Science and technology company Merck is expanding its production of lipids to be used by German biotechnology firm BioNTech in the manufacture of the Pfizer-BioNTech COVID-19 vaccine, the company announced on 5 February.
For a vaccine to be effective, lipids are critical to the drug delivery system of Messenger RNA (mRNA) therapies to the body.
The mRNA is a single-stranded RNA molecule that is complementary to one of the DNA strands of a gene. The mRNA is an RNA version of the gene that leaves the cell nucleus and moves to the cytoplasm where proteins are made.
Merck said it was planning to “significantly accelerate” the supply of urgently-needed lipids and increase lipid deliveries towards the end of this year.
“What unites BioNTech and Merck is our strong belief in mRNA technology and our collaboration in vaccine development. We are convinced that now is the time to pull together to supply as much vaccine as possible to the world”, said Merck CEO and chairman of the executive board Stefan Oschmann.
Leading lipid producer Merck provides custom lipids and other critical components such as synthetic cholesterol for lipid nanoparticle formulations. The company works in collaboration with many companies using lipid-based technologies to formulate COVID-19 vaccines and treatment.
Due to the complexity of vaccine manufacture and the lack of standardised processes, Merck has developed customised manufacturing platforms for industrial-scale production. Many of its products are used for this purpose, such as single-use assemblies, systems for biopharmaceutical production and consumables.
The Pfizer-BioNTech Covid-19 Vaccine (BNT162b2), which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer, and the marketing authorisation holder is BioNTech in Canada, Europe, the UK, USA and other countries.
It has been authorised for use by the health regulatory authorities of about 50 countries, including Switzerland and EU member states where it has been granted conditional marketing authorisation, and has been authorised for emergency use in a number of counties, including Canada, the UK and USA.
According to data from the global Phase III clinical trial of the Pfizer-BioNTech vaccine, it had an effectiveness rate of 95% in preventing COVID-19 in adults and 94% in adults over 65 years.