Moderna

Moderna and Tabuk Pharmaceuticals Partner to Commercialize Moderna’s COVID-19 Vaccine in Saudi Arabia

Friday, June 11, 2021 - 1:30pm

Under the terms of this agreement, Tabuk Pharmaceuticals will hold the marketing authorization for the Moderna COVID-19 vaccine in Saudi Arabia.

Key Points: 
  • Under the terms of this agreement, Tabuk Pharmaceuticals will hold the marketing authorization for the Moderna COVID-19 vaccine in Saudi Arabia.
  • We appreciate the collaboration of Tabuk Pharmaceuticals in this new partnership in Saudi Arabia, said Stphane Bancel, Chief Executive Officer of Moderna.
  • We welcome the opportunity to work with Tabuk Pharmaceuticals to bring the Moderna COVID-19 and potentially other Moderna mRNA products to Saudi Arabia in the future, said Corinne Le Goff, Pharm.D., M.B.A., Chief Commercial Officer of Moderna.
  • Established in Saudi Arabia in 1994, Tabuk Pharmaceuticals is a leading regional pharmaceutical in the Middle East and North Africa (MENA).

Moderna Files for Emergency Use Authorization for its COVID-19 Vaccine in Adolescents in the United States

Thursday, June 10, 2021 - 1:00pm

We are pleased to announce that we have submitted for an emergency use authorization for our COVID-19 vaccine with the FDA for use in adolescents in the United States, said Stphane Bancel, Chief Executive Officer of Moderna.

Key Points: 
  • We are pleased to announce that we have submitted for an emergency use authorization for our COVID-19 vaccine with the FDA for use in adolescents in the United States, said Stphane Bancel, Chief Executive Officer of Moderna.
  • We are encouraged that the Moderna COVID-19 vaccine was highly effective at preventing COVID-19 and SARS-CoV-2 infection in adolescents.
  • 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.
  • Individuals who have received one dose of Moderna COVID-19 Vaccine should receive a second dose of Moderna COVID-19 Vaccine to complete the vaccination series.

Moderna and Medison Pharma Partner to Commercialize Moderna’s COVID-19 Vaccine Across Central Eastern Europe and Israel

Monday, June 7, 2021 - 1:00pm

Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines and Medison Pharma, a leading commercial partner for highly innovative therapies in international markets, today announced a new agreement to commercialize the Moderna COVID-19 Vaccine across Central Eastern Europe and Israel.

Key Points: 
  • Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines and Medison Pharma, a leading commercial partner for highly innovative therapies in international markets, today announced a new agreement to commercialize the Moderna COVID-19 Vaccine across Central Eastern Europe and Israel.
  • "We are excited to partner with Moderna in 20 markets, covering over 175 million lives across the entire Central Eastern Europe region and in Israel, said Meir Jakobsohn, Founder and CEO of Medison Pharma.
  • We appreciate this new partnership with Medison Pharma to ensure successful delivery of our mRNA COVID-19 vaccine to market, said Corinne Le Goff, Pharm.D., M.B.A., Chief Commercial Officer of Moderna.
  • This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding an agreement between Moderna and Medison Pharma to commercialize the Moderna COVID-19 Vaccine (known as COVID-19 Vaccine Moderna outside the U.S.) in Central Eastern Europe and Israel.

Moderna and Medison Pharma partner to commercialize Moderna's COVID-19 vaccine across Central Eastern Europe and Israel

Monday, June 7, 2021 - 1:00pm

and ZUG, Switzerland, June 7, 2021 /PRNewswire/ -- Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines and Medison Pharma, a leading commercial partner for highly innovative therapies in international markets, today announced a new agreement to commercialize the Moderna COVID-19 Vaccineacross Central Eastern Europe and Israel.

Key Points: 
  • and ZUG, Switzerland, June 7, 2021 /PRNewswire/ -- Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines and Medison Pharma, a leading commercial partner for highly innovative therapies in international markets, today announced a new agreement to commercialize the Moderna COVID-19 Vaccineacross Central Eastern Europe and Israel.
  • "We are excited to partner with Moderna in 20 markets, covering over 175 million lives across the entire Central Eastern Europe region and in Israel," said Meir Jakobsohn, Founder and CEO of Medison Pharma.
  • "Moderna's breakthrough mRNA vaccine and Medison's international commercialization platform for highly innovative treatments, makes our partnership a natural fit."
  • This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding an agreement between Moderna and Medison Pharma to commercialize the Moderna COVID-19 Vaccine (known as COVID-19 Vaccine Moderna outside the U.S.) in Central Eastern Europe and Israel.

Moderna Files for Authorization with Health Canada for its COVID-19 Vaccine in Adolescents

Monday, June 7, 2021 - 12:49pm

Moderna, Inc. , (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it has submitted for authorization of its COVID-19 vaccine in adolescents with Health Canada.

