A scientist’s opinion : Interview with Dr Kari Johansen about vaccine procedure

Dr Kari Johansen is expert in influenza and other respiratory viruses and vaccine-preventable diseases at the ECDC. She obtained her medical degree from the Karolinska Institute in Stockholm, where she also did her PhD (1999). Prior to joining the European Centre for Disease Prevention and Control (ECDC) in 2008, Dr Johansen worked for the Swedish Institute for Infectious Disease Control (SMI) and the Swedish National Reference group for Vaccine Preventable Diseases (REFVAC). Since 2014, she has been a member of the World Health Organization’s Strategic Advisory Group of Experts on Immunization (SAGE), of which she was elected vice-chair in 2016 and has represented at the Global Advisory Committee on Vaccine Safety. Since 2018, she has led a new EU-EEA national immunisation technical advisory group (NITAG) collaboration initiative hosted by the ECDC, which was set up to share and collate evidence on the efficacy, effectiveness and safety of new and updated vaccines used in EU-EEA national immunisation programmes.

In your opinion, how can political attitudes influence vaccine confidence and what can politicians do to boost it?

Kari JohansenKari Johansen: In my view, scientific studies that assess vaccine safety and effectiveness both in the short and long-term are absolutely key. Showing that these vaccines are safe and effective when rolled out in the real world will hopefully convince everyone to have it. This would include healthcare workers and politicians, who can then base their recommendations on solid scientific evidence.

Industry-independent post-authorisation studies are currently being funded by the Commission and planned by the ECDC and the EMA (European Medicines Agency) in line with the Commission’s communications of 15 and 28 October. These studies need to consider the safety and effectiveness of pharmaceutical products Many new vaccines are expected to become available in the Member States, but they may not be equally effective in all age and target groups. We still have a lot to learn, and studies that go beyond the routine safety monitoring available in all EU/EEA countries are therefore needed, and are indeed already planned.

Politicians can help ensure that adequate human and financial resources are set aside for the required studies, which should include comparative studies between different vaccine products at the EU and national levels. Negotiations for the industry-independent studies mentioned in the Commission’s communications are ongoing. If many vaccines receive authorisation, greater efforts will be needed in the short and long-term to understand their impact on the population.

Once the vaccines are shown to be safe and effective, each country needs to put adequate resources into rolling them out, including using websites at the governmental, public health, and regional and local levels to keep people informed and encourage them to get vaccinated. Other reach-out activities may be needed. Identifying different stakeholders has also been proven to be beneficial.

According to your paper ‘Introduction of new vaccines: How can storytelling help?’, healthcare professionals have a key role in promoting vaccination programmes and need to know the facts about vaccine safety and efficacy.

In your opinion, what would be the most effective way of giving healthcare workers a greater role in promoting vaccine safety and in tackling vaccine hesitancy in the current pandemic?

Kari Johansen: Adequate vaccination training for healthcare workers is key. Healthcare workers need to understand why there are so many vaccine products, how each vaccine works and how they differ, and whether some vaccines will only be recommended for certain target groups. They also need to understand their safety and effectiveness and be aware that significant efforts are put into the studies I mentioned earlier, both in the EU and in North America.

Training can be organised online or in person. Both are likely needed, with online training playing a key role. These campaigns will only be successful when a majority of healthcare workers are confident that the new vaccines are safe and effective. A slow start is therefore to be expected. In parallel, evidence-based information about the vaccines can be presented in different forms of traditional and social media. Anti-vaccine activities should be carefully assessed and the scientific information needs to be presented as much as possible.

It is also good to present key findings on natural immunity and on complications that have been observed in COVID-19 patients, including the phenomenon of ‘long COVID-19, and get the message across that care is getting better over time as our understanding of the disease improves and more treatment options become available. Any attention that can be focused on the COVID-19 situation is likely to be helpful.

The Russian and Chinese vaccines currently under development face worldwide scepticism. According to a study carried out in the USA, 78 % of respondents believe that vaccine approval is more influenced by politics than science, and 83 % said they would worry about how safe a COVID-19 vaccine would be if it were approved quickly.

Do you have concerns that the race for the vaccine could compromise quality or safety?

Kari Johansen: I can only respond for the EU/EEA. The studies conducted follow the EU routine recommendations for pre-authorisation studies. EU regulatory evaluations will also be done in accordance under the routine evaluation framework. Due to the current situation, vaccine developers and the regulatory agencies are trying their utmost to shorten the time required for each step, but this must not affect the quality of the work. What will be unknown at the time of authorisation ⁠– and it is common for there to be a number of unknowns when any vaccine is authorised ⁠– is whether these vaccines protect against hospitalisation, severe disease and death, and whether they prevent transmission between individuals. Information is needed on their long-term safety and effectiveness, as is the need for booster doses dependent upon natural virus evolution and antigenic changes.

In your opinion, what is the reason behind the scepticism toward the Russian and Chinese vaccines? Does the WHO/SAGE have a role in responding to this worldwide scepticism, and if so, what can it do?

Kari Johansen: The Russian and Chinese vaccines have both been recommended and used without there being any results available from the phase III clinical trials currently underway. We are now waiting for those results, but have no reason to believe that they will be worse than for any other vaccine candidates in development and which use the same type of technology. Both China and Russia have significant expertise and experience when it comes to producing vaccines both for domestic and international use.

For the last question on what the WHO/SAGE should or shouldn’t do, I think that it is best to refer to them directly.

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