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@Taurus been hammering at this this point for months. Like virtually since day one.
Not to mention that Covid deaths are hugely under reported.
Either that or we're in the middle of three Biblical plagues at once.
(C19, pneumonia and flu)
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@Taurus been hammering at this this point for months. Like virtually since day one.
Which of the very trustworthy organizations are backing this? The wait, what? CDC? The FDA? Which independent scientific body are you referring? As far as medical company bosses saying trust me, please. They’d sell you cyanide if they thought they could get away with it. While I can see how people would want to believe that everyone has the best interests of the country at heart, I also see a CDC which has bent under pressure to continually modify it message, to the point of openly contrasting things it had said a few weeks before. I see people who want to be seen as the saviors who will do what they need to get that title in history. When there is this much at play, I don’t blindly trust anyone.I know this is meant to be very lighthearted, but there will likely be one or more vaccines approved before the end of the year, quite possibly one in the next few weeks. This will be driven by the science, not anything else. The people in charge at the companies would have their heads of actual chopping blocks if they requested approval for a vaccine that their data showed to be dangerous or ineffective. The people in charge (staff scientists, etc) at the various Federal Agencies will not "approve" something that does not meet the standards of safety and efficacy. The efficacy rate they are looking for is between 50-60%. I am sure that will be scoffed at upon approval, but that is the standard the Scientists have set. Early next year, there will likely be one or more additional vaccines approved. The US Government has secured, through VERY early production contracts, hundreds of millions of doses of these vaccines, which will be available, starting soon after approval. In regard to vaccine purchases and future availability upon approval, the USA is FAR ahead of the rest of the World. It is not even close. The USA (Federal Government) has production contracts in place to vaccinate the entire population more than once, when you add it up over the various vaccine candidates. More than one vaccine is actually a great thing because some people will respond better to certain types of vaccines and more types of vaccines can be produced in multiple facilities at the same time. The USA has also bought up a massive number of glass vials and syringes. Most of this is something that does not get the headlines, because many other actions or inactions are just so obvious. On this front (vaccine testing and funding of production, future roll out, etc), the US Federal Government is actually doing a great job. It would be nice if this effort was supported by all of our leaders.
Which of the very trustworthy organizations are backing this? The wait, what? CDC? The FDA? Which independent scientific body are you referring? As far as medical company bosses saying trust me, please. They’d sell you cyanide if they thought they could get away with it.
Nobody is saying some totally independent board, there has never been such a thing in the entirety of human existence (all people have some sort of opinion about everything), would make some "decision" on a vaccine. BUT, there will be at least two totally independent (from each other) regulatory agencies looking at any vaccine approvals. In the United States and in The European Union. (I don't think anyone in the USA really believes that people in Washington DC decide what happens in Europe.) The UK has also decided to go with a framework outside of the EU regulatory authorities. Should the USA wait until all other countries have reached a decision, or make a decision based on the science and guidance? If the EU and UK say yes, should we still say no for political reasons, or should we say yes for political reasons? I don't think either will happen.
In the EU, the decision to approve a vaccine is made by the European Medicines Agency. (It does not take direction from the US FDA. and they SURE DON'T take directions from US politicians.) I think most people would say that if the people in the EU approve something, that it would be done without political pressure from the USA.
In addition, the United Kingdom has already made the decision to "fast track" approval of a potential vaccine, independent of the EU approval process. I don't think the EU Regulatory authorities take their marching orders from US political leaders either.
The EU:
The UK:
"Any new and effective Covid vaccine will be given emergency approval for use in the UK and an expanded workforce will be trained to give the injections to immunise as much of the population as possible quickly, the government has said.
A change in the law will allow the UK regulator, the Medicines and Healthcare Products Regulatory Agency (MHRA), to grant temporary approval for a vaccine from October, before it has been given a licence by the European authorities, which would be the normal procedure. The UK will be out of the EU from January and will approve drugs and vaccines without Brussels’ involvement.
