While COVID-19 demonstrated the biopharma industry’s capacity for innovation and its ability to scale up manufacturing, it also exposed the challenges of ensuring equitable distribution of vaccines. In an effort to work towards solving these issues and being better prepared to respond to future pandemics, the industry has created the Berlin Declaration, a collaborative proposal to be discussed with the G7, G20 and health regulators. James Anderson, Executive Director, Global Health, at IFPMA, explains.

As the world looks to build better preparedness against future pandemics, it is vital that we build on what worked during the COVID-19 pandemic. One clear lesson learned from COVID-19 is that science and innovation delivered, against a remarkable timeline and in historic quantities.

The approval of the first vaccine in just 326 days after information about the virus sequence was published was a scientific marvel – but it did not happen in isolation. Decades of prior research and investments conducted within a robust innovation ecosystem allowed scientists to turn to mRNA or viral vaccines, and to test whether existing treatments could work against COVID-19.

The successful manufacturing scale-up that ensued has been dubbed as the “second miracle” of the pandemic. Prior to the pandemic, the total world production of all vaccines was between 3 to 5 billion. The response to COVID-19 was a remarkable feat of the best in public-private partnerships, with biopharmaceutical companies adopting a “business not as usual” approach, teaming up with biotechs, academia, and even ‘traditional’ competitors to respond quickly. By the end of December 2021, more than 11 billion COVID-19 vaccines doses were produced – more than sufficient for all adults in the world if they were shared equitably. Over 370 voluntary partnerships and technology transfer agreements played a huge role in making this happen.

 

Vaccine nationalism, trade barriers and export bans, as well as a lack of early and adequate financing mechanisms for international partnerships such as COVAX, contributed to a widening gap in vaccination rates between high-income and low-income countries.

 

But while innovation and vaccine scale-up worked, there have been significant challenges in ensuring COVID-19 vaccines were equitably distributed, despite a strong early start. Vaccine nationalism, trade barriers and export bans, as well as a lack of early and adequate financing mechanisms for international partnerships such as COVAX, contributed to a widening gap in vaccination rates between high-income and low-income countries.  Likewise, while there is now broad acknowledgment that supplies of COVID-19 vaccines have outstripped global demand since mid-2021, lack of country readiness and absorption capacity continue to leave highest risk populations in many countries vulnerable.

To find a solution to these challenges and to be better prepared to respond to future pandemics, the biopharmaceutical industry has tabled the Berlin Declaration, a collaborative proposal to be discussed with the G7, G20, health regulators, and other international stakeholders.

 

The Declaration has the potential to be a powerful social contract for future pandemic equity …

 

With the Declaration, industry expresses its willingness to reserve a meaningful allocation of real-time production of vaccines, diagnostics, and treatments (VTDs) for high-risk populations in low-resource settings. IFPMA has taken a leading role in driving forward the framework of the Berlin Declaration, garnering endorsement at CEO level within the IFPMA membership. We are now seeking support from further private sector players, including the diagnostics sector, generics, biotechs, and developing country vaccine manufacturers. It is essential to ensure that all relevant life-science companies are behind the declaration as all companies could play a critical role in bringing innovative solutions to a future pandemic.

The Declaration has the potential to be a powerful social contract for future pandemic equity, but it can only succeed if it is complemented with the necessary political and financial support. From discussions held so far, we are encouraged to see positive reactions from stakeholders who want to work with us on how to operationalize the framework. With support of G7 and G20, this could be up and running by early 2023.

We have learned that other foundational prerequisites of the future pandemic preparedness system are:

  1. Robust pandemic plans to deliver pandemic VTDs and care to populations in all countries, as well as ongoing healthcare, built on and complementing progress toward universal health coverage
  2. Rapid detection and open sharing of pathogens and their information on emerging infectious diseases
  3. Acceleration of R&D and regulatory pathways for delivering new pandemic VTDs
  4. Optimized manufacturing scale-up and sustainable supply for the whole world, including de-risking mechanisms to support the R&D, manufacturing scale up, and procurement
  5. Aligned, evidence-based prioritization of populations and VTD demand forecasts
  6. Long-term political commitment and adequate funding to establish and maintain pandemic readiness as part of a resilient healthcare system

The Declaration presents a realistic picture of what the industry can achieve and what is required to be successful. The lack of support for health infrastructure and human resources was a major barrier to vaccine uptake in lower income countries during the COVID-19 pandemic. That is why one of the prerequisites of the proposal is that all stakeholders collaborate to ensure that health systems in lower-income countries are better prepared to absorb and deliver vaccines and treatments.

 

We are optimistic that the world can work together to deliver better preparedness for the future and are committed to playing our part and working with all stakeholders to get there.

 

The Declaration also underscores the necessity of removing trade and regulatory barriers, as well as preserving the solid intellectual property rights framework. The existence of this innovation framework remains key to shape robust pandemic plans and deliver VDTs and care to everyone, everywhere.

The COVID-19 pandemic has been a wakeup call, highlighting the consequences of not prioritizing investments in strengthening national health systems and ensuring universal health coverage for all. The Declaration leverages three focus areas – innovation, manufacturing scale-up, and planning ahead for equitable access – as implementation priorities to ensure no one is left behind in future pandemics.

Through this Declaration of intentions for pandemic equity, the biopharmaceutical industry commits to building on what we have learned during COVID-19 and doing better in the future. We are optimistic that the world can work together to deliver better preparedness for the future and are committed to playing our part and working with all stakeholders to get there.