traffic_analyzer/DigitalVision V
Pfizer, BioNTech COVID-19 Vaccine Expands to Latin America
Eurofarma will manufacture doses of Pfizer and BioNTech's COVID-19 vaccine within the company’s global vaccine supply chain and manufacturing network.
Pfizer and BioNTech recently signed a letter of intent with Eurofarma Laboratoriors SA, a Brazilian pharmaceutical company, to manufacture its COVID-19 vaccine, Comirnaty, in Latin America.
Eurofarma will manufacture within Pfizer and BioNTech’s global COVID-19 vaccine supply chain and manufacturing network, spanning four continents and including over 20 manufacturing facilities.
Under the terms of the agreement, Eurofarma will acquire drug products from US facilities. The manufacturing of finished doses will begin in 2022, and the yearly dose production will exceed 100 million.
“Everyone – regardless of financial condition, race, religion or geography — deserves access to lifesaving COVID-19 vaccines,” Albert Bourla, chairman and chief executive officer at Pfizer, said in the announcement.
“Our new collaboration with Eurofarma expands our global supply chain network to another region – helping us continue to provide fair and equitable access to our COVID-19 vaccine. We will continue to explore and pursue opportunities such as this to help ensure that vaccines are available to all who are in need,” Bourla continued.
Pfizer and BioNTech select manufacturers through a complex process based on many factors, including quality, compliance, safety track record, technical capability, project management abilities, and commitment to working with flexibility through a fast-paced program, a Pfizer spokesperson stated.
BioNTech is the Marketing Authorization Holder of Comirnaty in the US, the EU, and the UK, and the holder of emergency use authorizations in the US (jointly with Pfizer), Canada, and other countries.
To date, the companies have shipped over 1.3 billion COVID-19 vaccine doses to more than 120 countries and territories in every region of the world. They expect to deliver 1 billion vaccine doses each year.
Moderna Completes Rolling Submission Process for its BLA
Moderna recently announced that it completed the rolling submission process for its Biologics License Application (BLA) to the FDA for full licensure of its COVID-19 vaccine.
The completed submission includes clinical data from the Phase 3 COVE study of the vaccine, which enrolled over 30,000 participants in the US.
In the study, the vaccine elicited a 93 percent efficacy, which remained durable for six months after administering the second dose. Moderna has also requested priority review designation as part of the completed BLA submission.
“This BLA submission for our COVID-19 vaccine, which we began in June, is an important milestone in our battle against COVID-19 and for Moderna, as this is the first BLA submission in our company’s history,” Stéphane Bancel, chief executive officer of Moderna, said in the announcement.
“We are pleased that our COVID-19 vaccine is showing durable efficacy of 93% through six months after dose 2. I would like to thank the FDA for their hard work and guidance through the BLA submission process and the entire Moderna team for their relentlessness in pursuing our mission of delivering on the promise of mRNA science,” Bancel concluded.
Novavax Evaluates Safety of Third COVID-19 Vaccine Dose
Novavax recently announced a trial evaluating a third dose of its COVID-19 recombinant nanoparticle protein vaccine candidate in the UK.
The OCTAVE-DUO trial, funded by the UK government’s Vaccine Taskforce and the UK Research and Innovation (UKRI), will evaluate the safety and immunogenicity of a third COVID-19 vaccine dose in participants with impaired immune systems.
The trial is a follow-on to OCTAVE, which evaluated the immune response to COVID-19 vaccines in participants with impaired immune systems due to cancer, inflammatory arthritis, kidney or liver diseases, or a stem cell transplant.
Researchers will evaluate participants for changes in vaccine-specific immune responses and any adverse events. Novavax expects to announce trial findings later this year.
“We expect the results of this study to be particularly helpful to better understanding how our vaccine might work as a heterologous third dose in immunocompromised individuals,” Gregory M. Glenn, MD, president of research and development at Novavax, said in the announcement.
“As the pandemic continues to surge, the ability to have a flexible approach to vaccine regimens will be important for both medically vulnerable individuals as well as to achieving population-wide coverage,” Glenn continued.
