those aged 6 to 17 years, pending FDA authorization. The shots, which contain the mRNA components of both the spike genes of SARS-CoV-2 virus ancestral strain and the BA.4/5 subvariants, will be available to those who have already received their primary vaccine series.
Both BA.4 and BA.5 currently appear to be the most vaccine-evasive strains of the virus and also largely bypass immunity from a previous infection.
Pfizer’s updated booster shot is currently authorized for use as a single booster dose in those aged 12 years and older, while Moderna’s is authorized for adults 18 and older. The FDA authorized the updated boosters in August.
The CDC formally recommended the booster shots soon after, claiming they help “to restore protection that has waned since previous vaccination by targeting variants that are more transmissible and immune-evading.”
But there is no human clinical data to support the claim.
Meanwhile, the Biden administration has ordered over 170 million doses of the updated bivalent COVID-19 vaccine ahead of this fall and winter as part of its plan to manage the virus across the nation.
According to a statement from The White House on Sept. 8, the administration hopes the updated vaccine rollout will “ensure that the nation continues to effectively manage COVID-19 and minimize its disruptions, and to stay prepared for whatever may come.”
The plan includes “free and easy access to new, updated COVID-19 vaccines” for Americans, and “empowering people with facts and answers to their questions” regarding the shots and the virus.
Reuters contributed to this report.