RNA vaccines

Sanofi and GSK initiate global Phase 3 clinical efficacy study of COVID-19 vaccine candidate

Retrieved on:

Thursday, May 27, 2021

Clinical trials, Health sciences, Health, Medicine, COVID-19 vaccines, RNA vaccines, Medical research, Vaccines, COVID-19 vaccine, Sanofi, Vaccine, Herpes simplex research

The design of the Phase 3, conducted across a broad diversity of geographies, also allows evaluation of the efficacy of the candidate against a variety of circulating variants.

Key Points:

The design of the Phase 3, conducted across a broad diversity of geographies, also allows evaluation of the efficacy of the candidate against a variety of circulating variants.
Following encouraging interim results from the recent Phase 2 study, the companies will also begin clinical studies in the coming weeks to assess the ability of the adjuvanted recombinant-protein COVID-19 vaccine candidate to generate a strong booster response regardless of initial vaccine platform received.
Adjusting our technology and study designs reflects this need and will further build the potential of this adjuvanted protein-based vaccine.
In addition to the adjuvanted recombinant protein-based vaccine in collaboration with GSK, Sanofi is developing a messenger RNA vaccine in partnership with Translate Bio.

MyBio: Has My Vaccine Worked? A New Covid-19 Rapid Test That Can Verify Antibody Response to Any Vaccine

Retrieved on:

Thursday, May 27, 2021

Kilkenny based life sciences company MyBio and commercial partner, German manufacturer MLab GmbH, today launch the Sars-COV-2 Neutralising Antibody Test (Nab) Test in the UK and Ireland a finger-prick rapid test that can verify an individuals antibody response to Covid-19 vaccines in just 10 minutes.

Key Points:

Kilkenny based life sciences company MyBio and commercial partner, German manufacturer MLab GmbH, today launch the Sars-COV-2 Neutralising Antibody Test (Nab) Test in the UK and Ireland a finger-prick rapid test that can verify an individuals antibody response to Covid-19 vaccines in just 10 minutes.
The test will also be used to monitor the duration of vaccination protection, even for those who have responded positively to the vaccine.
The Sars-COV-2 NAb test detects "neutralizing" IgG antibodies that prevent SARS-CoV-2 from entering our cells, and measures the anti-SARS-CoV-2 immune response both after infection and after vaccination.
To verify the response to the vaccine, the neutralising antibody test should be performed at least 10 days after the administration of the second dose of the vaccine.

Moderna Announces TeenCOVE Study of its COVID-19 Vaccine in Adolescents Meets Primary Endpoint and Plans to Submit Data to Regulators in Early June

Retrieved on:

Tuesday, May 25, 2021

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.

Key Points:

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.
It is particularly exciting to see that the Moderna COVID-19 vaccine can prevent SARS-CoV-2 infection, said Stphane Bancel, Chief Executive Officer of Moderna.
We will submit these results to the U.S. FDA and regulators globally in early June and request authorization.
The primary endpoint of non-inferior immunogenicity versus the Phase 3 adult study comparator group was met.

Statement from the Chief Public Health Officer of Canada on May 22, 2021

Retrieved on:

Saturday, May 22, 2021

Health, Medicine, COVID-19 vaccines, Clinical trials, RNA vaccines, Medical research, Vaccination, Vaccine adverse event, COVID-19 vaccine, National Advisory Committee on Immunization, Vaccine, COVID-19 vaccination in Canada

Their videos can be found on several social media platforms by searching for their hashtags including #IndigenousYouth4Vaccine and #SmudgeCOVID.

Key Points:

Their videos can be found on several social media platforms by searching for their hashtags including #IndigenousYouth4Vaccine and #SmudgeCOVID.
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.
They also tell us, together with results of serological studies, that a large majority of Canadians remain susceptible to COVID-19 .
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.

Moderna and South Korea Explore Collaboration on mRNA Vaccines

Retrieved on:

Saturday, May 22, 2021

b'Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced two Memoranda of Understanding (MoU) with the government of South Korea: one MoU with the Korea National Institute of Health (KNIH), an agency of the Korea Centers for Disease Control and Prevention Agency (KDCA) for a new collaboration on mRNA vaccine research in South Korea; and an additional MoU with the Ministry of Trade, Industry and Energy of the Republic of Korea (MOTIE), the Ministry of Health and Welfare of the Republic of Korea (MOHW) to explore local manufacturing opportunities for mRNA vaccines in South Korea.\nThe MoUs were signed today by Kwon Junwook, Director, KNIH and St\xc3\xa9phane Bancel, Moderna\xe2\x80\x99s Chief Executive Officer at a signing ceremony in Washington, D.C. With these MoUs, Moderna and the KNIH will explore areas of collaboration for scientific research on mRNA vaccines.

