Cambridge trio accelerate COVID-19 initiatives
From the White House to the wider world, a triumverate of global BioMedTech heavyweights with Cambridge Cluster roots – AstraZeneca, Gilead Sciences and Sanofi – this week strengthened their credentials as potential saviours in the global campaign to eradicate COVID-19.
The trio’s vaccines and drugs to battle the coronavirus took centre stage – not least because US President Donald Trump was dosed with Gilead’s remdesivir in a cocktail of treatments after succumbing to the virus. Gilead’s local operations are at Granta Park.
Cambridge headquartered Big Biotech AstraZeneca saw Japan become the latest country to back a renewal of manufacture for its vaccine developed with Oxford University.
And Sanofi, with operations in Haverhill, joined partner GSK to reveal that they will provide up to 300 million doses of their own proprietary COVID-19 vaccine candidate to the European Union.
Gilead recently decided to ramp production of remdesivir and rapidly expand the supply of the investigational antiviral drug.
Gilead says it is meeting real-time demand for the drug in the US and anticipates meeting global demand this month – even in the event of potential future surges of COVID-19.
The company’s distribution deal with the US government is now being widened through direct distribution to hospitals. To date, remdesivir has been approved or authorised for temporary use as a COVID-19 treatment in some 50 countries worldwide even though it has not been approved by the U.S. Food and Drug Administration for any use, and its safety and efficacy have not been established.
There is no evidence that lives have been saved with the anti-viral remdesivir. Like monoclonal antibodies remdesivir is likely to have its biggest impact early on in the course of an infection.
Also this week, the Phase I/II clinical trial for the Oxford University-AstraZeneca COVID-19 vaccine AZD1222 has resumed in Japan after discussion with the Japanese Pharmaceuticals and Medical Devices Agency.
A standard review process triggered a voluntary pause to vaccination across all global trials on September 6 to allow review of safety data by an independent committee.
The recommendations have been supported by international regulators in the UK, Brazil, South Africa, India and now in Japan, who have deemed that the trials are safe to resume.
AstraZeneca continues to work with the Food and Drug Administration to facilitate review of the information needed to make a decision regarding resumption of the US trial.
Sanofi and GSK finalised and signed this week an advanced purchase agreement with the European Commission for the supply of up to 300 million doses of a COVID-19 vaccine, once it is approved.
The vaccine candidate is based on the recombinant protein-based technology used by Sanofi to produce an influenza vaccine and GSK’s established adjuvant technology.
The EU will provide upfront funding to support the scale-up of Sanofi and GSK manufacturing capabilities on European soil. The antigen and final vaccine doses will be manufactured in European countries, leveraging Sanofi and GSK’s industrial sites in Belgium, Italy, Germany and France.