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CAMBRIDGE, Massachusetts – (BUSINESS WIRE) – Moderna, Inc. (Nasdaq: MRNA), a biotech company pioneering messenger RNA (mRNA) therapies and vaccines, announced today that, based on the stability data presented, the U.S. Food and Drug Administration . (FDA) has cleared Moderna’s COVID. 19 The vaccine should be kept at room temperature after removal from the refrigerator for administration for 24 hours, an increase from the previous 12 hours. Additionally, a perforated vial can now be used for up to 12 hours, an increase from the previous 6 hours. These new guidelines are reflected in an updated Emergency Use Authorization (EUA) label. Modern COVID-19 vaccine is ready to use and does not need to be diluted.
The FDA also authorized the inclusion of a new vial presentation with a maximum of 15 doses of its COVID-19 vaccine. In parallel, the FDA also authorized a maximum of 11 doses of its COVID-19 vaccine in the current format, out of the 10 doses per vial previously authorized. Modern COVID-19 vaccine can now be delivered in two-vial presentations (a multi-dose vial containing a maximum of 11 doses or a multi-dose vial containing a maximum of 15 doses). The Company expects the 15-dose vials to begin shipping in the coming weeks.
“We are committed to constantly learning and improving to facilitate the administration of our COVID-19 vaccine for medical personnel and accelerate immunization programs. Thank you to the US FDA and CDC for their continued collaboration, ”said Stéphane Bancel, Moderna CEO. “We remain focused on doing everything we can to help end the COVID-19 pandemic with a vaccine.”
Moderna is continually learning, adapting, and working closely with its partners and the US government to identify ways to facilitate accelerated vaccine delivery, address bottlenecks, and accelerate production. An identified limitation in the production process has been the capacity of the filling and finishing process. Moderna studied the possibility of adding more doses to each vaccine vial to address bottlenecks, speed production and reduce the need for consumable materials that are in high demand. Moderna will continue to collaborate with its manufacturing partners and the federal government to increase the efficiency of its production process without compromising quality or safety.
About the Modern COVID-19 vaccine
Moderna COVID-19 vaccine is an mRNA vaccine against COVID-19 encoding a prefusion-stabilized form of the Spike (S) protein, which was jointly developed by Moderna and researchers at the National Institute of Allergy and Infectious Diseases (NIAID). Vaccine Research Center. The first clinical batch, which was funded by the Coalition for Epidemic Preparedness Innovations, was completed on February 7, 2020 and underwent analytical testing; was submitted to the National Institutes of Health (NIH) on February 24, 2020, 42 days from the sequence selection. The first participant in the NIAID-led phase 1 study of the Modern COVID-19 vaccine received the dose on March 16, 2020, 63 days from sequence selection to phase 1 study dosing. May 2020, the US FDA awarded Modern COVID-19 Vaccine Fast Track designation. On May 29, 2020, the first participants in each age cohort were dosed in the phase 2 vaccine study. On July 8, 2020, the Phase 2 study completed enrollment.
The results of the second interim analysis of the NIH-led Phase 1 study of the Modern COVID-19 vaccine in the age groups 56-70 and 71+ were published on September 29, 2020 in The New England Journal of Medicine. On November 30, 2020, Moderna announced the main efficacy analysis of the phase 3 study of the vaccine in 196 cases. On November 30, 2020, the company also announced that it applied for an Emergency Use Authorization with the US FDA and a Conditional Marketing Authorization (CMA) application with the European Medicines Agency. On December 18, 2020, the US FDA authorized the emergency use of the Modern COVID-19 vaccine in people 18 years of age and older. Moderna has also received clearance for its COVID-19 vaccine from health agencies in Canada, Israel, the European Union, the United Kingdom, Switzerland, Singapore, and Qatar. Additional authorizations are currently being reviewed in other countries and by the World Health Organization.
The Advanced Biomedical 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 ongoing research and development of the Company’s COVID. 19 federally funded vaccine development efforts under contract no. 75A50120C00034. BARDA is reimbursing Moderna 100 percent of the allowable costs incurred by the Company to carry out the program described in the BARDA contract. The US government agreed to purchase the supply of mRNA-1273 under US Department of Defense contract No. W911QY-20-C-0100.
AUTHORIZED USE
Modern COVID-19 vaccine is licensed for use under an Emergency Use Authorization (USA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV). -2) in 18-year-olds. age and older.
