Giraffe
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[Edit to add: Please ignore this post. They have been testing two vaccine candidates. The one discussed here ist not the one used in the final product. I will post about the real one later in this thread.]
The Pfizer / Biontech (so-called) vaccine got approved in the UK for rollout next week. The first who shall be vaccinated are "residents in a care home for older adults and their carers".
Priority groups for coronavirus (COVID-19) vaccination: advice from the JCVI, 2 December 2020 - GOV.UK (www.gov.uk)
So far only data from the phase I/II trial in a small population (45 participants including 9 in the placebo group), age range 19-54 have been published. The study lasted only a few weeks.
Phase I/II study of COVID-19 RNA vaccine BNT162b1 in adults
Study Design
Tolerability
figure 3
Discussion
The Pfizer / Biontech (so-called) vaccine got approved in the UK for rollout next week. The first who shall be vaccinated are "residents in a care home for older adults and their carers".
Priority groups for coronavirus (COVID-19) vaccination: advice from the JCVI, 2 December 2020 - GOV.UK (www.gov.uk)
So far only data from the phase I/II trial in a small population (45 participants including 9 in the placebo group), age range 19-54 have been published. The study lasted only a few weeks.
Phase I/II study of COVID-19 RNA vaccine BNT162b1 in adults
Study Design
Between 4 May 2020 and 19 June 2020, 76 participants were screened, and 45 participants were randomized and vaccinated. Per dose level (10 μg and 30 μg), 12 participants were vaccinated with BNT162b1 on days 1 and 21, 12 participants received a 100-μg dose on day 1 and 9 participants received placebo (Fig. 1). The study population consisted of healthy male and female participants with a mean age of 35.4 years (range, 19–54 years); 51.1% were male and 48.9% were female.
Tolerability
- 100% pain at the injection side
- 100% headache
- fever, fatigue, chills, muscle pain, joint pain ...
figure 3
Discussion
Our study had several limitations. Although we used convalescent sera as a comparator, the kind of immunity (T cells versus B cells or both) and level of immunity needed to protect from COVID-19 are unknown. Furthermore, this analysis of available data did not assess immune responses or safety beyond 2 weeks after the second dose of vaccine. Both are important to inform the public health use of this vaccine.
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