mRNA-1273.214 Exhibited a Greater Than 5-Fold Boost in Neutralizing Antibodies Against BA.4 and BA.5 Subvariants in Phase 2/3 Study

Data Being Submitted to Regulators and for Peer Reviewed Publication

CAMBRIDGE, MA / ACCESSWIRE / June 22, 2022 / Moderna, Inc., (NASDAQ:MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced new clinical data on its bivalent (Omicron) COVID booster candidate, mRNA-1273.214. One month after administration in previously vaccinated and boosted participants, a 50 µg booster dose of mRNA-1273.214 elicited potent neutralizing antibody responses against the Omicron subvariants BA.4 and BA.5 in all participants regardless of prior infection. Based on this and prior data, the Company is working to complete regulatory submissions in the coming weeks requesting to update the composition of the booster vaccine to mRNA-1273.214.

In today's data, mRNA-1273.214 boosted neutralizing titers against BA.4/BA.5 by 5.4-fold (95% CI: 5.0, 5.9) above baseline in all participants regardless of prior infection, and by 6.3-fold (95% CI: 5.7, 6.9) in the subset of seronegative participants. Neutralizing titers against BA.4/BA.5 were approximately 3-fold lower than previously reported neutralizing titers against BA.1. One month after an mRNA-1273.214 booster, neutralizing geometric mean titers (GMT) against BA.4/BA.5 were 941 (95% CI: 826, 1071) in all participants, and 727 (95% CI: 633, 836) in seronegative participants. For context, prior studies of a third dose of the prototype booster induced neutralizing GMT against BA.1 of 629 (95% CI: 526, 751) and against Delta of 828 (95% CI: 738, 928)[1],[2]. A third dose of the prototype booster was shown to be effective against Delta and BA.1 infection and hospitalization in observational studies [3],[4].

"In the face of SARS-CoV-2's continued evolution, we are very encouraged that mRNA-1273.214, our lead booster candidate for the fall, has shown high neutralizing titers against the BA.4 and BA.5 subvariants, which represent an emergent threat to global public health," said Stéphane Bancel, Chief Executive Officer of Moderna. "We will submit these data to regulators urgently and are preparing to supply our next generation bivalent booster starting in August, ahead of a potential rise in SARS-CoV-2 infections due to Omicron subvariants in the early fall."

Today's data add to results shared earlier this month from the Company's ongoing Phase 2/3 study in approximately 800 participants. Previous results showed a 50 µg booster dose of mRNA-1273.214 met all pre-specified primary endpoints, including superiority in neutralizing antibody GMT against Omicron (BA.1) when compared to a 50 µg booster dose of the prototype booster (mRNA-1273). The bivalent booster was generally well tolerated, with a reactogenicity and safety profile that was consistent with the prototype booster. Moderna believes these data collectively support updating the composition of the Company's booster to bivalent (Omicron) mRNA-1273.214 for the fall.

The Company has already shared these data with regulators and is submitting a manuscript for peer reviewed publication.

About Moderna

In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.

Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding: the Company's development of a bivalent booster vaccine targeted at the Omicron variant of the SARS-CoV-2 virus (mRNA-1273.214); the ability of mRNA-1273.214 to trigger an antibody response against the Omicron subvariants BA.4 and BA.5; the Company's submission of data to regulators in support of authorization of mRNA-1273.214 as a fall booster; and the safety and tolerability profile of mRNA-1273.214. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include those other risks and uncertainties described under the heading "Risk Factors" in Moderna's most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date hereof.

Moderna Contacts

Media:
Chris Ridley
617-800-3651
Vice President, Corporate Communications & Head of Media
Chris.Ridley@modernatx.com

Investors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
617-209-5834
Lavina.Talukdar@modernatx.com

SOURCE: Moderna, Inc.