Marty Makary, M.D., a professor of surgery and health policy at the Johns Hopkins University School of Medicine:
Finally, the FDA needs to stop playing games and authorize the Oxford-AstraZeneca vaccine. It’s safe, cheap ($2-$3 a dose), and is the easiest vaccine to distribute. It does not require freezing and is already approved and being administered in the United Kingdom.
Sadly, the FDA is months away from authorizing this vaccine because FDA career staff members insisted on another clinical trial to be completed and are punishing the company for inadvertently giving a half-dose of the vaccine to some people in the trial.
It’s like the FDA is holding out, pontificating existing excellent data and being vindictive against a company for making a mistake while thousands of Americans die each day.
Ironically, those in the Oxford-AstraZeneca trial who inadvertently received half the initial vaccine dose had lower infection rates. And this week Dr. Moncef Slaoui, the chief adviser to Operation Warp Speed, acknowledged that using half a dose might be a good broader strategy for the U.S. to double our supply as long our supply is severely constrained. That’s a good strategy that makes sense.
That's the vaccine I'm testing. The test I'm participating in is designed to determine the vaccine's effectiveness in the general population. It has apparently been proven safe - but I can understand why the FDA wants Americans to trust it's effectiveness before they resume their pre-covid lifestyles.
We're losing 100K/mo here in the states. Let's not wait too long.
Yes, I know. Public Health is the most difficult industry I've ever analyzed.
If you have ever participated in any clinical trials, and my ex-husband and i did, both for people & dogs (Lyme-related) you would know how Absolutely Extraordinary that "mistake" of half-doses is/was, under any protocols! In fact a HUGE red flag indicating that at the very least, something was poorly planned & poorly executed.
It's being used for 3 weeks in UK. If it's successful there, which we will soon find out, with huge population sample, we should use it here.
Safety is one thing, but effectiveness is also important in our uniquely unhealthy American population.
This may be a unique request, but IMO you should preface your comment with your relevant qualifications AND your source of any information.
My comment is No Comment [UK Citizen]
I didn't make a comment. I shared a link. UK is doing a much better job inoculating their population than the US. AZOx will be approved in the US eventually, let's do it now. There. I made a comment. I did give sources. We have 400K dead Americans. I would roll my sleeves up right now for the Oxford vaccine, even Sputnik V if it were available to me. You choose not to make a comment? I just made one.
@barjoe You are right my suggestion does not apply to the original post
There are no vigorous studies that have shown that half a dose is as effective as a full dose. The half dose results were not fully examined because it was a mistake. The vaccine currently being used here in the US has over a 90% effectiveness and that is much higher than the AstraZeneca one.
Lancet trials show Oxford vaccine efficacy against infectivity, MRNA 95% speaks of symptom free not stopping the spread. Vector vaccine is also much safer. Over I million vaccines in UK. Think about this. Pfizer and Moderna have made billions in stock appreciation. Oxford vaccine is a non profit effort. [bmj.com]
I'm glad you're for a non-profit which is good if you aren't sacrificing efficacy. As I recall efficacy is much less. Look at the flu vaccine, even if you get it you have a 50% chance of getting it. We need 90%+ efficacy because this is both more debilitating and there is a pandemic going on.