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COVID-19: ‘Secret sauce’ of mRNA vaccines to be revealed?
Pharmaceutical giants, aka “Big Pharma”, are protected by undisclosed trade secrets and patents. An exclusive group of drug makers has ensured that rich countries can lay claim to most of their miracle drugs — while limiting the number of companies that can also produce the vital vaccines.
America follows an advanced system and strict laws to protect the intellectual property (IP) of its most innovative companies from copycats or knockoffs. But with COVID-19 vaccines, the US has made a sweeping policy U-turn by supporting a vaccine patent waiver proposal at the World Trade Organisation (WTO).
In effect, the move announced late on Wednesday (out on Twitter on Thursday), allows other pharma companies within and outside the US to make copies of the most advanced COVID-19 vaccines, notably the mRNA shots.
On May 5, 2021, US President Joe Biden threw his support behind waiving IP rights for COVID-19 vaccines, in a landmark decision. World leaders lauded the US move.
Biden’s support for a waiver — a sharp reversal of the previous U.S. position — is historic. It was followed swiftly by a statement from his top WTO negotiator, Ambassador Katherine Tai.
The most well-known types are copyrights, patents, trademarks, and trade secrets.
US response to global health crisis
Ambassador Tai stated:“This is a global health crisis, and the extraordinary circumstances of the COVID-19 pandemic call for extraordinary measures.” Her statement came amid growing concerns that big outbreaks in India could allow the rise of vaccine-resistant strains of the deadly virus, undermining a global recovery.
President Biden and drugmakers had been facing demands from activists and global leaders to suspend IP rights cover for vaccines as pandemic-driven deaths and infections rise, even as the world faces the worst economic downturn in decades, triggered by vicious cycles of lockdown and infections.
Such a policy would waive the IP rights of vaccine makers to potentially enable companies in developing countries and others to manufacture their own versions of COVID-19 vaccines.
Countries suffering from a massive spike in new cases — including India and South Africa — have pushed for the waiver. In India, now facing a “COVID tsunami”, it was reported recently that less than 2% of the population had been vaccinated. New COVID cases are at record highs globally, as the pandemic rages unchecked in many poor and middle-income countries.
In effect, the US government is now saying that the intellectual property (IP) protection for the COVID vaccines — especially the mRNA shots developed by US researchers dubbed as “incredibly effective”, but not widely available — will now be “open-sourced”.
The move is dubbed “monumental”. But that means super-profits expected by the companies behind it may no longer be realised. But the flipside could potentially end the pandemic sooner, instead of later.
It’s not the first time that it happened.
In 1921, soon after Federick Banting discovered that insulin could be used to treat diabetes, he sold the patent to the University of Toronto for about a dollar. (Banting later won a Nobel prize, as his discovery meant a life-saving drug could become widely available.)
With the IP waiver, “generic” or lower-priced mRNA shots made by third parties could theoretically become more widely produced by a network of second-tier vaccine makers closer to where they’re needed, where they could also be delivered much faster.
This raises the “soft power” and do-gooder profile of America — but would incense the CEOs of its biggest pharmaceutical companies, notably Pfizer, Modern and Novavax.
mRNA ‘secret sauce’ will now be known?
Moreover, the move will, in theory, make the “secret sauce” to the revolutionary mRNA vaccine technology — such as how “lipoprotein nanoparticles” (LNPs) are used to deliver mRNA to target cells to boost immunity — known to other drug makers, who until now have no idea how it’s made using the Kariko-Weissman technique.
In declaring IP waivers for the COVID-19 vaccines and therapies, the Biden government has made a bold policy decision that could end the pandemic sooner.
The US evaluation regime for new drugs is one of the most advanced, due to the independence of its scientists as well as massive government support for research and development. Stringent rules also govern clinical trials of new drugs/vaccines, manufacturing and post-distribution.
It’s not immediately known what part of the mRNA vaccines will be “open-sourced”. Tesla, a US-based EV maker, has also open-sourced much of its car-making techniques, except the self-driving AI software.
It’s not clear how the move would hasten the production and distribution of badly-needed COVID-19 vaccines, especially for the developing world, given the WTO process can be tedious. Ambassador Tai cautioned deliberations would “take time” but that the US would also continue to push for increased production and distribution of vaccines – and raw materials needed to make them – around the world.
Shares in vaccine makers Moderna Inc and Novavax Inc dropped several percent in regular trade, although Pfizer Inc stock fell only slightly.