Winter is Coming!

In the words of House Stark of Winterfell, “Winter is Coming,” and with the lengthening nights and colder climate comes the potential for greater COVID-19 infection rates and new viral strains. Unsurprising, there have been announcements on vaccine agreements, and further research has been highlighted in the news.

Bivalent candidates

An announcement was released, in early August 2022, by Moderna that its agreement with the European Commission (EC) for COVID-19 vaccine doses had been amended (1). According to the release, the company will now provide the EC with its Omicron-containing bivalent vaccines (pending regulatory approval) versus the originally agreed upon Spikevax doses of messenger RNA (mRNA) vaccines.

There are, in fact, two next-generation bivalent candidates that Moderna is advancing through development—mRNA-1273.214, based on the BA.1 subvariant of Omicron, and mRNA 1273.222, based on the BA.4/5 strain. A conditional authorization for the use of mRNA-1273.214 has already been granted by the United Kingdom’s Medicines and Healthcare products Regulatory Agency, and Moderna is working with other regulatory bodies for authorization of both booster vaccines (2).

Across the Atlantic, Pfizer and BioNTech have also submitted an application for emergency use authorization of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine with the US Food and Drug Administration, and the companies have shared study data on their Omicron BA.1 bivalent vaccine candidate with the regulators (3).

Oral vaccine promise

Moving to a bit earlier in the R&D pipeline, there is a potential oral tablet vaccine under development by clinical-stage biotechnology company, Vaxart. Recently, Vaxart reported additional Phase I clinical data on its Spike/Nucleocapsid (S+N) oral tablet COVID-19 vaccine, which indicated that it induced long-lasting mucosal IgA antibodies against coronaviruses (4).

“These findings support our view that the cross-reactivity of our vaccine candidates’ mucosal immune responses could have a significant impact in the fight against evolving SARS-CoV-2 variants,” said James Cummings, Vaxart’s SVP and chief medical officer, in a press release (4).

References

1. Moderna, “Moderna and the European Commission (EC) Amend COVID-19 Vaccine Agreement to Supply Omicron-Containing Bivalent Candidates; EC Purchases Additional 15 Million Doses,” Press Release, 9 Aug. 2022.
2. Moderna, “Medicines and Healthcare Products Regulatory Agency (MHRA) Authorizes Moderna’s Omicron-Containing Bivalent Booster in the UK,” Press Release, 15 Aug. 2022.
3. Pfizer, “Pfizer and BioNTech Submit Application to US FDA for Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine,” Press Release, 22 Aug. 2022.
4. Vaxart, “Vaxart Publishes Clinical Data Suggesting its Oral COVID-19 Pill Vaccine Candidate Induces Long-Lasting Mucosal Immune Responses that are Highly Cross-Reactive,” Press Release, 20 July 2022.

About the author

Felicity Thomas is the European/senior editor for Pharmaceutical Technology Group.

Article details

Pharmaceutical Technology Europe
Vol. 34, No. 9
September 2022
Page: 6

Citation

When referring to this article, please cite it as F. Thomas, “Winter is Coming!” Pharmaceutical Technology Europe 34 (9) 2022.