Author: Natalia Vasnier Published: 29/07/2021
For over a year now the world has been in a global pandemic with the spread of the Covid-19 virus. Updates on the number of cases, the new variants and other aspects of this virus constantly flood our TVs and phones. But what to do with all this information, what do they mean or are they relevant?
The Conference Corner is here to shed some light on the current headlines, to this end we have interviewed Christophe Lafleche a specialist of the Big Pharma industries. During his career he worked for two of the world’s biggest global healthcare companies, GSK and then Pfizer as a Senior Pharmaceutical Executive.
"If there is no International Property rights, then there is no innovation" - Dr Lafleche -
The quick development and commercialisation of the Covid-19 vaccine.
For many it is rather surprising that a vaccine for Covid-19 was created in only 8 months, while generally it takes several years for vaccines to pass preclinical and clinical tests. Dr Lafleche explains that normally to conceive a vaccine the process starts with preclinical tests, then Phase I trials, Phase II, Phase III, followed by the construction of factories to manufacture the product. Each phase in regular conditions takes place sequentially and can take a long time to complete. However, due to the emergency of the situation in Spring 2020, preclinical tests were run simultaneously, clinical trials II and III were combined and early scale up of manufacturing were carried out to save time. Moving only as fast as the science allowed without facing the immense political and societal pressure.
What are the risks of the strategy of simultaneously running all phases? How was this possible?
Dr Lafleche admits that there are risks when implementing this strategy, if one trial is inconclusive all research must start back from the beginning. When this happens huge amounts of money goes to waste. Despite this he informs us that in the case of the Covid-19 vaccine this was a risk Big Pharmas were willing to take because they received massive funds from the private and public sectors. This allowed what specialist call ‘de-risking’ the clinical tests which are the most expensive tests.
Moreover, simultaneous testing was possible because all the Pharma companies shared their test results and research documents with each other. Pfizer, Sanofi, and Johnson & Johnson prior to the pandemic were already well-established companies in the vaccine world, they had experience and created strong links with global healthcare officials. While Moderna and AstraZeneca were new to this industry and were borne out of the ambition of entrepreneurs who had no experience of the vaccine market. Therefore, this collaboration was very fruitful too for these companies, as they could work alongside the experts. Rapid vaccine results were possible because Big Pharmas were allowed emergency regulatory approval which allows quicker drug approval by healthcare authorities.
The technology of the mRNA has been in the works for around two decades, for Katalin Kariko a biochemist there was not doubt that this technology would work one day. Her work allowed for the elaboration of the Pfizer/BioNTech and Moderna vaccines. The mRNA technology is poised to revolutionize vaccines and to open a new field of research which will help to find solutions to the world’s most fatal conditions such as cancers or strokes.
Why did this collaboration happen only now? What will this bring in the future?
This collaboration occurred due to the severity of the situation and rising number of deaths in the world. Governments and the public were under lockdown in many countries, the need for a vaccine was essential. During the later months of his mandate the United States President Trump initiated the creation of a platform that would allow collaboration between health experts: the Operation Warp Speed, OWS. Generally, a company needs at least one or two billion USD to develop a vaccine. OWS managed to provide this vital funding to many companies such as the kid on the block, Moderna.
Collaboration allowed for the rapid creation of a vaccine; it will also increase data sharing in the future. It will enhance the rapidity to find solutions to other viruses and diseases, such as HIV and cancer. Christophe Lafleche acknowledges that the pandemic has opened a door to further research and cooperation in the healthcare sector.
If collaboration was so successful, why was there a lack of vaccine at the start of 2021?
The interview highlights two main reasons why the manufacturing process of the vaccine was so slow. The first being the time taken up by the control of the quality of each batch. It is important to understand that in the manufacturing process of the vaccine 70% of the time of production is dedicated to quality and control.
The second reason is the rarity of the substances which compose the vaccine, they are difficult to find and produce. Dr Lafleche explains that the active ingredient (mRNA) of the vaccine needs to be stable and surrounded by different materials (lipids,…) that will allow the vaccine to easily penetrate the cells once injected. The materials are very rare and created only in certain companies located in different regions in the world. Creating more companies for this purpose would be a solution, however one must understand that it takes a lot of expertise and time to do such a thing. Time is a commodity that is very valuable at the present, and for many spending more time to wait for the end of this episode is not a solution.
"The scientific community does not fear the appearance of variants. The media frenzy around variants has shaken the public sentiment surrounding governments actions to suppress contaminations" - Dr Lafleche -
What about variants?
Dr Lafleche reassures that the scientific community does not fear the appearance of variants. The media frenzy around variants has shaken the public sentiment surrounding governments actions to suppress contaminations. Furthermore, he informs that if there is real a need for a vaccine to fight these variants it would be easy to create. Since laboratories already have the technology to isolate quickly Covid-19 to do the same with the new variants will not be a problem. He estimates that if required, such a vaccine can be created in the space of three to six months. In July 2021, scientists confirmed that the current vaccine does protect against the Delta variant for the majority of people.
International property rights?
