[CTC] Developing countries can make the mRNA vaccines they need AND HIV or COVID-19, inequity is deadly

[Arthur Stamoulis]

Two important pieces below from Achal Prabhala, Alain Alsalhani and Winnie Byanyima…


https://rdcu.be/cF5Bp <https://rdcu.be/cF5Bp>

Developing countries can make the mRNA vaccines they need 

To the editor — Since the start of the COVID-19 pandemic, it has been clear that vaccinating the world is not only a moral priority, but also an epidemiological necessity to break the cycle of infections and mutations. Despite an impressive increase in global production towards the end of last year, we failed to produce enough doses to cover the world through most of the year, as well as to distribute those doses equitably across countries.

One year after vaccines became widely available, in January 2022, the world’s low-income countries remain largely unvaccinated, whereas high-income countries are rushing to administer third doses of mRNA vaccines in response to Omicron. Although Omicron seems to result in milder infections and fewer critical cases, it substantially escapes antibodies induced by existing vaccine doses — hence the turn to booster doses. Moreover, we face the possible emergence of new variants that may both escape immunity and be more aggressive. To withstand Omicron and prepare for future threats, the world needs to produce enough doses of the most effective, adaptable and rapidly manufacturable vaccines we have: mRNA vaccines, which have been delivering on all these fronts for the past year.

Until now, mRNA manufacturing has been controlled by three companies and their contract manufacturers, almost all of which are based in North America and Europe. This needs to change. Access to this key resource must be geographically distributed to facilities in Asia, Africa and Latin America. This would allow every region of the world to be equipped as quickly as possible with the best available defence, now and in the future. Worryingly, there is no sign that this solution will become our reality.

Why the focus on mRNA vaccines? Among the vaccine technologies on offer, the mRNA platform involves routine biochemistry — unlike traditional vaccines, which rely on biology and the production of cell-based components. This means that mRNA vaccines are easier to make. In fact, they already are being made by pharmaceutical manufacturers with no previous experience in biological pharmaceutical agents (such as Rovi, in Spain), which expands the number of companies that can potentially make them. In a recent report1, we found that over 100 companies in Asia, Africa and Latin America could manufacture mRNA vaccines, given that they currently manufacture sterile injectable products, a family of pharmaceutical products that are an indicator of potential ability to make mRNA technology.

This also means that mRNA vaccines are faster to make. It took between three and seven days to manufacture a batch of the active ingredient for the Pfizer–BioNTech vaccine, as compared to two months for an equivalent batch of the AstraZeneca vaccine2.

With the Omicron variant surging, mRNA vaccines are crucial to both the current, as well as the future, response. Data suggest that the two mRNA vaccines in use — those from Pfizer–BioNTech and Moderna — show better results as boosters than do other vaccines3. Additionally, as the need for a reformulated vaccine grows in response to Omicron, mRNA technology offers distinct advantages. In the recent
past, it took Moderna 30 days to prepare a reformulated version of its vaccine for trials, as compared to 5 months for a reformulation of a biological vaccine4.

Distributing the production of mRNA vaccines across the world would serve both low-income and high-income countries. This requires Pfizer, BioNtech and Moderna to engage other capable companies in the developing world, which they have shown few signs of wanting to do. The US and German governments (who funded the development of mRNA vaccines) can do much more to encourage these companies to work with others. But international organizations aiming to increase vaccine equity also have a responsibility to more accurately understand the contours of the problem they are trying to solve, so that they can find solutions that are hiding in plain sight.

Their failure is that they think of mRNA manufacturing capacity in the developing world as something that has to be built, rather than something that already exists. When the Coalition for Epidemic Preparedness Innovations estimated vaccine manufacturing capacity across the world, they did not fully account for the differences between biological and mRNA vaccines, and thereby excluded the largest share of potential manufacturers of mRNA vaccines: manufacturers of sterile injectable products. In another instance, the World Health Organization invited expressions of interest from companies to join a series of continental mRNA manufacturing hubs; however, without any encouragement to sterile injectable manufacturers to apply, very few did — thereby reinforcing the misguided idea that mRNA vaccines can be made only by companies that are already making biological vaccines.

In the nearly two years that we have lived through the coronavirus pandemic, we have thought of mRNA vaccines as a luxury that only a few can make and have. But an examination of the evidence will force us to acknowledge that the opposite is true, and this conclusion has the potential to end the pandemic everywhere. Prolonging the delusion that companies in countries of the developing world are not ready to make mRNA vaccines may serve a handful of corporations, but it harms the world. 

