I think we can expect similar priorities for the vaccine in UK and around the word.
A new US report aims to prioritize groups to receive Covid-19 vaccine and focuses on who is at risk, rather than using job categories or ethnic groups to determine who should be at the front of the line.
It was widely expected that health care workers would be the first priority grouping, and some — though not all — are. There were also many voices arguing for people of colour to be given priority access, because the pandemic has exacted a disproportionately heavy toll on Black and Latinx people, both in terms of overall numbers of infections and deaths.
But in the end the panel of experts that wrote the priority setting framework for the National Academies of Sciences, Engineering, and Medicine chose instead to focus on the factors that create the risk for some people of color — systemic racism that leads to higher levels of poor health and socioeconomic factors such as working in jobs that cannot be done from home or living in crowded settings. The report, a draft, was issued Tuesday.
"This virus has no sense of skin color. But it can exploit vulnerabilities,” said Bill Foege, a former director of the CDC, who is co-chair of the committee. Foege said he expects pushback especially as when Covid-19 vaccines are approved for use, initial supplies will be tight — potentially in the tens of millions of doses. Most of the vaccines under development will require two doses per person: a priming dose followed by a booster either three or four weeks later.
I always figured a perk for being in a high risk covid group due to our Cll would be early access to a vaccine (which may or may not work for us).
If anyone my age without Cll wants to trade their intact immune system with me for my early vaccine access, I’m up for the trade. Maybe we can work something out on platelets too.
Being an ever glass half full person, I’ll show up for bright and early for my vaccine jab. I figure even if it doesn’t give me full protection, it will give me enough to turn covid from a deadly virus into a bad summer cold.
Moderna is one of the messenger rna vaccines that show great promise, but to this point are theoretical. To my understanding it’s not a live vaccine, that’s one of its benefits. Another is that it can be mass produced faster than traditional vaccines.
It will be a very, very big deal if the messenger rna vaccines work, and not just for covid. Covid will not be the last novel virus mankind encounters and mRNA technology could allow more rapid response to viruses in the future.
I always intended, if possible, to be among the first in line for a Covid vaccine. However, if it comes out before the November election, I'll let others be the guinea pigs. The basis for a vaccine comming out that soon in the U.S. is political, not science, not medical.
It is what it is and if it’s not live, I’ll take it. Perhaps it works as advertised? I’ll take that chance to break these chains.
I’ve taken chances before in clinical trials and I trust my doctor. If he says to take it, I’ll gladly take your place in line if you are giving it up.
I highly doubt that your doctor will recommend it if it comes out that soon. It's one thing to be part of a "clinical trial", but my comment assumed otherwise. But, in any event, good luck!
I am NOT an anti-vaxer. Personally, I believe the anti-vaxers are nuts. I always assumed that it would take until December or after the 1st of the year for any vaccine to be adequately tested. For me, that changed about a week ago when the CDC suddenly and illogically changed the criteria for getting tested for covid by saying the people who are exposed to someone who has covid don't need to be tested if they are not "vulnerable" due to some other condition. Personnally, I concluded that this was a politically motivated decision which led me to believe if they would do this, they will, for political purposes, "clear" a vaccine before the November election. I no longer trust any of the government agencies involved with covid decisions with the possible exception of NIH.
The announcement that a vaccine will be available a couple days before the election was most likely political. I will not spend much time worrying about it. I suppose it is possible they might symbolically inoculate a few people outside of a clinical trial by then. I think the chances a vaccine would be available to me and other cll patients before the election are close to zero.
I do think by November we will have a lot of info on the phase three Moderna and Pfizer trials as to whether their vaccines are safe and effective. This is different than the polio vaccine trials that gave people polio 70 years ago. These vaccines are not live and covid is not as deadly as polio.
I suspect we will know more about safety than efficacy. I expect these vaccines to be proven safe, that's a main part of the phase 1 and phase 2 trials they have been through.
I'll just keep an open mind and see what happens. There will be a lot of scrutiny by doctors and scientists. My vaccine would likely come through MD Anderson and I trust my doctors there to know what is best.
Based on all I have read, I think my chances of having a vaccine in 2020 are about 50/50, which is a better chance than I would have guessed a month ago.
Each of these two trials are enrolling 30k or more people. Preliminary results should start rolling in during October. It is possible by November there will be enough data to know if they can roll out one of these vaccines.
