Přidat odpověď
Samo ockovani muze velmi vyjmecne zhorsovat i to onemocneni
https://stm.sciencemag.org/content/scitransmed/12/568/eabe0948.full.pdf?casa_token=8-WTZ7n5YyQAAAAA:Ag0_UBGGLot4UjvjHCd1jJbcHSWoxXgfekGDqiiQ4UFJAqqKCPejeF06MzEJRw58TQ-HZWrWXjBCaV0M
tohle je pekne review z nedavna, jak moce se to ocekava nyni a jak se to sleduje, at uz ty symptomy jsou shodne s onemocnenim, nebo ne
Pro Hroudu, k cele strategii toho testovani, tam pisou
The design of COVID-19 vaccine clinical trials takes these points
into account by progressing from small (about 100 person) phase 1
safety trials through large (~30,000 person) phase 3 efficacy trials.
The primary efficacy analysis in a phase 3 trial may occur less
than 12 months after the start of the phase 1 trial, and phase 3 trials
are expected to include enough incident COVID-19 cases (e.g., 150 infection events) at that point to confidently assess whether a vaccine
candidate is reducing disease incidence by a factor of 2 or greater. All phase 3 trial participants are expected to be followed for
at least 1 year
U.S. Food and Drug Administration (FDA) guidelines for industry for emergency use authorization for vaccines to
prevent COVID-19 were recently issued. These guidelines require
that the trials (i) meet the prespecified success criteria for the study’s
primary efficacy end point, (ii) provide all safety data from phase 1,
2, and 3 trials, (iii) conduct follow-up of phase 3 participants for a
median duration of at least 2 months after completion of the full
vaccination regimen, and (iv) report five or more severe COVID-19
cases in the placebo group to assess the possibility of VAED in the
vaccine group. (VAED Vaccine-associated enhanced
disease)
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