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Related: Editorials & Other Articles, Issue Forums, Alliance Forums, Region ForumsTrump Fake Vaccine by November 1
https://www.cnn.com/2020/09/02/health/cdc-covid-19-vaccine-distribution/index.htmlThis fake vaccine theater is the redo of the Reich Wing WMD hoax of the Iraq Debacle.
Fool the rubes, and then say sorry. Years later.
radius777
(3,635 posts)They've sent signals out, FDA/Hahn is a tool, and I fear Fauci is simply not strong enough to stand up to them if they try to ram this through. Fauci is another Mueller in that alot people see him as part of the resistance but in reality he's an establishment white guy who likes being in the club.
If Fauci gets up there with them and gives it his support - this will be bad for us - and we need to be ahead of this now.
A vaccine without proper phase 3 testing, that is done for political purposes, would be the height of medical and scientific negligence.
kairos12
(12,858 posts)like Mueller did. Both Mueller and Fauci are by the rules fighters. They come out like standup boxers and Drumpt comes out kicks them square in the jewels. Down goes Mueller, down goes Fauci.
Eliot Rosewater
(31,109 posts)era officials like Comey maybe and others, using lies like spying on rump campaign and of course an indictment of a son of a famous Democrat.
But this too will be part of the surprise, the vaccine and it wont be safe technically speaking from the simple standpoint of protocol.
radius777
(3,635 posts)especially if it's Fauci endorsed.
I don't trust Fauci and never have, just as I never trusted Mueller and Rosenstein, who wound up fucking us in the end.
Eliot Rosewater
(31,109 posts)doc03
(35,328 posts)will be trying it.
OnDoutside
(19,956 posts)Jarqui
(10,123 posts)Monday, August 31, 2020
Phase 3 Clinical Testing in the US of AstraZeneca COVID-19 Vaccine Candidate Begins
https://www.nih.gov/news-events/news-releases/phase-3-clinical-testing-us-astrazeneca-covid-19-vaccine-candidate-begins
...
After an initial screening, participants will receive two injections of either the investigational vaccine or a saline placebo approximately four weeks apart.
...
The trial primarily is designed to determine if AZD1222 can prevent symptomatic COVID-19 after two doses. The trial also will evaluate if the vaccine candidate can prevent SARS-CoV-2 infection regardless of symptoms and if it can prevent severe COVID-19. It also will assess if the experimental vaccine can reduce the incidence of emergency department visits due to COVID-19.
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Participants will be followed for two years after their second vaccination. They will be asked to provide blood and nasopharyngeal samples at their initial visit and will be asked to provide blood samples periodically for the duration of the trial. Scientists will examine the blood samples in the laboratory to measure and characterize immune responses. The severity of the disease observed will be measured and used to assess the activity of the investigational vaccine.
...
They're not getting that done before the election.
kairos12
(12,858 posts)done anytime soon the election.
radius777
(3,635 posts)All of the articles on this topic suggest that, and Hahn has shown himself to be a tool.
US National Institutes of Health (NIH) Director Francis Collins said regulatory approval for any potential COVID-19 vaccine included in the governments Operation Warp Speed is unlikely to occur before November.
In an interview with reporters, Collins said even the most promising coronavirus vaccine candidates will not win approval any earlier than November or December, and added that testing a vaccine in at least 10,000 people could potentially provide enough data to support wide-scale distribution.
I would not expect, on the basis of what we know scientifically, that we would be at the point where the US Food and Drug Administration could make such a judgment until considerably later than 1 October, said Collins, adding: Maybe November or December would be my best bet.
The Trump administration-backed Operation Warp Speed initiative aims to deliver 300 million doses of a COVID-19 vaccine to the American public by January 2021.
A host of vaccine candidates have already been selected to receive funding, in a bid to advance development and bolster manufacturing capabilities for their respective COVID-19 candidates. This includes potential vaccines from Johnson & Johnson, AstraZeneca/Oxford University, Pfizer/BioNTech, GlaxoSmithKline/Sanofi, Moderna and Novavax.
In the same call with reporters, Collins said he is confident that at least one of the several candidates funded by Operation Warp Speed will be shown to be safe and effective by the end of the year.
Last week, President Donald Trump announced that it was possible a coronavirus vaccine would be available in the US before the start of the general election on 3 November. However, Collins dismissed concerns that Operation Warp Speed is advancing candidates too quickly without determining safety and efficacy first.
http://archive.is/kdTbc {archived version}
The Trump administration is considering bypassing normal US regulatory standards to fast-track an experimental coronavirus vaccine from the UK for use in America ahead of the presidential election, according to three people briefed on the plan.
One option being explored to speed up the availability of a vaccine would involve the US Food and Drug Administration awarding emergency use authorisation (EUA) in October to a vaccine being developed in a partnership between AstraZeneca and Oxford university, based on the results from a relatively small UK study if it is successful, the people said.
The AstraZeneca study has enrolled 10,000 volunteers, whereas the US governments scientific agencies have said that a vaccine would need to be studied in 30,000 people to pass the threshold for authorisation. AstraZeneca is also conducting a larger study with 30,000 volunteers, although the results from that will come after the smaller trial.
Making a vaccine available before the election could allow US president Donald Trump to claim he has turned the tide on a virus that has killed more than 170,000 Americans following widespread criticism of his handling of the pandemic. In his convention speech on Thursday night, Joe Biden, Mr Trumps Democratic opponent, said that the US response to the virus was the worst performance of any nation.
Jarqui
(10,123 posts)21 AUGUST 2020
Pfizer and BioNTech report positive data of second Covid-19 vaccine
https://www.clinicaltrialsarena.com/news/pfizer-biontech-second-vaccine-2/
Based on these data, the companies decided to advance a two-dose regimen of 30µg BNT162b2 into a Phase II/III trial, which is currently enrolling participants in the US, Argentina and Brazil.
So they're about the same place as Oxford.
No way this vaccine can be distributed - two doses over four week spread, studied and proven by the election.
Jarqui
(10,123 posts)Moderna vaccine produces antibodies in trial of older people
https://www.bnnbloomberg.ca/moderna-vaccine-produces-antibodies-in-trial-of-older-people-1.1485192
Moderna is totally on track for enrolling all 30,000 patients into its phase 3 trial by September, Bancel said. Now we are really going at full speed.
The company said on August 21 that it had already enrolled more than 13,000 patients in the trial. Results are possible by late fall.
Moderna might be a little ahead of the others.
But unlike Oxford for example, their approach has never been used in humans before.
I do not know how they can overcome that hurdle in such a short period of time.