As a scientist leading a company focused on RNA, I have cheered Pfizer, BioNTech, Moderna, and others as the biopharmaceutical industry raced to create vaccines that will end the tragic loss of life and the economic devastation wrought by Covid-19.
So far, two Covid-19 vaccines, one from Pfizer/BioNTech and one from Moderna, have been approved by the FDA under emergency use authorizations. Both are RNA-based vaccines that show strong efficacy and few side effects. Other vaccines, using other technologies, have been approved for use in other countries.
While RNA science has been developing for two decades, this is the first time we have needed to make billions of doses ASAP. Ingredients for these mRNA vaccines that were stockpiled in advance of FDA approval will be enough to cover the first billion doses or so. Bottlenecks will emerge after that.
I’d like to help. My company and others can, in fact, help by breaking a number of production bottlenecks with our technologies, facilities, and staff. But for now we can only stand by because we don’t know what the bottlenecks are. We do know one thing: Our help is needed — no one company can solve this alone.
Stumbles in delivery have already emerged across two types of vaccine. Pfizer, maker of the first RNA vaccine to be approved, cut its 2020 production forecast from the original 100 million to 50 million doses. AstraZeneca, which recently received approval to roll out its adenovirus vaccine in the United Kingdom, lowered its production targets from 30 million vials to 4 million vials by the end of 2020. Several other companies are expected to release the results of their Covid-19 vaccine trials soon and seek approval for them, with unknown manufacturing schedules.
To speed production, governments and other biotechnology companies need to know where the problems are. With that knowledge, we could turn out tens of millions of doses in short order. If RNA vaccines continue to be the most effective against the virus, the pressure to ramp up worldwide production for them will be intense.
But companies across the RNA vaccine supply chain are not being transparent about the problems they face in production and delivery.
Now is not the time for those involved in developing and manufacturing Covid-19 vaccines to hold their cards tightly to their chests. We must work together and commit to helping each other: Our enemy is the virus, not our business competitors. We welcome the offer by Ugur Sahin, CEO of BioNTech, to cooperate with other companies. The entire industry needs to work together.
It is fully understandable that companies built on the sweat and dollars of hard-won research and development, like mine and many others, hesitate to open up on the pain points in their processes. In this pandemic, though, social good must override profit goals. But it’s unlikely this will emerge from grassroots organizing by biotech companies. Only the government can truly gather the industry together.
In the U.S., President-elect Biden’s advisers have said he will enlist the Defense Production Act to speed vaccine production. He should go further and create a coordinating council of relevant companies working together for the public good, as well as explicitly state that deep coordination among industry players won’t trigger antitrust investigations.
The nascent global supply chain, now pressed to scale to billions of doses of Covid-19 vaccines, has just a few producers of many key ingredients and needs our collective brains and brawn to expand rapidly enough to defeat this pandemic.
Nucleotides, the building blocks of RNA vaccines, are widely produced and consumed in food and beverages. But there are only a few manufacturers that make pharmaceutical-grade nucleotides for medical use. Most RNA vaccine producers rely on Roche Pharma as the major supplier to the world market.
RNA is fragile and needs to be wrapped in lipid nanoparticles, an oily protective layer that enables delivery of messenger RNA. Yet there are relatively few producers of lipid nanoparticles. I believe there are only two of scale in Europe. Recent reports suggest that Pfizer halved its 2020 production estimate after encountering challenges securing enough high-quality lipid nanoparticles. It may be possible to trade off one supply-constrained ingredient against another. Developing the right lipid nanoparticle, for example, boosts the effectiveness of smaller doses of the vaccine, thus requiring less RNA and therefore fewer nucleotides.
Capping agents — a kind of book cover telling the body where to start reading RNA — come in chemical and enzyme format. There are several suppliers of the enzyme format, but just one supplier — Trilink — of chemical capping agents.
It is in the self-interest of biotechnology and pharmaceutical companies to cooperate on the production of Covid-19 vaccines. Although the largest ones stand to profit handsomely under the current set up, if they don’t move quickly enough, the economies of the world will lose trillions of dollars more and these companies will be quickly transformed from heroes to villains.
Manufacturing RNA vaccines is a complex process that involves multiple ingredients, each of which can face numerous bottlenecks. If businesses across the vaccine supply chain work together and we harness companies and scientists everywhere to unleash our individual and collective ingenuity, we can supercharge production and vaccinate the world.