An unprecedented commitment of the pharmaceutical industry, says IFPMA

According to Thomas Cueni, "Public health has clearly taken a back seat to profit. The managers of the 60 “candidate” vaccines have indicated their willingness to make production capacity available as soon as it is available."

Moderna Therapeutics thinks that they can provide caregivers with a vaccine against Covid-19 by the fall. We spoke to Thomas Cueni, the Director of The International Federation of Pharmaceutical Manufacturers & Association (IFPMA), about his thoughts on the latest developments. He is in close contact with the biopharmaceutical industry and has privileged access to first-hand information about the issue.

GS News: How do you work with major pharmaceutical companies to develop a Covid-19 vaccine?

Thomas Cueni: When containment ends, the solution to Covid-19 will be provided by pharmaceutical companies. Two months after the arrival of the virus, more than 60 laboratories, including Sanofi Pasteur, Johnson & Johnson, GlaxoSmithKline (GSK), as well as start-ups and academics, started working on the vaccine. Ten to 20 of these will be really effective. We hope that a large-scale vaccine will be available in 12 to 18 months.

How is this possible? It usually takes usually 10 to 15 years to develop a vaccine.

On a large scale, without bypassing the rules in force and respecting the principles of precaution and patient safety, 18 months seems realistic. In such a pandemic, with not only health, but also economic and social threats, there is an urgent need to accelerate development. Regulatory agencies are ready to give the green light on the basis of raw data. Teams have been reallocated to combat Covid-19. On the other hand, we're not starting from scratch. We already have a base with which to understand the coronavirus family from 2003 (SARS) and 2014 (MERS). In addition to this, researchers have taken advantage of the fact that the genome of the virus was shared freely on the GISAID (Global Initiative on Sharing Avian Influenza Data) platform as early as January. They began studying it before biological models of the virus were available. We also benefit from the collaboration of government regulatory agencies.

Are clinical trials already underway?

Yes, on two types of animals in which Covid-19 has been detected, including monkeys. Tests on 45 volunteers have also started in Seattle with Moderna Therapeutics. Virtually every major company I've mentioned has started. For the first time, they are already deciding on investments and setting up teams even before the vaccine is found so that it will be available to everyone. We are talking about 1 to 2 billion doses, which is enormous.

How much does it cost to produce one to two billion vaccines?

Based on pharmas' commitments, several billion dollars. Compared to the figures spent on economic damage, it's worth it.

Who invests?

Companies that develop vaccines without yet knowing whether their product will work. This market will most probably not to be very lucrative. Public health has clearly taken a back seat to profit. But there is also risk sharing between them, such as Sanofi Pasteur or Johnson & Johnson, and organizations such as the Biomedical Advanced Research and Development Authority (BARDA). If these vaccines are to reach the least developed countries, an effort by the international community to share the costs will be required, with the mobilization of GAVI, CEPI, support such as the Bill & Melinda Gates Foundation, but also the governments of the G7 and G20.

How is it possible to produce vaccines on such a large scale? Do we have the resources?

The managers of the 60 “candidate” vaccines are already discussing this issue and have indicated their willingness to make production capacity available. This is extraordinary. Some health authorities are also willing to share them. For example, Johnson & Johnson has signed a billion-dollar contract with BARDA at their own risk to ensure industrial production capacity for a vaccine on a large scale. Sanofi-Pasteur has also made a commitment with BARDA. The Coalition for Epidemic Preparedness Innovations (CEPI) is collaborating with GSK. Other national and regional health authorities, such as the Bill and Melinda Gates and others, have also announced that they will invest in production capacity on no condition of success.

The pharmaceutical industry has been accused of turning away from infectious diseases because of a lack of financial interest. Why this sudden shift?

I understand what you're saying, but in this crisis, we're taking advantage of an industry that's thriving. As a whole, it has not turned away from it. On the one hand, we have sixty or so vaccine leads and five or six major vaccine companies working on them. On the other hand, more than 100 clinical trials are aimed at a short-term effective treatment to soften the effects or fight the virus. A dozen companies, such as Novartis, Bayer and Sanofi, have made donations for clinical trials on chloroquine, which could help patients affected by Covid-19. Gilead, which developed Remesivir, the most talked-about product, launched clinical trials a few weeks ago and has pledged to make everything available to the health authorities. Although ineffective for Ebola, there is hope for Covid-19. Finally, there is Roche's Actemra (an immunosuppressant for rheumatoid arthritis). Here again, the pharmaceutical industry, which has a reputation for being fiercely competitive, strongly demonstrates its social responsibility in times of crisis and has reacted collectively in an unprecedented way.

How will distribution occur, with governments closing their borders and a lack of overall coordination?

There is no global situation comparable to Covid-19. In terms of effect, we're talking about the public health crises of 1919 and the economic shock of 1929 combined. I see mobilisation, but there are always problems of coordination and the temptations of one country or another not to export masks or medicines. It is crucial that the borders remain open. For example, for tests that are developed extremely rapidly, such as those by Roche, the components are manufactured in Switzerland, Germany and the United States. Without open borders, this is impossible. According to Roche, contracts are respected and the collaboration works. We're better prepared than we were in 2003 and 2014 thanks to the WHO's International Health Regulations, which allowed the WHO to declare a pandemic, travel restrictions and state epidemic legislation. The power of international institutions such as CEPI has been strengthened. I have often found reluctance to include the private sector in pandemic preparedness and public health challenge committees. With this crisis, there is a need for dialogue and channels of communication. We would have been better prepared had we implemented such mechanisms.

Some drugs were sometimes scarce before the crisis.  Are there now shortages on protective equipment?

From a preparedness point of view, questions will need to be answered about the lack of face masks or alcohol to prepare gels. In the industry, we are encountering problems with certain drugs that are rarely used, such as the relaxants needed for intubation. But when you go from 2 to 50 doses a week, they are not easy to get. But with the WHO, we don't generally notice any disruption in the supply chains except in a few cases related to panic buying or at the state level, where particular states only considering of their national interest.

Are we over-dependent on China?

In all industrial countries, the only criteria for purchasing off-patent medicines is the price at which China and India are the most competitive. This raises questions. For innovative drugs, as is the case for Covid-19, this dependence does not exist. The production mechanisms are in the United States, Europe, Switzerland and Japan.

Thomas Cueni is the Director General of IFPMA since the 1st of February 2017. He is a Swiss economist, political scientist, former journalist and ambassador in multilateral diplomacy, and former Secretary General of Interpharma.

IFPMA is the voice of the biopharmaceutical industry in dialogue with the World Health Organization, the World Intellectual Property Organization, the World Bank and the World Trade Organization. Its mission is to bring the innovative biopharmaceutical industry and the health community together to tackle global health challenges and facilitate collaboration and dialogue.