The Ethics of International Vaccine Distribution
At least 50 million doses of the AstraZeneca are sitting in American facilities unused.
There have been a plethora of articles in recent weeks and months lamenting the inequity and short-sightedness of the wealthy countries being first in line for COVID vaccines, leaving the developing world unprotected possibly for years to come. From a public policy standpoint, I’m sympathetic to those arguments but the political reality is that the citizens of the countries that paid to develop and distribute the vaccines would revolt if their health and economic recovery weren’t prioritized.
Thus, I initially rolled my eyes at the NYT headline “The U.S. Is Sitting on Tens of Millions of Vaccine Doses the World Needs.” But it actually points to a much more complicated moral dilemma:
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.
AstraZeneca is involved in those conversations.
“We understand other governments may have reached out to the U.S. government about donation of AstraZeneca doses, and we’ve asked the U.S. government to give thoughtful consideration to these requests,” said Gonzalo Viña, a spokesman for AstraZeneca.
About 30 million doses are currently bottled at AstraZeneca’s facility in West Chester, Ohio, which handles “fill-finish,” the final phase of the manufacturing process during which the vaccine is placed in vials, one official with knowledge of the stockpile said.
Emergent BioSolutions, a company in Maryland that AstraZeneca has contracted to manufacture its vaccine in the United States, has also produced enough vaccine in Baltimore for tens of millions more doses once it is filled into vials and packaged, the official said.
But although AstraZeneca’s vaccine is already authorized in more than 70 countries, according to a company spokesman, its U.S. clinical trial has not yet reported results, and the company has not applied to the Food and Drug Administration for emergency use authorization. AstraZeneca has asked the Biden administration to let it loan American doses to the European Union, where it has fallen short of its original supply commitments and where the vaccination campaign has stumbled badly.
The administration, for now, has denied the request, one official said.
Some federal officials have pushed the White House to make a decision in the next few weeks. Officials have discussed sending doses to Brazil, which has been hard hit by a worsening coronavirus crisis, or the European Union or Britain.
This is much more challenging. The politics are roughly the same: the vaccine will almost certainly be approved and Biden has every incentive in the world to reserve tens of millions of doses for his own citizens. Here, though, they could almost immediately go into the arms of people elsewhere while it could potentially take months for the vaccine to be approved for American use.
Of course, this dilemma would be avoided altogether if we had more sane drug approval policies. At a minimum, reciprocity with the EU and the UK would seem a no-brainer—especially in the midst of a public health crisis of this magnitude.
Given the reality that there’s no immediate prospect of releasing those doses to American citizens, though, I’m strongly inclined to release these doses to Brazil, Mexico, and others and count on ramped-up production to backfill the shortage by the time this vaccine is approved here.
The fact that they have not submitted results and requested approval is concerning. They have data sufficient for European approval. Why isn’t that enough for the US? Or did something arise post-approval they don’t want to share with the FDA?
This pandemic has pointed out some major flaws in the short-term-focused, selfish behavior that Capitalist countries adopt. Normally looking out solely for one’s narrow interest is effective, if not moral, but healthcare in general turns that notion on it’s ear.
When whole communities are left unvaccinated, those areas become breeding grounds for new variants and strains that will ultimately infect the people who selfishly kept vaccines for themselves – and ironically those vaccines may not be effective anymore because they chose to not share.
Point is, there’s a balancing act here. Just like with all things healthcare related, it’s not beneficial to the world to have a sick person preparing our food, even if we are not sick ourselves.
This is why capitalism and the free market are not appropriate for all socio-economic problems, and sometimes the government must step in with benevolence and simply do the right thing for the long term even if it is not profitable in the short term.
@MarkedMan: Thalidomide was never approved in America for morning sickness because we had tougher standards than some European countries.
@Teve: I’m not familiar with FDA pharmaceutical approvals but I am with the Medical CE mark for devices. We would often go for European approval first because we only needed to prove safety over there, rather than safety and efficacy. But even if the same is true for Pharma I don’t see how it would apply here. The results submitted for European approval showed three other vaccines have already been approve, two of them almost three months ago. But AZ haven’t even submitted for approval. There’s more here than meets the eye. One possibility is they are trying to get those doses released to Europe rather than their contractual obligated release in the US. Another is that post release data shows problems, or they have discovered flaws in the initial submission. I’m sure there are other reasons possible but regardless it seems very odd they are not asking for approval.
