Posted on 10/01/2020 11:45:26 AM PDT by madprof98
Moderna’s chief executive, Stéphane Bancel, told the Financial Times that the company’s experimental covid-19 vaccine is not expected to be available for widespread use until the spring. Moderna’s is one of four vaccine candidates undergoing final tests in the United States. President Trump has repeatedly suggested that at least one vaccine will be approved and made available this year, though experts are skeptical and polls show Americans are worried about the process being rushed.
(Excerpt) Read more at washingtonpost.com ...
The “clinical trials” they have implemented are garbage, but the FDA will doubtlessly rubber-stamp them.
I think the vaccine will be approved this year. I think what the CEO is talking about is distribution and his thoughts on wide-spread distribution. I believe Trump’s Operation Warp Speed has brought in the military and I would expect the distribution to be quicker.
I hope that this vaccine will make and finish it’s phase 3 trial later this month or into next month and get FDA emergency approval and then full approval.
Bingo. Approval is one thing, getting the actual product out to end users is something else again. Particularly if this is the one that needs to be stored at -94 F.
Having a neighbor who ended up disabled by his swine flu shot in 1975 I am all for caution.
He stated that for the the safety part of the phase three trial, they have to watch half the people in the test group, 15,000 of 30,000 subjects, for two months after they get the second dose, before applyingfor the emergency use authorization. They just dosed the 15,000th subject with the second dose, so that takes us out to the end of October.
In my opinion this is the dem bureaucrats at FDA sandbagging Trump. If the first 5000 patients have had zero serious events after two months, you can be pretty sure it is safe enough for emergency use authorization. Just like the effectiveness, how many subjects you need to get to a given confidence level of an acceptable percentage result depends on the numbers you get. A more math literate treatment of clinical trials is one of the key knobs we have to achieve Warp Speed.
The effectiveness aspect has two early offramps. It could be demonstrated effective before the election if it actually is very effective. But this kind of safety criterion makes it impossible to apply for the EUA early.
Unless the Warp Speed people wake up.
Thanks for the details. I appreciate it. Yes. What the FDA did was even more conservative than what they have done for other trials and yes, I think it was, sadly, politically motivated. But, it looks like this vaccine is still on track for the end of the year unless safety and efficacy don’t live up to expectations.
” vaccine is not expected to be available for widespread use until the spring.” Well, unless Biden wins...
Seriously it doesn’t matter.
What matters is how quickly vaccines are distributed under EUA to the most at-risk.
Which will be about Election Day for most of them.
Distribuition among the general public will be much later.
I’m not in the high=risk group. Those who are can weigh their risks and benefits.
Also, Trump already secured manufacturing of the vaccine candidates during the trial in order to cut the time a vaccine is available to high risk groups.
It might be wasted money on one or more of the vaccines but Trump spent the money to cut time to market. Waiting 2 years for a COVID-19 vaccine because of the usual slow ramp up of manufacturing after all the approvals are complete is not going to help NOW.
This was SMART. Spend the money to stockpile supply of the leading vaccine candidates and be ready on DAY ONE of approval for any of them to begin distribution.
meant to say, that takes us to the end of November.
Trump have already paid for a stockpile of vaccines. It is one way to accelerate the process. So if the vaccine passes, we will have a lot of vaccines available right then. They are already made and waiting. If the test fails, we will destroy them and lose money. Take a chance. Typical entrepreneurial idea!
Biden would never came with that kind of idea!
Thanks for president Trump!
The problem is that, in reality, COVID isn’t an emergency. The democrats have painted it as a dire thing, but then they will block the vaccine.
If they really believed 2 million people could die from COVID, it would be acceptable to take a risk of killing a thousand people with the vaccine, once you knew it worked.
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