CDC tells states: Be ready to distribute vaccines on Nov. 1
By: MICHELLE R. SMITH (YahooNews)
S E E D E D C O N T E N T
PROVIDENCE, R.I. (AP) — The federal government has told states to prepare for a coronavirus vaccine to be ready to distribute by Nov. 1.
The timeline raised concern among public health experts about an "October surprise" — a vaccine approval driven by political considerations ahead of a presidential election, rather than science.
In a letter to governors dated Aug. 27, Robert Redfield, director of the U.S. Centers for Disease Control and Prevention, said states "in the near future" will receive permit applications from McKesson Corp., which has contracted with CDC to distribute vaccines to places including state and local health departments and hospitals.
"CDC urgently requests your assistance in expediting applications for these distribution facilities and, if necessary, asks that you consider waiving requirements that would prevent these facilities from becoming fully operational by November 1, 2020," Redfield wrote.
He wrote that any waivers will not compromise the safety or effectiveness of the vaccine. The Associated Press obtained the letter, which was first reported by McClatchy.
The CDC also sent three planning documents to some health departments that included possible timelines for when vaccines would be available. The documents are to be used to develop plans for early vaccination when the supply might be constrained, according to one of the documents, which outlined a scenario in which a vaccine could be available as soon as the end of October.
"The COVID-19 vaccine landscape is evolving and uncertain, and these scenarios may evolve as more information is available," the document reads.
Another of the documents says that limited COVID-19 vaccine doses may be available by early November and that supply will increase substantially in 2021.
It also states that initially available vaccines will either be approved by the Food and Drug Administration or authorized by the agency under its emergency powers.
The documents encourage health officials to work out now which groups to prioritize for a vaccine, identify providers who will administer vaccine, and take other steps to prepare. The planning documents were first reported by The New York Times.
Redfield told Yahoo Finance that officials were preparing "for what I anticipate will be reality, is that there'll be one or more vaccines available for us in November, December."
James S. Blumenstock, a senior vice president at the Association of State and Territorial Health Officials, said the CDC was offering "an aggressive but necessary timetable" and that public health agencies were mobilizing to prepare detailed plans.
Several public health experts pointed out that final stage trials of experimental vaccines are still recruiting, and are at best halfway through that process. The vaccines are two doses, and each is given a month apart. The experts told the AP they did not understand how there could be adequate data on whether the vaccines work and are safe before Nov. 1.
"Being ready is reasonable. Cutting short phase 3 trials before you get the information you need isn't," said Dr. Paul Offit, a Children's Hospital of Philadelphia immunization expert who sits on the FDA's vaccine advisory committee.
Peter Hotez, dean of Baylor University's tropical medicine school, said he was "very concerned" about whether the FDA would use an emergency use authorization to approve a vaccine before knowing whether it works and is safe.
"It gives the appearance of a stunt rather than an expression of public health concern,″ Hotez said.
FDA Commissioner Stephen Hahn previously said the agency wouldn't cut corners in evaluating vaccines, though it would aim to expedite its work. He told the Financial Times this week that it might be "appropriate" to approve a vaccine before clinical trials were complete if the benefits outweighed the risks.
Unlike a therapeutic that is given to sick people who may have no alternative, a vaccine is given to healthy people, "so you have a much higher burden of proof," said Ashish Jha, dean of Brown University's public health school.
"I think it's reasonable to be communicating to hospitals and saying — at some point late in the fall or winter," Jha said. "November feels awfully early."
Michael Osterholm, a University of Minnesota infectious disease expert, said he was concerned about an "October surprise" with a vaccine being rushed through ahead of the election.
"The public health community wants a safe and effective vaccine as much as anybody could want it," Osterholm said. "But the data have to be clear and compelling."
He said there was a "credibility gap" between doctors and the FDA about how rigorously products are being evaluated during the pandemic.
Some state officials said Wednesday that they were working on next steps while still awaiting details from CDC, and some sounded a cautious note.
Kris Ehresmann, Minnesota's infectious disease director, told the AP the state would only move forward "once we know it is safe." She said they would take their lead from the CDC's Advisory Committee on Immunization Practices, which she said "will only recommend a vaccine that has met the safety criteria."
