Covid 'monovalent' vaccines not banned, FDA approval not withdrawn

The FDA announced amendments to its original authorization of the mRNA vaccines on April 18

(Reuters) - The original “monovalent” versions of Moderna and Pfizer Covid vaccines are no longer recommended or authorized for emergency use in the United States after the Food and Drug Administration (FDA) announced that the newer bivalent versions are fully authorized for everyone. But the original vaccines remain licensed in the United States and are not “banned” as suggested by some social media users.

The FDA announced amendments to its original authorization of the mRNA vaccines on April 18 (here), making the newer bivalent versions that target both the original novel coronavirus and the Omicron strains the only shots authorized for use in all groups over six months of age, and regardless of a person’s history of Covid vaccination (here), (here).

“Now we are retiring the monovalent (vaccines) and if you’ve never been vaccinated, the single hybrid vaccination will serve the equivalent,” Thomas Russo, an infectious disease expert and professor at the University at Buffalo Jacobs School of Medicine and Biomedical Sciences (here), told Reuters.

An FDA spokesperson also commented on the agency’s official Twitter account: “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” (archive.is/6RpdS).

One of the misleading tweets read: “Last year you couldn’t enter a restaurant without a vaccine card. That same vaccine today is BANNED. Last year I was canceled off Youtube for saying the vaccine doesn’t work. Today the FDA agrees. Do you still believe their lies?” (here). Another example can be seen (here). 

The FDA’s amendment of the original authorizations for the Moderna and Pfizer-BioNTech Covid vaccines to favor use of the current bivalent vaccine versions was described in the agency’s announcement as a way “to simplify the vaccination schedule for most individuals,” so that one version is recommended for all uses.

EFFECTIVENESS OF ORIGINAL VACCINES

The update does not mean the old vaccines were ineffective, but that the bivalent versions are more effective than the old ones against the virus strains circulating now, FDA press officer Abby Capobianco told Reuters via email. “Available evidence suggests that the original monovalent mRNA Covid-19 vaccines continue to provide protection against serious disease from Covid-19,” she said, but “data have emerged indicating that the bivalent vaccine provides improved protection compared to the original monovalent mRNA Covid-19 vaccines.”

Reuters has previously addressed claims about the effectiveness of the original Moderna and Pfizer mRNA Covid vaccines (here), (here).

The FDA’s April 18 announcement noted that the bivalent vaccines’ formulation remains comparable to the originals, adding that “these vaccines are manufactured using the same process” and that authorization of the newer versions was based in part on safety and effectiveness data from the original versions (here).

EMERGENCY USE AUTHORIZATION

The FDA announcement “amends” the original Emergency Use Authorizations (EUA) issued in late 2020 for use of the Moderna and Pfizer vaccines in adults.

EUA information for the Moderna and Pfizer vaccines can be seen on the FDA website (here) , (here).

EUAs for both vaccines have already been amended multiple times to add authorizations and dosing recommendations for children, and to update these to accommodate the bivalent vaccines, as described in the executive summary (pages 4-5) of the April 18 decision memorandum for Comirnaty, the Pfizer vaccine (here).

The decision memorandum for Comirnaty also states (page 37) that the current amendment “removes” authorization for emergency use of the monovalent vaccine, and “revises” the EUA “to provide for use” of the bivalent version instead.

A similar FDA decision memorandum for Spikevax (Moderna) can be seen (here).

STILL APPROVED, LICENSED

Documents from the FDA and the Centers for Disease Control and Prevention (CDC) make clear that the original approval and license of the monovalent vaccines remains in effect.

Both agencies note that the original vaccines are still approved and could still be suitable in some situations - for example, to provide additional booster shots to immunocompromised individuals - but as a practical matter, supplies of the older shots are no longer sufficient for broad use.

In its Letter of Authorization (LOA) to Moderna, reissued April 18, the FDA lists (page 16) (here) among its criteria for authorizing the bivalent vaccines the fact that “There is no adequate, approved, and available alternative” for preventing Covid. A footnote clarifies that although the original Moderna and Pfizer vaccines “are approved to prevent Covid-19” in people who are eligible for the bivalent versions, “there is not sufficient approved (monovalent) vaccine available for distribution to this population in its entirety at the time of the reissuance of this EUA.”

FDA’s authorization letter to Pfizer (here) makes the same point (page 17).

In a presentation the day after the FDA announcement (here), Sara Oliver, lead for the CDC’s Advisory Committee on Immunization Practices (ACIP) working group for COVID vaccines, also pointed out (page 13) that the original monovalent vaccines remain licensed (biologicals license application, or BLA) but that only a limited number of pediatric doses are available, and all remaining adult doses are already expired. The slide can also be seen at the 1:55:45 timestamp in a video of the presentation (here).

VERDICT

Missing context. The FDA withdrew authorizations for emergency use of Pfizer-BioNTech and Moderna monovalent Covid vaccines while authorizing use of the updated, bivalent versions in all age groups. The agency did not withdraw its approval or license of the original vaccines, nor “ban” their use.