Tozinameran

Pfizer and BioNTech Reach Agreement with COVAX for Advance Purchase of Vaccine to Help Combat COVID-19

Retrieved on: 
Friday, January 22, 2021
Medical research, Health sciences, Medicine, Articles, COVID-19 vaccine, Clinical trials, BioNTech, Access to COVID-19 Tools Accelerator, Pfizer, Tozinameran

For the COVAX Advanced Market Commitment 92 countries, Pfizer and BioNTech will provide the vaccine to COVAX at a not-for-profit price

Key Points: 
  • For the COVAX Advanced Market Commitment 92 countries, Pfizer and BioNTech will provide the vaccine to COVAX at a not-for-profit price
    NEW YORK CITY, NY and MAINZ, GERMANY, January 22, 2021 (GLOBE NEWSWIRE) Pfizer and BioNTech SE today announced an advance purchase agreement with COVAX for up to 40 million doses of the Pfizer-BioNTech COVID-19 Vaccine.
  • For the COVAX Advanced Market Commitment 92 countries, Pfizer and BioNTech will provide the vaccine to COVAX at a not-for-profit price.
  • "This agreement with Pfizer and BioNTech will enable COVAX to save lives, stabilize health systems and drive the global economic recovery.
  • Pfizer and BioNTech are also committed to coordinating with international agencies to support supply and distribution in refugee and other vulnerable populations.

Pfizer and BioNTech Reach Agreement with COVAX for Advance Purchase of Vaccine to Help Combat COVID-19

Retrieved on: 
Friday, January 22, 2021
Infectious diseases, Hospitals, Clinical trials, Other Health, Biotechnology, General Health, Pharmaceutical, Health, Science, Other Science, Medical research, Health sciences, Medicine, Articles, Clinical trials, COVID-19 vaccine, BioNTech, Pfizer, Access to COVID-19 Tools Accelerator, Tozinameran, Pfizer: Breakthroughs That Change Patients’ Lives, BioNTech

Pfizer and BioNTech SE today announced an advance purchase agreement with COVAX for up to 40 million doses of the Pfizer-BioNTech COVID-19 Vaccine.

Key Points: 
  • Pfizer and BioNTech SE today announced an advance purchase agreement with COVAX for up to 40 million doses of the Pfizer-BioNTech COVID-19 Vaccine.
  • For the COVAX Advanced Market Commitment 92 countries, Pfizer and BioNTech will provide the vaccine to COVAX at a not-for-profit price.
  • "This agreement with Pfizer and BioNTech will enable COVAX to save lives, stabilize health systems and drive the global economic recovery.
  • Pfizer and BioNTech are also committed to coordinating with international agencies to support supply and distribution in refugee and other vulnerable populations.

Moderna Announces First Participant Dosed in Phase 1/2 Study of Moderna COVID-19 Vaccine in Japan Led by Takeda

Retrieved on: 
Thursday, January 21, 2021
Biotechnology, Infectious diseases, Other Health, Health, Pharmaceutical, Medicine, Medical research, Health sciences, Articles, Clinical trials, COVID-19 vaccine, MRNA-1273, Moderna, Vaccine, Tozinameran, RNA vaccine

(Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the first participant has been dosed in the Phase 1/2 study of Modernas vaccine candidate against COVID-19 (mRNA-1273 or TAK-919) in Japan, led by Takeda Pharmaceutical Co., Ltd (NYSE: TAK).

Key Points: 
  • (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the first participant has been dosed in the Phase 1/2 study of Modernas vaccine candidate against COVID-19 (mRNA-1273 or TAK-919) in Japan, led by Takeda Pharmaceutical Co., Ltd (NYSE: TAK).
  • We are pleased that this Phase 1/2 study of our COVID-19 vaccine in healthy adults in Japan has begun.
  • This placebo-controlled Phase 1/2 study will evaluate the safety and immunogenicity of two vaccinations of mRNA-1273 given 28 days apart.
  • Takeda and Moderna previously announced that Takeda will import and distribute 50 million doses of Modernas COVID-19 vaccine candidate starting in the first half of 2021, pending licensure in Japan.

