Prashant Yadav, a supply chain expert and senior fellow at the Center for Global Development, said the biggest barrier to increasing the global vaccine supply is a lack of raw materials and facilities that manufacture the billions of doses the world needs. Temporarily suspending some intellectual property, as the U.S. proposes to do, would have little effect on those problems, he said.
There are currently no generic vaccines primarily because there are hundreds of process steps involved in the manufacturing of vaccines, and thousands of check points for testing to assure the quality and consistency of manufacturing. One may transfer the IP, but the transfer of skills is not that simple, said Norman Baylor, who formerly headed the Food and Drug Administration’s Office of Vaccines Research and Review, and who is now president of Biologics Consulting.While there are factories around the world that can reliably produce generic Lipitor, vaccines like the ones from Pfizer and Moderna — using messenger RNA technology — require skilled expertise that even existing manufacturers are having trouble sourcing.
Damian Garde, Helen Branswell & Matthew Herper
In such a setting, imagining that someone will have staff who can create a new site or refurbish or reconfigure an existing site to make mRNA [vaccine] is highly, highly unlikely, Yadav said.
The issue of patent waivers for vaccine manufacturing has sparked a lot of discussions, especially since President Biden has backed this proposal officially. Personally, this measure seems simplistic, considering the complex manufacturing steps of mRNA vaccines, constraints on raw materials (Brazil had to interrupt production of the AstraZeneca vaccine earlier this month due to a lack of ingredients), on trained staff and quality assurance (human errors at a US site producing both Johnson & Johnson and AstraZeneca vaccines already lead to millions of doses being discarded). Eliminating patents will not magically solve these other issues: Moderna publicly stated last October they will not enforce COVID-19 related patents during the pandemic, and the vaccine RNA sequence has also been reverse-engineered, yet no company or country took this opportunity to start manufacturing on their own.
The US is much better at exporting vaccine misinformation than actual vaccines https://t.co/UpnVpFg2HY
— Bryan Walsh (@bryanrwalsh) May 21, 2021
Looking at this cynically, it seems president Biden’s position is mostly intended to deflect attention from the fact that the US is still restricting vaccine and raw materials exports, despite several pledges and announcements – not to mention, with the exception of Moderna, all mRNA patents are held by European companies. Unsurprisingly, Germany and France oppose this proposal and called on the US to share more vaccines with the rest of the world.
Fortunately, there are some encouraging signs for increased vaccine production and distribution. BioNTech partnered with a Chinese company to produce some 1 billion doses in China; and the storage requirements for their vaccine have been relaxed further, allowing it to be kept in a regular refrigerator for up to a month, which should make it easier to distribute around the world. At the recent G20 health summit (notable for the absence of presidents Biden and Putin), Pfizer, Moderna and Johnson & Johnson pledged to supply around 3.5 billion Covid-19 vaccine doses at cost or discount to poorer nations until the end of 2022, while the EU pledged to donate 100 million vaccine doses in 2021. It is certainly possible that Biden’s support for patent waivers has to some extent forced the hard of pharma companies to agree to this compromise; hopefully, they can also fulfill these promises at the earliest.
Post a Comment