Good enough for Britain. Good enough for the European Union. Not good enough for the United States.
That’s what the U.S. Food and Drug Administration thinks about the evidence for the Oxford-developed, AstraZeneca-made COVID-19 vaccine: the cheap, refrigerator-friendly, easy-to-transport injection that, so far at least, is 100% successful at keeping people with COVID-19 out of the hospital. The Oxford vaccine has been given to more than a million British citizens, and the EU is now scrambling to find as many doses as it can to compensate for its own slow vaccine rollout.
The FDA’s deadly delay should end immediately. It should let Americans get the Oxford vaccine, a vaccine with millions of doses ready to go, manufactured right in Baltimore, Maryland.
So why hasn’t the Oxford vaccine been approved for use in the U.S.? Because the FDA made clear that AstraZeneca needed to finish its lengthy trials in the U.S., above and beyond the trials AstraZeneca had already run in the United Kingdom, Brazil, and South Africa.
Read more at Washington Examiner.
{Matzav.com}
A government agency has to stand behind the product it approves. This same agency has no control over the standards of one from a different country. How could the FDA, with any degree of responsibility, approve a medication/therapy/vaccination without having complete control of the process of approval? Perhaps the foreign government agency uses steps of which the FDA would not agree? Let us say, for example, that a patient is seeing a local doctor for a medical condition. This doctor orders a whole slew of tests (x-rays, scans, MRIs, etc.). If the patient decides that he would like to switch to a specialist, the new doctor will require that all the tests be repeated. The new specialist will not be willing to depend on the testing over which he had no control at facilities with which he has no connection. Protocol is in place for a reason. It is for your protection.
Timing for this post is interesting. A study just showed that the Oxford vaccine doesn’t protect against the South African mutation. They’re working on fixing that. Do we want people to get a vaccine that won’t help for some strains?
umm… does this person call for dissolving the fda? we need to test medicine ourselves before we approve it. is guy a dimwit?
no, because Fauci makeshis $$ off ofthe moderna & Pfizer vaccines and not Astrazeneca…
Always follow the money- you’ll be enlightened as to what you will find
You can get vaccinated if you choose, but you can still get sick if you were exposed to the virus within a week or so before you got the shot, and even perhaps a few days or a week after, before the vaccine kicks in.
A bigger question is why the FDA and CDC isn’t promoting ivermectin or the Hydroxychloroquine Protocol (Hydroxychloroquine plus azithromycin [or doxycycline] plus zinc) to treat people as soon as they show symptoms.
Hundreds of studies (many pet reviewed) showing their effectiveness are at http://www.c19study.com
Also many links to board certified online doctors (including Dr. Zelenko) who will prescribe prescription medications that will save your life are at https://tinyurl.com/InfoForDrsToBeatCovid
Best results come from starting treatment within days of getting sick.
For all those comments about the alleged government control over testing. I just searched the web and found a document on the subject dated 2012 on the http://www.fda.gov site. Title “FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND”, the opening portion states as follows (note the section about relying SOLELY on foreign clinical studies):
> On April 28, 2008, the Food and Drug Administration (FDA or Agency) amended its regulations
on the acceptance of foreign clinical studies not conducted under an investigational new drug
application (IND) (“non-IND foreign clinical studies”) as support for an IND or a new drug
application …
> Some sponsors may even seek to rely solely on foreign clinical data as support for an IND or application
marketing approval in the U.S. Indeed, the number of INDs and applications for marketing
approval supported by foreign clinical trials has increased in recent years and will likely continue
to increase in the future.
And it points to the ecfr (electronic code of federal regulations) where the latest code is kept (current as of February 2021);
> As sole basis for marketing approval. An application based solely on foreign clinical data meeting U.S. criteria for marketing approval may be approved if ….