Achal Prabhala1 􏰁 and Alain Alsalhani2 􏰁 1The AccessIBSA project, Bangalore, India. 2Vaccines and Special Projects, Access Campaign–Médecins Sans Frontières, Paris, France.
􏰁e-mail: aprabhala at gmail.com; Alain. ALSALHANI at paris.msf.org 




https://www.nature.com/articles/s41562-022-01307-9 <https://www.nature.com/articles/s41562-022-01307-9> 
HIV or COVID-19, inequity is deadly

Winnie Byanyima <https://www.nature.com/articles/s41562-022-01307-9#auth-Winnie-Byanyima> 
Breaking pharmaceutical monopolies helped to address the HIV crisis. The same could be done to end the COVID-19 pandemic, but we must act decisively, writes Winnie Byanyima.

As we embark on a new year of the battle between humanity and COVID-19, the virus is still winning. Leaders of high-income nations have made huge and ultimately inexcusable errors of judgement. They have failed to consider vaccines and COVID-19 technologies as global public goods.

We are witnessing the same deadly mistakes made in the mid-1990s, when treatment for HIV became available. Pharmaceutical companies set the extortionate price tag of US $10,000 per person per year, rendering this life-saving treatment out of reach for the millions of people living with HIV in the Global South. Between 1997 and 2006, UNAIDS estimates that 12 million African individuals died because the medicines were priced out of their reach by pharmaceutical monopolies and the greed of profit versus public good.

It was only when a movement of people living with HIV, healthcare advocates, religious leaders and many other partners mobilized to generate global political pressure that companies in developing countries (Brazil, India and Thailand) were able to manufacture the medicines by making use of the flexibilities within the World Trade Organization’s (WTO) Trade-Related Aspects of Intellectual Property Rights Agreement.

This important tool allowed for competition within the pharmaceutical market, which led to dramatic drops in the price of HIV medicines to less than US $75 in some countries today, giving millions access to life-saving treatment. But this took years to achieve, and many countries still cannot access the generic market owing to trade barriers. We cannot let that happen with COVID-19, and this time we must act much faster.

However, the world is currently failing to heed the lessons of the injustice that took place with the AIDS pandemic, and leaders are still putting narrow and ultimately self-defeating nationalism ahead of what is needed. They are continuing to defend the profits and monopolies of their pharmaceutical corporations, instead of sharing the successful vaccines and the technologies that would scale up their production worldwide.

It has been a year since the first Pfizer-BioNTech vaccine was given, and yet Africa has still only received enough doses to fully vaccinate around 10% of its population. This is in stark contrast to high-income countries. In the European Union, for example, around 70% of people have received at least two doses, with many countries now administering third booster jabs to keep their populations safe.

High-income nations have behaved appallingly, hording billions of doses of vaccines while doctors in countries such as my own, Uganda, have faced COVID-19 unprotected and unvaccinated. Even when high-income countries do donate some of their excess doses, it is too little, too late — often delivered close to their expiry dates, and virtually unusable. Donations and charity, though welcome, will never be enough.

At least five million people have already died of COVID-19, while world leaders have allowed companies such as Pfizer and Moderna to make as much as US $1,000 profit a second, hiding behind their monopolies to artificially restrict the supply of these vaccines and making them the most lucrative medicine ever developed — creating new vaccine billionaires instead of vaccinating billions.

Putting profits first has also created an optimal breeding ground for new variants, such as Omicron. One thing we know for sure is that the impact of Omicron will be felt by the poorest worldwide. The poorest people and low-income nations will be least able to take the actions needed to combat it.

We know that already scarce vaccines will become hugely scarcer. Being fully vaccinated will soon mean having multiple doses, leading to higher-income nations buying up all the vaccines for boosters. We may discover that some existing vaccines are not able to face the challenge of new variants, and, as new vaccines are developed, existing supply capacity will be diverted to this aim.

There are steps we can, and must, take to help to fix this. The proposed temporary intellectual property waiver covering all COVID-19 vaccines and technologies at the WTO remains a necessary precondition to defeat COVID-19. The waiver could curb pharmaceutical companies’ global monopolies, while still allowing them to be financially compensated.

We also need to invest now in building vaccine-production capacity all over the world, especially for the very successful mRNA vaccines. There are more than 100 producers worldwide that could be making the Pfizer-BioNTech vaccine today. Know-how must be shared: these vaccines have been paid for by public money and they must be made a global public good.

Everyone has the right to health; we cannot afford to make the same mistakes we did in response to the emergence of HIV. We need greater global equity in healthcare and in access to health commodities and technologies, and we need it quickly.

It is madness to think that if we keep doing the same thing we can expect a different outcome. This year has to be the year that we finally make these incredible vaccines a global public good — the year that high-income nations do the right thing and that pharmaceutical companies share their successful vaccine recipes with producers all over the world.


Arthur Stamoulis
Citizens Trade Campaign
(202) 494-8826


Arthur Stamoulis
Citizens Trade Campaign
(202) 494-8826




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