FDA approves OMICRON booster shots for babies, children
BY CAROLYN HENDLER, J.D.
Republished below in full unedited for informational, educational, & research purposes.
In early December 2022, the U.S. Food and Drug Administration (FDA) amended the Emergency Use Authorization (EUA) for the Pfizer/BioNTech and Moderna/NIAID mRNA Covid-19 shots to include administration of the Omicron Covid booster shots to children as young as six months old. The action allows everyone over the age of six months to get the newest booster shot.1
The FDA made the decision to authorize the vaccination of infants and very young children just three days after Pfizer submitted an application to the regulatory agency for the Omicron BA.4/BA.5-Adapted Bivalent Covid vaccine.2
The bivalent Covid booster, which contains the original strain of the SARS-COV-2 virus along with spike proteins from the BA.4 and BA.5 variants of the Omicron strain, was approved for children five years of age and older on Oct. 12, 2022.3 FDA commissioner Robert Califf, MD said:
More children now have the opportunity to update their protection against Covid-19 with a bivalent Covid-19 vaccine, and we encourage parents and caregivers of those eligible to consider doing so–especially as we head into the holidays and winter months where more time will be spent indoors.4>
COVID Vaccination Uptake Has Been Slow Among Babies and Young Children
Omicron Covid booster shot uptake is limited because it is only available to infants and children who have received both doses of the original Covid shots developed by Pfizer and Moderna. Children who have already received three doses of the original Pfizer Covid shot are not eligible for the booster.
U.S. Centers for Disease Control and Prevention (CDC) officials have reported that less than five percent of children aged two to four and only three percent of children and babies under the age of two have received the original Covid shots.5 Therefore, there is not much demand for Omicron booster shots among very young children. Meanwhile, 32 percent of children aged five to 11 years are fully vaccinated against Covid.6
Yale School of Medicine pediatrician Leslie Sude, MD said:
While a significant proportion of the population was not eligible for vaccination, there was still the opportunity for widespread circulation of COVID among children, who could then keep transmitting it to older people. And as long as the virus spreads from person to person, the virus can keep changing and evolving into new variants.7
However, Dr. Sude’s comment conflicts with CDC director Rochelle Walensky’s acknowledgment that getting a Covid shot does not prevent infection with and transmission of the SARS-CoV-2 virus to others. Dr. Walensky stated:
Our vaccines are working exceptionally well … but what they can’t do anymore is prevent transmission.8
Covid Shot Study Data Not Peer Reviewed or Published
The FDA and a committee of independent vaccine experts relied on data provided by the vaccine manufacturers when extending the EUA for the bivalent Omicron Covid booster shot to infants and very young children. The data presented by vaccine manufacturers have not been peer-reviewed or published.9
When extending the EUA status of the Moderna Covid booster shot to babies and young children, the FDA relied on a clinical study looking at the immune response of adults to the Moderna product. The FDA also compared a clinical study looking at the immune response of 56 children aged 17 months through five years after getting the full dose series of the original Covid shots plus the booster dose to a study examining the immune response of 300 young adult participants, who received the two-dose original Moderna Covid shot. The FDA concluded that the immune response of infants and very young children were comparable to the immune response in young adults.10
The FDA also looked at a clinical study examining the safety of a single dose Moderna Covid booster shot in 145 children aged six months through five years old. The study showed the common side effects in babies 17 through 36 months old were irritability/crying, sleepiness, and loss of appetite. Previous clinical trials showed the common side effects in this age group to also include fatigue, muscle pain, headache, joint pain, nausea/vomiting, and chills.11
The third dose of the monovalent Pfizer Covid shot will no longer be used in very young children and will, instead, be replaced with the booster dose. The FDA relied on efficacy data previously submitted by the drug manufacturer in individuals aged six months through four years old, 16 years and older, and adults aged 55 years and up who received the original two-dose series of shots, the monovalent booster as well as the bivalent booster dose.12
The safety of the Pfizer Covid booster shot for children aged six months through five years old was determined by looking at safety data from a clinical study of the bivalent booster shot in participants aged 55 years and older; clinical trials looking at the safety of the primary vaccine series in children six months and older with the monovalent booster, as well as safety data from clinical trials and post-marketing safety data of the booster shot in participants five years and older.
Even though the safety data presented did not include the bivalent Covid booster shot, the FDA concluded the previous trials and studies on the monovalent booster were relevant to the approval process of the bivalent Omicron version due to the fact the same manufacturing process was used to make both versions of the shot.13
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Click here to view References:
1 Gumbrect J. Children as young as 8 months can now receive an updated COVID-19 vaccine. CNN Dec. 9, 2022.
2 Pandolfo C. FDA authorizes bivalent COVID-19 booster shots for children under 5. Fox News Dec. 8, 2022.
3 Cáceres M, Fisher BL. FDA Authorizes COVID Bivalent Shots for Children as Young as Five Years Old. The Vaccine Reaction Oct. 17, 2022.
4 Gumbrect J. Children as young as 8 months can now receive an updated COVID-19 vaccine. CNN Dec. 9, 2022.
5 Pandolfo C. FDA authorizes bivalent COVID-19 booster shots for children under 5. Fox News Dec. 8, 2022.
6 MacMillan C. COVID-19 Vaccines for Kids Under 5; What Parents Need To Know. Yale Medicine Dec. 12, 2022.
7 Ibid.
8 Stykes E. CDC Director: Covid vaccines can’t prevent transmission anymore. MSN Jan 10, 2022.
9 MacMillan C. COVID-19 Vaccines for Kids Under 5; What Parents Need To Know. Yale Medicine Dec. 12, 2022.
10 News Release. Coronavirus (COVID-19) Update: FDA Authorizes Updated (Bivalent) COVID-19 Vaccines for Children Down to 6 Months of Age. U.S. Food and Drug Administration Dec. 8, 2022.
11 Ibid.
12 Ibid.
13 Ibid.