FDA Approves Bivalent COVID-19 Vaccines for Children as Young as 6 Months

December 8, 2022 by Dan McCue
FDA Approves Bivalent COVID-19 Vaccines for Children as Young as 6 Months
FILE - In this Wednesday, Oct. 7, 2020, file photo, a vial of the phase 3 Novavax coronavirus vaccine is seen ready for use in the trial at St. George's University hospital in London. Novavax says its vaccine appears effective against COVID-19 in a large study, including against variants. Results from the study in the U.S. and Mexico were released on Monday, June 14, 2021. (AP Photo/Alastair Grant, File)

WASHINGTON — The Food and Drug Administration on Thursday amended its emergency use authorizations for the updated (bivalent) Moderna and Pfizer-BioNTech COVID-19 vaccines, saying the shots are safe to administer to children as young as 6 months old.

“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,” said FDA Commissioner Dr. Robert M. Califf, in a written statement. 

“As this virus has changed, and immunity from previous COVID-19 vaccination wanes, the more people who keep up-to-date on COVID-19 vaccinations, the more benefit there will be for individuals, families and public health by helping prevent severe illnesses, hospitalizations, and deaths,” Califf said.

Parents are advised that children 6 months through 5 years of age who received the original (monovalent) Moderna COVID-19 vaccine are now eligible to receive a single booster of the updated (bivalent) Moderna COVID-19 vaccine two months after completing a primary series with the monovalent Moderna COVID-19 vaccine.

Children 6 months through 4 years of age who have not yet begun their three-dose primary series of the Pfizer-BioNTech COVID-19 vaccine or have not yet received the third dose of their primary series will now receive the updated (bivalent) Pfizer-BioNTech COVID-19 vaccine as the third dose in their primary series following two doses of the original Pfizer-BioNTech COVID-19 vaccine.

Additionally, the agency says parents should be aware that children 6 months through 4 years of age who have already completed their three-dose primary series with the original Pfizer-BioNTech COVID-19 vaccine will not be eligible for a booster dose of an updated bivalent vaccine at this time. 

That’s because children in this age group who already completed their primary series would still be expected to have protection against the most serious outcomes from the currently circulating omicron variant. 

The Moderna and Pfizer-BioNTech bivalent COVID-19 vaccines include an mRNA component corresponding to the original strain to provide an immune response that is broadly protective against COVID-19 and an mRNA component corresponding to the omicron variant BA.4 and BA.5 lineages to provide better protection against COVID-19 caused by the omicron variant. 

Individuals who receive the updated (bivalent) vaccines may experience similar side effects reported by individuals who received previous doses of the original (monovalent) mRNA COVID-19 vaccines, the agency said.

“Vaccines remain the best defense against the most devastating consequences of disease caused by the currently circulating omicron variant, such as hospitalization and death,” said Dr. Peter Marks, Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. 

“Based on available data, the updated, bivalent vaccines are expected to provide increased protection against COVID-19,” he continued. “Parents and caregivers can be assured that the FDA has taken a great deal of care in our review, and we encourage parents of children of any age who are eligible for primary vaccination or a bivalent COVID-19 vaccine booster dose to consider seeking vaccination now as it can potentially help protect them from COVID-19 during a time when cases are increasing.”

Dan can be reached at [email protected] and at https://twitter.com/DanMcCue

A+
a-
  • children
  • COVID
  • FDA
  • Food and Drug Administration
  • vaccines
  • In The News

    Health

    Voting

    Health

    March 27, 2024
    by Dan McCue
    One-Time Treatment Could Revitalize Immune Systems in the Elderly

    PALO ALTO, Calif. — A new study suggests that a one-time treatment that modulates the composition of a type of... Read More

    PALO ALTO, Calif. — A new study suggests that a one-time treatment that modulates the composition of a type of immune cell could potentially revitalize the immune systems of the elderly, helping their bodies better react to viral and bacterial threats. The research was carried out... Read More

    March 27, 2024
    by Dan McCue
    Insurers to Expand Access to ‘Navigation Services’ for Cancer Patients

    WASHINGTON — Seven of the nation’s largest health insurance companies are expanding access to so-called “navigation services” to help patients... Read More

    WASHINGTON — Seven of the nation’s largest health insurance companies are expanding access to so-called “navigation services” to help patients and their families navigate the myriad challenges that might arise during treatment for cancer and other serious illnesses. The insurers involved are Aetna; Blue Cross Blue... Read More

    Five Takeaways From the Abortion Pill Case Before US Supreme Court

    WASHINGTON (AP) — U.S. Supreme Court justices on Tuesday did not appear ready to limit access to the abortion pill mifepristone,... Read More

    WASHINGTON (AP) — U.S. Supreme Court justices on Tuesday did not appear ready to limit access to the abortion pill mifepristone, in a case that could have far-reaching implications for millions of American women and for scores of drugs regulated by the Food and Drug Administration. It's... Read More

    Biden and Harris Argue Democrats Will Preserve Health Care and Republicans Would Take It Away

    RALEIGH, N.C. (AP) — President Joe Biden and Vice President Kamala Harris on Tuesday promoted their health care agenda in... Read More

    RALEIGH, N.C. (AP) — President Joe Biden and Vice President Kamala Harris on Tuesday promoted their health care agenda in the battleground state of North Carolina, arguing that Democrats like themselves would preserve access to care while Republicans would reverse gains made over the past decade... Read More

    March 26, 2024
    by Tom Ramstack
    Supreme Court Skeptical of Ban on Abortion Pill Mifepristone

    WASHINGTON — A hearing Tuesday before the Supreme Court indicated a majority of the justices want to maintain women’s access... Read More

    WASHINGTON — A hearing Tuesday before the Supreme Court indicated a majority of the justices want to maintain women’s access to the abortion pill mifepristone despite objections from anti-abortion activists. The doctors and organizations who sued argued the Food and Drug Administration was wrong in granting... Read More

    March 26, 2024
    by Dan McCue
    Consumers Warned to Avoid Certain Topical Pain Relief Products 

    WASHINGTON — The Food and Drug Administration warned consumers on Tuesday not to use certain over-the-counter pain relief products marketed... Read More

    WASHINGTON — The Food and Drug Administration warned consumers on Tuesday not to use certain over-the-counter pain relief products marketed for topical use before, during or after certain cosmetic procedures. The warning came after the agency issued warning letters to six companies for marketing these products... Read More

    News From The Well
    scroll top