Short resume of the EMA Public stakeholder meeting on assessment, approval and roll-out of pandemic vaccines
Here is a short resume of the “European Medicines Agency (EMA) Public stakeholder meeting on assessment, approval and roll-out of pandemic vaccines” (the video – duration 2h14mins – is available below)
by Heiko Santelmann
In this seminar with Q&A at the end, EMA presented the first 2 vaccines that received conditional approval Comirnaty and Moderna.
Here are a few highlights and some warnings:
- After being vaccinated, some body cells are reading the mRNA information and temporarily produce the spike protein. The immune system will produce antibodies against these foreign proteins and be ready to defend the body against the virus, when in contact later. The mRNA is broken down shortly after vaccination.
- Studies with over 30,000 were performed, where 1/2 got a dummy injection. 95% reduction in the number of symptomatic C19 cases. = 84 cases of symptomatic C19 prevented, 4 cases not, 9,912 participants without any symptoms. Very few side effects.
- Reducing symptomatic disease will be an important step in beating the pandemic, but masks, hand washing and social distancing will remain essential.
- No data to conclude how well the vaccines work for people who already had C19. There were not seen additional side effects. But we are aware of the possibility of ADE. Until now we have no indication to be afraid of this overreaction of the immune system.
- We are still waiting for results from studies, ongoing for the next 2 years, showing how long the effect will last, how well severe cases are prevented and what the outcome will be for children, pregnant women and immunocompromised people.
- It is still too soon to know the wider impact on preventing infection, asymptomatic transmission and viral spread in the community.
- All vaccines are only approved if overall benefits outweigh their risks. Due to large numbers of vaccinated, we need to ensure safety monitoring reacts quickly. If new side effects are caused by a vaccine, it is included in the package leaflet. Safety will not be compromised. Please report suspected side effects.
- It is important to fight misinformation and spread factsheets and videos.
- The companies will continue to provide study results and data as they continue to be generated. Member states will also use other means to gather data, like AI-based signal generation-early identification of unknown side effects and identification of unreported side effects. Everyone has a right to be informed on how the vaccine has been developed, approved and is being monitored.
From the Q&As:
EMA is waiting for efficacy and safety-studies on different groups, as elderly and people with other diseases. But the EMA is not in a position to mandate these studies from the producers. We hope we soon can find out if the vaccine will help stopping spreading and infection, if it is safe for pregnant women and their unborn children (the university of Utrecht has just started a study to look at that). Anaphylactic reactions have happened ca. 10 times more often than after the flu-vaccines, but there is good information given to the vaccinators on how to handle these rare reactions. We have no indication that it can lead to infertility or ADE, but have to be aware that it can happen. It looks like the Pfizer vaccine is also effective against the mutated strains. Monitoring awareness, safety and effectiveness is very important in order to gain trust. We hope and believe that these vaccines will get us out of the worst health crisis in this century.
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