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U.S. FDA Profile picture
@US_FDA
Apr 18 • 12 tweets • 2 min read Twitter logo Read on Twitter
Today, FDA amended the EUAs of the Pfizer-BioNTech and Moderna COVID-19 bivalent mRNA vaccines to simplify the vaccination schedule for most individuals. fda.gov/news-events/pr…
What you need to know. 🧵👇 Image
This action includes authorizing the current bivalent vaccines (original and omicron BA.4/BA.5 strains) to be used for all doses administered to individuals 6 months of age and older, including for an additional dose or doses for certain populations.
The monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States.
Most individuals, depending on age, previously vaccinated with a monovalent COVID-19 vaccine who have not yet received a dose of a bivalent vaccine may receive a single dose of a bivalent vaccine.
Most individuals who have already received a single dose of the bivalent vaccine are not currently eligible for another dose. We intend to make decisions about future vaccination after receiving recommendations on the fall strain composition at an FDA advisory committee in June.
Individuals 65 years of age and older who have received a single dose of a bivalent vaccine may receive one additional dose at least 4 months following their initial bivalent dose.
Most individuals with certain kinds of immunocompromise who have received a bivalent COVID-19 vaccine may receive a single additional dose of a bivalent COVID-19 vaccine at least 2 months following a dose of a bivalent COVID-19 vaccine.
Additional doses may be administered at the discretion of, and at intervals determined by, their healthcare provider. However, for immunocompromised individuals 6 months through 4 years of age, eligibility for additional doses will depend on the vaccine previously received.
Most unvaccinated individuals may receive a single dose of a bivalent vaccine, rather than multiple doses of the original monovalent mRNA vaccines.
Children 6 months through 5 years of age who are unvaccinated may receive a two-dose series of the Moderna bivalent vaccine (6 months through 5 years of age) OR a three-dose series of the Pfizer-BioNTech bivalent vaccine (6 months through 4 years of age).
Children who are 5 years of age may receive two doses of the Moderna bivalent vaccine or a single dose of the Pfizer-BioNTech bivalent vaccine.
Children 6 months through 5 years of age who have received one, two or three doses of a monovalent COVID-19 vaccine may receive a bivalent vaccine, but the number of doses that they receive will depend on the vaccine and their vaccination history.

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More from @US_FDA

U.S. FDA Profile picture
Jan 31
Since the start of the COVID-19 public health emergency [declared under the Public Health Service Act], the U.S. Food and Drug Administration has been committed to providing timely recommendations and regulatory information to support response efforts. Over a dark background, an image of the coronavirus. TEXT: C
The COVID-19 public health emergency declared under section 319 of the Public Health Service Act has allowed the FDA to provide important tools and flexibilities to manufacturers, health care facilities, providers, patients, and other stakeholders.
The FDA intends to issue a Federal Register notice regarding how HHS’ determination to end the COVID-19 public health emergency declared under the Act will impact the Agency’s COVID-19-related guidances and which of those guidances it is temporarily extending or letting expire.
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U.S. FDA Profile picture
Dec 8, 2022
Today, we amended the emergency use authorizations (EUAs) of the updated (bivalent) Moderna and Pfizer-BioNTech COVID-19 vaccines to include use in children down to 6 months of age. fda.gov/news-events/pr… Over a dark background, an image of the coronavirus. The tex
Here's what parents and caregivers need to know:
⬇️⬇️⬇️
➡️ Children 6 mos-5 yrs who received the original (monovalent) Moderna COVID-19 Vaccine are now eligible to receive a single booster of the updated (bivalent) Moderna vaccine two months after completing their primary series.
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U.S. FDA Profile picture
Dec 6, 2022
Today’s “FDA Roundup” includes info on homeopathic drug products, an updated device safety communication, and FDA’s Rare Disease Day. fda.gov/news-events/pr… Newspaper mockup graphic with image of FDA headquarters in t
Today, we issued a final guidance, Homeopathic Drug Products, describing the agency’s approach to prioritizing enforcement and regulatory actions for homeopathic products marketed in the U.S. without the required FDA approval. federalregister.gov/public-inspect…
We also issued an updated safety communication on the use of Endologix AFX endovascular grafts. This update includes information about new labeling and a required postmarket study for the AFX2 Endovascular AAA System (AFX2).
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U.S. FDA Profile picture
Sep 9, 2022
Today’s “FDA Roundup” includes monkeypox testing FAQ info, BiPAP/CPAP safety communication, and a public health alert for an infant formula not manufactured in compliance with the FDA’s infant formula regulations. fda.gov/news-events/pr…
Today, we posted FAQs on Testing for Monkeypox with answers to frequently asked questions relating to the development and performance of tests for monkeypox. fda.gov/medical-device…
These questions and answers provide additional clarity on existing policies and do not introduce any new policies or modify any existing policies.
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U.S. FDA Profile picture
Aug 31, 2022
Today, we amended the authorizations of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine to authorize updated formulations of the vaccines for use as a single booster dose at least two months following primary or booster vaccination. fda.gov/news-events/pr… An image of the coronavirus over a dark background. White te
These bivalent vaccines, as they are called, contain two messenger RNA (mRNA) components of SARS-CoV-2 virus, one from the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2.
The Moderna COVID-19 Vaccine, Bivalent, is authorized for use as single booster dose in individuals 18 years of age and older. The Pfizer-BioNTech COVID-19 Vaccine, Bivalent, is authorized for use as a single booster dose in individuals 12 years of age and older.
Read 5 tweets
U.S. FDA Profile picture
Aug 30, 2022
Today’s edition of “FDA Roundup” includes a new FDA Voices, a virtual public listening session announcement, an update on the Philips Respironics recall, and info on a new treatment for chronic constipation. fda.gov/news-events/pr…
Today, we published the FDA Voices: “FDA’s Overdose Prevention Framework Aims to Prevent Drug Overdoses and Reduce Death,” by @DrCaliff_FDA.
Also, @FDAanimalhealth announced registration is now open for a virtual public listening session on the agency's regulation of animal foods with certain types of claims.
Read 6 tweets

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