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mRNA tech takes a giant leap forward


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11 November 2020

GAM Investments’ Dr Jenna Denyes examines the encouraging Covid-19 vaccine news in detail and discusses the possible implications for mRNA therapies and the wider healthcare sector.

On Monday, 9 November Pfizer and BioNTech announced that a Phase III clinical trial had shown their Covid-19 (SARS-Cov-2) vaccine candidate was 90% effective. This was based on a planned interim analysis of data from 94 infection events across the placebo and vaccine arms. The trial continues in multiple countries, with more than 43,000 participants currently enrolled, and will continue until 164 cases occur.

Originally, Pfizer and BioNTech had planned to unblind the data after 32 cases, but this interim data analysis was removed after discussions with the US Food & Drug Administration (FDA). This amendment was only made public during the announcement of the efficacy data, and was a positive explanation for the two week delay in data. They had actually agreed to unblind the data after 62 events, but by the time this agreement was finalised the trial had already surpassed this threshold handily with the noted 94 events and the data was unblinded for an initial analysis. No further data breakdown had been made available as of 9 November.

The interim efficacy data, combined with a safety data package available during the third week of November, will be used to initiate an emergency use approval in the US. Review in the European Union (EU) began last month, with further efficacy data to be submitted as it becomes available. Pifzer and BioNTech have secured pre-orders for close to 500 million doses, with options to expand this to more than 1 billion. This largely speaks for their predicted capacity of 1.3 billion doses by the end of next year. It is likely that additional vaccine candidates will also be approved. The Moderna vaccine candidate, for example, uses very similar technology and is currently under investigation in a placebo controlled Phase III trial as well.

The Pfizer / BioNTech vaccine uses a cutting edge technology based on messenger RNA (mRNA), and, if approved, would be the first therapy or vaccine in its class. Vaccines work by essentially showing the immune system a piece of a pathogen, or an antigen, that it would see if you became infected, so the immune system can learn what to watch out for. mRNA vaccines do this by delivering instructions to our cells so they create this antigen themselves, in this case the spike protein from the SARS-CoV-2 virus particle. This means that the antigen is produced inside our cells, in the same way they would if the cells were infected, and is processed and presented to our immune system in the proper way for a virus. mRNA vaccines are easy to produce, easy to alter if the virus evolves, and can be easily administered multiple times, unlike some other nucleic acid vaccine technologies.

This news is not only exciting in the context of producing a powerful weapon in the world’s arsenal for fighting the ongoing pandemic, but is a huge positive boost for all mRNA therapies in clinical development, which represent a potential USD 3.5 billion market. This is a treatment modality which has been under development for several decades, which has overcome several serious challenges for delivery and potency, and which took a huge leap forward this year; it could offer hope for millions of patients with no viable treatment options. BioNtech alone has 22 public pipeline candidates, mostly oncology focused, but other mRNA companies are also testing treatments for heart disease, autoimmune diseases and different infectious diseases. An approval of the SARS-CoV-2 vaccine would be a powerful validation of its platform, its pipeline and the technological modality which would read through across not only other mRNA companies, but likely the healthcare sector as a whole. The healthcare sector has faced unique overhangs this year in addition to the pandemic, with not only the US elections but also a US Supreme Court ruling which could affect access to health insurance for millions of Americans. The market has welcomed a series of positive news catalysts, including the results of the US elections and now the first of what will likely be many positive vaccine data announcements. The sector is responding strongly to the removal of these overhangs, and hopefully will continue to do so.

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