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b'Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced two Memoranda of Understanding (MoU) with the government of South Korea: one MoU with the Korea National Institute of Health (KNIH), an agency of the Korea Centers for Disease Control and Prevention Agency (KDCA) for a new collaboration on mRNA vaccine research in South Korea; and an additional MoU with the Ministry of Trade, Industry and Energy of the Republic of Korea (MOTIE), the Ministry of Health and Welfare of the Republic of Korea (MOHW) to explore local manufacturing opportunities for mRNA vaccines in South Korea.\nThe MoUs were signed today by Kwon Junwook, Director, KNIH and St\xc3\xa9phane Bancel, Moderna\xe2\x80\x99s Chief Executive Officer at a signing ceremony in Washington, D.C. With these MoUs, Moderna and the KNIH will explore areas of collaboration for scientific research on mRNA vaccines.
The teams will engage in discussions regarding collaboration opportunities such as pre-clinical or clinical development of mRNA vaccine candidates against viruses that create a high burden of disease in South Korea.
These MoUs may also facilitate discussions between Moderna and South Korea for a potential manufacturing facility for mRNA vaccines in South Korea.\n\xe2\x80\x9cWe thank the South Korean government and we look forward to exploring this collaboration to bring mRNA vaccines that may help address areas of unmet need,\xe2\x80\x9d said St\xc3\xa9phane Bancel, Chief Executive Officer of Moderna.
GC Pharma in South Korea is the Company\xe2\x80\x99s marketing authorization holder and distributor of Moderna\xe2\x80\x99s COVID-19 vaccine for South Korea.

Ministry of Food and Drug Safety of South Korea (MFDS) Authorizes Moderna’s COVID-19 Vaccine

Retrieved on:

Friday, May 21, 2021

b'Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the Ministry of Food and Drug Safety of South Korea (MFDS) has approved the Company\xe2\x80\x99s application for Conditional Marketing Authorization for its mRNA vaccine against COVID-19.

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b'Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the Ministry of Food and Drug Safety of South Korea (MFDS) has approved the Company\xe2\x80\x99s application for Conditional Marketing Authorization for its mRNA vaccine against COVID-19.
We are committed to protecting people around the world with our COVID-19 vaccine and if authorized, with our variant booster candidates,\xe2\x80\x9d said St\xc3\xa9phane Bancel, Chief Executive Officer of Moderna.
To learn more, visit www.modernatx.com .\nThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding the approval of Moderna\xe2\x80\x99s COVID-19 vaccine (mRNA-1273) by the Ministry of Food and Drug Safety of South Korea; the distribution of the Company\xe2\x80\x99s COVID-19 vaccine in South Korea; the establishment of a commercial subsidiary in South Korea by the Company; and the potential establishment of manufacturing capabilities for the Company\xe2\x80\x99s products in South Korea.
These forward-looking statements are based on Moderna\xe2\x80\x99s current expectations and speak only as of the date hereof.\nView source version on businesswire.com: https://www.businesswire.com/news/home/20210521005307/en/\n'

Japan’s Ministry of Health, Labour and Welfare (MHLW) Approves Moderna’s COVID-19 Vaccine

Retrieved on:

Friday, May 21, 2021

Health, Infectious diseases, Genetics, Clinical trials, Pharmaceutical, Biotechnology, COVID-19 vaccines, Clinical trials, RNA vaccines, Medicine, Medical research, Health sciences, Medical specialties, Moderna COVID-19 vaccine, COVID-19 vaccine, Vaccine, Moderna, Neutralizing antibody

The Company is actively hiring locally.\n\xe2\x80\x9cThis is an important moment in Moderna\xe2\x80\x99s history as it is the first approval for a Moderna product in Japan.