Whether it is political or not, waiting a month or two to see how the first wave of people getting the vaccines do is not a bad idea. There will be no shortage of people willing to take the vaccine.
Might be or will be, either way, I agree with mteaney and the many scientists and doctors that the announcement a vaccine might be available on November 1, two days before election day, is to some extent a politically driven announcement.
You proved my point. This has sadly like all things these days dissolved into a political discussion where a president is not to be trusted and all government agencies aside from possibly the NIH from another post, shouldn’t be either.
I am leaving this post now while I can and hope we can stop drawing attention to politics.
If the vaccine didn't seem "safe", it wouldn't go to "phase 3". But "phase 3 is an important phase in clinical trials to determine the safety and efficacy. If I correctly understand the status of the various clinical trials, none of the vaccines will have completed "phase 3" by election day.
All clinical trials have ongoing analysis of the results . At some point the monitoring may show that the vaccine group has statistically significant lower incedence of Corona virus than the Placebo group. This could happen with trial and it has happended with ather clinicai trial. In other words it may show benefit with results from 15k subjects, berore the resuts from all 30k subjects are available.In that case the FDA might issue an emergency authorization before the phase 3 trial was completed. But it would only do so if preliminary results indicated that the vaccine was effective and safe.
The following article from livescience.com pretty much covers this issue:
The head of the U.S. Food and Drug Administration says that coronavirus vaccines may be given emergency approval before rigorous clinical trials are complete, according to recent news reports.
Only a couple of coronavirus vaccine candidates in the U.S. have advanced to phase 3 clinical trials, which are the most critical tests needed to prove, in tens of thousands of people, that a vaccine is both safe and effective at preventing COVID-19. Typically, a vaccine must pass these advanced trials before given approval — but the pandemic has pushed vaccine development to unprecedented timescales.
"It is up to the sponsor [vaccine developer] to apply for authorization or approval, and we make an adjudication of their application," Dr. Stephen Hahn, the FDA Commissioner told The Financial Times. "If they do that before the end of phase three, we may find that appropriate. We may find that inappropriate, we will make a determination."
Hahn said a safe way to roll out the vaccine prior to results from phase 3 trials, is to issue an emergency use authorization for only a select group of people, according to the Financial Times. "Our emergency use authorization is not the same as a full approval," he told the Times.
Emergency use authorization is permission granted to unapproved products to be used in an emergency to diagnose, treat or prevent serious or life-threatening conditions, "when there are no adequate, approved and available alternatives," according to the FDA. China and Russia have both given emergency approvals to coronavirus vaccines for a limited group of people prior to phase 3 results, according to the Times.
But approving vaccines too soon can be risky, public health officials have warned.
Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, previously told Reuters that a vaccine should not receive an emergency use authorization before it's shown to be effective. "One of the potential dangers if you prematurely let a vaccine out is that it would make it difficult, if not impossible, for the other vaccines to enroll people in their trial," he said.
"To me, it's absolutely paramount that you definitively show that a vaccine is safe and effective, both," Fauci told Reuters. "We would hope that nothing interferes with the full demonstration that a vaccine is safe and effective."
Last week, the FDA gave an emergency use authorization to plasma therapy, or antibody-rich plasma taken from recovered patients, to treat COVID-19, quickly reversing its announcement that the FDA wouldn't issue an EUA until there was more data that the therapy works, Live Science previously reported. The authorization followed on the tail of President Donald Trump's remarks that the FDA's decision to wait for more data before giving an EUA to plasma therapy could be political, according to the report.
Hahn told the Times that the decision to give an EUA on vaccines wouldn't be politically driven.
"We have a convergence of the COVID-19 pandemic with the political season, and we're just going to have to get through that and stick to our core principles," he told the Financial Times. "This is going to be a science, medicine, data decision. This is not going to be a political decision."
In the U.S., just two candidate vaccines are in phase 3 trials: one made by Moderna and the other by Pfizer and BioNTech, according to a Live Science roundup of coronavirus vaccine candidates in clinical trials. But there are several others that are expected to start phase 3 trials in the coming weeks.
The phase three trials will likely not be over by November but that does not prevent any company from presenting preliminary data from the trials to the FDA to seek an emergency use authorization (EUA).
If a vaccine is proven safe, if I were on the FDA I would consider an EUA for any vaccine that the data shows is likely to have efficacy even if it technically has not completed a phase three trial. The worst that could happen is the vaccine would not work
It’s going to depend on how much data there is and how scientists interpret it. So long as a vaccine is safe, you can take more chance it’s not as effective as we would want it to be.
