Yesterday, the director of the CDC appeared before a Senate panel to talk about a potential coronavirus vaccine. To be clear, the vaccine still does not exist in any way which could be mass-manufactured, or exist in a way where its efficacy could be widely touted. There are vaccines still being tested and some of them look promising, but who knows when they’ll be *really* ready. Well, Director Robert Redfield had an educated guess about the timeline:
The U.S. should have enough Covid-19 vaccine doses for Americans to return to “regular life” by the third quarter of next year, the head of the Centers for Disease Control and Prevention said Wednesday. CDC Director Dr. Robert Redfield told a Senate panel he expects vaccinations to begin in November or December, but in limited quantities with those most in need getting the first doses, such as health-care workers. He said it will take about “six to nine months” to get the entire American public vaccinated.
“If you’re asking me when is it going to be generally available to the American public so we can begin to take advantage of vaccine to get back to our regular life, I think we’re probably looking at third … late second quarter, third quarter 2021,” he told the U.S. Senate Appropriations subcommittee on labor, health and human services, education, and related agencies.
The CDC later walked back Redfield’s testimony after President Donald Trump criticized him at a White House press conference. The CDC said Redfield’s timeline referred to when all Americans will complete their immunizations. “He was not referring to the time period when COVID-19 vaccine doses would be made available to all Americans,” CDC spokesman Paul Fulton Jr. said in an email to CNBC.
Redfield’s comments were spread widely yesterday and most people thought they made perfect sense – perhaps we would have a vaccine available, in small quantities, by December, but an effective vaccine being mass-produced and available to the public at large? It’s going to be next year, well into next year, realistically. But of course Donald Trump threw a tantrum about “his” CDC director issuing a cautiously optimistic and reasonable prediction. Trump said he called Redfield after his testimony and that Redfield “got confused” and “made a mistake.” Sure, Bigly. Trump also claimed (again) that a vaccine might be ready by October. It will not be.
Oh, and Redfield also said in his Senate testimony that masks are incredibly important until we do have a vaccine, saying: “I might even go so far as to say that this face mask is more guaranteed to protect me against Covid than when I take a Covid vaccine, because the immunogenicity may be 70%. And if I don’t get an immune response, the vaccine is not going to protect me. This face mask will.” Trump responded in his press conference last night: “I think there’s a lot of problems with masks.” *deep sigh* We’re six months into the pandemic and this is what we’re fighting about.
Also: Trump is not being subtle at all at his “October Surprise.” He honestly thinks he can bully a vaccine to market in October, just before the election, and that will be what wins him re-election.
The best defense we currently have against this virus are the important mitigation efforts of wearing a mask, washing your hands, social distancing and being careful about crowds. #COVID19
— Dr. Robert R. Redfield (@CDCDirector) September 16, 2020
When I said I trust vaccines, and I trust the scientists, but I don't trust Donald Trump — this is what I meant: https://t.co/oBDXcFUAek
— Joe Biden (@JoeBiden) September 16, 2020
Photos courtesy of Avalon Red.
I firmly believe Trump will force a vaccine to be available by the election and it will be a disaster. Given what we have seen from the Astra Zenica trials, which look to be a possible neurological reaction, this will not only potentially harm millions of Americans but also feed into the delusions of anti-vaxers who will use this as more proof of the evils of vaccines.
Enis your last sentence gives me such headaches, because I think that is already happening. The crazy anti-vaxxers are only gaining steam with all this. God only knows what the ramifications of that will be. The damage Trump is doing to us, I feel like no one but God will ever have the true body count.
I for one will not take a vaccine that was so quickly developed and did not get a proper testing. 45 is not interested in a safe vaccine, he’s just interested in saying we have a vaccine before the election. I have no idea why he wants to get a vaccine when he and his cult followers are saying that Covid 19 is a hoax. Why have a vaccine for a hoax.
But the vaccines *are* being properly tested. Trump hoping for one in October is just him spouting bullshit.
Vaccines trials take as long as they take. There’s no rushing that. The reason we could see a vaccine to market so quickly is that the drug companies have “tooled up” and begun production before FDA approval. That process can take years for an ordinary drug or vaccine.
Almost no drug endures long term testing before it goes to market. Phase IV (long term) testing takes place after a drug goes to market and is always done as data collection on users and not in clinical trials.
Researchers also already had a SARS vaccine they could plug the RNA into which is why the actual development of this vaccine was so quick.
We need to stop spreading misinformation about how this vaccine is being researched and produced.
@Onerous—Thank you for this smart comment.
There is at least one vaccine, manufactured by a major pharm company, in human trials right now. A teacher friend of mine is in the trial and has posted about a mild immune reaction on social media. No reputable company in the US (and Europe, I’d imagine) is going to release a vaccine without proper testing and human trials. I can’t speak to the vaccines being produced in China or Russia.
