This article is part of our special report Transparency in the race for a COVID vaccine.
Over the last few weeks, the European Medicines Agency (EMA) announced they have begun a “rolling review” process on COVID-19 vaccines from AstraZeneca in collaboration with Oxford University, Moderna and from Pfizer in partnership with BioNTech. The announcements are indicative of the industry-wide commitment to finding new diagnostics, treatments and vaccines to stop this pandemic in its tracks.
Nathalie Moll is the Director General of the European Federation of Pharmaceutical Industries and Associations (EFPIA).
As the coronavirus continues to have a devasting impact on people’s lives and livelihoods, this important milestone in the development of three COVID-19 vaccines is positive news.
The rolling review is described by the EMA as “one of the regulatory tools that EMA uses to speed up the assessment of a promising medicine or vaccine during a public health emergency.
Normally, all data on a medicine’s effectiveness, safety and quality and all required documents must be submitted at the start of the evaluation in a formal application for marketing authorisation.
In the case of a rolling review, EMA’s human medicines committee (CHMP) reviews data as they become available from ongoing studies before a formal application is submitted. Once the CHMP decides that sufficient data are available, the formal application should be submitted by the company. By reviewing the data as they become available, the CHMP can reach its opinion sooner on whether or not the medicine or vaccine should be authorised.”
In short, it means reviewing data as it becomes available rather than waiting until the end to begin the review process.
Vaccine developers’ top priority is always safety – and that’s no different for COVID-19 vaccines. Rigorous clinical studies, with many thousands of participants, in centres around the world are underway to ensure that vaccines are safe and they work.
Any vaccine will only be approved for use when its safety, efficacy and quality are validated by regulatory authorities such as the EMA. The rolling review process can help this happen faster and importantly, it does not remove any of the steps taken by developers or regulators to establish the safety, efficacy and quality of a vaccine.
There is no doubt that safe and effective vaccines represent our best chance of a permanent route out from under the shadow of the pandemic.
In Europe, there have been more than 3.7 million reported cases and tragically, around 210,000 people have lost their lives. The crisis continues to have a profound impact on the European economy. It is estimated that on average, GDP across Europe will fall by 6.44%. To put that figure in context, according to the OECD, GDP can fall by 1.5% and 2.5% after a recession, and by up to 4.0% after a severe recession.
For vaccines to play the key role in addressing the health and economic emergency caused by COVID-19, requires much more than the critical steps of research, development and regulatory approval.
In the case of COVID-19: it means creating the manufacturing, supply and distribution capacity to supply more than 7 billion doses around the world.
It means ensuring the infrastructure is in place to deliver a vaccination programme on the ground, at an unprecedented scale.
And perhaps most critically, it means ensuring that citizens have confidence in the safety and effectiveness of the vaccines for COVID-19. Experts agree that around 70% of the population must be immune to COVID-19 in order to achieve community immunity (sometimes called “herd protection” by the scientific community).
Reaching that figure requires the scientific community, manufacturers, regulators, health authorities, governments and citizens to work together to make the case for vaccines, to underline the lengths both manufacturers and regulators have gone to in order to ensure the safety of COVID-19 vaccines.
It means making sure the infrastructure is in place to deliver the vaccine on the ground, particularly for vulnerable and hard to reach groups and it means, in the extremely rare event of an individual having an adverse reaction to a vaccine, that citizens know they can access the support they need, when they need it.
As with any drug or vaccine, there could be rare or unexpected cases of adverse events. Side effects related to vaccines are usually mild, and severe side effects are extremely rare, with a rate of only 1-2 per million doses given (a per-person risk of 0.00005%).
People may also mistake normally occurring health problems for vaccine-related side effects. In the case of COVID-19 vaccines, where billions of doses need to be given to people around the world in order to protect them against the virus, it is likely there will be rare or unexpected cases of adverse events – whether actually connected to the vaccination or not.
It is vital that citizens know that if they suffer serious adverse events attributable to the administration of COVID-19 vaccines, no matter how rare this may be, they can access appropriate and timely compensation. The best way to achieve this is to establish compensation systems that work for all, getting the right support to the right people, swiftly and fairly.
Compensation systems that work for all should also include common-sense protections from unwarranted, lengthy and costly litigation for those involved in development and deployment of COVID-19 vaccines – that includes doctors, health systems, governments, pharmaceutical companies and others.
These protections only apply if they have acted on the best available science and complied in good faith with all applicable guidelines and regulatory requirements. They would not cover any violations of regulatory requirements or willful misconduct.
Such compensation systems and protections are already established in a number of European countries, avoiding costly and time-consuming litigation, which takes many years, during which time people live with the impact of their injury and the stress of long, complex and expensive litigation with no guarantee of a successful outcome.
Considering the scale of the COVID-19 crisis and the impact that safe and effective vaccines can have on the human and economic costs of the pandemic, it is critical that compensation systems that work for all are put in place across the whole of Europe.
It was the 31 December 2019 when the World Health Organization (WHO) was formally notified about a cluster of cases of pneumonia in Wuhan City, China. Ten days later, WHO was aware of 282 confirmed cases, of which four were in Japan, South Korea and Thailand. At that stage, few predicted the impact of COVID-19 around the world, and attention quickly turned to the scientific community and particularly the research-based industry to find the tools to fight the virus.
We have witnessed an unprecedented, collaborative research effort involving huge mobilisation of people and resources by our industry and beyond. We are just beginning to see the fruits of that investment but the fight against COVID-19 is really just beginning.
Delivering a successful vaccination programme around the world will continue to require new collaborations, investment, new ways of working and new levels of solidarity.
As an industry #WeWontRest in the fight against COVID-19.