This summer saw the opening of one of the broadest statutory investigations in UK history, the UK’s COVID-19 inquiry, as well as the WHO’s declaration of monkeypox as a public health emergency of international concern. The public inquiry into the UK’s handling of the COVID-19 pandemic, with preliminary hearings due this year, will consider the country’s preparedness and response to the disease which claimed more than 200,000 lives in the UK.
The COVID-19 vaccines were developed rapidly and approved by regulators in record time, which could be contrasted to the vaccine currently being used in response to the monkeypox outbreak. This poses the question: is “pandemic preparedness” key for governments to successfully handle future largescale health issues?
The COVID-19 pandemic
At the height of the COVID-19 pandemic, the light at the end of the tunnel was the creation of a vaccine. Traditionally the process of developing a vaccine from scratch has been a very slow one, usually spanning ten years or so, with the process rarely being achieved in less than five. The development of the COVID-19 vaccines was achieved in less than a year and one of the main factors that made this possible was funding.
Both public and private money was poured into the race to develop a vaccine, driven by demand and urgency; and this pushed aside many of the usual financial barriers that pharmaceutical companies and many pioneering scientists face. Governments pre-bought the vaccine, which meant many financial (and other) challenges could be overcome at earlier stages. Clinical trials were carried out in parallel with vaccine manufacturing to speed up the process, and the advent of social media meant that it was much easier to recruit trial participants. Regulatory approval of the vaccines was accelerated by using “rolling review” with information released to regulators as it was acquired.
The speed and efficiency of the roll-out demonstrated how much can be achieved under the most pressured of circumstances. Despite this, the fact that a vaccine had to be developed and then manufactured and distributed was a large contributory factor to the rapid spread COVID-19, which in turn had a very personal impact on many at an individual level. Governments and those in the life sciences sector were trying to achieve something unprecedented.
The monkeypox endemic
Echoing what happened during the COVID-19 pandemic, there is currently a lack of doses of the monkeypox vaccine as there are reportedly supply chain issues. This is due to the fact that there is only one company that manufactures the vaccine, a Danish biotech firm called Bavarian Nordic. However, there is a stark difference to that which the world faced when tackling COVID-19: there has been no race to create a monkeypox vaccine. An effective vaccine has already been in existence for some 20 years and its creation demonstrates the importance of “pandemic preparedness”.
In September 2001, following an anthrax attack on U.S. Senators, the U.S. government began investing in creating and stockpiling vaccines and treatments for dangerous pathogens that posed a national security risk. Smallpox in particular was included in this effort. As a result of this, the U.S. government partnered with Bavarian Nordic. One of the company’s projects was creating a smallpox vaccine, known as Jynneos. Despite smallpox being eradicated in 1980, Bavarian Nordic had found a market for its vaccine as governments around the world began stockpiling it in fear of the virus being weaponised.
The vaccine was developed to be a “just in case” vaccine that hadn’t actually been in use. It was approved by the FDA in 2019 and this included use against monkeypox. The US government has over the years purchased millions of doses of it with the hope that they would never need it. Before the outbreak, Bavarian Nordic was struggling as it was a difficult task to persuade governments to buy something they might not ever need. But now, its product Jynneos is the only vaccine in the world currently approved for vaccination against both smallpox and monkeypox.
The development of the monkeypox vaccine has been labelled as “pandemic preparedness” because the only reason we have the tool to fight the virus is thanks to contingency planning by (predominately in this instance) the U.S. government two decades ago. The emergence of multiple organisations with a common goal of preparedness for future outbreaks is promising and other countries have begun to follow the lead of the U.S. in making long-term investments.
The Coalition for Epidemic Preparedness Innovations (CEPI) has recently announced funding of $375,000 to the UK’s MHRA to support the development of key laboratory tools to advance and standardise assessment of vaccines used to protect against monkeypox. The funding forms part of the “Transform” pillar of CEPI’s $3.5bn pandemic preparedness plan, which seeks to invest and scale critical enabling programmes to further accelerate vaccine development and deployment. CEPI is itself funded in a variety of ways, including through private and public donations, to then finance independent research programs developing vaccines.
Such initiatives are key in ensuring responses to future outbreaks can be contained quickly and efficiently with fewer fatalities. However, it is clear that funding is central to their success.
It is extremely important for these health security programs to continue to have adequate funding, backed by governments and others, to prepare for the threats facing the global population, both known and unknown. It is often challenging for pharmaceutical companies to invest in such schemes alone, thus is it important for governments to incentivise investment. For example, a subscription-style model for antibiotics has been launched in the UK to encourage new development. Pharmaceutical companies will be paid upfront for their products based on the value it provides to the NHS as opposed to how much is used. The existing reimbursement system is based on sales volume, and often fails to provide sufficient revenue to justify the efforts poured into research and development. To be successful there needs to be a global approach and cross-border collaboration.
In order to address many of the potential health threats of the future, it is not enough to merely invest in developing new vaccines and treatments — this investment must also be carried through to manufacturing and stockpiling wherever possible. That is a critically important lesson learnt from COVID-19 and monkeypox; it takes time to vaccinate large groups of people, even when a vaccine is immediately available. GSK’s recent contract with HERA (the European Commission’s Health Emergency Preparedness and Response Authority) for the reservation of future production and supply of 85 million doses of the influenza vaccine in the event of an influenza pandemic demonstrates a good example of this forward planning.
Ultimately, countries need to take a coordinated forward-thinking approach to science and health policies, to ensure readiness for future outbreaks. This requires global leaders to see the value of similar long-term funding for medical countermeasure development and stockpiling strategies as well as funding efforts to prepare for the next biological threat that could be just around the corner.