RNA vaccines

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

Retrieved on: 
Thursday, June 3, 2021
Medical Supplies, Health, Infectious diseases, General Health, Pharmaceutical, Biotechnology, COVID-19 vaccines, Clinical trials, Medical research, Medicine, Health sciences, Articles, RNA vaccines, BioNTech, Moderna COVID-19 vaccine, Emergency Use Authorization, Moderna, Pfizer–BioNTech COVID-19 vaccine, the COVID-19 Vaccine Moderna, Moderna, THE COVID-19 VACCINE MODERNA, MODERNA

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.

Patients Taking Anti-Inflammatory Drugs Respond Less Well to COVID-19 Vaccine

Retrieved on: 
Wednesday, June 2, 2021
COVID-19 vaccines, Clinical trials, Medicine, RNA vaccines, Medical specialties, Health sciences, Vaccination, Virology, Vaccine, Pfizer–BioNTech COVID-19 vaccine, COVID-19 vaccine, Attenuated vaccine

Led by researchers at NYU Grossman School of Medicine, the new study looked specifically at patients' responsesto the Pfizer-BioNTech mRNA COVID-19 vaccine, which they measured by looking at the antibodies produced in each patient by the vaccine.

Key Points: 
  • Led by researchers at NYU Grossman School of Medicine, the new study looked specifically at patients' responsesto the Pfizer-BioNTech mRNA COVID-19 vaccine, which they measured by looking at the antibodies produced in each patient by the vaccine.
  • Patients with immune-mediated inflammatory disorderswho were taking methotrexate achieved an adequate response in only 62 percent of cases.
  • Similarly, while healthy patients and those with common immune disorders who were taking anti-inflammatory drugs other than methotrexate produced CD8 T cells, patients taking methotrexate did not show an increase in CD8 T cell activation after vaccination.
  • "This may not necessarily mean that the vaccine is not efficacious, but that alternate vaccine strategies need to be investigated."

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

Retrieved on: 
Wednesday, June 2, 2021
Infectious diseases, Biotechnology, Pharmaceutical, Health, COVID-19, COVID-19 vaccines, Clinical trials, Medicine, Responses to the COVID-19 pandemic, Medical research, RNA vaccines, Moderna COVID-19 vaccine, COVID-19 vaccine, COVAX, Moderna, RNA vaccine, the COVID-19 Vaccine Moderna, Moderna, THE COVID-19 VACCINE MODERNA, MODERNA

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 New Drug Substance Production Agreement with Lonza in the Netherlands

Retrieved on: 
Wednesday, June 2, 2021
Health, Infectious diseases, Genetics, Other Health, Pharmaceutical, Biotechnology, Companies, COVID-19 vaccines, Clinical trials, RNA vaccines, Life sciences, Health sciences, Moderna COVID-19 vaccine, Medical research, Catalent, Sanofi, COVID-19 vaccine, Thermo Fisher Scientific, the COVID-19 Vaccine Moderna, Moderna, THE COVID-19 VACCINE MODERNA, MODERNA

Both new drug substance lines in the European Union are expected to be operational before the end of 2021.

Key Points: 
  • Both new drug substance lines in the European Union are expected to be operational before the end of 2021.
  • This additional production will help us continue to scale up our production as we continue to develop best-in-class variant boosters so we can help end this pandemic as fast as possible.
  • In the U.S., the Company also works with Lonza Portsmouth for drug substance production, and partners with Catalent, Baxter BioPharma Solutions, Sanofi and Thermo Fisher Scientific for fill/finish services.
  • 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

Retrieved on: 
Tuesday, June 1, 2021
Packaging, Health, Infectious diseases, Manufacturing, Genetics, Pharmaceutical, Biotechnology, Medical research, COVID-19 vaccines, Clinical trials, RNA vaccines, Health sciences, Medicine, Health, Moderna COVID-19 vaccine, Pfizer–BioNTech COVID-19 vaccine, Fill and finish, Moderna, Thermo Fisher Scientific

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

Retrieved on: 
Tuesday, June 1, 2021
FDA, Health, Infectious diseases, Clinical trials, Pharmaceutical, Biotechnology, COVID-19, COVID-19 vaccines, Clinical trials, Medicine, Health sciences, Medical research, RNA vaccines, Moderna COVID-19 vaccine, COVID-19 vaccine, Moderna, Vaccine, COVID-19 vaccination in the Philippines, the Moderna COVID-19 Vaccine, Moderna, THE MODERNA COVID-19 VACCINE, MODERNA

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.

