Moderna Announces FDA Advisory Board Votes Unanimously for Emergency Use of Moderna’s COVID-19 Vaccine Booster Dose in the United States | 2021-10-14 | Press Releases

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Unanimous positive vote for the recall of mRNA-1273 at the dose level of 50 µg for people aged 65 and over as well as those aged 18 to 64 at high risk of contracting COVID-19 at least 6 months after the end of the primary series

Company estimates that a booster at the 50 µg dose level could result in up to 1 billion additional doses

Moderna, Inc. (Nasdaq: MRNA), a pioneering biotechnology company in messenger RNA (mRNA) therapies and vaccines, today confirmed that the Vaccines and Related Biologics Advisory Board (VRBPAC) of The United States Food and Drug Administration (FDA) has recommended that the FDA grant an Emergency Notice of Authorization for Use (EUA) for a booster dose of Moderna COVID-19 vaccine (mRNA-1273) at the dose level 50 µg for people aged 65 and over; people aged 18 to 64 who are at high risk of severe COVID-19; and people aged 18 to 64 whose exposure to COVID-19 puts them at risk of complications from COVID-19 or serious illness. The positive vote was unanimous with 19 VRBPAC members recommending the EUA. The booster dose should be given at least six months after the end of the primary vaccination course.

“We are grateful for the opportunity to present the clinical data set for our COVID-19 booster vaccine to the FDA advisory committee today.” We thank the committee for its review and for its positive recommendation in support of the emergency use authorization. This positive recommendation is supported by data on the 50 µg booster dose of our COVID-19 vaccine, which shows strong antibody responses against the original virus, but also against the Delta variant, ”said Stéphane Bancel, Managing Director of Moderna. “We remain committed to staying one step ahead of the virus and to monitoring the evolving epidemiology of SARS-CoV-2. We look forward to making our booster available to people in the United States to help protect themselves against this ongoing public health emergency. ”

VRBPAC based its recommendation on the body of scientific evidence, including an analysis of data from the Phase 2 clinical study of mRNA-1273, which was modified to provide a booster dose of mRNA-1273 at the 50 µg dose level to interested participants 6-8 months after their second dose (n = 344). Neutralizing antibody titers had decreased prior to the booster, particularly against the variants of concern, to approximately 6 months. Notably, a booster dose of mRNA-1273 at the dose level of 50 µg increased the neutralizing titers significantly above the phase 3 baseline. After a booster dose, a similar level of neutralizing titers was achieved. in all age groups, especially the elderly (65 years and over). The safety profile after the booster dose was similar to that observed previously for dose 2 mRNA-1273.

Moderna estimates that the positive vote for mRNA-1273 at the 50 µg dose level and subsequent approval could result in up to 1 billion additional doses available for distribution in 2022.

FDA advisory committees provide non-binding recommendations. The FDA will take VRBPAC’s recommendation into consideration when making a final clearance decision. Under an EUA, the FDA has the authority to authorize the use of unapproved medical products or unapproved uses of approved medical products in an emergency to diagnose, treat or prevent serious illnesses or conditions. or potentially fatal in a declared public health emergency when there are no adequate, approved and available alternatives. Next, the U.S. Centers for Disease Control and Prevention’s (CDC) Immunization Practices Advisory Committee (ACIP) will meet to discuss their recommendations regarding the use of COVID-19 boosters.

Separately, on August 13, Moderna announced that the US FDA had approved an update to the emergency use authorization for the Moderna COVID-19 vaccine to include a third dose at the 100 µg dose level. for immunocompromised persons 18 years of age or older in the United States. Conditions that have undergone a solid organ transplant, or that are diagnosed with conditions that are considered to have an equivalent level of immunosuppression.

