Latest COVID Conundrum: Accessibility of Vaccines (When They Are Available)

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Despite the challenges of addressing a previously unknown virus, development of an effective vaccine, soon, is a distinct possibility (see "Multiple Candidate Coronavirus Vaccines Being Developed According to WHO").  But as set forth in an article in Nature on Monday ("The unequal scramble for coronavirus vaccines — by the numbers") by Ewen Callaway, there is a legitimate concern that such vaccines may not be equitably accessible based on medical need.

The issue is a practical one:  how to produce enough doses in a short enough time to be effective in stemming the pandemic and delivering these doses where they are most needed.  Some of this is simply math:  as the subtitle of the article notes, "[w]ealthy countries have already pre-ordered more than two billion doses").  These are, as may be expected, countries like the U.S.  ("By mid-August, the United States had secured 800 million doses of at least 6 vaccines in development, with an option to purchase around one billion more") and UK ("the world's highest per-capita buyer, with 340 million purchased:  around 5 doses for each citizen"), as well as EU nations and Japan, Brasil, and Indonesia.  These statistics are illustrated in a graphic provided in the Nature article.

Of course, these statistics fly in the face of the need, recognized by public health officials, that the pandemic will not be quelled until it is eradicated globally; after all, the days when diseases like COVID-19 can be limited to one region of the globe ended with international air travel and global mobility.  The article captures these sentiments (and the realities behind them) by quoting Tedros Adhanom Ghebreyesus, the director of the World Health Organization (WHO) as saying "We need to prevent vaccine nationalism."

And this form of at least attempted vaccine hoarding is not new; as the article notes something similar happened in 2009 with the H1N1 influenza vaccine, but the severity of the COVID-19 pandemic raises the stakes on this type of behavior dramatically.

There are several international organizations mobilizing to reduce this threat, including Gavi ("a Geneva-based funder of vaccines for low-income countries"), the WHO, and the Coalition for Epidemic Preparedness Innovations (CEPI), "a fund based in Oslo that was created to finance and coordinate vaccines for outbreaks," in support of the COVAX facility in an effort obtain vaccine supplies for the rest of the world.  Their goal is 2 billion doses of COVID-19 vaccines, with half of that amount targeted to "92 low- and middle-income countries and economies (LMICS)" and the rest to 75 "wealthier" countries (these countries are expected to pay for these doses).  Efforts by the COVAX group to date have amounted to 300 million doses of the vaccine developed by the University of Oxford, according to Mr. Calloway's article.  But the estimated cost of the desired 2 billion doses ($18 billion, or $9/dose) makes financing the effort a daunting task.

There are any number of ideas on how to address the problem, including (not unexpectedly) permitting countries to impose compulsory licenses that would enable manufacturers in each country to make the vaccine.  There are alternatives that vaccine makers could pursue (such as partnering with domestic manufacturers in each country having the industrial capacity to do so) but such schemes may be premature in view of the present non-existence of an effective vaccine.  And as the article notes, these are only effective if there are patents protecting the vaccine product; it is difficult if not impossible to impose such licenses on trade secrets for example.  With a firm grip on the realities of vaccine development not often heard in such debates, Mark Feinberg, head of the International AIDS Vaccine Initiative in New York City is quoted in the article as saying "Patents and intellectual property are not what's standing in the way of fair distribution of COVID-19 vaccines; rather, equitable access and affordable prices require collaboration between governments and vaccine makers."

The article optimistically asserts that 10 billion doses could be available by the end of 2021; this would require that "all of the frontrunner candidate vaccines are approved" (emphasis added), which is unlikely, and Jeffrey Almond, who is a vaccinologist and visiting scholar at the University of Oxford is quoted in the article as saying such estimates are "a guestimate" based on assumptions that are "overly optimistic."  Other, perhaps more realistic estimates (produced by Airfinity, a London life-sciences market analytics firm) estimates 2-4 billion doses by the end of 2021.

And of course the article reminds us that how many people these dose estimates will vaccinate depends on the number of doses needed; for many of these vaccines are expected to need 2 doses to provide effective immunity, although some companies (including Johnson & Johnson and AstraZeneca) are attempting to produce a one-dose vaccine.

These efforts are perhaps almost as big a challenge as producing the vaccine, which is constrained by biology and understanding of that will be needed to make an effective vaccine.  Distribution involved logistics, industrial-scale manufacturing, and perhaps most importantly the international politics, which has not proven to be either predictable, reliable, or particularly transparent in recent times.  Nevertheless, as this Nature article illustrates, perhaps now is the best time to begin to address these issues; once a vaccine is available it will not get any easier.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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