EMA to review Moderna’s Omicron vaccine

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The EMA announced Friday in Amsterdam that the vaccine is designed to better protect against infection with the virus and its Omicron variant coronavirus. Experts will first review data from laboratory studies and compositional, manufacturing, and control data.

EMA to review pharma company Moderna’s Omicron vaccine
The U.S. company presented preliminary efficacy data on its adapted Corona vaccine on June 8. The 437 subjects who received the new preparation as a second booster had significantly more neutralizing antibodies after one month than after booster vaccination with the conventional practice, particularly against Omicron.

Tests and studies are evaluated on an ongoing basis following the review process
Under the expedited review process, data from tests and studies are evaluated on an ongoing basis, even if all data are not yet available and a regulatory submission has not yet been made. The fast-track procedure is intended to ensure that health authorities in EU countries have adapted vaccines in time for a possible new wave of infection in the fall.

EMA also initiated a review procedure on Pfizer/Biontech vaccine
Just Wednesday, the EMA launched the review process for a Corona vaccine adapted for viral variants from manufacturers Pfizer and Biontech. It is not known how long the trials will last. So far, no vaccine has been approved in the EU that also targets variants of the coronavirus.

  • source: vienna.at/picture: pixabay.com
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