Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending marketing authorization for Moderna’s COVID-19 vaccine (Spikevax) to include adolescents 12 years of age and older. Spikevax is the trade name authorized by the European Medicines Agency (EMA) for the Moderna COVID-19 vaccine.
“The CHMP recommendation of the authorization of our COVID-19 vaccine for use in individuals 12 years of age and older in the European Union is a positive step forward toward authorization of our vaccine in this age group,” said Stéphane Bancel, Chief Executive Officer of Moderna. “As we help to combat the pandemic, we hope to be able to help get adolescents safely back to school this fall.”
Following the CHMP’s positive opinion, the European Commission will consider authorizing the use of the Moderna COVID-19 Vaccine in adolescents ages 12 years of age and older.
On June 10, Moderna announced data from the ongoing Phase 2/3 study, which enrolled 3,732 participants ages 12 to less than 18 years in the U.S. The study met its primary endpoint, successfully bridging immune responses to those observed in the COVE efficacy study in adults. After two doses of the Moderna COVID-19 vaccine, no cases of COVID-19 were observed in the vaccine group using the case definition from the adult Phase 3 COVE study, compared to four cases in the placebo group, resulting in a vaccine efficacy of 100% starting 14 days after the second dose using the U.S. Centers for Disease Control and Prevention’s (CDC) primary definition of COVID-19 infection. The Moderna COVID-19 vaccine was generally well tolerated with a safety and tolerability profile consistent with the Phase 3 COVE study in adults. The majority of adverse events were mild or moderate in severity. The most common solicited local adverse event was injection site pain. The most common solicited systemic adverse events after the second dose of mRNA-1273 were headache, fatigue, myalgia and chills.
Safety data continue to accrue, and the study continues to be monitored by an independent safety monitoring committee. All participants will be monitored for 12 months after their second injection to assess long-term efficacy and safety. The Company will revise the age range to capture adolescent data in its ongoing and planned post-authorization studies. Moderna has submitted data from the Phase 2/3 study to a peer-reviewed publication. These data have also been submitted to health authorities around the world and the Company expects authorizations for adolescents in the coming weeks.
Moderna is also conducting a Phase 2/3 study, called the KidCOVE study, of mRNA-1273 in children ages 6 months to less than 12 years.
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). Moderna has filed for emergency (or other conditional, interim or provisional) authorization for use of its COVID-19 vaccine in adolescents with global health agencies.
Spikevax (COVID-19 Vaccine Moderna) has been granted conditional marketing authorisation by the European Commission for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older.
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. Today, 24 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.
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 to protect against the SARS-CoV-2 virus (mRNA-1273, also referred to as the Moderna COVID-19 Vaccine or Spikevax), the potential for the Moderna COVID-19 Vaccine to prevent COVID-19 disease in adolescents; the safety profile for the Moderna COVID-19 Vaccine in adolescents; and the potential for additional authorizations for the administration of the Moderna COVID-19 Vaccine to adolescents by the European Medicines Agency and other regulatory authorities and the timing for those authorizations. 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.