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originally posted by: Phage
a reply to: putnam6
The data in VAERS is used as per the disclaimer, they use it to establish if they need to go further analysis.
Indeed. But the document provided has nothing to do with VAERS.
originally posted by: Phage
a reply to: putnam6
The document is a compilation of media reports. It is not a compilation of VAERS data.
here's another link.
originally posted by: incoserv
I'm trying to access the PDF file but I get an ERROR 1020 denied access.
Anybody else having this problem?
Again I ask you would these vaccines as is get past normal FDA regulations and thresholds?
Clinical development is a three-phase process. During Phase I, small groups of people receive the trial vaccine. In Phase II, the clinical study is expanded and vaccine is given to people who have characteristics (such as age and physical health) similar to those for whom the new vaccine is intended. In Phase III, the vaccine is given to thousands of people and tested for efficacy and safety.
Many vaccines undergo Phase IV formal, ongoing studies after the vaccine is approved and licensed.
Surely you jest.
To usurp normal FDA protocols so even more people die paving the way for a GREENER planet less-populated one.
originally posted by: Phage
a reply to: putnam6
Again I ask you would these vaccines as is get past normal FDA regulations and thresholds?
I don't know, but stage III trials were completed. What more do you think is required?
Clinical development is a three-phase process. During Phase I, small groups of people receive the trial vaccine. In Phase II, the clinical study is expanded and vaccine is given to people who have characteristics (such as age and physical health) similar to those for whom the new vaccine is intended. In Phase III, the vaccine is given to thousands of people and tested for efficacy and safety.
Many vaccines undergo Phase IV formal, ongoing studies after the vaccine is approved and licensed.
www.cdc.gov...
Surely you jest.
To usurp normal FDA protocols so even more people die paving the way for a GREENER planet less-populated one.
A Phase 3 randomized, placebo-controlled, observer-blind clinical trial to evaluate the efficacy, safety, and immunogenicity of the Moderna COVID‑19 Vaccine in participants 18 years of age and older is ongoing in the United States (NCT04470427).
I find it staggering how our government has changed dosing schedules, to cover how short we are ,and now suggesting a mix and match approach.
These vaccine are not approved and licensed.
www.nejm.org...
Conclusions
The mRNA-1273 vaccine showed 94.1% efficacy at preventing Covid-19 illness, including severe disease. Aside from transient local and systemic reactions, no safety concerns were identified. (Funded by the Biomedical Advanced Research and Development Authority and the National Institute of Allergy and Infectious Diseases; COVE ClinicalTrials.gov number, NCT04470427)
Key limitations of the data are the short duration of safety and efficacy follow-up. The trial is ongoing, and a follow-up duration of 2 years is planned,
Whether mRNA-1273 vaccination results in enhanced disease on exposure to the virus in the long term is unknown.
Pregnant women and children were excluded from this trial, and additional evaluation of the vaccine in these groups is planned.
trial is ongoing, and the investigators remain unaware of participant-level data. Designated team members within Moderna have unblinded access to the data, to facilitate interface with the regulatory agencies and the data and safety monitoring board; all other trial staff and participants remain unaware of the treatment assignments.