IMPORTANT SAFETY INFORMATION
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Do not give Moderna COVID-19 vaccine to people with a known history of severe allergic reaction (for example, anaphylaxis) to any component of Moderna COVID-19 vaccine.
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Appropriate medical treatment to control immediate allergic reactions should be available immediately in the event of an acute anaphylactic reaction after administration of Moderna COVID-19 vaccine. Monitor Modern COVID-19 vaccine recipients for immediate adverse reactions according to the guidelines of the Centers for Disease Control and Prevention (https://www.cdc.gov/vaccines/covid- 19 / clinical-considerations / managing-anaphylaxis.html).
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Immunosuppressed people, including people receiving immunosuppressive therapy, may have a decreased response to the Modern COVID-19 vaccine.
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The Modern COVID-19 vaccine may not protect all vaccine recipients.
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Adverse reactions reported in a clinical trial after administration of Moderna COVID-19 vaccine include injection site pain, fatigue, headache, myalgia, arthralgia, chills, nausea / vomiting, axillary swelling / tenderness, fever , swelling at the injection site, and erythema at the injection site.
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Serious allergic reactions, including anaphylaxis, have been reported after administration of Moderna COVID-19 vaccine during mass vaccination outside of clinical trials.
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The data available on the Modern COVID-19 vaccine administered to pregnant women is insufficient to inform the risks associated with the vaccine during pregnancy. No data are available to evaluate the effects of Modern COVID-19 vaccine on the breastfed infant or on milk production / excretion.
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No data is available on the interchangeability of Modern COVID-19 vaccine with other COVID-19 vaccines to complete the vaccination series. Individuals who have received one dose of Moderna COVID-19 vaccine must receive a second dose of Moderna COVID-19 vaccine to complete the vaccine series.
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Additional adverse reactions, some of which can be serious, may become apparent with the more widespread use of the Modern COVID-19 vaccine.
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Vaccination providers must complete and submit reports to VAERS online at https://vaers.hhs.gov/reportevent.html. For more help with reporting to VAERS, call 1-800-822-7967. Reports must include the words “Modern COVID-19 Vaccine USA” in the description section of the report.
Click for the Fact Sheet for Healthcare Providers Administering the 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 statements regarding: the Company’s development of a vaccine (mRNA-1273) to protect against the SARS-CoV-2 virus, which causes COVID-19; the conditions under which the vaccine can be stored and administered; the number of doses that can be included in each vial; the schedule of shipments of vials containing 15 doses; and continuous improvements in the vaccine manufacturing and shipping process. In some cases, forward-looking statements can be identified by terminology such as “will”, “may”, “should”, “could”, “expects”, “intends”, “plans”, “aims”, “anticipates,” ” “Believe”, “estimate”, “predict”, “potential”, “continue” or the negatives of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are not promises or 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 control. . which could cause actual results to differ materially from those expressed or implied in these forward-looking statements. These risks, uncertainties and other factors include, but are not limited to: the fact that there has never been a commercial product using mRNA technology approved for use; the fact that the rapid response technology used by Moderna is still being developed and implemented; the safety, tolerability, and efficacy profile of Modern COVID-19 vaccine observed to date may change adversely in ongoing analyzes of trial data or post-marketing; Modern COVID-19 Vaccine may be less effective against variants of the SARS-CoV-2 virus, or the Company may not be successful in developing future versions of its vaccine against these variants; Despite having ongoing interactions with the FDA or other regulatory agencies, the FDA or other regulatory agencies may not agree with the Company’s regulatory approval strategies, the components of our submissions, such as clinical trial designs, conduct and the methodologies, or the sufficiency of the data presented; Moderna may encounter delays in meeting manufacturing or supply deadlines or disruptions in its Moderna COVID-19 vaccine distribution plans; whether and when biological product license applications and / or additional applications for emergency use authorization may be submitted in various jurisdictions and ultimately approved by regulatory authorities; Potential adverse impacts due to the global COVID-19 pandemic, such as regulatory review delays, clinical and manufacturing trials, supply chain disruptions, adverse effects on health systems, and disruption of the global economy; and 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 US Securities and Exchange Commission (SEC) and in subsequent filings made. by Moderna before the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, Moderna denies any intention or responsibility to update or revise the 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.
