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EU's New Drug Agency Head Warns of Vaccine Safety Challenges

By Life Sciences Review | Sunday, December 06, 2020
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FREMONT, CA: Monitoring the safety of Covid-19 vaccines, especially those relying on novel technologies such as messenger RNA, is one of the biggest challenges. According to Europe's new drug agency, since mRNA vaccines haven’t been used before, safety must be ensured when it goes into a large population.


According to Modern Inc, its covid-19 mRNA vaccine was 94.5% effective in preliminary analysis of a large late-stage clinical trial, beating rivals Pfizer and partner BioNTech SE, who became the first drugmakers in the race to release advanced trial data. Their mRNA vaccine was more than 90% effective in preventing illness.


Vaccine advocates have become concerned that fadin trust in governments, political interference and the quest to create a shot in record time could fuel doubts about covid vaccines, hindering the rollout. But with promising results, it should be easier to explain the benefits of the vaccines. Another priority is outlining its differing stance from the FDA on an efficacy benchmark for vaccines. Unlike its U.S counterpart, the EMA has declined to put a target on how effective  a vaccine must be to gain approval, opting to wait until more data are available. The U.S agency has said, any shot would need to prevent disease or desease severity in at least 50% of those vaccinated.


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