ipopba - stock.adobe.com
Moderna, Aldevron Expand Partnership for mRNA COVID-19 Vaccine
In other COVID news, Pfizer initiates a study of its pneumococcal vaccine candidate following its COVID-19 vaccine in adults 65 and older and supplies 900M COVID vaccine doses to Europe.
Moderna and Aldevron recently expanded their partnership to support Moderna’s mRNA COVID-19 vaccine and clinical development therapeutic pipeline.
Aldevron is a provider of plasmid DNA, mRNA, and proteins necessary for vaccines, gene and cell therapy, and diagnostic application. The company will supply plasmid DNA to help advance Moderna’s COVID-19 vaccine and other programs in its pipeline, according to the announcement.
Aldevron’s production of DNA takes place in its 70,000 square foot GMP facility located in North Dakota. An additional 189,000 square foot build out to the facility was recently completed.
“Aldevron has been a long-standing partner of Moderna. We appreciate their collaboration and their expertise in the biologics space,” Juan Andres, chief technical operations and quality officer of Moderna, said in the announcement.
“We look forward to our ongoing work with this expanded partnership,” Andres continued.
Moderna’s pipeline consists of RSV and mRNA vaccine candidates for various chronic diseases.
At the end of April, Moderna announced that in a Phase 1 study of its RSV vaccine, mRNA-1345, a single dose vaccination of 50 micrograms or 100 micrograms was generally well-tolerated in younger adults.
Additionally, the company’s mRNA-1647 vaccine combines six mRNAs in a single vial. A Phase 2 study found that mRNA-1647 at 50 micrograms, 100 micrograms, and 150 micrograms was generally well-tolerated in the study population.
Finally, Moderna’s mRNA-1644 is a novel approach to HIV vaccine strategy in humans that is designed to elicit neutralizing HIV-1 antibodies (bNAbs). A Phase 1 study for mRNA-1644 will use human testing to validate the approach and antigens, and multiple novel antigens will be used for germline-targeting and immuno-focusing.
“Aldevron’s support of the Moderna pipeline spans nearly a decade, and we’re incredibly proud of the trust they’ve placed in us” said Kevin Ballinger, chief executive officer of Aldevron.
“Our deep experience, coupled with enhanced operational efficiencies and recent capacity expansion place us in an excellent position to support Moderna’s efforts – especially during this critical time. We look forward to expanding our strategic partnership to serve a pipeline of important new programs in the future,” Ballinger continued.
Pfizer Initiates Study of Pneumococcal Vaccine Candidate Following COVID-19 Vaccine
Pfizer recently announced that the first participants have been dosed in a study exploring the company’s 20-valent pneumococcal conjugate vaccine (29vPnC) candidate following a booster dose of its COVID-19 vaccine.
The study will enroll 600 adults 65 years of age and older from the Phase 3 Pfizer-BioNTech COVID-19 vaccine trial. Participants will have received their second dose of the vaccine at least six months before entering the coadministration study.
Participants will be randomized into one of three groups that will receive either 20vPnC plus a Pfizer-BioNTech COVID-19 vaccine booster, 20vPnC plus a placebo, or the Pfizer-BioNTech COVID-19 vaccine booster plus a placebo.
In December, FDA issued the first emergency use authorization for a COVID-19 vaccine to Pfizer-BioNTech.
Since then, the vaccine has proved effective in multiple clinical trials. Last week, the companies announced the initiation of a Biologics License Application for full FDA approval of the vaccine.
Pfizer, BioNTech Supply 900M Doses of COVID-19 Vaccine to Europe
Pfizer and BioNTech recently announced a new agreement with the European Commission (EC) to supply 900 million doses of their COVID-19 vaccine to the European Union (EU).
The agreement includes an option to request up to an additional 900 million doses of the vaccine, bringing the potential total doses to 2.4 billion.
At the beginning of January, Pfizer and BioNTech supplied a total of 300 million doses of their COVID-19 vaccine to the 27 EU member states two months after the EU exercised its option to purchase additional doses under its Advanced Purchased Agreement from November 2020.
The new agreement is in addition to the doses that have already been committed to the EU through 2021. The additional 900 million will start to be delivered in December and continue through 2023.
Pfizer and BioNTech stated that they can manufacture at least 2.5 billion doses of the vaccine, in total, by the end of 2021, with the potential to supply nearly three billion doses.
“Ongoing vaccination beyond 2021 is critical as COVID-19 continues to spread rapidly throughout Europe and the globe,” Albert Bourla, chairman and chief executive officer of Pfizer, said in the announcement. “More than a year later, we continue to learn about COVID-19 and are working to determine if, similar to seasonal influenza, annual vaccination may provide the most enduring protection.”
