Moderna CEO sees COVID shot being used for teens within weeks, Reuters says » 13:2910/2710/27/21
Moderna CEO Staphane…
Moderna CEO Staphane Bancel said he believes the drugmaker's COVID-19 vaccine will be authorized for 12- to 17-year-olds by the U.S. Food and Drug Administration in the next few weeks, Reuters' Carl O'Donnell reports, citing comments by Bancel. Moderna expects to apply for separate U.S. regulatory clearance in children ages six through 11 "very soon" and is hopeful that age group could start getting vaccinations by year end. Reference Link
Hanson Wade to hold a virtual summit » 09:1010/2710/27/21
PFE, JNJ, AMGN, GSK, BMY, AZN, LLY, SNY, BAYRY, KYMR, ARVN, CCCC, GLUE, NRIX, FHTX, NVS
4th Targeted Protein…
4th Targeted Protein Degradation Virtual Summit to be held on October 26-29.Webcast Link
Pfizer, BioNTech confirm FDA panel supports EUA for COVID vaccine in children » 18:2010/2610/26/21
Pfizer (PFE) and BioNTech…
Pfizer (PFE) and BioNTech (BNTX) announced that the U.S. Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee voted 17 to 0, with 1 abstention, to recommend the FDA grant Emergency Use Authorization for the companies' COVID-19 vaccine in children 5 to less than12 years of age. VRBPAC is made up of independent experts who advise the FDA on scientific and regulatory matters, including the evaluation of vaccine safety and efficacy. The committee reviewed the totality of scientific evidence shared by the companies, including results from a Phase 2/3 randomized, controlled trial that included ~4,500 children 5 to less than12 years of age. Participants in this age group received a two-dose regimen of 10-microgram doses administered 21 days apart, one-third of the 30-microgram dose used for people 12 years and older. This dose level was carefully selected for use in the trial based on safety, tolerability and immunogenicity data evaluated as part of a dose-ranging study. The Phase 2/3 trial showed a favorable safety profile, robust immune responses and a vaccine efficacy rate of 90.7% in participants without prior SARS-CoV-2 infection, measured from 7 days after the second dose. The Data Monitoring Committee for the study has reviewed the data and has not identified any serious safety concerns related to the vaccine. "We appreciated the opportunity to present our clinical data demonstrating the safety and high efficacy of our COVID-19 vaccine in children 5 to under 12 years of age," said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development, Pfizer. "COVID-19 is an ongoing threat for the more than 28 million young children in this age group in the U.S., as they remain at risk for this infection. About 10% of all weekly U.S. cases occur in children 5 to under 12 years of age with a potential risk of complications. In addition, immunizing children will help to get us closer to herd immunity, with the potential to stem the pandemic sooner. We thank the FDA advisory committee for their review and positive recommendation in support of Emergency Use Authorization to help protect this young population."
Trillium shareholders approve acquisition by Pfizer subsidiary » 17:1610/2610/26/21
Trillium Therapeutics (TRIL) announced that its securityholders approved a statutory arrangement with PF Argentum, a wholly-owned, indirect subsidiary of Pfizer (PFE) at the special meeting of Trillium securityholders. Pursuant to the arrangement, PF Argentum will acquire all of the issued and outstanding shares and warrants of Trillium, other than Trillium securities owned by Pfizer and its affiliates. The arrangement is subject to court and regulatory approvals and clearances, as well as other customary closing conditions. Subject to the satisfaction of such conditions, the transaction is expected to be completed in Q4 of 2021 or the first half of 2022.
FDA panel votes in support of Pfizer-BioNTech vaccine for kids aged 5-11 » 16:1910/2610/26/21
An FDA Advisory Committee…
An FDA Advisory Committee voted 17 yes to 0 no with 1 abstention that the totality of scientific evidence available supports the benefits of the Pfizer (PFE) and BioNTech (BNTX) COVID vaccine when administered as a 2-dose series outweigh its risks for use in children 5-11 years of age.
Moderna reports first dosing in Phase 3 study of mRNA CMV vaccine » 14:3910/2610/26/21
Moderna announced the…
Moderna announced the first participant has been dosed in the Phase 3 pivotal registration study of mRNA-1647, the company's cytomegalovirus, or CMV, vaccine candidate. The Phase 3 study, known as CMVictory, will evaluate the safety and efficacy of mRNA-1647 against primary CMV infection in women ages 16-40 years. The company will seek to enroll approximately 8,000 participants in the study, including 6,900 women of childbearing age, from approximately 150 sites globally, beginning in the U.S.
