New COVID-19 Vaccine Version Will be Available for Fall Campaigns

Pharmacists can expect to be administering a new type of COVID-19 vaccine this fall. The FDA has recommended the product contain spike proteins for the XBB.1.5 sublineage of SARS-CoV-2. Shortly after that announcement, Moderna submitted an application for its new vaccine version. Here is more information.

SILVER SPRING, MD – Shortly after the Food and Drug Administration (FDA) advised manufacturers who will be updating their COVID-19 vaccines, that they should develop vaccines with a monovalent XBB 1.5 composition,

Moderna, Inc., the biotechnology company that played a leading role in the development of messenger RNA (mRNA) therapeutics and vaccines, said it had completed the submission of a regulatory application to the FDA for its updated COVID-19 vaccine containing spike proteins for the XBB.1.5 sublineage of SARS-CoV-2 (mRNA-1273.815).

Pharmacists should expect the updated vaccine to be available before autumn.

"The agility of our mRNA platform has enabled us to update Spikevax, Moderna's COVID-19 vaccine, to target XBB variants with speed and clinical rigor," said Stéphane Bancel, CEO of Moderna. "We have been working diligently for months to build ample supply, with doses ready to ship in time for the fall vaccination season in the Northern Hemisphere. In addition, our preliminary clinical testing has demonstrated that mRNA-1273.815 is effective in generating an immune response against the current XBB variants of concern.”

On June 15, the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) met to discuss and make recommendations for updated COVID-19 vaccines beginning in the fall of 2023. The committee unanimously voted that the vaccine composition for 2023-2024 be updated to a monovalent COVID-19 vaccine with an XBB-lineage of the Omicron variant. After a discussion of the evidence, the committee expressed a preference for XBB.1.5.

The advisory committee took into account manufacturing timelines as well as available data on:

  • the circulation of SARS-CoV-2 virus variants,
  • current vaccine effectiveness,
  • human immunogenicity data of current vaccines against recently circulating virus variants,
  • the antigenic characterization of circulating virus variants,
  • animal immunogenicity data generated by new candidate vaccines expressing or containing updated spike components and
  • preliminary human immunogenicity data generated by one XBB.1.5 candidate vaccine.

The June 15 VRBPAC was a follow-up to the Jan. 26 meeting, where the FDA discussed the process for determining the need for recommending updates to the composition of COVID-19 vaccines, and the timing for implementation of such an update.

Moderna said it was the only company at the recent VRBPAC to submit preliminary clinical data comparing monovalent and bivalent vaccines and showing robust human immune responses across multiple XBB descendent sublineages such as XBB.1.5, XBB.1.16 and XBB.2.3.2.

The company said the most common solicited local adverse event for Moderna's updated COVID-19 vaccine was injection site pain. The most common solicited systemic adverse events include headache, fatigue, myalgia and chill were the most common solicited systemic adverse events, in line with previous vaccines against SARS-CoV-2.

In its recent press release, Moderna reminded pharmacists and other vaccine providers that they should not administer the vaccines to individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any component of the Moderna COVID-19 vaccine and that appropriate medical treatment to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction.

In addition, because syncope might occur in association with the administration of injectable vaccines, procedures should be in place to avoid injury from fainting.

Moderna also noted that postmarketing data demonstrate increased risks of myocarditis and pericarditis, especially within 7 days following the second primary series dose or first booster dose.

In terms of effectiveness, the press release reminded vaccine providers that immunocompromised persons, including individuals receiving immunosuppressive therapy, might have a diminished response to the vaccines and the vaccines may not protect all recipients.