The crucial third party players in the pandemic fight
Good afternoon, readers.
Drug development and drug manufacturing aren’t exactly the same thing. Research for the development of innovative new compounds may begin in the halls of academic institutions, proceed to collaborations with pharmaceutical companies, and then reach even further into other links in the supply chain who help scale up the production of a pharmaceutical product.
That last part is, for obvious reasons, extremely important in the midst of a pandemic. You need to ramp up manufacturing, whether that be replicating a substance in bulk or helping put a COVID vaccine or therapeutic into a vial, to facilitate a global immunization campaign. And that’s where contract manufacturers such as Catalent, Lonza, and Emergent BioSolutions come into play.
Those may not be household names, but these firms are on the frontlines of the pandemic fight in one way or another, as I explore in my most recent piece on how COVID vaccine production works on the ground level.
Take it from Moderna, one of the first companies to gain FDA authorization for its mRNA technology-based coronavirus shot.
“For us, with mRNA in particular, I would say, the contractors are an especially critical path upfront as suppliers, to help with our processes,” says Ray Jordan, chief corporate officer at Moderna and a veteran of both Pfizer and Johnson & Johnson.
“And then downstream to things like fill and finish, which is where once you have your drug substance and you’re then trying to get it into, you know, the usable vials and so on, that process is not one that we have. So, we’re entirely dependent on contract firms for that.”
Read my full report here. And then read on for the day’s news. Back to David Z. Morris tomorrow.
Omada care program aims to cut down on doctor visits. Digital health firm Omada has launched a new service to attempt to cut down on the need for primary care doctor visits through a care program that provides access to virtual doctor appointments in between physical ones. The company describes it as an integrated model that can keep tabs on patients' changing health metrics and potential need for shifting medications. It also says that such a system could both cut down on the hassles faced by patients and on health care costs by helping catch medical issues earlier. (MobiHealthNews)
The future of mRNA vaccines in Europe. My colleague David Meyer provides a fascinating look into the future of mRNA technologies in drug development. As David reports, Europe may very well move away from adenovirus-based COVID vaccines such as AstraZeneca's and Johnson & Johnson's following blood clot concerns to focus solely on administering mRNA-based vaccines such as Pfizer/BioNTech's and Moderna's. “We need to focus now on technologies that have proven their worth,” she said European Commission President Ursula von der Leyen in a statement. “mRNA vaccines are a clear case in point.” (Fortune)
Questions continue to loom over Russia's Sputnik vaccine. Nearly 60 nations have signed up to use Russia's Sputnik COVID vaccine. But that doesn't mean the dust has settled (as with other vaccines) on just how many others will join - and that's an issue that almost certainly plays into geopolitics. EU officials are still combing through the clinical data before recommending it in the region, while Russian officials have fired back that there's political bias fueling those decisions. (Fortune)
THE BIG PICTURE
Feds announce new mask guidelines for workers. There are, yet again, new federal guidelines on masks more than a year into the pandemic. The guidance is meant to facilitate getting new N95 masks to frontline health care workers, rather than recycling available ones after proper decontamination. This is in part meant to address a flip in the supply-demand relationship; the early days of the pandemic saw a huge glut of available N95 masks, especially as they were triaged specifically for health workers. Now, the flood gates may open up a bit more with the new FDA and CDC guidelines while giving a boost to mask makers themselves. (ModernHealthcare)
5 ways the EU's dreadful COVID vaccine rollout harms the global economy, by Bernhard Warner