Pfizer and BioNTech Publish Results of Study Showing COVID-19 Vaccine Elicits Antibodies that Neutralize Pseudovirus Bearing the SARS-CoV-2 U.K. Strain Spike Protein in Cell Culture

Retrieved on: 
Wednesday, January 20, 2021
Medicine, Health sciences, Health, Medical research, Clinical trials, Pfizer, Tozinameran, COVID-19 vaccine, BioNTech, Coronavirus disease, Vaccine, RNA vaccine

That study showed efficient neutralization of the N501Y mutated spike bearing virus by sera of individuals who had received the Pfizer-BioNTech COVID-19 vaccine.

Key Points: 
  • That study showed efficient neutralization of the N501Y mutated spike bearing virus by sera of individuals who had received the Pfizer-BioNTech COVID-19 vaccine.
  • To this aim, a pseudovirus featuring the UK strain spike protein was generated.
  • Pfizer and BioNTech are encouraged by these early in vitro study findings.
  • Further data are needed to monitor the Pfizer-BioNTech COVID-19 vaccines effectiveness in preventing COVID-19 caused by new virus variants.

Statement from the Council of Chief Medical Officers of Health: Implementing COVID-19 Vaccination in Canada -- Vaccine Dose Interval

Retrieved on: 
Thursday, January 14, 2021
Health sciences, Medical research, Medicine, Health care, Vaccine, BioNTech, Pfizer, Moderna, COVID-19 vaccine, Tozinameran

Canada's vaccine regulatory system conducts independent scientific review of vaccines and authorizes their use in Canada only when strict standards for safety and effectiveness have been met.

Key Points: 
  • Canada's vaccine regulatory system conducts independent scientific review of vaccines and authorizes their use in Canada only when strict standards for safety and effectiveness have been met.
  • Two vaccines, Pfizer-BioNTech and Moderna, have met these requirements to date and are now available to vaccinate Canadians.
  • Throughout 2021, vaccine will be offered to increasing groups of people as the vaccine supply grows, ultimately reaching all eligible Canadians.
  • We are acting on available data and our decisions are based on achieving the greatest public health benefit for Canada.

Press release - COVID-19 vaccines: Public Health Committee MEPs to quiz Commission

Retrieved on: 
Monday, January 11, 2021
Medical research, Health sciences, Medicine, Health, COVID-19 vaccine, BioNTech, Pfizer, Moderna, Vaccine, Tozinameran, The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations

At the Plenary session in December 2020, Parliament expressed support for speedy authorisation of safe vaccines.

Key Points: 
  • At the Plenary session in December 2020, Parliament expressed support for speedy authorisation of safe vaccines.
  • The Commission has since given conditional marketing authorisation for two COVID-19 vaccines, one developed by BioNTech and Pfizer and one by Moderna Biotech Spain, S.L.
  • You can follow the committee meeting live here from 9 am on Tuesday 12 January.
  • On 22 September 2020, Parliament held a public hearing on How to secure access to COVID-19 vaccines for EU citizens: clinical trials, production and distribution challenges.

United Kingdom Medicines and Healthcare products Regulatory Agency Authorizes Use of COVID-19 Vaccine Moderna

Retrieved on: 
Friday, January 8, 2021
Infectious diseases, Biotechnology, Pharmaceutical, Health, Responses to the COVID-19 pandemic, Medicine, Health sciences, Medical research, Clinical trials, COVID-19 vaccine, RNA vaccine, Moderna, Medicines and Healthcare products Regulatory Agency, Vaccine, Coronavirus disease, Tozinameran, the COVID-19 Vaccine Moderna, Moderna

Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the UKs Medicines and Healthcare products Regulatory Agency (MHRA) has approved its mRNA vaccine against COVID-19 (COVID-19 Vaccine Moderna) for use under Regulation 174.