Approaching the early months of Spring 2021 the US President Biden evoked that he wished to waive international property rights, IP. His motive was to make the vaccine more accessible to lower-income countries and accelerate the production time. The refusal of many European countries to accept Biden’s proposal sparked their criticism by public opinion. However, Dr Lafleche simply explained that if there are no IP rights then there is no innovation.
It is IP rights, which leads to investment and therefore pushes start-ups or Big Pharma companies to pursue a research project. The CEO of Moderna clearly said that if there were no incentives or the possibility to make profit, he would have never created Moderna. This is the reality of the situation, like any company the healthcare industry must generate profit to survive. If Big Pharma companies are not awarded for taking risks and finding solutions, then they will produce bad quality results. In the case of this global pandemic poor results is simply not an adequate solution. Nevertheless Pfizer struck a deal recently with the Biovac Institute to help manufacture millions of doses of their mRNA vaccine for exclusive distribution throughout Africa with Biovac’s facility located in South Africa.
Vaccine roll outs
Therefore, healthcare companies must sell their products at production price and for underdeveloped countries via donations. Currently around 4 billion doses of vaccine have been administered to the world population, countries such as the United Kingdom, the U.A.E or Mongolia have the highest ratio of vaccine administered to their population. Dr Lafleche notes that for now experts must observe and analyse how the virus will evolve in these countries over the coming months. Observing these trends will allow countries to create an appropriate strategy to battle the virus in the future.
After the AstraZeneca crisis in Spring 2021, there has been a major vaccine hesitancy by people who fear getting injected with the AZ vaccine. This has led to big numbers of AZ vaccines being kept in the EU without being used due the refusal of people to receive it. The primary solution is to donate these unwanted doses to the Covax scheme. Dr Lafleche confirms that the fatal cases induced by the AZ vaccine are extremely rare and that the vaccine itself is very efficient to combat Covid-19.
Currently, experts are looking for solutions to treat mild symptoms of Covid-19 and Pfizer is currently working on antiviral medicine to block mild symptoms of Covid will potentially be commercialized in early 2022.
Solutions such as nasal sprays, patch, air-blast injection vaccines are being studied by biotech companies.
The United Kingdom has ordered Pfizer vaccines for autumn 2021, why?
In 2020 after the summer in most western countries there was a surge of Covid-19 patients in hospitals. A fear by governments of such a scenario repeating itself is understandable but hopefully the impact will not be as fatal as last year due to the vaccination of the population. This summer in most EU and Western countries vaccine roll out has been wide and lockdown measures are loosening up. What Dr Lafleche calls a ‘booster’ vaccine will be necessary in the autumn to protect a part of the population with low levels of antibodies once the summer ends. In the future the possibility of an annual Covid-19 vaccine jab like the flu jab is still under discussion.
Finally, Christophe Lafleche affirms that he is rather optimistic about the future. By the end of the summer, he hopes there will be some level of herd immunity which will allow most of the restrictions to disappear. It can be estimated that a third dose will be useful in reboosting the immune system especially in the most vulnerable people. All that is left to do is observe and compare the approach of various countries vis à vis Covid-19 and the efficiency of the various vaccines rolled out.
To go further: Using the Pfizer strategy as model for all businesses
Finally, Dr Lafleche brings our attention to the June 2021 ‘month’ issue of Harvard Business Review which features an article by the CEO of Pfizer, Albert Bourla, on how his company developed this pioneering and highly effective new vaccine in record time. It’s a compelling and insightful read. Bourla powerfully illustrates five key elements of outstanding leadership and culture effectiveness:
Put Purpose First: “the positive financial impact of Pfizer of the Covid-19 vaccine became possible only because return on investment was never a consideration”.
Serving People, Not Pushing Products: “throughout my career […] I have encouraged the entire organisation to adopt a patient-first mentality, measuring outcomes by people served rather than drugs sold”.
Collaboration and Teamwork: “first and most important, success is a team effort…the need to embrace cooperation – especially in a crisis”. Getting people emotionally engaged and inspired to work together is imperative for post-pandemic leadership to “build back together”.
Set Stretch Goals: “moon-shot challenges that align with the right purpose are galvanizing…encourage the out-of-the-box thinking required to achieve it”.
Bureaucracy Busting: “we isolated our scientists from financial concerns and freed them from excessive bureaucracy”. Most high-performing cultures turn their organizations upside down to serve those who are serving customers.
These are strategies that any organization in any industry can use to solve their own problems and to produce important work that will benefit a broad part of society.
Natalia Vasnier is an undergraduate student at King's College London, reading History. She has a passion for journalism and policymaking. Namely in issues related to human rights, migration, EU foreign policy and the environment.
Featured images by Virus Masquer Coronavirus - Images vectorielles gratuites sur Pixabay, Vaccin Coronavirus Médicaux - Photo gratuite sur Pixabay and Vaccin Vaccination Covid-19 - Photo gratuite sur Pixabay.
The Guardian. 21 Nov 2020. Covid vaccine technology pioneer: 'I never doubted it would work' | Medical research | The Guardian
Harvard Business Review. June 2021. The CEO of Pfizer on Developing a Vaccine in Record Time (hbr.org)