Big Pharma throws out old models in the race to a Covid-19 vaccine

From research collaborations to changes to drug development, pharma will have to find new ways of working to discover Covid-19 treatments.

Corporate strategy

Given the sheer enormity of developing and distributing a vaccine against the coronavirus, the assistance of big pharma, with existing expertise and vast capacity, was always going to be required to pull off the massive feat of vaccinating the world.

What was less clear were the new processes and partnerships that would be required to get to that goal. 

Yesterday saw updates on two approaches to this herculean task. Johnson & Johnson laid out an accelerated development plan for its SARS-CoV-2 vaccine and Sanofi and Glaxosmithkline, two of the world’s biggest vaccine makers, announced a collaboration to put another vaccine into the clinic by the end of the year.

Initially it was small biotechs who were quick to tout new potential vaccines for the pandemic and they were handsomely rewarded by the markets despite no tangible evidence of their ability to bring a product to market.

It swiftly become clear that even if their efforts in the lab did bear fruit one limiting factor would be the capability to build or repurpose manufacturing infrastructure to deliver the billions of vaccines that will be required.

Working at risk

Yesterday, J&J claimed that it could potentially produce of hundreds of millions of vaccine by 2021, scaling up to billions by 2022. Sanofi and Glaxo forecast that they might be able to start human trials by the second half of the year, with the aim of a working product by the end of 2021.

To get to this point both companies are taking a massively risky approach in abandoning the usual linear method of development and are simultaneously preparing to increase manufacturing capacity alongside clinical trials. This is expected to cut the usual 10 year development time for a vaccine down to two or three.

The potential for failure with this process is significant, but reflects the high stakes here.

 

By manufacturing its lead candidate and two backup at risk, J&J expects to generate safety data for its lead candidate by the end of year, potentially leading to emergency use of the vaccine by early 2021.

In further departure from the standard pharma model, J&J, which is collaborating with Barda, is in talks with potential partners in Europe and Asia to expand manufacturing capacity, in recognition that a global problem will require a global solution.   

By pooling their manufacturing resources as the respectively biggest and fourth biggest vaccine makers Glaxo and Sanofi should also be able to help answer the call for huge manufacturing capability.

First do no harm

How companies indemnify themselves against potential claims of harm from any novel vaccine might also be a new consideration for pharma. 

J&J, Sanofi and Glaxo have assured that they will not be cutting corners when it comes to safety, but it is hard to see how the limited testing the groups will be able to carry out in their ambitious developmental timeframes will identify all potential toxicities. Particularly once a product that goes into millions or billions of people.

As such, companies trying to accelerate vaccine development will have to consider how, alongside protecting people against SARS-CoV-2, they will protect themselves against potential litigation. Deals to waive liability could well be sought with governments, as was previously seen in the swine flu outbreak. This could be particularly important for companies pursuing more experimental RNA-based vaccines, like Pfizer and Biontech, and Moderna, which has already started dosing people with its lead candidate.

What is emerging from the Covid-19 pandemic is that old ways of working will not get the industry to where it needs to be with coronavirus. Alongside the necessary multi-pronged development approaches to account for clinical failure, the need for sharing manufacturing, data, expertise, facilities and logistics will only increase in the coming weeks and months.

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