In creating Operation Warp Speed, the Trump administration grasped the necessity of wartime procurement early on. The COVID-19 pandemic would be a war, and vaccines and treatments would be its weapons systems. To achieve superiority, the US needed to fund development of those weapons whether they worked or not, and the gamble would be worth it if we could just develop one superweapon to destroy the enemy.
As it turned out, we developed several, and a couple of those are close to getting emergency-use approval. We ate an investment in Merck’s candidate, which was the known fiscal risk for achieving victory as quickly as possible. But what about the one weapons system that has been stuck in limbo here in the US — but put to use around the world? The New York Times reports that the Biden administration has to decide what to do with 30 million doses of AstraZeneca’s vaccine, purchased in OWS but unable to get an EUA at the moment from the FDA:
Tens of millions of doses of the coronavirus vaccine made by the British-Swedish company AstraZeneca are sitting idly in American manufacturing facilities, awaiting results from its U.S. clinical trial while countries that have authorized its use beg for access.
The fate of those doses of AstraZeneca’s vaccine is the subject of an intense debate among White House and federal health officials, with some arguing the administration should let them go abroad where they are desperately needed while others are not ready to relinquish them, according to senior administration officials.
The number of manufactured doses actually runs much higher than 30 million. That count reflects the number of doses ready for shipment. Much more has been produced, but stuck in storage. This could represent enough vaccine in to vaccinate entire countries, although AstraZeneca does require two shots for maximum effectiveness. (In fact, part of the delay in the FDA process was the calculation of the first dose, which got screwed up in AstraZeneca’s initial Phase 3 tests.)
Vaccinating entire countries is what’s made the issue of the US doses so acute, in fact. AstraZeneca has not been able to keep pace on production in its overseas facilities, and it has missed key delivery goals, especially in the EU. Since the US has a plethora of vaccines coming into its markets from other manufacturers, they have asked the US to “loan” its inventory of AstraZeneca back to the company so that it can meet its delivery and vaccination targets in Europe.
The problem for the White House: who wants to be the president that gave its weapons system away when the war wasn’t entirely over?
The administration’s hesitation is at least partly related to uncertainties with vaccine supply before a benchmark of late May laid down by President Biden when he promised enough vaccine doses to cover every adult in the United States. Vaccine production is notoriously complex and delicate, and problems like mold growth can interrupt a plant’s progress.
Biden moved that date up to May 1 in his speech last night, perhaps making it even more difficult to take doses out of the distribution line — even theoretical doses like AstraZeneca’s. Biden has been arranging purchased of mass doses of the other vaccines, notably Johnson & Johnson’s Janssen vaccine, which might end up delivering enough on its own to vaccinate the whole country. The delivery of the new purchases have been promised more or less for the summer rather than the spring, however; the AstraZeneca doses are already produced, and could be delivered within days if the FDA issues an EUA for its use.
Oddly, AstraZeneca has not yet filed a request for that EUA — yet, anyway. That means the US cannot use these doses even though we own them regardless of whether their use would strategically benefit the US. Biden could try ordering AstraZeneca to submit its EUA application, or perhaps even order the FDA to take the data on its own and decide whether the vaccine meets safety and effectiveness standards.
That, however, has its own risks — as several countries have now discovered:
The coronavirus vaccine developed by AstraZeneca and the University of Oxford has now been suspended in a number of countries across Europe and Asia, following reports of blood clots in some vaccinated people. Many other nations, however, have defended their use of the shot and said they will continue their respective inoculation campaigns.
Thailand on Friday became the first Asian country to halt the use of the jab over safety concerns, shortly after Denmark announced a two-week pause to its nationwide rollout after reports of blood clots and one death.
In a setback to Europe’s ailing vaccination campaign, seven other countries have also suspended the use of the Oxford-AstraZeneca shot: Norway, Iceland, Bulgaria, Luxembourg, Estonia, Lithuania, and Latvia.
Austria and Italy, meanwhile, have said that they will stop using certain batches of the vaccine as a precautionary measure.
There is zero chance the FDA would push through an EUA with this as background, even if AstraZeneca submitted an application. And if the production expansion of Pfizer, Moderna, and J&J arrives as expected, there won’t be any need to push it — at least not for the US. On top of that, another OWS candidate might soon enter the battlefield:
The Maryland-based biotech company Novavax reported Thursday that its experimental Covid-19 vaccine is more than 96 percent effective in preventing mild and severe illness. …
The two-dose vaccine was found to be more than 96 percent effective against earlier strains of the virus circulating in the U.K., putting it on par with vaccines already in use from Moderna and Pfizer-BioNTech.
Effectiveness was slightly lower — around 86 percent — against the more contagious B.1.1.7 variant, which was first identified in the U.K. The variant has already been detected in nearly half of U.S. states, and the Centers for Disease Control and Prevention has predicted that it will be the predominant variant by the end of the month.
The Novavax vaccine was also 100 percent effective against the most severe forms Covid-19, regardless of the variant — much like the other vaccines in use in the U.S.
Their Phase 3 trial in the US has not yet finished, so Novavax can’t apply for an EUA until it does. That’s expected to be in the spring, which might mean that it’s a bit late too, given the massive procurement in the three approved vaccines by the Trump and Biden administrations. At this rate, though, Novavax might still beat AstraZeneca to the US market, and of course the global market will still be wide open.
So what do we do with tens of millions of vaccines we bought but we cannot use? The safe decision would be to hoard them just in case, but that would be out of character with the US’ reputation for charity. It seems clear that we will have enough vaccine doses already to vaccinate everyone in the US who wants to receive an inoculation (or two), and those doses are badly needed elsewhere. If we do eventually approve AstraZeneca, we have domestic manufacturing capacity to replace the “loaned” doses.
The Biden administration should arrange to help out Europe and Asia, at least for those countries still willing to use AstraZeneca — especially since the longer transmission of COVID-19 continues, the more variants it might produce that could render our current weapons systems ineffective. That is the smart strategy — forgoing a battle that’s already won to ensure we don’t lose the war.