Researchers from the National School of Tropical Medicine in Texas tried for five years to develop a vaccine for Severe Acute Respiratory Syndrome (SARS), a disease caused by the SARS-Cov coronavirus, which killed 774 people in Asia between 2002 and 2003. They produced a test batch which was ready for clinical trials when the study was halted in 2016, due to lack of financing.
“Though we were well advanced and the evidence was really solid, unfortunately we had to put this material in a freezer since producing a SARS vaccine was no longer a priority”, remembers Maria Elena Bottazzi, co-director of the both the Center and School for the Development of Vaccines at Texas Children’s Hospital.
With the suspension of funding by the National Health Institute, a public support entity, the scientists sought help from the private sector. The answer they got was that there was no interest in the project.
The similiarities between the genetic material of SARS-Cov and SARS-COV-2, the virus that causes covid-19 is over 79,5%. In both cases, the gateway enabling the virus to reproduce in other cells, is a the molecule known as ACE2 that is located in the lungs.
This discovery, published in the British magazine Nature, delighted the researchers who had their SARS studies interrupted. For Bottazzi, the vaccine frozen in 2016 would allow for the skipping of certain stages in order to deal with the current pandemic and thus, be more agile.
“Though it was formulated to combat SARS, it could result in joint protection against SARS-COV-2. We have concrete evidence of this possibility and would like to confirm this in humans”, said the scientist. In the worse case scenario, negative results would ensure that others don’t waste time and money going through the same scientific route, he added.
The price of innovation
The end of clinical testing shows the logic behind the market that guides vaccine studies. After the peak of an epidemic, research groups are dismantled and the scientific advancements are simply lost due to a lack of demand.
So what explains the lack of interest on the part of big-pharma, amid the novel coronavirus pandemic, in vaccines that are already in their final phase of production? Why do they prefer to start from scratch instead of continuing with advanced studies already in place? Bottazzi has a hypothesis.
“The majority of vaccines in development against the novel coronavirus – certainly the ones with the most resources – are betting on new technologies, never used before”, she ponders. By prioritizing innovative, high cost methods, big laboratories tend to concentrate production, delaying access to the product on a global scale.
“The vaccines being prioritized today, are responding to a logic tied to the commercial interests surrounding intellectual property. I am very concerned about how this will be implemented globally, because it will be expensive and people won’t know how to make it. Though they may be safe and effective, it will take a while before other countries are able to produce them, and even buy them”, says the researcher.
The most innovative method of producing vaccines by industry standards, is using fragments of genetically modified material. The vaccine made at the Texas School of Tropical Medicine on the other hand, is based on the production of recombining proteins.
“It’s a cheaper process, simple and widely known the world over”, states the School’s director. As soon as it is discovered and properly tested in a lab in the USA, for example, Brazil could begin production the very next day, as it already does with hepatitis B.
Researcher Maria Elena Bottazzi is on the front lines of the race to develop a covid-19 vaccine / National Institute of Tropical Medicine
Parties involved
Out of the 115 studies underway to develop a covid-19 vaccine, up to the firs week of April, only 23 used recombining proteins, according to Nature magazine.
Private enterprise is responsible for three quarters of the research being done. Some of the parties involved are giants in the sector, like French Company Sanofi, US based Pfizer, Dynavax and Johnson & Johnson, as well as British companies GlaxoSmithKline and Seqirus.
Data published by the World Health Organization (WHO) on May 11th, considers there to be 110 official studies being undertaken to come up with a SARS-COV-2 vaccine. Most of them are taking place in the United States, China and the European Union.
In the past week, two studies done in Brazil joined the list of those “showing most promise” in the world” - one developed in a lab at the Federal University of Minas Gerais (UFMG), and another at the Heart Institue in São Paulo (SP).
The director of the Global Health Policies Center at Duke University, Gavin Yamey, thinks that the discovery of a vaccine will not necessarily mean the end of the pandemic. He agrees that difficulties in production as well as the price may limit global access, which will force the international community to come up with distribution and monitoring criteria.
“Coming up with a vaccine is a long process, which involves lots of stages. However, we need to worry about distribution starting now, since we know that at first, there won’t be enough available to everyone”, he explains.
Yamey is part of the Covid-19 Vaccine Development Task Force, a working group started by the World Monetary Fund in partnership with the Coalition for Epidemic Preparedness and Innovation (CEPI), based in Norway. The group is made up of investors and scientists to ensure large scale production of doses, with haste and a global outreach.
“Some countries – I would rather not say which - are already trying to monopolize access to the vaccine even before it is ready. We need fair and equitable distribution, that respects public health principles”.
CEPI’s project is in its clinical phase, during which, eight potential vaccines are tested in different countries. Six of these move onto the next phase, where new experiments and regulatory adjustments are made. At least 3 of these will be selected for large scale production within a period of 12 to 18 months, being counted since March 2020. The project’s budget is an estimated 2.25 billion dollars.
Conflicting Interests
Different world leaders have been pouring resources into the development of a vaccine against covid-19. British premier Boris Johnson donated around U$ 270 million to CEPI at the end of March. US president Donald Trump, preferred to invest in a private lab and gave Johnson and Johnson 500 million dollars.
Gavin Yamey considers global expenditures during a pandemic necessary, but could have been a lot lower if governments had taken certain precautions. In February 2018, he signed off on an editorial published by the Global Health Institute at Duke University titled, “The odds of a devastating pandemic just went up”.
