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Moderna Announces New Study Showing Its COVID-19 Vaccine Maintains Antibodies Against Variants of Concern and Interest to 6 Months

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Aug. 12, 2021-- Moderna, Inc. (Nasdaq:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced the publication of new data on the durability of the Moderna COVID-19 vaccine in generating neutralizing antibodies against variants of concern. The manuscript was published in Science. According to the paper, the majority of individuals vaccinated with the Moderna COVID-19 vaccine maintained both binding and functional antibodies against SARS-CoV-2 variants for six months after the second dose.

“We are pleased with these new data showing that people vaccinated with two doses of the Moderna COVID-19 vaccine maintained antibodies through six months, including against variants of concern such as the Delta variant. Along with our partners, we are committed to generating data on the Moderna COVID-19 vaccine and sharing this as available,” said Stéphane Bancel, Chief Executive Officer of Moderna. “These data support the durable efficacy of 93% seen with the Moderna COVID-19 vaccine through six months. We expect that these data and the growing body of real-world evidence will help inform health regulators’ approaches to how and when to administer additional boosting doses.”

This study used a variety of assays and showed that after two doses of the Moderna COVID-19 vaccine, binding and neutralizing antibodies were generated against ancestral strain of the virus and against the variants of concern, Alpha, Beta, Gamma, Delta, Epsilon and Iota. While some waning in antibody levels was observed over time, the majority of participants had detectable neutralizing antibody titers at six months after the completion of the primary series.

A trend towards lower antibody levels against SARS-CoV-2 spike variants was observed in the oldest individuals at Day 209 (through six months). Differences were small, however, and there was overlap between age groups. Importantly, many individuals in the oldest group retained neutralizing activity against the variants six months after the second vaccine dose.

These data complement other recent observations based on real world evidence demonstrating robust longevity of clinical efficacy of the Moderna COVID-19 vaccine1, effectiveness in the face of rising levels of the Delta variant of concern2 and in those harder to treat populations such as those people in long term care facilities3, or those patients living with cancer4.

About the Moderna COVID-19 Vaccine

The Moderna COVID-19 Vaccine is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein. On December 18, 2020, the U.S. FDA authorized the emergency use of the Moderna COVID-19 Vaccine in individuals 18 years of age or older. Moderna has received emergency (or other conditional, interim or provisional) authorization for use of its COVID-19 vaccine in adults from health agencies in more than 50 countries and an Emergency Use Listing (EUL) from the World Health Organization (WHO).

The Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS) is supporting the continued research and development of the Company’s COVID-19 vaccine development efforts with federal funding under contract no. 75A50120C00034. BARDA is reimbursing Moderna for 100 percent of the allowable costs incurred by the Company for conducting the program described in the BARDA contract. The U.S. government has agreed to purchase supply of mRNA-1273 under U.S. Department of Defense contract no. W911QY-20-C-0100.

About Moderna

In 10 years since its inception, Moderna has transformed from a science 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 six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. 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 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 autoimmune diseases. Today, 23 development programs are underway across these therapeutic areas, with 15 programs having entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit www.modernatx.com.

AUTHORIZED USE IN THE U.S.

Moderna COVID-19 Vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older.

IMPORTANT SAFETY INFORMATION

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 the Moderna COVID-19 Vaccine (mRNA-1273); the ability of the Moderna COVID-19 Vaccine to provide protection against COVID-19 for up to six months and to trigger an antibody response against variants of concern; and the potential for the authorization of booster doses by regulatory authorities. 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.

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1 https://www.medrxiv.org/content/10.1101/2021.08.06.21261707v1
2 https://www.medrxiv.org/content/10.1101/2021.08.11.21261885v1
3 https://www.medrxiv.org/content/10.1101/2021.08.06.21261721v1
4 https://www.nature.com/articles/s41375-021-01354-7

Source: Moderna, Inc.

Posted: August 2021

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