Moderna announces that the European Medicines Agency’s Committee for Medicinal Products for Human Use recommends a booster dose of Moderna’s COVID-19 vaccine in the European Union | Business
CAMBRIDGE, Mass .– (BUSINESS WIRE) – October 25, 2021–
Moderna, Inc. (Nasdaq: MRNA), a pioneering biotechnology company in messenger RNA (mRNA) therapies and vaccines, today announced that the European Agency’s Committee for Medicinal Products for Human Use (CHMP) Medicines (EMA) concluded that a booster dose of Spikevax, the COVID-19 vaccine, at the dose level of 50 µg can be considered in people 18 years of age and older at least six months after completing primary vaccination.
“This recommendation is supported by clinical evidence that a booster dose of 50 µg induces a strong immune response against COVID-19. We thank the EMA and the CHMP for their review, ”said Stéphane Bancel, CEO of Moderna. “We believe that mRNA vaccines are well placed to adapt to the epidemiological evolution of SARS-CoV-2. We are grateful for the opportunity to provide individuals in the EU with another layer of protection. “
The EMA based this positive opinion on scientific evidence shared by the company, including an analysis of data from the Phase 2 clinical study of mRNA-1273, which was modified to offer a booster dose of MRNA-1273 at the dose level of 50 µg to interested participants. 6 to 8 months after their second dose. 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, including the elderly (65 years and over). The safety profile after the booster dose was similar to that observed previously for dose 2 mRNA-1273.
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 large-scale clinical and commercial production at unprecedented speed. 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.
Spikevax ▼ (COVID-19 Vaccine Moderna) has obtained conditional marketing authorization from the European Commission for active immunization to prevent COVID-19 caused by SARS-CoV-2 in people 12 years of age and older .
IMPORTANT SAFETY INFORMATION
- Do not give Spikevax to people with a known history of a serious allergic reaction (eg, anaphylaxis) to any of the ingredients of Spikevax.
- Appropriate medical treatment to manage immediate allergic reactions should be immediately available in the event of an acute anaphylactic reaction following administration of Spikevax. Monitor recipients of Spikevax for the occurrence 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 Spikevax.
- Spikevax may not protect all people who are vaccinated.
- Adverse reactions reported in clinical trials after administration of Spikevax include pain at the injection site, fatigue, headache, myalgia, arthralgia, chills, nausea / vomiting, axillary swelling / tenderness, fever, swelling at the injection site. injection and erythema at the injection site, and rash.
- Cases of anaphylaxis and other severe allergic reactions, myocarditis, pericarditis and syncope have been reported following the administration of Spikevax during mass vaccination outside of clinical trials.
- There are insufficient data available on Spikevax given to pregnant women to inform about the risks associated with the vaccine during pregnancy. No data are available to assess the effects of Spikevax on the breast-fed infant or on milk production / excretion.
- Additional side effects, some of which can be serious, may become apparent with more widespread use of Spikevax.
- The black equilateral triangle indicates that additional monitoring is needed to capture any adverse reactions. This will allow rapid identification of new security information. Individuals can help by reporting any side effects they may be experiencing. Side effects can be reported to EudraVigilance ( https://www.adrreports.eu/ ) or directly to Moderna using the email [email protected]
For full information on the safety of Spikevax, please always refer to the approved summary of product characteristics and the package leaflet available in all European Union languages on the EMA website.
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); approval of mRNA-1273 for use as a booster dose by the European Medicines Agency; the ability of mRNA-1273 boosters at a dose of 50 µg to trigger an immune response, and the safety profile of these boosters. 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 because they involve risks, uncertainties and other known and unknown 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 the other risks and uncertainties described under the heading “Risk Factors” in Moderna’s most recent annual report on Form 10-K filed with the State Securities and Exchange Commission (SEC). United and in subsequent filings 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 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.
Director, Corporate Communications
Senior Vice President and Head of Investor Relations
KEYWORD: EUROPE UNITED STATES NORTH AMERICA MASSACHUSETTS
INDUSTRY KEYWORD: BIOTECHNOLOGY INFECTIOUS DISEASES PHARMACEUTICAL HEALTH CLINICAL TRIALS
Copyright Business Wire 2021.
PUB: 25/10/2021 16:52 / DISC: 25/10/2021 16:52
Copyright Business Wire 2021.