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The Company is actively hiring locally.\n\xe2\x80\x9cThis is an important moment in Moderna\xe2\x80\x99s history as it is the first approval for a Moderna product in Japan.
Initial results showed an immune response with results from Moderna\xe2\x80\x99s Phase 3 COVE study conducted in the U.S.
Binding and neutralizing antibody titers were elevated at 28 days after the second dose of the Moderna COVID-19 vaccine candidate in 100% of participants.
These forward-looking statements are based on Moderna\xe2\x80\x99s current expectations and speak only as of the date hereof.\nView source version on businesswire.com: https://www.businesswire.com/news/home/20210520006147/en/\n'

Pfizer and BioNTech to Supply the European Union with up to 1.8 Billion Additional Doses of COMIRNATY®

Retrieved on:

Thursday, May 20, 2021

BioNTech, COVID-19, Health sciences, COVID-19 vaccines, Clinical trials, RNA vaccines, Medical research, Health, Pfizer–BioNTech COVID-19 vaccine, Pfizer, BioNTech, COVID-19 vaccine

The additional 900 million agreed doses are expected to be delivered on a monthly schedule beginning December 2021 and continuing into 2023.

Key Points:

The additional 900 million agreed doses are expected to be delivered on a monthly schedule beginning December 2021 and continuing into 2023.
This contract with the European Commission will ensure sufficient doses of COMIRNATY are available for all EU citizens in 2022 and 2023,\xe2\x80\x9d said Ugur Sahin, M.D., CEO and Co-Founder of BioNTech.
Based on current projections, Pfizer and BioNTech believe they can manufacture at least 2.5 billion doses of the vaccine, in total, by the end of 2021, with the potential to supply up to 3 billion doses.\nThe Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer.
All information in this press release is as of the date of the release, and BioNTech undertakes no duty to update this information unless required by law.\n"

Pfizer and BioNTech to Supply the European Union With up to 1.8 Billion Additional Doses of COMIRNATY®

Retrieved on:

Thursday, May 20, 2021

View the full release here: https://www.businesswire.com/news/home/20210520005450/en/\nThis new agreement is in addition to the 600 million doses that have already been committed to the EU through 2021.

Key Points:

View the full release here: https://www.businesswire.com/news/home/20210520005450/en/\nThis new agreement is in addition to the 600 million doses that have already been committed to the EU through 2021.
The additional 900 million agreed doses are expected to be delivered on a monthly schedule beginning December 2021 and continuing into 2023.
This contract with the European Commission will ensure sufficient doses of COMIRNATY are available for all EU citizens in 2022 and 2023,\xe2\x80\x9d said Ugur Sahin, M.D., CEO and Co-Founder of BioNTech.
Based on current projections, Pfizer and BioNTech believe they can manufacture at least 2.5 billion doses of the vaccine, in total, by the end of 2021, with the potential to supply up to 3 billion doses.\nThe Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer.

Health Canada authorizes more flexible storage conditions for Pfizer-BioNTech COVID-19 vaccine

Retrieved on:

Wednesday, May 19, 2021

COVID-19, Medical research, Health sciences, BioNTech, COVID-19 vaccines, Clinical trials, RNA vaccines, Health, Pfizer–BioNTech COVID-19 vaccine, Pfizer, BioNTech, COVID-19 vaccine

b'OTTAWA, ON, May 19, 2021 /CNW/ -Today, Health Canada authorized a submission from Pfizer-BioNTech to allow its COVID-19 vaccine to be stored at regular refrigerated temperatures (2-8C) at the point of use for up to one month.

Key Points:

b'OTTAWA, ON, May 19, 2021 /CNW/ -Today, Health Canada authorized a submission from Pfizer-BioNTech to allow its COVID-19 vaccine to be stored at regular refrigerated temperatures (2-8C) at the point of use for up to one month.
This change means that there will be more storage options available for the Pfizer-BioNTech vaccine, which will allow for more flexibility in distribution plans.\nHealth Canada received the application from Pfizer-BioNTech to change the storage conditions of its COVID-19 vaccine on May 10, 2021.
On March 3, 2021, Health Canada authorized a change to enable storage at -25C to -15C (-13F to 5F) for up to 2 weeks.\nSince the initial authorization of the vaccine, the manufacturer has continued to develop additional, longer-term data on the stability of the product under different conditions.
As a result of this research, Pfizer provided additional data to support more flexible storage conditions.