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FDA Recommends People Only Take One mRNA COVID Vaccine, No More Boosters

The U.S. Food and Drug Administration (FDA) has revised the emergency use authorizations (EUAs) for the Moderna and Pfizer-BioNTech COVID-19 mRNA vaccines to simplify the vaccination schedule for most individuals.

The updated EUAs authorize the use of the current bivalent vaccines, covering the original strain and the omicron BA.4/BA.5 strains, for all doses given to individuals aged 6 months and older, including additional doses for certain populations. However, the monovalent versions of the Moderna and Pfizer-BioNTech vaccines are no longer authorized for use in the United States.

Key Points to Note:

  1. Individuals previously vaccinated with a monovalent COVID-19 vaccine who haven’t received a bivalent vaccine may receive a single dose of the bivalent vaccine, depending on their age.
  2. Individuals who have already received a single dose of the bivalent vaccine are currently not eligible for an additional dose. The FDA will make decisions regarding future vaccinations after receiving recommendations from an FDA advisory committee meeting in June to discuss the fall strain composition.
  3. Individuals aged 65 and older who have received a single dose of a bivalent vaccine may receive one additional dose at least four months after their initial bivalent dose.
  4. Most individuals with specific types of immunocompromise who have received a bivalent COVID-19 vaccine may receive a single additional dose at least 2 months after a dose of the bivalent vaccine. Additional doses can be administered based on the discretion and guidance of healthcare providers. However, eligibility for additional doses for immunocompromised individuals aged 6 months to 4 years will depend on the previously received vaccine.
  5. Unvaccinated individuals can receive a single dose of a bivalent vaccine instead of multiple doses of the original monovalent mRNA vaccines.
  6. Children aged 6 months to 5 years who are unvaccinated may receive a two-dose series of the Moderna bivalent vaccine or a three-dose series of the Pfizer-BioNTech bivalent vaccine. Children who are 5 years old can receive two doses of the Moderna bivalent vaccine or a single dose of the Pfizer-BioNTech bivalent vaccine.
  7. Children aged 6 months to 5 years 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 individuals may 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 for now,” 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 healthcare 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 around 12.5 million doses unused.

The CDC had previously limited the emergency use authorization of the J&J vaccine to adults who could not receive other vaccines due to the risk of the rare clotting condition known as thrombosis with thrombocytopenia syndrome (TTS). The J&J vaccines were linked to 60 confirmed cases of TTS, including nine deaths, according to the CDC.

Only about 7% of vaccinated individuals in the US received the J&J vaccine as their first shot, with the majority opting for the mRNA vaccines from Pfizer/BioNTech and Moderna.

While wealthier nations have primarily chosen the Pfizer/BioNTech and Moderna vaccines due to their effectiveness against COVID-19 variants, 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 now over in the US, the mRNA vaccines from Pfizer/BioNTech and Moderna will continue to be administered free of charge, as long as federal supplies last.

The World Health Organization (WHO) recommended in a statement on Thursday that future COVID-19 vaccines no longer include the original SARS-CoV-2 virus, but instead a different version that closely matches circulating variants.

The WHO’s Technical Advisory Group on COVID-19 Vaccine Composition on May 18 suggested including the XBB.1.5 variant, which is responsible for most new infections worldwide. The updated vaccine should focus on a single XBB variant rather than multiple versions.

Although not binding, this recommendation serves as a foundation for national vaccine decisions. Some experts have advocated for including multiple virus strains in the next shot, akin to the annual flu shot’s approach. The WHO group highlighted that slight differences exist among existing XBB variants and alternative formulations or platforms that generate strong neutralizing antibody responses against XBB descendent lineages may be considered.

The latest U.S. COVID-19 booster is bivalent, targeting the original SARS-CoV-2 version and two Omicron variants (BA.4 and BA.5). While these shots and previous vaccines remain effective against severe 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 waning effectiveness, provided the strains in the vaccine closely match circulating ones. Targeting a single version of the virus may reduce the chances of achieving this alignment.

The WHO’s recommendation will be considered by the U.S. Food and Drug Administration (FDA) when its vaccine experts meet in June to discuss the strains to include in the next COVID-19 vaccine. The FDA’s VRBAC committee is moving towards endorsing an annual single shot for most individuals, with additional doses for the elderly and immunocompromised.

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OPINION: This article contains commentary which reflects the author's opinion.