A day after Pfizer's COVID-19 vaccine candidate achieved positive results in late stage trials, Croda International Plc (Croda) on Tuesday entered into an agreement with the US-based drug maker to supply additives used in manufacturing the coronavirus vaccine. Pfizer Inc. expects to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021.
The COVID-19 vaccine, BNT162b2, being jointly developed by Pfizer Inc. and German firm BioNTech is in late stage of vaccine trials.
The deal with Pfizer will run for five years and award Croda an initial supply contract for four component excipients used in the production of the vaccine candidate for the first three years of the contract.
"Demand remains subject to relevant approvals," the UK-based speciality chemicals company said in a press release.
Commenting on the deal, Steve Foots, Chief Executive Officer, said that the company is proud to contribute in the battle to fight the most significant pandemic that we have seen in a generation.
"The application of our innovative capabilities is testament to the strong progress we have made to create industry-leading drug delivery systems, focused on developing speciality excipients and adjuvants to improve the effectiveness and stability of complex drug actives and vaccines. It is another example of why our Purpose - Smart Science to Improve Lives - sits at the heart of our strategy and will continue to drive our priorities and ambitions in the years ahead," said Steve Foots.
Croda recently acquired Avanti Polar Lipids, which specialises in the development and production of high-purity lipids, to produce, research and conduct clinical trials on quantities of excipients in order to stabilise formulations and enable delivery into the body by parenteral mechanism (injection) for drug and vaccine applications.
"Croda has reprioritised investment, resources and other projects across the group over the last few months to focus on the delivery of this project," the London Stock Exchange-listed firm said.
On Monday, Pfizer Inc and BioNTech announced that their COVID-19 vaccine candidate was found to be more than 90 per cent effective in preventing COVID-19. The trial result was based on the first interim efficacy analysis conducted on November 8, 2020, by an external, independent Data Monitoring Committee (DMC) from the Phase 3 clinical study.
Following strong progress in the interim efficacy analysis, the drug makers plan to soon apply for Emergency Use Authorisation (EUA) to the US Food and Drug Administration (FDA) after the required safety milestone is achieved, which is currently expected to occur in the third week of November.
Along with the efficacy data generated from the clinical trial, Pfizer and BioNTech are working to prepare the necessary safety and manufacturing data to submit to the FDA to demonstrate the safety and quality of the vaccine product produced.
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