I’m not taking a vaccine that is rushed so it can be out before the election. I don’t want to turn into a dark walker. My sister in law is in a vaccine trail so we’ll wait and see what happens. I think the CDC director’s guidance is realistic. I was hoping my son could return to college after spring break for spring quarter but ti looks like the whole freshman year will be virtual.
I think he’d like to try, but I think (and hope, and pray) that these companies have higher standards than that.
what’s going on with the AZ-Oxford vaccine study hold, while unusual in a phase 3 pivotal trial, isn’t as bizarre as people are making it out to be. There has been one subject who experienced a Serious & Unexpected Serious Adverse Event rumored to be traverse myelitis. Putting enrollment/randomization on hold in a situation like this (heck, sometimes they don’t even unblind before they make the decision to hit the pause button) is standard so they can make their best determination of whether there is a potential causal relationship (they will err on the side of caution to assume at least some causal relationship unless there’s clear data to the contrary) and, if so, assess the risk which will include trying to figure out what characteristics/populations make someone more susceptible to that risk.
This vaccine, obviously, would not be ready for an EUA submission by the end of October.
Pfizer may have an interim analysis w/top line results as early as the end of October – they will have data w/up to 5-6 months safety follow up of subjects that were randomized into the phase 1/2 trials. The data from these subjects was used to select what dose would move forward in phase 3 and study subjects are still participating in the trial to provide long-term immunogenicity & safety data that will be included as part of any EUA (and the final BLA) submission. That data will also be analyzed as part of the interim analysis (IA) when they hit the threshold for the blinded data review, this is what Albert Bourla was referring to when he referenced possibly having an answer as early as the end of October. They already have over 25K of the 30K needed to complete enrollment of the study. They have done a massive scale up of manufacturing of commercial product of the dose used in phase 3 to have 100M doses (since it’s a 2-shot series, that would be vax for 50M people) by the end of this calendar year. The most aggressive thing I could see them doing would be to unblind the entire study and then, if the data is overwhelmingly positive, offer those who were randomized to placebo the opportunity to get the vaccine while all participants are followed up for long term data collection through the 2 years post-dose study visits in the current protocol or rolled over to an extension study (I have no idea how the protocol is written and whether it includes the ability to do this per protocol or whether they’ve written an open-label extension protocol to roll subjects into).
I don’t work I vaccines but I do know people in the vaccine groups of clinical development at both companies and they would revolt if the companies capitulated to Trump on this (no, I don’t ask them about their COVID vax work). Also, please understand that the situation with COVID has greatly complicated the work we do on treatments for other indications and, in addition to being highly motivate to find safe & effective preventatives/treatments for this virus, we are also aware that bowing to political pressure for expediency’s sake would not only undermine all vaccines but also undermine our ability to develop safe & effective treatments for other indications.
Pottymouth Pup, Thank you for this information. I’m cautiously optimistic. I’ll continue to ignore Trump and listen to the scientists.
duplicate
@pottymouth pup thanks for the great info!
Part of the reason these vaccine clinical trials can move so fast is that there is an unbelievable rate of infection out there. This virus is spreading like wildfire in many places. That should allow enough “events” (infections) to occur in a study to make a statistically robust comparison between the vaccine group and the placebo group.
I don’t believe a word Trump says- he is a despicable liar- but I do believe that the indicators for having a decent vaccine in the next year are really good. It is very lucky that scientists had done a lot of work on coronaviruses (namely SARS and MERS) leading up to this pandemic. People say- well there has never been a coronavirus vaccine before —but honestly the demand was not there. SARS was bad but NOTHING like this— probably because SARS did not spread well from the asymptomatic and mildly ill. MERS is a bad virus but there have been like two travel associated cases of it in the US, ever.
This virus has stopped the world in its tracks and I have faith in the scientists and actually even the pharma companies working on these trials. Props to all the people working on it and volunteering to be participants.
I think there is a big difference between a vaccine being approved…and being available. They won’t be able to mass produce it immediately. So even if it is approved before the election, I don’t think most people will have access to it for months.
I’m happy to wait for spring or summer to be vaccinated. I don’t want to be a guinea pig since Trump is pressuring for a vaccination. I’m really worried medical officials are going to think of Trump first instead of the people.
I hear you! The anti vaxxer uprising over this fool’s errand is the most frightening part because it’s not just in the US, this feeds into anti vaxxer crazies around the world.
Fortunately, all of the drug companies have pledged not to put out a vaccine before they are ready. Because they are the ones who will get sued into oblivion if it all goes wrong.
Look, even if a vaccine is ready by next month, if still won’t get out to the general public until early next year. It will first go out to frontline and health care workers and then the elderly.
I’ve recently recovered from Covid that I contracted at my job. My mom ended up in the hospital with it. My boyfriend was sick for a month with it. It is an unpredictable, horrifying virus, and I would not wish it on anyone. But I definitely don’t want the vaccine rushed for the sake of Dear Leader.