I don’t assume that if a vaccine is approved early that it’s purely for political reasons. But I am aware that there can be politics involved. I will just keep an open mind and see how it plays out. I favor cutting corners to get a vaccine to market depending on the data and what scientists say.
Dr Fauci has said we might get a vaccine soon. If he sees the data and supports an EUA, that would influence me. If it appears the FDA was pressured into an EUA, that would make me less likely to try a vaccine.
I’ll just make the call when the time comes. My hope is the trials are yielding a lot of great early data that would support an EUA whenever that happens. Since one of these trials started enrolling people in July, it seems reasonable to me we might have enough data by November for early authorization before the trial is complete. We are in an emergency.
Another article that provides detail as to the unlikely odds that a vaccine could be available before the election:
The US Centers for Disease Control and Prevention is asking states to get ready to distribute a coronavirus vaccine by as early as next month. The CEO of Pfizer says he thinks it's possible his company will have enough data to ask the US Food and Drug Administration for authorization by October.
And officials inside the FDA have told CNN that Trump has consistently pressed agencies to speed up their timeline for developing a vaccine so he can have a vaccine victory by Election Day.
Is it really possible we could have a coronavirus vaccine by November?
Doctors who are running the clinical trials would know best, and they don't think so.
"Do the simple math," said Dr. Larry Corey of the Fred Hutchinson Cancer Research Center in Seattle, who is leading the team coordinating the clinical trials for federally backed coronavirus vaccines in the US.
"We designed the trial to get to 130, 140 endpoints seven months from starting the trial," Corey told CNN. "The first one started in mid-July.
"Endpoints" are coronavirus infections. What Corey is saying is that the trials are designed to go on until 140 or 150 people catch the coronavirus. The researchers would look to see if people who got the real vaccine were less likely to be among those infected.
But if you add seven months to July, you get February.
That doesn't mean it's impossible to have an answer before then. If one of the vaccines being tested is highly effective, and there is a high rate of infection among the people volunteering in the trials, it's possible many people who got placebo shots would get infected quickly. "If you had a highly effective vaccine, maybe you'd find that five months from designing the trial," Corey said.
But if you add five months to July, you get December.
And there are other obstacles. Dr. Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia and a member of the Food and Drug Administration's Vaccine and Related Biological Products Advisory Committee, said most of the Phase 3 trials underway now aim to enroll 30,000 people each. That's because the people who designed the trials think it will take that many volunteers for them to see 140 or 150 infections.
None is fully enrolled yet, so it's already September and many, if not most, of the volunteers have yet to receive their first dose.
The vaccines in advanced, Phase 3 trials all require two doses, given one month apart. So people who received their first dose in August could not be given a second dose until September. And those receiving vaccines this month won't get their second dose until October.
"Then you have to wait two weeks after the second dose to really have full immunity," Offit told CNN.
So why is the administration talking about results in November, or even October?
"It's highly unlikely, but it is theoretically possible without doing anything nefarious," said Dr. Ann Falsey, a professor of medicine at the University of Rochester School of Medicine in New York, who is coordinating the clinical trial there for AstraZeneca's candidate coronavirus vaccine.
For instance, if the virus is spreading fast, that would make for a lot of data, very fast. "Unfortunately, there may be a real hotspot and there may be a lot of activity," Falsey told CNN.
And if one of the vaccines being tested is highly effective, it would quickly become clear. People in the placebo group will get infected at a much higher rate than people who got the real vaccine.
"So maybe you get to a definitive answer sooner than you thought you would," she said. "That would be unlikely," she added.
Offit agreed. The trials are not designed to detect symptomless or mild infections, Offit said. "The clinical endpoint is severe disease," he said. That makes it even less likely the trials are going to produce a lot of surprise data ahead of schedule.
And the FDA has already told companies a vaccine has to be at least 50% effective to be considered. That means it will have to lower the risk of death or severe disease by 50%.
Even if volunteers are in a virus hotspot, Offit said, they will have been counseled to be careful. It is an ethical requirement of the trials to caution the volunteers about the risks of becoming infected. "You are telling people to wear face masks and social distance," he said.
"You are not telling them to go to a maskless biker's convention in South Dakota. You want them to protect themselves."