The Oregon Board of Pharmacy said it would expedite McKesson's applications but wouldn't waive requirements necessary to maintain public health and safety. Its executive director, Joe Schnabel, said in a statement that the board didn't have enough information on how distribution would work "to speculate about whether it will be fully operational by November 1st."
The office of Pennsylvania Gov. Tom Wolf, a Democrat, said state officials don't know yet what is being asked of them, and will first need to do "an extensive review of the potential benefits or pitfalls of such waivers."
New Mexico Human Service Secretary David Scrase said the state was preparing to administer coronavirus vaccines on a limited basis starting in November to health care workers and residents of long-term care facilities. The broad public vaccine roll-out is slated for January. He said current vaccine provider networks are robust and adequate for the COVID-19 effort.
Regarding the timing of the CDC request to expedite or waive permits for distribution centers to open Nov. 1, Scrase said, "I can't tell you about the political motivations on that."
A spokesman for Tennessee Republican Gov. Bill Lee said the state was reviewing its next steps.
"News of a vaccine is encouraging and a testament to the power of American innovation," said the spokesman, Gillum Ferguson.
And in Florida, Republican Gov. Ron DeSantis said he wasn't aware of the CDC news, but he said people shouldn't think that the virus will be gone in two months once a vaccine is released.
"I would hope that the federal government would kind of take the lead on that," said DeSantis, a Trump ally. "Hopefully they have a plan to do it and will really focus on those vulnerable among us."
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AP writers Marc Levy, Brendan Farrington, Morgan Lee, Andrew Selsky and Jonathan Matisse contributed to this report.
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That soon???
Hat's off to American research!
Trump and his supporters are off topic
CDC releases this and then this morning and then Fauci says not so fast, not before the end of the year. Sure would be nice if we could get a consistent message.
I'm not sure on Fauci's statement. I believe it went like this: “The way the pace of the enrollment is going on and the level of the infections that are going on in the United States, it is likely that we’ll get an answer by the end of the year.” I think he means by then we should have something. I'm hoping for late October!
It reminds me of that sales pitch "up to 45 miles per gallon. Your mileage may vary." Leaves a LOT of options open to be right .....................................either way
I think it's ready now. Something is holding it back.
It's those "people in dark shadows".
Right Pat, people like Kevin Clinesmith
Is that all ya got ?
The only people in Dark Shadows are the original cast from the TV show.
I thought an indictment would have been enough for anyone, Pat.
By all means, call the fire department, start the engines, the sky is falling because one of
2,000,093 federal employees was indicted.
You seem upset.
Honestly Vic, to me this feels rushed because of the election. We were just told that the vaccine was not going to be ready until early next year. But here is my prediction. All of the Trump supporters will take it asap, even if they said the disease was a hoax. I, on the other hand, will wait to see how well it works and if it has any side effects.
I very much want a vaccine, but not one that isn't effective long term and produces antibodies and is safe.
Perrie, I respect that opinion. You do know a lot of red tape was cut to get this on the fast track, so I'm not surprised by the speed of it. You are correct there is a lot of politics with this. I'm sure that radical progressives want the country in the dumps right up to election day. You are also right about some people getting it as soon as possible - I am one. Not because I am a Trump supporter, but because I'm 68 years old. I'll do just as Americans did with the rushed Polio vaccine - I'l be in line!
Vic,
My daughter is a medical researcher, and she spelled it out for me. No matter how fast you want it, it takes time to get 30,000 people, give them both the placebo and real vaccine, let them loose in the general population to see if they get infected or not, if they produce antibodies or not, look for side effects and analyze all this information. Well, the vaccine just came out and they are only just beginning to find people to try this on. You can't do this all in 2 months. It's just not safe. Even having it done by Dec 1 would be uber fast-tracked.
I'm no kid, and I have autoimmune issues which means that potentially my body could overreact. I also take care of 3 seniors. So, believe me, I want this vaccine, but not if it is not safe.
Understood Perrie. I want to be one of the first nonetheless. You have to do what you think is best. Everyone should be free to do that.
