By: Chandan Borgohain
April 28 2023
No, monovalent COVID-19 vaccines have not been banned
Share Article:
Fact-Check
The Verdict Misleading
FDA has recently withdrawn the EUAs for monovalent COVID-19 vaccines in the U.S. However, the vaccines are not banned and are still licensed.
Claim ID 4fc1f40d
Context
In a press release issued on April 18, the U.S. Food and Drug Administration (FDA) announced its updated COVID-19 vaccine guidance. According to the updated recommendations, the "monovalent" versions of the Moderna and Pfizer-BioNTech COVID-19 vaccines are "no longer authorized for use in the United States." Instead, the newer bivalent versions of the vaccines, which target both the novel coronavirus and the Omicron BA.4/BA.5 strains, are authorized for all individuals over 6 months of age.
Many social media posts, primarily by anti-vaxxers, spread claims that the monovalent versions of COVID-19 vaccines are ineffective and dangerous, causing the FDA to ban them. Another Facebook user shared a video of a man reading out the tweet by the FDA announcing the change, insinuating that the vaccine had been withdrawn due to issues, and questioning the efficacy and the approval from the agency.
However, such posts are false or missing essential context.
In Fact
In its press statement on April 18, the FDA made amendments to the use of Pfizer-BioNTech and Moderna mRNA COVID-19 vaccines. It said that the original "monovalent" versions of the vaccines are "no longer authorized for use in the United States." According to the release, the new guidelines aim to "simplify the vaccination schedule for most individuals" as the updated bivalent versions of Pfizer-BioNTech and Moderna vaccines can target both the original novel coronavirus and the newly emerged Omicron strains. However, this does not mean that the federal agency banned the original versions, as suggested by many on social media platforms.
In reply to a question from Twitter owner Elon Musk, FDA also clarified its decision. "Hi, Elon. Thanks for your question. It's probably worth clarifying that the monovalent vaccines are still approved (licensed). That hasn't changed. But they are no longer authorized for *emergency use* in the United States," the FDA's official account wrote. According to the new amendment, FDA has only withdrawn the "emergency use authorizations" (EUAs) from the monovalent Pfizer-BioNTech and Moderna vaccines.
In response to Reuters, FDA press officer Abby Capobianco explained that the old vaccines were still effective and had only been replaced by the more effective bivalent versions, which could target both strains. "Available evidence suggests that the original monovalent mRNA COVID-19 vaccines continue to protect against serious disease from COVID-19," she said, adding that "data have emerged indicating that the bivalent vaccine provides improved protection compared to the original monovalent mRNA COVID-19 vaccines."
Further, the FDA states that the "bivalent vaccines are manufactured using the same process" as the original monovalent vaccines. The newer versions were authorized based on safety and effectiveness data from the original versions.
In a presentation on April 19, available on the U.S. Centers for Disease Control's (CDC) YouTube channel, Sara Oliver, lead for the CDC's Advisory Committee on Immunization Practices (ACIP) working group for COVID vaccines, also confirmed that the biological license applications (BLAs) of the monovalent vaccines are still in place. However, she has also noted that only a limited number of pediatric doses are available, and all remaining adult doses are already expired.
The Verdict
FDA has withdrawn the "emergency use authorizations" (EUAs) from the monovalent Pfizer-BioNTech and Moderna vaccines and instead authorized bivalent versions. However, this doesn't mean that the federal agency has banned the monovalent vaccines and clarified that they are still licensed and approved. Therefore, we have marked this claim as misleading.