Monday, March 30, 2020

Coronavirus crisis. When, if ever, will a vaccine be widely available?

There would seem to be good prospects for safe and effective vaccines against the SARS-CoV-2 [COVID-19] coronavirus.

First, numerous teams of scientists are working in parallel, applying diverse approaches to the problem. According to Dr. Stanley Plotkin, inventor of the rubella vaccine,[1] at least forty possible vaccines are already under development. Besides European and North American biotech companies, Chinese, Indian, and Japanese companies are now in the race. China alone is developing nine potential vaccines.

In addition, the Oslo-based Coalition for Epidemic Preparedness Innovations is funding several research efforts by non-commercial organizations.[2] Non-commercial projects are of special value, because they are not bound by the commercial secrecy that impedes cooperation among scientists working for different companies.

The Boston-based company Moderna has already begun a first-phase clinical trial of an RNA vaccine – a new type – on human subjects.[3]

Second, the evidence so far indicates that the virus is slow to mutate. Genetic differences among the strains that have emerged in different countries are slight. This greatly simplifies the task. Any vaccines developed to protect against the virus in its current forms will probably remain potent for a considerable period.  

Third, the SARS-CoV-2 virus is new but not completely new. It bears some similarity to other coronaviruses and especially to the SARS coronavirus of 2002—2003 (this is why it is labeled as SARS No. 2) and also to the MERS coronavirus of 2012—2014. This family resemblance to viruses that have already been studied facilitates the search for a vaccine.[4]  

Squandered advantage

However, much of the advantage that this family resemblance could have given was squandered when research into SARS and MERS was discontinued after the corresponding epidemics ended. In particular, Dr. Maria Elena Bottazzi and her team at Baylor College of Medicine and Texas Children’s Hospital Center for Vaccine Development developed early vaccines against SARS and MERS but in 2016 were unable to obtain funding to conduct clinical trials. Such trials that would have given a head start to current work on a SARS-CoV-2 vaccine. Researchers would already have some idea of how humans react to one class of possible vaccines against members of the SARS family of coronaviruses.[5]

Why then was ‘no one interested’ in funding trials of these vaccines? Presumably, funders saw little if any point in developing vaccines against viruses that had apparently disappeared and seemed unlikely to return. That attitude would have reflected not only a poor understanding of the science but also a narrowness of vision typical of a profit-driven society, in which decision makers see no palpable advantage in contributing to a broadly conceived research program. 

It is precisely such a program that we humans need in our present predicament. To quote another scientist[6]:   

We need coordinated research, worldwide, on virus illnesses, to be prepared for the next mutation. It will be impossible to cover all possible variants, but we would be much closer to a new mutation than we are now.

This makes good sense. A socialist world community would do it that way. But is such a high degree of global coordination feasible in a world of competing producers and rival nation-states?

Delay, delay

The time needed from the start of research on a new vaccine until it is marketed is commonly estimated as 12—18 months, although many commentators say that it could easily take two years and some give an upper limit of three years or even longer. Dr. Plotkin recalls that ‘it took at least five years before a vaccine [for rubella] was on the market’ and adds: ‘We cannot afford to have that kind of delay in an emergency like this one.’ He urges companies to ‘go into superaction’ immediately, with a view to having a vaccine available in the event of a second wave of the pandemic next winter – that is, within about 8 months. 

One major reason why the process takes so long is the number and duration of the clinical trials required to get a vaccine licensed by regulatory agencies like the US Food and Drug Administration. The official purpose of licensing is to ensure the safety and efficacy of drugs and vaccines. In practice, the FDA was long ago ‘captured’ by the companies it is supposed to regulate, with most of the scientists who sit on its advisory committees dependent on those companies.[7] FDA decisions therefore tend to reflect the interests of the companies that have the most political clout at the time.  

Monopolization and extortion

Another recommendation made by Dr. Plotkin is that the FDA should license not one but several vaccines against SARS-CoV-2, ‘because if we need millions of doses a single manufacturer will not be able to make enough for the world.’ This too makes good sense. Or at least it would if production were carried on to satisfy human needs. However, we live under a global system in which production is for profit. 

How then does a company that develops and produces vaccines act in order to maximize its profit? It seeks to monopolize the market for a vaccine against a specific disease by ensuring that its vaccine – and its vaccine alone! – is licensed. Then it applies for a patent on its vaccine – another significant cause of delay. Monopolization sets the scene for extortion. The company sells its vaccine at an exorbitant price that makes it unaffordable to most of those who need it.   

How many times this has happened in the past! A few years ago, for instance, the Joint Committee on Vaccination and Immunization, one of the committees that advises the British National Health Service, recommended that a new vaccine against Meningitis B manufactured by Novartis NOT be made available to all children in the UK, even though this terrible disease afflicts 1,870 people per year. It was ‘highly unlikely to be cost effective’ – in other words, it was too expensive.[8] And this in a country that for over seven decades now has had what ‘progressive’ Americans politicians call ‘Medicare for All’! Vaccines against the scourge of viral hepatitis are likewise too expensive for large-scale use.[9] 

Indeed, there has already been an attempt to monopolize a future SARS-CoV-2 vaccine – one that does not yet even exist. In mid-March, the German press reported that the Trump Administration was trying to secure exclusive rights to any vaccine created by the German pharmaceutical company CureVac. Research and development would then be moved to the United States and the vaccine made available only in the United States.[10]

Notes

 [1] Interviewed here.

 [2] As of March 21, six projects. See http://cepi.net/news_cepi.


 [4] See the article by researchers at La Jolla Institute for Immunology in the March 16 online issue of Cell, Host and Microbe.

 [5] https://www.independent.co.uk/news/world/americas/coronavirus-vaccine-cure-doctor-peter-hotez-covid-19-us-trump-congress-states-a9378001.html. For a detailed assessment and references to articles by members of the Bottazzi team, see comments by pharmaceutical engineer Christopher C. VanLang on the question-and-answer website quora.com.  

 [6] Physicist Cees J.M. Lanting on the question-and-answer website quora.com.

 [7] This includes scientists directly employed by companies, scientists working for them on contract, and the many university scientists who depend on corporate money to fund their research. In fact, there are so few genuinely independent scientists that the FDA would be unable to rely mainly on them even if its leading officials wished to do so. 

 [8] 10% of victims die, while many survivors become deaf or blind or have to have limbs amputated (The Independent, July 24, 2013; Daily Mail, August 24, 2013). 

 [9] Vaccines exist for types A and B of this disease. See here. For a discussion of the availability of vaccines in underdeveloped countries, see here.

 [10] The Washington Post, March 16. 

Stephen Shenfield
http://www.wspus.org/2020/03/coronavirus-crisis-when-if-ever-will-a-vaccine-be-widely-available/

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