"The European Medicines Agency, which was based in London before Brexit, will fast-track any vaccine and is known to work efficiently, but sources say there are language requirements that could make MHRA approval quicker.
Ministers say there will be no shortcut on safety or effectiveness, and that any vaccine will be approved for the UK only if it meets the highest standards The deputy chief medical officer for England, Prof Jonathan Van-Tam, said: “We are making progress in developing Covid-19 vaccines, which we hope will be important in saving lives, protecting healthcare workers and returning to normal in future."
UK to give emergency approval to any Covid vaccine breakthrough
Legal change will enable population to be immunised as quickly as possiblewww.theguardian.com
In the USA, the FDA takes a great deal of guidance from the Vaccines and Related Biological Products Advisory Committee. (Again, this is the group that would give a Yes or No, on approval. It is not 100% binding, but if it is not followed, it would be a very rough thing to get through.)
Here are a few of the members of this committee:
Hana El Sahly, M.D.
Expertise: Vaccines, Infectious Diseases
Associate Professor
Department of Molecular Virology and Microbiology
Department of Medicine
Section of Infectious Diseases
Baylor College of Medicine
Hayley Altman-Gans, M.D.
Expertise: Pediatrics, Infectious Diseases
Professor
Department of Pediatrics
Stanford University Medical Center
Stanford, CA 94305
Archana Chatterjee, M.D., Ph.D.
Expertise: Pediatrics, Infectious Diseases
Dean Chicago Medical School
Vice President for Medical Affairs
Rosalind Franklin University of Medicine and Science
North Chicago, IL 60064
Myron Levine, M.D., D.T.P.H., F.A.A.P
Expertise: Infectious Diseases
Grollman Distinguished Professor and
Associate Dean for Global Health
Vaccinology and Infectious Diseases
Center for Vaccine Development
University of Maryland School of Medicine
Baltimore, MD 21201
Andrea Shane, M.D., M.P.H., M.Sc.
Expertise: Pediatric & Infectious Diseases
Associate Professor of Pediatrics
Division of Pediatric Infectious Diseases
Emory University School of Medicine
Atlanta, GA 30322
And yes, there is industry representation, they know a great deal about the production of vaccines and the testing that takes place:
Paula Annunziato, M.D. ***
Expertise: Industry Representative
Vice President and Therapeutic Area Head
Vaccines Clinical Research
Merck
North Wales, PA 19454
And Government:
Prabhakara Atreya, Ph.D.
Division of Scientific Advisors & Consultants
Center for Biologics Evaluation & Research
Food and Drug Administration
Silver Spring, MD 20993
This link has the complete roster of the current members of this committee:
Roster of the Vaccines and Related Biological Products Adv Cmte
This is the Roster of the Vaccines and Related Biological Products Advisory Committeewww.fda.gov
Good thing LSU banned on campus tailgating for the season. Otherwise people would get drunk, have big parties, not wear masks, and hug on each other for pictures:
I get that this is outdoors which is better, but when you are this close together with no masks, it's still a really high risk activity. Hopefully this is one of a very few of such events. But I somehow doubt it.
This is my shocked face.
I think it’s important that people understand the normal approval process and any adjustments to that process for emergency use purposes so we can make informed decisions. It just seems unproductive for people to raise expectations and even promise delivery of vaccines by a specific date or political event. It raises questions about whether there is undue influence. And as I mentioned in this thread a couple of weeks ago, an unsafe vaccine doesn’t have to be approved for a carefully timed press release with questionable/alternative interpretations of the data to serve its purpose of changing the course of our country for years to come.
Good thing LSU banned on campus tailgating for the season. Otherwise people would get drunk, have big parties, not wear masks, and hug on each other for pictures:
I get that this is outdoors which is better, but when you are this close together with no masks, it's still a really high risk activity. Hopefully this is one of a very few of such events. But I somehow doubt it.
It's not (I hope you were sitting for that) - "homegating" is the big thing this season.