Key Points: 
  • Moderna, Inc. , (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it has submitted for authorization of its COVID-19 vaccine in adolescents with Health Canada.
  • We are pleased to announce that we have submitted for authorization of our COVID-19 vaccine for use in adolescents with Health Canada, said Stphane Bancel, Chief Executive Officer of Moderna.
  • We are encouraged that the Moderna COVID-19 vaccine was highly effective at preventing COVID-19 and SARS-CoV-2 infection in adolescents.
  • The vaccine efficacy in the nearly 2,500 adolescents who received the Moderna COVID-19 vaccine was observed to be 100% when using the same case definition as in the Phase 3 COVE study in adults.

Moderna Files for Conditional Marketing Approval for its COVID-19 Vaccine in Adolescents in the European Union

Monday, June 7, 2021 - 12:40pm

We are pleased to announce that we have submitted for conditional marketing approval of our COVID-19 vaccine with the European Medicines Agency for use in adolescents in the European Union, said Stphane Bancel, Chief Executive Officer of Moderna.

Key Points: 
  • We are pleased to announce that we have submitted for conditional marketing approval of our COVID-19 vaccine with the European Medicines Agency for use in adolescents in the European Union, said Stphane Bancel, Chief Executive Officer of Moderna.
  • We are encouraged that the Moderna COVID-19 vaccine was highly effective at preventing COVID-19 and SARS-CoV-2 infection in adolescents.
  • In the study, no cases of COVID-19 were observed in participants who had received two doses of the Moderna COVID-19 vaccine using the primary definition.
  • The vaccine efficacy in the nearly 2,500 adolescents who received the Moderna COVID-19 vaccine was observed to be 100% when using the same case definition as in the Phase 3 COVE study in adults.

Moderna Announces Agreement to Supply the Republic of Botswana with its COVID-19 Vaccine

Thursday, June 3, 2021 - 2:21pm

The Company also announced that the Botswana Medicines Regulatory Authority (BMRA) has issued an emergency use authorization for the COVID-19 Vaccine Moderna.

Key Points: 
  • The Company also announced that the Botswana Medicines Regulatory Authority (BMRA) has issued an emergency use authorization for the COVID-19 Vaccine Moderna.
  • We appreciate the collaboration with the Government of the Republic of Botswana for this supply agreement and with the Botswana Medicines Regulatory Authority for this EUA, said Stphane Bancel, Modernas Chief Executive Officer.
  • This agreement with Botswana is separate from the supply agreement with Gavi, the Vaccine Alliance, which Moderna announced in May.
  • The COVID-19 Vaccine Moderna has been granted emergency use authorization by the Botswana Medicines Regulatory Authority for use in adults aged 18 years and older.

UNICEF and Moderna Announce Long Term Agreement to Supply Vaccine on Behalf of the COVAX Facility

Wednesday, June 2, 2021 - 12:08pm

We are proud and humbled to be able to supply our vaccine through this long-term agreement with UNICEF in support of efforts to end this pandemic, said Stphane Bancel, Chief Executive Officer of Moderna.

Key Points: 
  • We are proud and humbled to be able to supply our vaccine through this long-term agreement with UNICEF in support of efforts to end this pandemic, said Stphane Bancel, Chief Executive Officer of Moderna.
  • We share in the mission of the COVAX Facility to ensure global access to vaccines including in low- and middle-income countries around the world.
  • The COVID-19 Vaccine Moderna (referred to in the U.S. as the Moderna COVID-19 Vaccine) is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein, which was co-developed by Moderna and investigators from the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center.
  • On May 12, the U.S Food and Drug Administration granted the Moderna COVID-19 Vaccine Fast Track designation.

Moderna Announces Agreement with Thermo Fisher Scientific for Fill/Finish Manufacturing of Moderna’s COVID-19 Vaccine

Tuesday, June 1, 2021 - 9:01pm

Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it has entered into an agreement with Thermo Fisher Scientific (NYSE: TMO) for fill/finish sterile manufacturing services and supply packaging for Modernas COVID-19 vaccine.

Key Points: 
  • Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it has entered into an agreement with Thermo Fisher Scientific (NYSE: TMO) for fill/finish sterile manufacturing services and supply packaging for Modernas COVID-19 vaccine.
  • Under the terms of the agreement, Thermo Fishers commercial manufacturing site in Greenville, North Carolina will be used for aseptic fill/finish, labeling and packaging to support the production of hundreds of millions of doses of the Moderna COVID-19 vaccine.
  • Thermo Fisher has been a critical partner in supplying raw materials for our COVID-19 vaccine and we are now pleased to further expand our relationship as an important manufacturing partner as well, said Juan Andres, Modernas Chief Technical Operations and Quality Officer.
  • The addition of Thermo Fisher to our network will support our efforts to scale up our manufacturing ability.

Moderna Announces Initiation of Rolling Submission of Biologics License Application (BLA) with U.S. FDA for the Moderna COVID-19 Vaccine

Tuesday, June 1, 2021 - 12:30pm

Once the rolling BLA submission is complete, FDA will notify the Company when it is formally accepted for review.

Key Points: 
  • Once the rolling BLA submission is complete, FDA will notify the Company when it is formally accepted for review.
  • On May 12, 2020, the U.S. FDA granted the Moderna COVID-19 Vaccine Fast Track designation.
  • 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.
  • Individuals who have received one dose of Moderna COVID-19 Vaccine should receive a second dose of Moderna COVID-19 Vaccine to complete the vaccination series.