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A formula for vaccine breakthroughs

Cast your mind back 12 months to when European countries were reporting their first clusters of COVID-19. There were no proven treatments, limited knowledge of how the virus spread, and no vaccines. In fact, there was concern that developing a vaccine could take a minimum of two years – and there was no absolute guarantee that it would be possible.

Fast forward to today and the picture is brighter, even with continued lockdowns and social distancing. The global pandemic, declared by the WHO on 11 March 2020, has claimed 2.5 million lives and dramatically impacted our societies. However, vaccine development has exceeded expectations. Hundreds of candidate vaccines are in various stages of testing, with dozens in human trials. Several approved vaccines are today being administered to the most vulnerable people in our communities.

More people have now received a vaccine against SARS-CoV-2 than have been diagnosed with COVID-19. Vaccination has gone viral.

How has this startling success story been written? The simple answer is that science and collaboration delivered. Companies, governments, academics, regulators and others turned their full attention to solving a shared problem. The result is a host of new tools that will help change the trajectory of the pandemic.

While human ingenuity was the active ingredient, the recipe for COVID-19 vaccine breakthroughs is far from simple. After all, human ingenuity was available during the 1918 pandemic. The advantages we had in 2020 was built on a formula that included decades of investment in basic science, expertise in vaccine development, and crucial manufacturing knowhow. This was supported by a dynamic regulatory system and a robust intellectual property (IP) regime.

 

Formula for success

Much of the above is universally celebrated, but there is a temptation in some quarters to pull at the threads of the IP system that helped to build up the knowhow that was unleashed on COVID-19 one year ago.

IP can be complex to understand, but the core principles are simple. The goals are to encourage creativity and reward innovation – whether for inventing electric vehicles, writing novels or formulating new vaccines.

It would be catastrophic to make an exception for vaccines. For a start, vaccine development is unpredictable and costly. And, ordinarily, it takes time. Look at CureVac – a company born at a German university 20 years ago to explore the potential of mRNA technologies. In 2017, EFPIA published a blog about the then little known company. The blog stated that “The combination of strong IP protection and prospective EU pharmaceutical incentives enables CureVac to continue product development in three different therapeutic areas in parallel.” Roll forward to 2021 and it is thanks to that IP protection that the start-up was able to attract millions of euros in investment as well as partnerships with larger companies. Last month, the European Medicines Agency began a rolling review of CureVac’s COVID-19 vaccine. If approved, the vaccine could help to accelerate vaccination rates in the EU, where 225 million doses have been ordered, with an option of purchasing a further 180 million.

In highlighting the success of a handful of COVID-19 vaccines, we must acknowledge that many more vaccine candidates have not progressed through clinical trials. Some of the most experienced companies in the world have abandoned trials.

Unfortunately, this is normal – not all potential vaccines are successful against a disease and meet the high standards required for regulatory approval. This is not unique to COVID-19 vaccines. For example, after years of research and investment, we are still working on a vaccines against HIV.

Expanding capacity

Notwithstanding these disappointments, the vaccine development ecosystem as a whole has shown remarkable innovation over the past 12 months. The task now is to continue scaling up manufacturing capacity to meet global demand. That is a challenge best solved by those with expertise. And it is already well under way.

Vaccine and non vaccine companies are working together to significantly expand the volumes that can be produced this year. By helping one another, manufacturers are pooling their expertise and infrastructure in a spirit of partnership. To be clear, the task of manufacturing biological products is highly specialised and not comparable to producing any other good.

In addition, companies that have developed COVID-19 vaccines are working with global partners in countries such as India and South Africa using technology transfer. This is being facilitated by well-established licensing agreements and will ensure billions of doses are available to low and middle-income countries.

Bringing the fruits of innovation to people around the world is in everyone’s interest. We know no one is safe unless everyone is safe. That is why vaccine companies have worked closely with CEPI, GAVI and the WHO in support of the COVAX facility. Not only will COVAX deliver billions of doses this year, but it is also investing in manufacturing capacity required to accelerate production.

The system works

All of this is being done without jeopardising the system that has given us COVID-19 vaccines. The expertise found in vaccine manufacturers exists because of the incentives provided by IP. Maximising the impact of innovation will be achieved through technology transfer and licensing.

The worst of the COVID-19 pandemic will pass. We will still want a sound IP system next year and the years after that. It is essential to our capacity to find new vaccines against HIV, TB, malaria and a universal flu vaccine. It is essential to our innovative medicines ecosystem. And it will be invaluable in rising to the challenge of future disease outbreaks.

Nathalie Moll

Nathalie Moll joined the European Federation of Pharmaceutical Industries and Associations (EFPIA) as Director...
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