About Moderna

In the 10 years since its inception, Moderna has grown from a company in the scientific research stage advancing programs in the field of messenger RNA (mRNA), to a company with a diverse clinical portfolio of vaccines and therapeutic products. through six modalities, a broad portfolio of intellectual property in areas such as the formulation of mRNA and lipid nanoparticles, and an integrated manufacturing facility that enables both clinical and commercial production on a large scale and at low speed. previous. Moderna maintains alliances with a wide range of domestic and foreign government and business collaborators, which has allowed the pursuit of both groundbreaking science and rapid scale-up of manufacturing. More recently, Moderna’s capabilities have come together to enable the licensed use of one of the oldest and most effective vaccines against the COVID-19 pandemic.

Moderna’s mRNA platform builds on continuous advancements in basic and applied mRNA science, delivery technology and manufacturing, and has enabled the development of therapies and vaccines for them. infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna was named one of the top biopharmaceutical employers by Science for six years. To learn more, visit www.modernatx.com.

USAGE PERMITTED IN THE UNITED STATES

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

IMPORTANT SAFETY INFORMATION

  • Do not administer the Moderna COVID-19 vaccine to people with a known history of a serious allergic reaction (for example, anaphylaxis) to any component of the Moderna COVID-19 vaccine.
  • Appropriate medical treatment to manage immediate allergic reactions should be immediately available in the event of an acute anaphylactic reaction following administration of Moderna COVID-19 vaccine. Monitor Moderna COVID-19 vaccine recipients for the onset of immediate adverse reactions as directed by the Centers for Disease Control and Prevention (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html).
  • Post-marketing data demonstrate an increased risk of myocarditis and pericarditis, particularly within 7 days of the second dose.
  • Syncope (fainting) may occur in association with the administration of injectable vaccines. Procedures must be in place to prevent injury from fainting.
  • People who are immunocompromised, including people receiving immunosuppressive therapy, may have a decreased response to the Moderna COVID-19 vaccine.
  • The Moderna COVID-19 vaccine may not protect all vaccinees.
  • Adverse reactions reported in clinical trials after administration of Moderna COVID-19 vaccine include pain at the injection site, fatigue, headache, myalgia, arthralgia, chills, nausea / vomiting, axillary swelling / tenderness, fever, injection site swelling and injection site erythema.
  • The following adverse reactions have been reported following administration of Moderna COVID-19 vaccine during mass vaccination outside of clinical trials:
    • Serious allergic reactions, including anaphylaxis
    • Myocarditis and pericarditis
    • Syncope
  • There is insufficient data available on the Moderna COVID-19 vaccine given to pregnant women to inform the risks associated with the vaccine during pregnancy. Data are not available to assess the effects of Moderna COVID-19 vaccine on the breastfed infant or on milk production / excretion.
  • There is no data available on the interchangeability of Moderna COVID-19 vaccine with other COVID-19 vaccines to complete the vaccination series. People who have received a dose of the Moderna COVID-19 vaccine should receive a second dose of the Moderna COVID-19 vaccine to complete the vaccination series.
  • Additional side effects, some of which can be serious, may become apparent with more widespread use of the Moderna COVID-19 vaccine.
  • Immunization providers should complete and submit reports to VAERS online at https://vaers.hhs.gov/reportevent.html. For help with reporting to VAERS, call 1-800-822-7967. Reports should include the words “Moderna COVID-19 Vaccine EUA & CloseCurlyDoubleQuote; in the description section of the report.

Click to Factsheet for healthcare providers administering the vaccine (vaccination providers) and full prescribing information from the EUA 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, in particular concerning: the development by the company of a vaccine against COVID-19 (mRNA-1273); the potential for FDA approval of the 50 µg dose level boosters for mRNA-1273, and the impact on the Company’s vaccine production capacity for 2022; the possibility that booster doses of 50 µg elicit an antibody response in different age groups; and the safety profile of the 50 µg booster doses of 1273 mRNA. The forward-looking statements contained in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements as 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 such forward-looking statements. These risks, uncertainties and other factors include the other risks and uncertainties described under the heading “Risk Factors & CloseCurlyDoubleQuote; in Moderna’s most recent annual report ‘on Form 10-K filed with the United States Securities and Exchange Commission (SEC) and in subsequent filings by Moderna with the SEC, which are available on the website SEC Web ‘ www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility to update or revise 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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