The US Food and Drug Administration (FDA) has revised the emergency use (US) authorizations for the Moderna and Pfizer-BioNTech COVID-19 mRNA vaccines to simplify the vaccination schedule of the most people
The updated US authorizes the use of the current bivalent vaccines, covering the original strain and omicron BA.4/BA.5 strains, for all doses administered to persons 6 months of age and older, including additional doses for certain populations. However, the monovalent versions of the Moderna and Pfizer-BioNTech vaccines are no longer licensed for use in the United States.
Key points to consider:
People previously vaccinated with a monovalent COVID-19 vaccine who have not received a bivalent vaccine may receive a single dose of the bivalent vaccine, depending on their age. People who have already received a single dose of the bivalent vaccine are currently not eligible for an additional dose. The FDA will make decisions on future vaccines after receiving recommendations from an FDA advisory committee meeting in June to discuss the composition of the fall strain. People age 65 and older who have received a single dose of a bivalent vaccine may receive an additional dose at least four months after their initial bivalent dose. Most people with specific types of immunocompromise who have received a bivalent vaccine against COVID-19 can receive a single additional dose at least two months after a dose of the bivalent vaccine. Additional doses may be administered at the discretion and guidance of health care providers. However, eligibility for additional doses for immunocompromised individuals between 6 months and 4 years of age will depend on the vaccine previously received. Unvaccinated people can receive a single dose of a bivalent vaccine instead of multiple doses of the original monovalent mRNA vaccines. Unvaccinated children 6 months to 5 years of age can receive a two-dose series of the Moderna bivalent vaccine or a three-dose series of the Pfizer-BioNTech bivalent vaccine. Children 5 years of age can receive two doses of the Moderna bivalent vaccine or a single dose of the Pfizer-BioNTech bivalent vaccine. Children 6 months to 5 years of age who have received one, two, or three doses of a monovalent COVID-19 vaccine may receive a bivalent vaccine, depending on the vaccine and their vaccination history.
“Most unvaccinated people can receive a single dose of a bivalent vaccine, rather than multiple doses of the original monovalent mRNA vaccines,” the FDA said.
“Most Americans who have already received a bivalent booster will not be eligible for another dose at this time,” the agency added.
The Centers for Disease Control and Prevention (CDC) recently announced that the Johnson & Johnson COVID-19 vaccine is no longer available in the United States. All remaining doses of the vaccine expired last week, and the CDC has directed health care providers to dispose of any remaining doses they may have had.
According to CDC data, approximately 19 million people in the US have received the J&J vaccine since its initial availability. However, more than 31.5 million doses were delivered to states and other jurisdictions, leaving about 12.5 million doses unused.
The CDC had previously limited emergency use authorization of the J&J vaccine to adults who could not receive other vaccines because of the risk of the rare clotting condition known as thrombosis with thrombocytopenia syndrome (TTS). J&J vaccines were linked to 60 confirmed cases of TTS, including nine deaths, according to the CDC.
Only 7% of vaccinated people in the US received the J&J vaccine as their first injection, with the majority opting for mRNA vaccines from Pfizer/BioNTech and Moderna.
While wealthier nations have mostly chosen the Pfizer/BioNTech and Moderna vaccines for their effectiveness against variants of COVID-19, poorer countries have relied on the Janssen vaccine as it is a single-dose option and more affordable
With the COVID-19 public health emergency in the US, mRNA vaccines from Pfizer/BioNTech and Moderna will continue to be administered free of charge, while federal supplies last.
The World Health Organization (WHO) recommended in a statement on Thursday that future vaccines against COVID-19 no longer include the original SARS-CoV-2 virus, but a different version that closely matches the circulating variants.
The WHO technical advisory group on the composition of the COVID-19 vaccine suggested on May 18 that the XBB.1.5 variant, which is responsible for the majority of new infections worldwide, be included. The updated vaccine should focus on a single XBB variant rather than multiple versions.
Although not binding, this recommendation serves as a basis for national vaccine decisions. Some experts have advocated including multiple strains of the virus in the next vaccine, similar to the approach of the annual flu shot. The WHO panel emphasized that slight differences exist between existing XBB variants and alternative formulations or platforms that generate strong neutralizing antibody responses against XBB descendant lineages may be considered.
The latest US COVID-19 booster is bivalent, targeting the original version of SARS-CoV-2 and two Omicron variants (BA.4 and BA.5). Although these and earlier vaccines remain effective against serious illness, hospitalization, and death, they offer less protection against infection as antibody levels decline over time. Updating the COVID-19 vaccine is crucial to address declining efficacy, as long as the vaccine strains closely match those in circulation. Targeting a single version of the virus can reduce the chances of achieving this alignment.
The WHO recommendation will be considered by the US Food and Drug Administration (FDA) when its vaccine experts meet in June to discuss which strains should be included in the next COVID vaccine -19. The FDA’s VRBAC committee is moving toward approving a single annual injection for most people, with additional doses for the elderly and immunocompromised.
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