The writing criticized the Trump administration’s decision to cut investments into disease prevention and pandemic response. That year, the American president cut the Center for Disease Control’s budget and dismantled the National Security Council’s epidemic team.
Yamey estimates that with a 10 billion dollar a year investment, the United States would be sufficiently ready to face the novel coronavirus – today, the country is the leading the world in covid-19 deaths.
British consultancy Oxford Economics estimates the global economy lost almost U$ 325 billion in the first semester of 2020 due to the pandemic. In the same period, Johnson & Johnson saw the sale of medicines go up 10,1%.
In other words, the crisis isn’t affecting big-pharma’s bottom line. On the contrary, the money governments “save” in research and prevention, is in part, redirected to the coffers of large corporations – as Trump did.
NGOs like Doctors Without Borders (DWB), have for years denounced the lack of transparency in the pharmaceutical industry, used as a strategy to increase profits, in detriment of public health.
“The pharmaceutical industry exaggerates its research and development costs for new drugs, to justify the high prices (…) In reality, it spends more on stock buy-backs to raise their own stock prices, on sales and marketing than they do on R&D”, states the article published on the DWB website, just weeks before the start of the pandemic.
In 2018, for example, the total sum of investments by the biggest pharmaceutical companies in the world, directed to research and development was around 70 billion dollars, just under 20% of their combined revenues.
Intellectual Property and Distribution
The United Nations Combined HIV/AIDS (UNAIDS) published on May 14th, a petition signed by 140 world leaders, demanding that any vaccine or treatment for covid-19 be patent free, mass produced and freely distributed.
The argument in defense of intellectual property rights is the need to stimulate industries to invest in the development of innovative solutions. At the same time, this assurance tends to restrict access to potentially life saving products.
Tedros Ghebreyesus, WHO general director, appealed at the beginning of April to labs the world over, to ensure transparency in their research, and free access to the data to help global access to vaccines and treatments. United Nations Secretary General, Antonio Guterres, believes that future covid-19 treatments should be seen as “a public asset”, free to all.
“We cannot repeat the mistake made in 2009 with swine flu”, reinforces Gavin Yamey, referring to the H1N1 pandemic, which killed more than 150 thousand people according to the WHO. At the time, wealthy countries monopolized the global vaccine supply, delaying policies to combat the disease all over the world.
CEPI proposes a free and unified distribution system, that prioritizes healthcare professionals on the front lines and those in high risk categories. This effort would entail public sector investments and “political will” from authorities, says Yamey. After all, wealthier nations would pay a bigger portion of the bill, without necessarily getting more doses.
“Past pandemics have shown that the poor population, living in countries with poorly structured public health systems, is the hardest hit”, highlights the researcher.
The World Health Organization leads the way in ensuring equitable distribution of the vaccine / Fabrice COFFRINI / AFP
This past Monday (28th), the World Health Organization held its first ever annual meeting via video-conference. World leaders defended that the vaccines be treated as an “asset of the public”. Chinese president Xi Jinping, promised to allocate U$ 2.75 billion to the global fight against covid-19, especially in developing countries.
When?
Over the last few weeks, the race for a covid-19 vaccine got tighter. Laboratories began anticipating their own prognosis, informing the public that doses may be available before the year’s end.
“The truth is that no one knows when the vaccine will be ready”, Gavin Yamey recognizes. “During the current pandemic, everything happened very fast, from when the virus was first identified in China, allowing for the production of an antidote in record time”, the scientist adds.
The novel coronavirus was first identified on January 7th, and had its genetic sequence mapped the following week. Within 63 days, the first vaccine was already being tested on humans, in the United States.
Since the search for perfection isn’t always compatible with the urgency of a pandemic, Texas researcher Maria Elena Bottazzi thinks it is important to balance the expectations between expediency and efficiency.
“Safe vaccines may offer 30% to 50% protection, and may be good for the high risk population, while we continue to find a better model, that may be 100% effective. In the end, we might up end up having a sort of tool box, in which some vaccines would be available quicker, though imperfect. We need to evaluate which vaccines would be useful on a case by case basis”, affirms Bottazzi.
The SARS vaccine which was in the final stages of production in Texas, was thawed for clinical trials on covid-19 patients. On May 5th, the National School of Tropical Medicine obtained funds from the NGO PATH, an organization that invests in public health innovations. Though she celebrates the resumption of the research, the scientist alerts of the risks of new stoppages.
“We have this concern, yes, because it has happened repeatedly. There is an outbreak, we react, but all of a sudden there is no more investment”, she laments. “And, even though one of these vaccines being tested actually works, we need to maintain our research, because down the road a new coronavirus may appear, and we need to have a strategy, not merely react’.
Previously mentioned Johnson & Johnson, the world’s biggest pharmaceutical company, recently made their position on some of the issues discussed in the article public. When releasing data showing an increase in sales during the first semester of 2020, vice-president Joseph Wolk wrote: “We recognize the deep impact the covid-19 pandemic is having on people, communities, businesses and the world. Though our company’s results in the first trimester are expressive, reflecting the resilience of our diversified business, this narrative is comprehensibly put in the back burner in the face of the more permanent concern of combating covid-19”.
The corporation has the goal of producing 1 billion doses till the end of 2021. Besides their factories in the US and Holland, Johnson & Johnson seeks to build two more in Asia and in Europe.
Speaking to the Washington Post newspaper, chief scientist Paul Stoffels, claimed that the company is not interested in profiting on a covid-19 vaccine, and agrees to prioritize healthcare professionals and high risk patients.
Edited by: Rodrigo Chagas