Key Points: 
  • Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the UKs Medicines and Healthcare products Regulatory Agency (MHRA) has approved its mRNA vaccine against COVID-19 (COVID-19 Vaccine Moderna) for use under Regulation 174.
  • The United Kingdom government has also exercised its option to purchase an additional 10 million doses of the COVID-19 Vaccine Moderna, bringing its confirmed order commitment to 17 million doses.
  • The first deliveries of the COVID-19 Vaccine Moderna to the UK from Modernas dedicated non-U.S. supply chain are expected to commence early in 2021.
  • The COVID-19 Vaccine Moderna has been authorized by the Medicines and Healthcare products Regulatory Agency (MHRA), based upon the recommendation of the Commission on Human Medicines, which authorizes the COVID-19 Vaccine Moderna for active immunization to prevent COVID-19 caused by SARS-CoV-2 virus in individuals 18 years of age and older.

An In Vitro Study Shows Pfizer-BioNTech COVID-19 Vaccine Elicits Antibodies that Neutralize SARS-CoV-2 with a Mutation Associated with Rapid Transmission

Retrieved on: 
Friday, January 8, 2021
Health sciences, Medicine, Medical research, Articles, Clinical trials, Tozinameran, COVID-19 vaccine, BioNTech, Pfizer, Neutralizing antibody, Coronavirus disease

These variants have multiple mutations in their spike or S glycoproteins, which are key targets of virus neutralizing antibodies.

Key Points: 
  • These variants have multiple mutations in their spike or S glycoproteins, which are key targets of virus neutralizing antibodies.
  • The sera of 20 participants from the previously reported Phase 3 trial neutralized the virus with the mutation as well as they neutralized virus without the mutation.
  • Pfizer, BioNTech, and UTMB are encouraged by these early, in vitro study findings.
  • Further data are needed to monitor the Pfizer-BioNTech COVID-19 vaccines effectiveness in preventing COVID-19 caused by new virus variants.

Research Centers of America Expedite Broad Study on Moderna's COVID-19 Vaccine

Retrieved on: 
Thursday, January 7, 2021
Medicine, Health sciences, Medical research, Health, Virology, Clinical trials, MRNA-1273, COVID-19 vaccine, Vaccine, Moderna, Tozinameran, Inovio Pharmaceuticals

HOLLYWOOD, Fla., Jan. 7, 2021 /PRNewswire/ --Research Centers of America (" RCA "), a CenExel Center of Excellence,joined nearly 100 other clinical research facilities across the United States to test the safety and efficacy of Moderna's mRNA-1273 vaccine against COVID-19.

Key Points: 
  • HOLLYWOOD, Fla., Jan. 7, 2021 /PRNewswire/ --Research Centers of America (" RCA "), a CenExel Center of Excellence,joined nearly 100 other clinical research facilities across the United States to test the safety and efficacy of Moderna's mRNA-1273 vaccine against COVID-19.
  • "The data demonstrated strong safety and efficacy results from a novel mRNA COVID-19 vaccine," he said.
  • "In the past several years, our Centers have supported over 100 vaccine trials and surpassed recruitment goals by 110%.
  • The CenExel Centers of Excellence deliver the engagement, expertise, and results to ensure that their clients achieve their clinical research goals.

Statement on the U.K. authorization of the AstraZeneca's COVID-19 vaccine

Retrieved on: 
Wednesday, December 30, 2020
Medical research, Health sciences, Medicine, Health, COVID-19 vaccine, Medicines and Healthcare products Regulatory Agency, AstraZeneca, Vaccine, Moderna, Tozinameran, The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations

OTTAWA, ON, Dec. 30, 2020 /CNW/ -Health Canada is aware that the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) has issued an authorization for a COVID-19 vaccine manufactured by AstraZeneca.

Key Points: 
  • OTTAWA, ON, Dec. 30, 2020 /CNW/ -Health Canada is aware that the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) has issued an authorization for a COVID-19 vaccine manufactured by AstraZeneca.
  • Health Canada has been reviewing AstraZeneca's vaccine since it was submitted on October 1, 2020, and is expediting the review of COVID-19 vaccines.
  • This is being done through rolling submissions, where data is being reviewed as it becomes available from the manufacturer.
  • Health Canada subsequently authorized a second COVID-19 vaccine, on December 23, manufactured by Moderna .