Distribution of the AstraZeneca vaccine has been suspended by Denmark, Iceland, Norway, Bulgaria, and other countries on safety grounds. I agree that richer countries, including the United States but not limited to the United States, should be subsidizing the distribution of vaccines that prevent SARS-CoV-2 not only moral grounds but on pragmatic ones. I don’t see how “herd immunity” can take effect unless we immunize enough people in the entire herd which is now the whole world. Just not the AstraZeneca vaccine until its safety is more assured than at present.
@David Schuler: Interesting. Perhaps that’s the reason they didn’t ask fo US approval. It could turn out to be unrelated but they are going to have to do the work
Just a quick comment without studying about the outcome… But recently the EU (or maybe the Italian gov’t) embargoed a shipment of vaccine paid for and bound for Australia. Australia sued in some international forum. Never heard the outcome. Saw headlines also last few days–apparently relaxing copyright on the vaccines would enable pharmaceutical industries in developing countries to make their own.
Who knew health care could be so complicated?
I was just speaking with a German student I’ve known for years- she graduated but I see her on occasion as she travels quite a bit. She’s just returned from the homeland and I asked how things were- the look said I shouldn’t have. “Everything is still locked down, aside from grocery/essential businesses…” and then she brought up AstraZeneca’s vaccine- how the people are avoiding it as there’s rumors it may cause blood clots, she was pretty pissed that the “rich” countries could afford the good vaccines- even Israel (yes, an homage to the still loathed Jews was tossed in there!)
Granted, her grandfather is pushing 80 and she’s concerned for his well being- but he nor many Germans will be taking the AZ vaccine due to said rumors. Anyhoo- she was definitely happy to be in DFW, where we’ve been open since last May, despite the piles of bodies laying all over the place……sorry, couldn’t help that one!
I wonder why you refuse to answer the following simple sanity test:
Who won the 2020 presidential election by 7 million votes?
Capitalist countries? Silly Leftist blithering as the entire history of the Soviets demonstrates.
Of course dictatorships can make choices that democracies can’t (see Russia).
Detroit turned down an allotment of J&J vaccine because it was seen as giving an African American population second best. Passing on the AstraZeneca stocks to third world countries with the blood clot issue open and without US approval would be seen the same way. Loaning them to the EU would be seen by poor countries as hogging them for European ethnics in rich countries and by the recipients as pawning off on them what we don’t want. Even if we reach a point that we have ample stocks and Republican driven vaccine reluctance is the choke point in the US, GOPs would attack Biden for giving away doses. Nasty little PR problem. Were I the administration I would certainly punt, at least until the safety/approval issue is resolved.
Given that the AZ vaccine has been given to tens of millions or more, it has certainly saved at least tens of thousands of lives already. Probably much more since it was given to the most susceptible and endangered first. The few cases of clotting that have been reported are concerning but they should be kept in perspective.
Of course the Trumpers will use this to say, “I told you so”, but like virtually everything else that comes out of their mouth, it makes no sense. On the one hand you have people trying to understand a disease and moving heaven and earth to fight it in the best way we know how, and on the other hand you have people so incapable of dealing with uncertainty they mindlessly follow the people selling certainty, latching onto the loudest, most certain and almost always, most uncoupled from reality of the bunch.
Hardcore Trumpers are to be pitied (and feared, inasmuch as they may gain power over rational people), but they shouldn’t be engaged*. To do so puts them on an equal footing against those who actually strive for truth and reason, and thereby pulls decent people down to their level.
*Making fun of them about something other than what they are blathering about is fair game, ala Michael. Although it will probably result in a derailed thread….
@gVOR08: Once we reach the 50% vaccination level I’m not sure this is going to be much of a problem, because at that point production will outstrip demand, and we will have hundreds of millions of doses we are committed to buying and fewer and fewer American arms to stick them in. My guess is that we will top out at 60-70% vaccinated, and then the freeloading Trumpers and anti-vaxers will feel safe enough to forego the vaccine entirely.