Moderna announces Swissmedic authorizes booster dose of Covid-19 vaccine » 09:4510/2610/26/21
Moderna announced Swissmedic has authorized a booster dose of Spikevax, the company's vaccine against COVID-19, at the 50 microgram dose level in particularly vulnerable individuals 12 years of age and older, at least six months after completion of the primary series. Swissmedic also approved a third dose of Spikevax at the 100 microgram dose level for people with a weakened immune system at least 28 days after the second dose. "We thank Swissmedic for their review and decision. This approval is supported by clinical evidence that a 50 microgram booster dose induces a strong immune response against COVID-19. We also appreciate their approval of a third dose of Spikevax for those with weakened immune systems," said Stephane Bancel, CEO of Moderna. "We believe that mRNA vaccines are well positioned to adapt to the evolving epidemiology of SARS-CoV-2. We are grateful for the opportunity to provide individuals in Switzerland with another layer of protection."
FDA Vaccines and Related Biological Products Advisory Committee to hold meeting » 08:2510/2610/26/21
The Committee discusses a…
The Committee discusses a request to amend Pfizer-BioNTech's Emergency Use Authorization (EUA) for administration of their COVID-19 mRNA vaccine to children 5 through 11 years of age in a virtual meeting to be held on October 26 at 8:30 am. Webcast Link
BioNTech to initiate construction of mRNA vaccine facility in Africa in mid-2022 » 08:1210/2610/26/21
BioNTech announced that…
BioNTech announced that the Company plans to initiate the construction of the first state-of-the-art manufacturing site for mRNA-based vaccines in the African Union in mid-2022. This is the next step in BioNTech's efforts to implement sustainable end-to-end vaccine supply solutions on the African continent. The decision is the result of a meeting between Rwanda's Minister of Health, Dr Daniel M. Ngamije, Senegal's Minister of Foreign Affairs Aissata Tall Sall, Ugur Sahin, M.D.,CEO and Co-Founder of BioNTech and Sierk Poetting, COO of BioNTech as well as Dr Sabin Nsanzimana, Director-General of Rwanda Biomedical Centre and Dr Amadou Alpha Sall, Directeur-General of Institut Pasteur de Dakar in Kigali, Rwanda. The meeting occurred upon the invitation of the kENUP Foundation and took place as a side-event of the Second Ministerial Meeting of the African Union and the European Union and resulted in a Memorandum of Understanding. This comes after the parties signed a Joint Communique at a previous meeting in Berlin on August 27, 2021. The parties agree to jointly establish end-to-end manufacturing capacities for mRNA-based vaccines in Africa starting immediately. BioNTech has finalized the construction plans and ordered the assets, which will be delivered by mid-2022. The new manufacturing facility could become the first node in a decentralized and robust African end-to-end manufacturing network enabling an annual manufacturing capacity of several hundreds of million mRNA vaccine doses. BioNTech plans to develop and implement a scalable construction network based on the expertise and learnings from the ramp-up of the Company's production facility in Marburg. To enable an expedient set-up of production capacities according to GMP standards, BioNTech will start with the construction and validation of a first production line enabling the manufacturing of drug product for about 50 million of e.g. COVID-19 vaccine doses per year, once fully operational. The capacity will be increased sequentially by adding further manufacturing lines and sites to the manufacturing network on the continent, supporting the production of several hundreds of millions of mRNA vaccine doses. BioNTech will initially staff, own and operate the facility to support the safe and rapid initiation of the production of mRNA-based vaccine doses. BioNTech plans to transfer manufacturing capacities and the know-how to local partners. Therefore, BioNTech, the Rwanda Development Board and Institut Pasteur de Dakar in Senegal agreed to swiftly build-up the required human resources capacity and systems so that the partners can take over ownership and operational duties. In parallel, the Republic of Rwanda and the Institut Pasteur de Dakar have committed themselves to scale-up fill and finish capacities to complete the local end-to-end manufacturing process. In addition, BioNTech is in discussions about an expansion of the current partnership with Cape Town-based vaccine manufacturer Biovac, which is part of the Pfizer-BioNTech COVID-19 vaccine manufaturing network.
Moderna enters MoU to make 110M COVID-19 vaccine doses available for Africa » 05:2810/2610/26/21
Moderna announced a new…
Moderna announced a new memorandum of understanding, or MoU, to make up to 110M doses of the Moderna COVID-19 vaccine available to the African Union. The company is prepared to deliver the first 15M doses in Q4, 35M doses in Q1 of 2022, and up to 60M doses in Q2 of 2022. All doses are offered at Moderna's lowest tiered price. The company is also working on plans to allow it to fill doses of its COVID-19 vaccine in Africa as early as 2023, in parallel to building an mRNA vaccine manufacturing facility in Africa. This new MoU would be in addition to Moderna's agreement with COVAX to supply up to 500M doses of its COVID-19 vaccine from Q4 of 2021 through 2022. Additionally, the company recently announced an investment of up to $500M to plan to build a mRNA facility in Africa with the goal of producing up to 500M doses of vaccines at the 50 microgram dose level each year.