Germany’s Merck to Expand Lipid Supply to BioNTech
BioNTech will use the lipids, critical to the drug delivery system of mRNA therapies to the body, in production of the Comirnaty Covid-19 vaccine it is producing with its US partner Pfizer. BioNTech is the marketing authorization holder in the US Europe, the UK, Canada, and other countries.
Merck and BioNTech had worked together in the past and at the start of the pandemic began to intensify their collaboration, CEO Stefan Oschmann said. Over the past weeks, Merck by its own account has begun further expanding its already very high lipid production capacity, adapting its production technology and implementing new highly complex process steps.
The Darmstadt-based chemicals , pharmaceuticals and life science group regards itself as a global leader in lipids, with extensive expertise in providing custom lipids and other critical components such as synthetic cholesterol for lipid nanoparticle formulations. It is active across multiple steps of the process flow and collaborates with many companies using lipid-based technologies to address Covid-19 vaccines and treatment.
Only a few companies worldwide are currently able to produce custom lipids in significant quantities and according to the highest quality requirements needed for vaccine production, Merck noted. Now is the time to pull together to supply as much vaccine as possible, Oschmann said, adding that the Darmstadt-based is “ready to take these steps to tackle one of the biggest challenges of humanity.”
Merck supports than 50 vaccine projects worldwide
Since the outbreak of the pandemic, Merck’s Life Science business segment has been supporting more than 50 vaccine projects, offering a full spectrum of raw materials and customized manufacturing platforms across the mRNA value chain to enable industrial-scale production.
With the acquisition of AmpTec, announced in early January, the German group said it has further strengthened its capabilities and capacities for the development and production of mRNA. In particular, the combination of AmpTec’s PCR-based mRNA technology with Merck’s extensive expertise in lipids manufacturing makes it possible to provide a truly integrated offering across the mRNA value chain.
In addition to vaccine development and production, the German group also supports more than 35 Covid-19 testing solutions. Merck said it is currently collaborating with many clinical laboratories and diagnostics manufacturers, supplying critical raw materials across all key steps involved in diagnosing Covid-19 infections.
J&J Files with FDA for Covid vaccine EUA
Johnson & Johnson has applied to the US Food and Drug Administration for an Emergency Use Authorization (EUA) for its single-dose COVID-19 vaccine. The FDA will discuss the application with its advisory committee at a Feb. 26 meeting.
The US healthcare group said last week its viral vector vaccine was shown in Phase 3 clinical trials, to be 66% effective in preventing moderate to severe disease, and as much as 85% in severe disease. J&J said it expects to have doses ready to ship as soon as it gets the green light from the FDA. It plans to deliver 100 million doses in the US by mid-2021.
UK orders 40 million more Valneva Vaccines
The UK government has exercised its option to order an additional 40 million doses of the Covid-19 vaccine developed by French vaccine manufacturer Valeneva for delivery in 2022. This brings its total order to 100 million.
London retains its option to order 90 million more doses for delivery between 2023 and 2025. UK vaccine taskforce chair Clive Dix said the additional contingent gives the country flexibility if it needs to revaccinate any of the population to cope with mutants.
If all supply options are exercised, the value of the deal with Valneva would be worth €1.4 billion.
The French vaccine maker began a Phase 1-2 study of its inactivated, adjuvanted candidate VLA2001 in December 2020. Results are expected to be reported within the next three months.
Author: Dede Williams, Freelance Journalist