The problem with Detroit’s injunction on it is that the J&J (Janssen) vaccine is fine. It may even be superior, because it was tested against some of the variants that Pfizer and Moderna weren’t. All three vaccines will prevent hospitalization and death from Covid-19. And the most recent research I’ve seen indicates that the possibility of asymptomatic transmission by the vaccinated (with any vaccine) is lower than previously thought.
Full disclosure: I’m white; I’ve had the J&J vaccine, and was very happy to get it. Mass. General Hospital was giving it to hundreds of other people along with me that day.
@CSK: I agree with you. My agreement does nothing to change the perceptions of others.
@MarkedMan: Heaven”s Sakes I love this place.
The mayor of Detroit seems to have backtracked. Or clarified.:
Nah, he’s afraid to answer, so it just dead-ends. Bill comes here for the purpose of repeating lies – not interesting or original lies, but that’s to be expected. But his failure to answer the simple question I posed marks him as a particular sort of liar – he’ll lie freely except about the election results, because if he says what he wants to say he knows he’s completely discredited as a Q-nut, but if he tells the truth he thinks he’ll invite the wrath of his Orange Jesus, like Peter denying Original Jesus.
Lie and run away, that’s the Q style now.
@Michael Reynolds: wow Mike- there were 80 million dumber voters?
Thx for keeping it under 1,000 words of gin soaked dribble- that’s progress!
That anyone would brag about voting for a known supporter of segregation who constantly ridicules minorities and has a proven history of inappropriate touching of women is a bit weird…even for you!
The blood clot thing now!
So, as I said, you can’t answer the question. Noted.
@Comrade Bill: from the article:
My knowledge comes from what my doctors told me when I went on blood thinners, and what I read about the causes of my pulmonary embolism — so, it’s sketchy— but I’m pretty sure that having both bleeding and clotting is very odd.
We approved the other three with emergency approval, so we’re responding quickly and nimbly — I’m not sure I would put the blame on our drug approval policies.
I would hope that we are working with AstroZeneca to understand where their data is coming up short, and not just waiting for them to figure it out. That’s where we should be bending our approval policies (at this point our looser emergency approval policies), not just throwing the policies away.
The J&J vaccine took longer to approve, but was very quick by historical measures.
But, overall, we (the public) don’t have the information about why it is taking so long, and I’m not sure we should know — we want the drug companies and the FDA to be able ask questions without the questions being picked up in the media and become fodder for anti-vaxxers.
You are free to ask the FDA questions before submission and they will give you guidance, so I doubt that’s the problem. For something like a COVID vaccine I’m sure they would pull out all the stops to get answers out. And once you have submitted they respond in the form of questions, which in my experience are clear and direct. The fact that they haven’t submitted yet, after successfully submitting elsewhere indicates something else is going on. I would imagine it’s the clotting cases. The original data may not have brought that up as an issue, as it may have only became apparent with larger numbers. But now that they know about it they have to understand the scope and probably re-examine the original patient set and maybe do additional follow ups.
There is nothing odd or slow moving about this. Once the drug is released they are obligated to provide field data as well as that from the clinical trial. If that field data revealed unanticipated problems, they will have to explain them. That’s the correct way to handle it.
Also, I was around for Thalidomide. It hit the UK harder but my family knew a US family who had a catastrophically deformed child. I’m in no hurry to lower standards outside of emergency situations.
I am not sure about why this is – in Canada the AZ has been approved, but then an advisory came down not to give it to people 65 and over. In Ontario it is being given to people 60-64. We are way behind on distribution overall and are just setting up clinics now for the other vaccines for people 80 and up.
One thing to remember: vaccines don’t stay in the body long term. They trigger a natural immune response and then get metabolized and the immune response us what provides the protection. A few weeks later the original vaccine will be long gone, so it is HIGHLY unlikely any surprise long term effects can result from a vaccine.
@Gustopher: Just for the hypothetical discussion of both bleeding and clotting: There is a horrible, usually end-stage condition called Disseminated Intravascular Coagulation in which the platelets spark off the clotting effect in one’s entire vascular system and this depletes the clotting factors and so the patient bleeds uncontrollably.
You don’t want that.
This is usually toward the end of a long road and it’s almost certainly NOT what the article is referring to. But just for the record, yeah–it’s a possible thing biologically speaking.