Happy to hear you’ve recovered. My love to you and your family. 🤗
glad to hear you’re doing well. Just to err on the side of caution, talk to your HCP to see if they’ll order pulmonary function tests for you to see if you have any longer term compromise of your lung function to which you’ve acclimated or at least get a baseline that can be used to assess you if you develop any respiratory issues in the future/from future respiratory tract infections.
Pregnant healthcare worker here, and I will not be getting any rushed vaccine pushed out by this administration. If anything happens the anti-vaxxers will gain so many new followers…
You first, donnie. And ivanka, jared, beavis, butthead, kimberly, lara, melania, etc, etc, etc.
But not Barron. He can wait for a non rushed vaccine.
No, he suffers enough with those toxic monsters as parents and relatives.
They have been working on a vaccine against HIV since the mid-80s. We still do not have a vaccine for HIV.
HIV and SARS-CoV-2 are very different virologically. It’s really not a meaningful comparison. Also the resources and urgency being pumped into developing these vaccines are not comparable. HIV as awful as it was and is did not shut down the global economy and cause unprecedented economic disaster.
Back in the 80s and early 90s, tons of resources were pumped into AIDS research and it was considered urgent at the time
but, as Tourmaline said, you’re comparing apples to oranges with regard to the viruses.
To this day there is no vaccine for any corona virus. This isn’t the first one. So if they succeed, it might be because they now have a greater incentive and more money to spend. They might also not find one that’s really effective long term. Why are people so sure we’ll get one at all? Masks are available, they’re effective, they’re without risk. We may have to just get used to them until this virus mutates into something less scary.
I think whatever vaccine we get will be like a flu vaccine that will have to be re-administered every year. Maybe every 6 months.
I am also hoping that it mutates into something far less deadly like the first SARS did.
Something that’s important to know about vaccines or really any medication. Prior to the FDA signing off on it, the drug company must provide results of the study that were monitored by a third-party and independent company that oversees the study. The drug companies themselves cannot submit their own results. It has to be done by the third party, an independent company.
Gina – No offense, but you’re wrong about that. The regulatory departments of pharma companies submit the final Clinical Study Reports (CSR) & marketing applications to the regulatory agencies directly. They may use vendors to help with report writing & compilation but the only time in my 20+ year career in clinical drug development that I’ve used a vendor to handle a regulatory submission to a health authority, it’s been to open a clinical trial application to start a trial, not to submit a marketing application. CSRs are submitted as amendments to the IND we opened to start trials in humans and then we compile & submit New Drug Application (NDA) for drugs or Biological License Application (BLA) for biologics that contains all the cumulative information & data (including all the raw data sets). There is no regulatory requirement for us to hire a CRO to monitor clinical trials (back in the day, companies had their own monitors and TBH I think the quality was much better then). The reason CROs are used to monitor is because companies think it’s better from an HR perspective than having their own monitoring departments (and, I also guess since the CRO cost is considered a research cost, there are favorable tax implications to outsourcing)
Getting a safe vaccine to the American public isn’t going to be the problem. Getting those idiot anti-vaxxers to actually get the vaccine is going to be the problem. The vaccination rates in some parts of the US are worse than some third world countries ( I know this term is problematic, but I don’t know what else to use). The whole point of vaccines is to have as many people possible to get one in order for them to be effective; it’s going to be another uphill battle.
The medical professionals in my family said in March 2020, 18-24 months before we have a viable vaccine. I have no interests in Druggie Donnie’s meaningless meanderings on vaccines. It’s become a toss up on what his physical, mental condition will be at the time of the election.
I agree. I will never look to Trump for any scientific or medical information. Win or lose, I predict that he will lose all interest in vaccines as soon as the election is over.
that’s what we in the industry were saying as well but trials (I assume they were adaptive design to pick doses to advance to later phase) started in April. Final dose selection was completed in July and they, immediately, started scale up to manufacture commerical supplies at the dose used in phase 3 in parallel with the start of the phase 3 trials at the end of July which helped compress timelines. If the data is robust enough that they start making the vaccine available commercially in Dec/Jan, they’d have enough data to be sure that the booster schedule wouldn’t be more often than every 6 months. Per clinicaltrials.gov, the primary completion date (collection of the final data point to measure the primary study variable in the last subject) for the Pfizer/BioNTech phase 3 is at the end of April 2021. I don’t know what the turn-around time is for analysis of the immunogenicity data but it’s feasible for an announcement of the top line data to come in June 2021 which should include enough info to know if they expect the booster schedule to be more frequently than annually or not
Thanks for your comments; really appreciate them.
“I think there’s a lot of problems with masks.” The hell??? The sheer insanity of this man refusing to going back on what he previously lied to his base about even though it would save lives. I mean they already know he lies like he breathes. November can’t come soon enough.
“I think there’s a lot of problems with masks” 24 hours after the blames Joe Biden for the lack of a national mask mandate…
That hair ought to be article 1 of his impeachment. 2-480 can be collusion, corruption, rape, incompetence, etc. etc.