I totally agree, and I wish you the best of luck. I do hope it works.
You'll be the first to know. Hopefully, I'll be calling from the gym!
And many Trump supporters of all ages say they will never take the vaccine.
Like the flu and the common cold there is no permanence to corona virus immunity - it only lasts 5 to 6 months
and there are no proven results at all.
As do I. As soon as I can get it.......................
Sure, it's possible politics has an influence in the effort, but I doubt that is going to allow an ineffective or dangerous virus to bypass all of the reviews that still exist. A lot of people will be looking at this.
On the other hand, it also looks very political to be resisting the vaccine simply based on the date mentioned.
There's no question this is happening with record speed, but that has been entirely intentional. The Trump administration has streamlined the legal part of the process and given millions of dollars to pharmaceutical companies so they can produce a vaccine without financial risk. So if the vaccine is approved, they will have many doses available right away.
Democrats may not like it, but if vaccines are available at all before the end of the year, Trump deserves some credit. What they fear is that he will get that credit before election day. For many, I suspect that fear outweighs their fear of people dying from the virus.
This is not a democrat or republican issue. It is a worldwide issue. There are multiple countries, like England who are all working on this. The issue is effectiveness and safety. And remember, this vaccine will be considered effective, even if it is only effective 50% of the time. That is a whole lot of ifs.
Personally, I would like to go back to life as usual, but of course, that doesn't preclude my concerns.
Of course it shouldn’t be, but it clearly is. We see it in the line I quoted and it’s been all over the news - accusations that the process is being dangerously rushed to benefit Trump. It’s terrible, but people are actually hoping the misery continues if it means he might not be reelected because of it.
Thing is, I see no way at this point for a vaccine to help Trump. The vaccine would have had to be distributed already and followed up by credible results that will put the electorate at ease.
At this point, Trump will bear the blame of an uncomfortable electorate in an unsettled economy. Short of Biden blowing up, I do not see a path for Trump to win reelection. Typically the electorate will change the guard (blindly even) if they are not happy (at a personal, local level). I do not see the electorate getting comfy and happy again as they were prior to COVID-19 until 2021.
You might not see it, but Democrats clearly do or they wouldn’t be talking about dates and October surprises and such.
Any guesses then on what they 'see' regarding a vaccine helping Trump win reelection?
Many Elected Democrats would rather see more Americans die of covid -19 than see a working vaccine become available to the public by Halloween.
I think whatever it is they see, it isn't going to be very objective. They'd be fools, frankly, to ignore the prospect of a vaccine helping Trump in the election. However, there is danger in saying out loud anything that might imply Trump would deserve credit when the vaccine appears. So instead, what we hear is fear-mongering that Trump will do something to push a dangerous or ineffective vaccine because he believes it will help him.
A proven vaccine would definitely help. A newly released vaccine that has not had time to be certified with good empirical results will not help much at all.
There is not enough time between now and election day to release a vaccine and get good numbers on efficacy in the real world.
I think any vaccine announcement will help. Enough to put him over the top? I don't think there is any way to know, but things can develop quickly in the last few weeks of a campaign. We have seen that before. Many people are undecided until the very end.
The government has gone ahead with the mass production of unapproved vaccines in the hope that they will be approved.
Good idea if the vaccines prove to be effective.
Bad idea if they don't work since valuable resources will have been wasted.
I don't trust Redfield.
I trust Dr. Fauci who has predicted that a vaccine will be ready by the end of this year.
I'll go with Dr. Fauci over Dr. Redfield anyday.
All the video I've seen of Redfield and tRump looks like Redfield absolutely adores tRump. Fawns over him. Kisses his big fat ass.
I don’t think they are disagreeing exactly. Fauci has been saying for a while that we should see data on efficacy by November. Actually distributing it might take a couple more months.
BUT THERE'S NO PLAN!
Why is it surprising those who are attempting to score political points from the pandemic are now screeching about planning?
CDC has set a date for states to have their plans in place. What're these damned objective experts expecting? Are we supposed wait for FDA approval before planning how to distribute a vaccine?
Expert idiots are still idiots.
You would think states would have already been thinking about it.
Exactly!