Normally, the FDA takes a year to approve a vaccine after all the Phase 3 data is submitted, Offit said. An expedited process would take 10 months.
In the case of a pandemic, that process is accelerated, and Operation Warp Speed has been running other needed steps in parallel with the clinical trials, helping companies start manufacturing vaccines even before the trials are over and ordering syringes and other equipment now instead of waiting until the trials are finished, so the FDA could be ready to move much, much sooner.
But the only way there would be enough data to move one of the vaccines in the queue for FDA emergency use authorization would be if one or more of the trials got a surprising amount of data very, very quickly.
Pfizer Chairman and Chief Executive Officer Dr. Albert Bourla thinks that could happen. He said the Phase 3 clinical trial of his company's Covid-19 vaccine has enrolled about 23,000 participants, and some are already getting the second dose of the vaccine.
Pfizer "should be able to have enough events to say if the product works or not" by the end of October, Bourla said Thursday in remarks to to the International Federation of Pharmaceutical Manufacturers and Associations.
The people making that decision are the Data and Safety Monitoring Board. That's an independent group of experts -- separate from the company making the vaccine, separate from the doctors running the clinical trials and separate from the federal government -- who get to peek at the data early.
"They are there to protect the safety and to define the accuracy of the vaccine," Corey said.
If they see a clear signal that the vaccine is unsafe, for instance -- if many people have severe reactions, or if people who get the vaccine are in fact more likely to get infected -- they can stop the trial. They can also stop the trial if they see the vaccine really is not protecting people -- if just as many people who get the real vaccine become infected as those getting a placebo.
And they can stop the trial if it looks like the vaccine is working better than expected. That's why the CDC is asking states to be ready to distribute a vaccine in October or November, Health and Human Services Secretary Alex Azar told CBS This Morning.
"God forbid we get great data and it comes out of the Data and Safety Monitoring Board and the FDA finds that it meets their standards, and we aren't ready to distribute," Azar said. "We need to be ready for all contingencies and that's why the CDC is doing this."
Corey said he doubted anyone on the DSMB would feel any pressure to stop a trial and recommend a FDA review because of pressure -- either political pressure or just the pressure of trying to end a pandemic that has killed 185,000 Americans.
"It's not like they don't understand the responsibility. All of them know how to read," Corey said.
Falsey doesn't think so, either.
"I don't think that the message is that we are going to look at the data in the middle of the trial and if it looks kind of good, we'll go with it," Falsey said. If a vaccine gets fast tracked, it will be because there is definitive evidence, she said.
Offit agrees. He said he trusts the FDA and the approval process. But not everyone does.
"The irony of this is you may, by the end of the year, have a safe vaccine. But you have an administration that hasn't garnered a lot of trust," he said.
"Maybe we will have a safe and effective vaccine but people still won't trust it because they don't trust the way the administration has handled science. That would be the ultimate irony."
"Safe and effective". Those are the key words. Which, in the context of a pre-election vaccine begs the question! Maybe it will be. Maybe it won't be. Certainly, if the only reason a a vaccine is approved is because the President wants it out before the election, the safety and efficacy will be questionable UNLESS all the appropriate test data is released to the public and demonstrates that it is safe and effective. And if the data supports approval, it should be the medical experts be recommending approval to the President and not the other way around!
Please abide by item 12 of our community guidelines "...do not post content of a political nature. Doing so is always divisive and contentious and everyone on the site must feel welcome regardless of their religious or political beliefs."
I suggest you re-read my post. More importantly, read the article I posted. If phase 3 of the testing of the vaccine is cut short, by definition, the vaccine may (or may not be) as safe and effective. As I said in my last post: "Maybe it will be" safe and effective. "Maybe it won't. "
Your post has not been moderated because I considered what you shared to be fairly balanced. I've just reminded you of our relevant guideline, because this topic has the potential to escalate.
All clinical trials are conducted by independant clinical scientists. The FDA provides independant oversight and regulatory aaapproval. Many people are misinformed and frighted about vaccines. Please don't add to tthese unfounded fears.
The plan is pretty broadly drawn. I think the two bigger challenges that follow will be ascertaining the effectiveness of vaccines and efficient distribution.
Also it is important to discuss which vaccine is right for you and when you can take it, if on active treatment, with your CLL specialist. I was told that one of my medications, that I finished, requires a 6 month waiting period. I found that very surprising.
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