Statement from the Chief Public Health Officer of Canada on May 31, 2021

Retrieved on: 
Monday, May 31, 2021
Health, Medicine, Articles, COVID-19 vaccines, Clinical trials, RNA vaccines, Health Canada, Medical research, Vaccine adverse event, COVID-19 vaccine, Vaccination, Immunization

You can reach a quit coach at 1-866-366-3667 or online , or talk to a health care professional for assistance.

Key Points: 
  • You can reach a quit coach at 1-866-366-3667 or online , or talk to a health care professional for assistance.
  • At the same time, the Public Health Agency of Canada is providing Canadians with regular updates on COVID-19 vaccines administered , vaccination coverage and ongoing monitoring of vaccine safety across the country.
  • Due to reduced reporting over the weekend, national seven-day averages have not been updated in today's statement.
  • Working together, Health Canada , the Public Health Agency of Canada , the National Advisory Committee on Immunization , Canada's Chief Medical Officers of Health and other health professionals across the country are closely monitoring vaccine safety , effectiveness and optimal use to adapt approaches.

DGAP-News: CureVac's First-Generation COVID-19 Vaccine Candidate, CVnCoV, Continues Toward Phase 2b/3 Efficacy Readout in Variant-rich Environment Following DSMB Recommendation

Retrieved on: 
Friday, May 28, 2021
COVID-19 vaccines, Clinical trials, RNA vaccines, Medicine, Health, CureVac COVID-19 vaccine, CureVac, COVID-19 vaccine, DSMB, CVnCoV, CureVac, CVNCOV, CUREVAC

CureVac's First-Generation COVID-19 Vaccine Candidate, CVnCoV, Continues Toward Phase 2b/3 Efficacy Readout in Variant-rich Environment Following DSMB Recommendation

Key Points: 
  • CureVac's First-Generation COVID-19 Vaccine Candidate, CVnCoV, Continues Toward Phase 2b/3 Efficacy Readout in Variant-rich Environment Following DSMB Recommendation
    The issuer is solely responsible for the content of this announcement.
  • As a standard procedure within a blinded trial, CureVac has no access to trial data.
  • The trial will continue to collect sufficient data in order to conduct statistically significant efficacy analysis.
  • COVID-19 cases within the trial are currently being sequenced to provide critical complementary data to the efficacy readout.

Pfizer and BioNTech Receive First Authorization in European Union for COVID-19 Vaccine in Adolescents

Retrieved on: 
Friday, May 28, 2021
COVID-19, COVID-19 vaccines, Clinical trials, BioNTech, RNA vaccines, Health sciences, Medical research, Medicine, Pfizer–BioNTech COVID-19 vaccine, BioNTech, COVID-19 vaccine, Pfizer

This follows the European Medicines Agencys (EMA) Committee for Medicinal Products for Human Use (CHMP) positive opinion to authorize the vaccine in this age group.

Key Points: 
  • This follows the European Medicines Agencys (EMA) Committee for Medicinal Products for Human Use (CHMP) positive opinion to authorize the vaccine in this age group.
  • COMIRNATY was the first COVID-19 vaccine to receive authorization in the EU and is the first to have its CMA extended to adolescents.
  • Todays extension of our COVID-19 vaccine authorization in the European Union is another critical milestone in our collective effort to broaden vaccination programs to as many people as possible, said Ugur Sahin, M.D., CEO and Co-founder of BioNTech.
  • The Pfizer-BioNTech COVID-19 vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer.

Statement from the Chief Public Health Officer of Canada on May 27, 2021

Retrieved on: 
Thursday, May 27, 2021
Medicine, Health, COVID-19 vaccines, Clinical trials, RNA vaccines, Medical research, Vaccination, Vaccine adverse event, National Advisory Committee on Immunization, Moderna COVID-19 vaccine, COVID-19 vaccine, Immunization

Over the past weeks, we've seen Canada make huge strides in ramping up our COVID-19 vaccination rollout.

Key Points: 
  • Over the past weeks, we've seen Canada make huge strides in ramping up our COVID-19 vaccination rollout.
  • Widespread immunization is an essential component towards allowing us to get back to many of the things we have been missing.
  • At the same time, the Public Health Agency of Canada is providing Canadians with regular updates on COVID-19 vaccines administered , vaccination coverage and ongoing monitoring of vaccine safety across the country.
  • Working together, Health Canada , the Public Health Agency of Canada , the National Advisory Committee on Immunization , Canada's Chief Medical Officers of Health and other health professionals across the country are closely monitoring vaccine safety , effectiveness and optimal use to adapt approaches.