Moderna Announces FDA Authorization of Booster Dose of COVID-19 Vaccine in the U.S. for Adults 18 Years and Older

Rhea-AI Summary

Moderna (MRNA) announced the FDA has extended emergency use authorization for its COVID-19 vaccine booster at a 50 µg dose for all adults aged 18 and older. This decision allows the booster to be administered to individuals who completed primary vaccination with any approved COVID-19 vaccine. The authorization is seen as critical due to rising COVID-19 cases. The FDA's decision was based on data from a Phase 2 study indicating a significant immune response from the booster dose. The CDC will meet to discuss rollout recommendations.

Positive

• FDA extended EUA for 50 µg booster for all adults 18+.
• Booster shown to significantly enhance immune response based on Phase 2 study data.

Negative

• None.

Authorization includes the use of Moderna’s booster dose following primary vaccination with other authorized or approved COVID-19 vaccines

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Moderna, Inc. (Nasdaq:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the U.S. Food and Drug Administration (FDA) has extended the emergency use authorization of a booster dose of the Moderna COVID-19 vaccine at the 50 µg dose level to all adults aged 18 and older. This booster can be used in all individuals 18 years and older who have completed a primary vaccination with any other authorized or approved COVID-19 vaccine.

“This emergency use authorization comes at a critical time as we enter the winter months and face increasing COVID-19 case counts and hospitalizations across the country,” said Stéphane Bancel, Chief Executive Officer of Moderna. “We thank the FDA for their review, and are confident in the robust clinical evidence that a 50 µg booster dose of mRNA-1273 induces a strong immune response against COVID-19.”

The booster dose is to be administered at least six months after completion of any primary series COVID-19 vaccination. On October 20th, the FDA authorized for emergency use a booster dose of the Moderna COVID-19 vaccine at the 50 µg dose level for people aged 65 and older as well as adults aged 18 to 64 who are at high risk of severe COVID-19; and people aged 18 to 64 with frequent institutional or occupational exposure to SARS-CoV-2. The Moderna COVID-19 booster vaccine is authorized for adults ages 18 and above regardless of occupational risk factors in many international markets. This follows the earlier approval of the 100 µg mRNA 1273 third dose in immunocompromised individuals.

The FDA based this EUA on the totality of scientific evidence shared by the company including a data analysis from the Phase 2 clinical study of mRNA-1273, which was amended to offer a booster dose of mRNA-1273 at the 50 µg dose level to interested participants 6-8 months following their second dose (n=344). Neutralizing antibody titers had waned prior to boosting, particularly against variants of concern, at approximately 6 months. Notably, a booster dose of mRNA-1273 at the 50 µg dose level boosted neutralizing titers significantly above the Phase 3 benchmark. The safety profile following the booster dose was similar to that observed previously for dose 2 of mRNA-1273.

As a next step, the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) will meet to discuss a potential recommendation for rollout of COVID-19 boosters to Americans.

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 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.

AUTHORIZED USE IN THE US

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

• Do not administer the Moderna COVID-19 Vaccine to individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any component of the Moderna COVID-19 Vaccine.
• Appropriate medical treatment to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of the Moderna COVID-19 Vaccine. Monitor the Moderna COVID-19 Vaccine recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention guidelines (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html).
• Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days following the second dose.
• Syncope (fainting) may occur in association with administration of injectable vaccines. Procedures should be in place to avoid injury from fainting.
• Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished response to the Moderna COVID-19 Vaccine
• The Moderna COVID-19 Vaccine may not protect all vaccine recipients.
• Adverse reactions reported in clinical trials following administration of the Moderna COVID-19 Vaccine include pain at the injection site, fatigue, headache, myalgia, arthralgia, chills, nausea/vomiting, axillary swelling/tenderness, fever, swelling at the injection site, and erythema at the injection site, and rash.
• Anaphylaxis and other severe allergic reactions, myocarditis, pericarditis, and syncope have been reported following administration of the Moderna COVID-19 Vaccine during mass vaccination outside of clinical trials.
• Available data on the Moderna COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. Data are not available to assess the effects of the Moderna COVID-19 Vaccine on the breastfed infant or on milk production/excretion.
• Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Moderna COVID-19 Vaccine.
• Vaccination providers must complete and submit reports to VAERS online at https://vaers.hhs.gov/reportevent.html. For further assistance with reporting to VAERS, call 1-800-822-7967. The reports should include the words “Moderna COVID-19 Vaccine EUA” in the description section of the report.

Click for Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Full EUA Prescribing Information for more 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 a vaccine against COVID-19 (mRNA-1273); the authorization of mRNA-1273 for use as a booster dose by the U.S. FDA; the ability of mRNA-1273 booster at the 50 µg dose to trigger an immune response, and the safety profile for that booster. 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20211119005436/en/

Moderna Contacts

Media:

Colleen Hussey

Director, Corporate Communications

617-335-1374

Colleen.Hussey@modernatx.com



Investors:

Lavina Talukdar

Senior Vice President & Head of Investor Relations

617-209-5834

Lavina.Talukdar@modernatx.com

Source: Moderna, Inc.

FAQ

What recent authorization did the FDA provide regarding Moderna's vaccine (MRNA)?

The FDA extended emergency use authorization for Moderna's COVID-19 vaccine booster at a 50 µg dose for all adults aged 18 and older.

When was the booster dose authorized for use by the FDA?

The booster dose was authorized by the FDA on October 20th.

What age group can receive the Moderna COVID-19 booster?

The Moderna COVID-19 booster is authorized for adults aged 18 and older.

How does the booster dose enhance immune response?

Data from a Phase 2 clinical study indicated that the booster significantly boosts neutralizing antibody titers.

What steps will follow the FDA's authorization for the Moderna booster?

The CDC's Advisory Committee on Immunization Practices will discuss potential recommendations for the rollout.