Hier ein Link zu einem Beitrag aus der NY Times bezüglich AstraZeneca. Anscheinend ist davon auszugehen, dass die Zulassung noch ein gutes Stück entfernt ist und weitere Prüfungen durchgeführt werden müssen. Das heisst auch, dass sich in den ersten Monaten der Impfungen maximal zwei Firmen den Kuchen teilen.
www.nytimes.com/2020/11/24/health/...epage§ion=Health
Ein Auszug aus dem Text:
Does this mean it will soon be available in the United States?
There’s still a long way to go. It is not yet clear whether the results announced on Monday are enough for AstraZeneca to take the first formal step of the regulatory process: submitting an application to the F.D.A. to get emergency authorization to distribute its vaccine. AstraZeneca plans to start testing the half-strength initial dose in its continuing United States trial and to ask the agency for guidance on how to proceed. The agency is likely to advise the company to collect more data on its promising dosing plan before submitting a formal application to authorization, several vaccine experts said.
Collecting more data might mean waiting for more results from participants in Britain who got the half dose. It might also mean waiting for the first results from the American study, which aren’t expected until next year.
How does the AstraZeneca vaccine stack up to the other candidates?
Outside experts have plenty of unanswered questions. “The only thing that you can really say right now is that the vaccine seems to work,” Florian Krammer, a virologist at the Icahn School of Medicine at Mount Sinai in New York City. “It’s just hard to say how well it works compared to others.”
Experts have had a hard time parsing the results because of the way they were announced. Like the results from Pfizer and Moderna, the data on AstraZeneca’s vaccine was summarized in a news release.
Although the announcement gave efficacy rates, it left out details that would have helped outside researchers independently assess the data: It did not say how many cases of Covid-19 were found in the group that got the half-strength initial dose, or in the group that got the regular-strength initial dose, or in the group that got a placebo. It also did not say how many severe cases were found in the placebo group.
The results were pooled from across the two studies in Britain and Brazil, which have slightly different designs. To complicate matters further, details weren’t available on exactly how those trials were designed, because AstraZeneca and Oxford haven’t publicly released the protocol documents that serve as a road map for how those trials are evaluating the vaccine. (AstraZeneca has, however, released the protocol for its continuing trial in the United States.) That means we don’t know, for example, how many Covid-19 cases will need to turn up in order to prompt the end of the British and Brazilian studies.
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