I can’t help suspending my usual deep cynicism about the pharmaceutical culture and its political economy today, even though there are real reasons for pessimism amongst what appears to be wonderful news. I can’t help myself thinking that I am just so desperate for something to latch on to with regard to halting COVID that I am prepared to put some faith into us doing the right thing in terms of access and equity. We have two developments to cautiously celebrate in the last 24 hours, albeit these being a COVID treatment and vaccine so far grounded on relatively small-scale studies. It is early days, but it seems good news.
Despite the need for more data it appears that we might have a very effective treatment and a viable vaccine, all announced on July 20th. The first development was for a beta interferon protein-based therapy, which has been used with nebulisers directly into the lungs of COVID infected patients. Even though the trial cohort was small (some 100 patients), the double-blind study found that the biologic drug cut the need for ventilation of acute cases by 79%, and reduced time to recovery and eased breathlessness. The therapy triggers a strong anti-viral response.
The Southampton based firm, Synairgen, developed the treatment, although beta inferno is a generic biologic and off patent. The trial lead, Professor Tom Wilkinson, is a respected and cautious respiratory physician and scientist, yet he described the Phase 2 results as a 'major breakthrough'. Although yesterdays announcement was a stock market notification and not the publishing of trial data in a scientific outlet or format, I think that this is truly promising. Even so, scaling up the production of biologics is notoriously complex, and all this will take time. Synairgen are speaking to only some couple of hundreds of thousands of doses being available by autumn. Hopefully, the firm will be rewarded for their efforts and the therapy will be licensed at little cost for generic roll out. Is it stupid to assume that patents and medical nationalism will not come into play?
Yes. Here for some cynicism. The stock market price rose some 460% on yesterday’s announcement, and I forecast a rapid acquisition of the small pharma-biotech outfit in the near future by a pharma giant. It is the way it goes. One promising blockbuster therapy is enough to secure a takeover of small boiotech and pharma firms in the billions. If patents come into play then access and equity will be an issue, and this despite the generic status of beta interferons. Will data describing method for delivery and so on be released? If not, there are serious questions about where, how and who will be able to produce the drug.
Following on the heels of this was the publication in The Lancet of the results of the Oxford University and Astra Zeneca vaccine (the Oxford vaccine). Again, initial results should be treated cautiously, but the 1000 cohort trail saw impressive results. The vaccine has manageable side effects and is well tolerated. It produced an immune response in 90% of those receiving the vaccine, generating both T cell and antibody responses. How long this immune response will last is unclear at present. But the publication seems to confirm simmering optimism about its efficacy over the last months.
The vaccine may be available for restricted release in the autumn to December. The issues of patents, licensing and equitable access again loom large. The world needs over 6 million doses and many countries and people cannot afford to pay either inflated or marginal cost of production prices. Two announcements should give some cheer (I think). Astra Zeneca has said it will not seek to profit from a successful vaccine during the pandemic, although the lure of monopoly production and pricing would be great. There also appears to already be deals made about producing the vaccine at multiple sites and licensed producers in parallel. Second, Matt Hancock, the hapless UK Minister for Health, announced in Parliament yesterday evening that access would not be limited by ‘narrow nationalism’. It would be the UK’s gift to the world was the strong sub-text of an unusaully confident speech. However, news emerged that the UK government had struck a deal to secure early access to 90 million doses of the vaccine.
The signals are all mixed here. This should be shared as widely as possible and steps should be undertaken to create additional vaccine plant capacity to ratchet up production of this or any successful COVID vaccine. We cannot afford to cut production of childhood vaccines such as MMR in order to head of COVID. The investments required will be huge, but will be small compared to the costs of not making vaccine coverage universal. Something also has to change in the production and development of these therapies and the reward system that the pharmaceutical system has come to rely on for super profits. R&D has been a real success story of the pandemic. Life science has got busy and really dramatically shrunk the normal pipeline for the development of a therapy or vaccine to almost nothing. This at least is worth celebrating, as is the fact that we appear, cautiously, to at the gates of cures and prophylaxis.