SCC Kaiser participating in Pfizer phase 3 trial - Printable Version
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SCC Kaiser participating in Pfizer phase 3 trial - M T - 08-13-2020
The Chron ran a story yesterday
Bay Area Kaiser sites to join one of first global coronavirus vaccine trials
Quote:Kaiser Permanente in California and Oregon, including sites in Santa Clara and Sacramento counties, has joined a global trial ...
The phase 3 trial, the last step before federal approval, is the first major study to seek Bay Area volunteers...
Kaiser gave the vaccine to its first Northern California volunteers on Monday.
About 1,400 participants at four Kaiser locations will be given the vaccine developed by Pfizer Inc. and the German technology company BioNTech.
Participants must be adults 18 to 85 who are Kaiser members. They cannot be pregnant or planning to become pregnant. Kaiser is especially looking for volunteers who are more likely to develop COVID-19, including people who are older, have underlying health issues, or work in jobs where they face greater risk of exposure to the virus.
The trial is a double-blind, placebo-controlled study, which means half of the participants will be given the vaccine and half a placebo.
RE: SCC Kaiser participating in Pfizer phase 3 trial - dabigv13 - 08-13-2020
The first phase 1 trial for a vaccine was also done at Kaiser, in Washington, with the Moderna mRNA vaccine.
RE: SCC Kaiser participating in Pfizer phase 3 trial - dabigv13 - 08-18-2020
https://www.covidvaccinestudy.com/
If you want to sign up for the Pfizer study, you can do so here. Open to anyone 18 to 85. Don't need to be a KP member.
RE: SCC Kaiser participating in Pfizer phase 3 trial - BostonCard - 08-18-2020
Walnut Creek is the closest site to me. I may make the treck if I qualify.
BC
RE: SCC Kaiser participating in Pfizer phase 3 trial - dabigv13 - 08-21-2020
Some more information on the vaccine they're testing in phase 3, apparently not the same one they initially tested, but one with apparently less side effects. They presented newer data on the comparison between the two. And check out the kicker....could seek approval in October. Seems incredible they would have good data that soon.
https://www.statnews.com/2020/08/20/pfizer-biontech-favored-covid19-vaccine-has-fewer-side-effects-than-first-one/
RE: SCC Kaiser participating in Pfizer phase 3 trial - BostonCard - 08-21-2020
Here's their pre-publication paper: https://www.medrxiv.org/content/10.1101/2020.08.17.20176651v1
Note that they are planning an event-driven study (at least for an interval analysis). With 30,000 participants, they'd be powered to hit a 50% efficacy, with a lower bound of the confidence interval of 30% efficacy, (which is the FDA's requirement as best I can tell from the guidance) with 75 COVID-19 infections. If they get 50 events in the placebo group and 25 in the treatment group, the 95% efficacy confidence interval is 31 - 81%, and of course, that is a reduction of 50%.
To get that many infections, they would need about 0.17% of participants to become infected, so that is reasonable.
Ironically, the worse the outbreak, the faster we may have a vaccine. If the outbreak slows down (generally a good thing), it might delay the development of a vaccine.
BC
RE: SCC Kaiser participating in Pfizer phase 3 trial - dabigv13 - 08-21-2020
Only 11k are already recruited so far tho. Would guess many of them international- Brazil, Argentina, Germany, and 39 US states appear to be the trial sites. The 1400 through KP seems to have just started recruiting.
Brazil is a hot spot, but I wonder how reliably they screen out participants who were asymptomatic beforehand, given how bad outbreak has been there for so long. Even with serology tests some may not have IgGs. And I would think they'd want to see a fair amount of US data to account for population differences before approval.
Below is trial website-
https://clinicaltrials.gov/ct2/show/NCT04368728?term=NCT04368728&draw=2&rank=1