The US Food and Drug Administration ?FDA, for its acronym in English? amended this Thursday, December 8, the emergency use authorizations (EUA) of the bivalent boosters of the Moderna and Pfizer-BioNTech COVID-19 vaccine to include use in children up to 6 months to 4 years of age.
“More children now have the opportunity to upgrade their COVID-19 protection with a bivalent COVID-19 vaccine, and we encourage parents and caregivers of those eligible to consider doing so, especially as we approach the holidays. and the winter months, where more time will be spent indoors," said FDA Commissioner Robert M. Califf.
The news comes in the middle of a winter in which the cases of COVID-19 have increased and in which diseases such as flu, influenza and VSR are added in the smallest, so the action comes at a great time to prevent Serious illnesses, hospitalizations, and deaths from COVID-19.
Starting this Thursday, children 6 months to 5 years of age who received the original Moderna COVID-19 ?monovalent? are now eligible to receive a one-time booster of the updated Moderna COVID-19 ?bivalent? two months after completing a primary series with Moderna monovalent Vaccine for COVID-19.
Children 6 months through 4 years of age who have not yet started 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? from Pfizer- as the third dose in its primary series after two doses of the original ?monovalent? Pfizer-BioNTech.
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.
Children in this age group who have already completed their primary series would still be expected to have protection against the more serious outcomes of the currently circulating omicron variant. Data to support the administration of an updated bivalent booster dose for these children is expected in January. The agency is committed to evaluating that data as quickly as possible.
Moderna and Pfizer-BioNTech's bivalent COVID-19 vaccines include an mRNA component corresponding to the parent strain to provide an immune response that is broadly protective against COVID-19 and an mRNA component corresponding to the BA.4 and BA lineages. 5 of the omicron variant to provide better protection.
People who receive updated ?bivalent? they may experience similar side effects reported by people who received previous doses of the original "monovalent" mRNA COVID-19 vaccines.
“Vaccines remain the best defense against the most devastating consequences of the disease caused by the currently circulating omicron variant, such as hospitalization and death. Based on available data, updated bivalent vaccines are expected to provide increased protection against COVID-19," said Peter Marks, director of the FDA's Center for Biological Research and Evaluation.
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