.. EMA hat Novavax zugelassen, obwohl es nur eine Studie aus letztem Sommer gibt, die bis auf wenige Ausnahmen nur gegen den WIldtyp erhoben wurde. Daten zu Omikron gibt noch garnicht, auch Delta kam nicht vor. Die zweite UK Studie ist auch nur gegen den Wildtyp.
Meinung: Die EMA tappt also im Dunklen und hat Novavax zugelassen, in der Hoffnung, dass die schon irgendwie auch gegen Omikron helfen werden. Bin gespannt auch die ersten Studien zu aktuellen Stämmen. Und wie lange Novavax dann zur Anpassung braucht, während Biontech schon fleissig den angepassten ab März ausliefert (Spekulation).
Auch hat Novavax einige Nebenwirkungen, es ist also keineswegs so, als seien die Todimpfstoffe Nebenwirkungsfrei und das Wundermittel:
"The first study, conducted in Mexico and the United States, found a 90.4% reduction in the number of symptomatic COVID-19 cases from 7 days after the second dose in people who received Nuvaxovid (14 cases out of 17,312 people) compared with people given placebo (63 out of 8,140 people). This means that the vaccine had a 90.4% efficacy in this study.
The second study conducted in the United Kingdom also showed a similar reduction in the number of symptomatic COVID-19 cases in people who received Nuvaxovid (10 cases out of 7,020 people) compared with people given placebo (96 out of 7,019 people); in this study, the vaccine efficacy was 89.7%.
Taken together, the results of the two studies show a vaccine efficacy for Nuvaxovid of around 90%. The original strain of SARS-CoV-2 and some variants of concern such as Alpha and Beta were the most common viral strains circulating when the studies were ongoing. There is currently limited data on the efficacy of Nuvaxovid against other variants of concern, including Omicron.
The side effects observed with Nuvaxovid in the studies were usually mild or moderate and cleared within a couple of days after vaccination. The most common ones were tenderness or pain at the injection site, tiredness, muscle pain, headache, a general feeling of being unwell, joint pain, and nausea or vomiting.
The safety and effectiveness of the vaccine will continue to be monitored as it is used across the EU, through the EU pharmacovigilance system and additional studies by the company and European authorities."
www.ema.europa.eu/en/news/...mends-nuvaxovid-authorisation-eu
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