In this commentary, NDA’s Thomas Lönngren discusses the regulatory learnings from the 2009 pandemic and how these are applicable to the current pandemic.
In April 2009 we were in the middle of an ongoing influenza pandemic and as the Executive Director of the European Medicine Agency I was ultimately responsible for the Agency’s response.
EMA’s responsibility was to ensure that we could get a vaccine approved as soon as possible and evaluate potential antivirals for the prevention and treatment of the infection. We also set up a robust surveillance system monitoring the safety of vaccines and antivirals when they were put on the market. All of this had to be done while ensuring that staff and experts working at the agency could continue to operate and deliver advice to developers of vaccines and antivirals while maintaining their own well-being.
One of these proposals was the idea to create what became known as the Mock-up vaccines. Specific guidance was developed by the Agency for an assessment procedure for pandemic influenza vaccines
It was an intense period with many meetings, ensuring the operation of the agency as well as daily teleconferences with European Commission, WHO, other regulators such as the FDA, and the industry. Luckily there were preparations in place.
When the pandemic broke out in April 2009 we were not taken by surprise. Warning signals came from WHO as early as the beginning of 2000. The SARS outbreak in 2002 had also served as a wakeup call. The outbreak of bird flu caused by H5N1 virus was an additional indication that a pandemic was imminent.
NDAs Advisory Board member and vaccines expert Pieter Neels together with a group of scientific and public health experts and key stakeholders convened for the 2nd International Alliance of Biological Science (IABS) to review the status of the current knowledge regarding the relationship between narcolepsy and the administration of the adjuvanted pandemic influenza vaccines, with the goal of being prepared for the next influenza pandemic.
The result of the discussions have been documented in the report: Meeting report narcolepsy and pandemic influenza vaccination: What we know and what we need to know before the next pandemic?
The highlights from the report include:
The association between the reported influenza vaccine and narcolepsy has been consistent in the countries in which it has been studied.
There are no clear associations observed between development of narcolepsy and the other pandemic adjuvanted vaccines.
The public health response during a pandemic is critical.
International collaboration and the capacity for data sharing should exist before the next pandemic.
Research on narcolepsy therapy should be supported and clinicians skilled in management should be available.
Dr Pieter Neels, Clinical Expert and Advisory Board member at NDA Group, has been invited to present and chair at Gifu Innovation Lecture International Symposium; Vaccine Development for Future. The symposium is being held at Gifu Pharmaceutical University, Gifu, Japan, on October 6th.
The objectives for this international lecture symposium are to discuss future vaccine development and to share various knowledges including different regulatory framework and B/R assessment in foreign countries from Japan. Dr Neels will present an EU and world perspective on vaccine development.
To read more about the event click here and to read the programme click here.
Dr. Pieter Neels, leading vaccines specialist and member of NDA’s Advisory Board, is taking part in a ‘Foundation Mérieux’ roundtable on pertussis vaccines. The event, held in Annecy, France between 11th to 13th November, brings together experts and interested individuals to explore more about the latest trends in pertussis epidemiology and the potential ways a pertussis vaccines might be improved.
During the roundtable, Dr. Neels will be asked to contribute to a consensus on the optimal use of current vaccines, with a particular focus on strategies to minimise severe morbidity and mortality among infants during the first months of life.
Pertussis, commonly called whooping cough, is a highly infectious disease, which during the last 5 years has seen multiple countries seen a substantial increase in reported cases, very young infants who are at greatest risk.
Dr. Neels has been invited to take part in the roundtable as a leading EU regulatory expert on vaccines. Dr. Neels is a former CPMP/CHMP member for Belgium, Vice-Chair of the CHMP Vaccine Working Party, he is also representing the EU at many WHO conferences and other meetings.
Dr. Pieter Neels, member of NDAs Advisory Board, will attend the SAGE meeting in Geneva between 20-22 October. Twice a year the Strategic Advisory Group of Experts meets to discuss the world wide recommendation of vaccines and Dr. Neels is also invited as an EU regulatory expert in this field.
The Strategic Advisory Group of Experts (SAGE) on Immunization was established by the Director-General of the World Health Organization in 1999 to provide guidance on the work of WHO. SAGE is the principal advisory group to WHO for vaccines and immunization. It is charged with advising WHO on overall global policies and strategies, ranging from vaccines and technology, research and development, to delivery of immunization and its linkages with other health interventions. SAGE is concerned not just with childhood vaccines and immunization, but all vaccine-preventable diseases.
Dr. Neels is an EU regulatory expert on vaccines and he is asked by WHO to attend their vaccine meetings and provide his viewpoint, in order to try to help them with guidance on how vaccines should be developed and registered in the world. In addition the post-authorization phase is also very important: the implementation might be a problem as not all circumstances are foreseen in the labelling, and so finding the right way forward is part of these discussions.
NDAs Dr. Pieter Neels is invited to a WHO workshop to improve and update the existing guidance document for the development of HPV vaccines at WHO HQ in Geneva, Switzerland 11-12 November.
Dr. Neels is an EU regulatory expert on vaccines and he is asked by WHO for his expertise in this field. He is invited on many occasions to attend and provide his viewpoint in their vaccine workshops and meetings, in order to try to help them with guidance on how vaccines should be developed and registered.
To find out more about WHO position on human papillomavirus vaccines click here.
NDA’s Pieter Neels will give a talk on vaccines highlighting why vaccines are important, and very different from other medicinal products. He will also clarify why vaccines are not easy to develop and why regulatory agencies best specialize in a few topics in the European Union and this on top of the generic knowledge of regulatory affairs.