Coronavirus

The FDA Could Double COVID-19 Vaccine Availability Immediately

So why doesn't it?

|

Here's a thought-experiment. What if the results of Johnson & Johnson Phase 3 clinical trial of the company's one-shot adenovirus-vector vaccine finds in January that it is safe and, say, 90 percent effective at preventing COVID-19 infections? Surely, the regulators at the Food and Drug Administration (FDA) would issue an Emergency Use Authorization (EUA) for that vaccine. After all, the agency in June set the efficacy threshold for a COVID-19 vaccine that it would prevent disease or decrease its severity in at least 50 percent of people who are vaccinated.

For comparison, the latest pneumonia vaccines protects 50 to 85 percent of relatively healthy adult recipients against invasive pneumococcal disease. With respect to seasonal influenza vaccinations, the Centers for Disease Control and Prevention notes that vaccine effectiveness has generally ranged between 40 percent to 60 percent. "This means that people who get vaccinated may still get sick, but they are about half as likely to get sick as someone who was not vaccinated," observes the agency. "Another important thing to remember is that vaccination may make illness less severe in people who get vaccinated and still get sick."

Keeping firmly in mind that clinical trials can report disappointing results, the initial data from the Phase 1 and 2 clinical trials in October for Johnson & Johnson's adenovirus-vector vaccine are quite promising. Those trials found that 97 percent of participants inoculated with the vaccine developed significant levels of antibodies against the COVID-19 virus.

Meanwhile, clinical trial results find that both the Pfizer/BioNTech and Moderna vaccines are around 95 percent effective at preventing COVID-19 after two doses. But here's where it gets interesting: Preliminary data finds that both vaccines are around 90 percent effective at preventing COVID-19 after just the first dose.

So back to the thought-experiment. If the FDA would issue an EUA for a COVID-19 vaccine that is 90 percent effective (or possibly even lower), then why continue to require a two-dose regimen for the already approved vaccines? I suspect the reason is bureaucratic lack of imagination and courage. Because the clinical trials were set up to evaluate two-dose regimens, hyper-cautious FDA regulators will only ratify what's put in front of them. Apparently, the pandemic "emergency" is not urgent enough for the FDA to authorize the use of effective one-dose of inoculations of the Pfizer/BioNTech and Moderna vaccines.

Assuming no big distribution and manufacturing snafus, Pfizer/BioNTech, Moderna, and Johnson & Johnson reportedly aim to deliver some 300 million doses of their vaccines before the end of the first quarter of 2021. If Pfizer/BioNTech and Moderna were authorized to switch their 200 million doses to a one-shot regimen, that would be more than enough vaccine to inoculate the vast majority of Americans by the end of March. If it turns out that one-shot immunity to the COVID-19 virus wanes, there would still be plenty of time to administer booster shots later as vaccine production ramps up.

Given that a 90 percent effective or even a 70 percent effective COVID-19 vaccine would receive an EUA from the FDA, the agency should urgently consider authorizing a one-shot inoculation of the Pfizer/BioNTech and Moderna vaccines now. Such an action would essentially double the amount of vaccine available, save thousands of lives, and bring the end of the pandemic that much closer.

 

NEXT: 'We're Not Doing Anything Wrong': This Pennsylvania Brewery Refuses To Obey State's Indoor Dining Ban

Editor's Note: We invite comments and request that they be civil and on-topic. We do not moderate or assume any responsibility for comments, which are owned by the readers who post them. Comments do not represent the views of Reason.com or Reason Foundation. We reserve the right to delete any comment for any reason at any time. Report abuses.

  1. Such an action would essentially double the amount of vaccine available, save thousands of lives, and bring the end of the pandemic that much closer.

    And relinquish these emergency powers?

    1. You like the emergency powers shreek. Stop pretending.

      1. I have received $17634 last month from home by working online in my part time. I am a full time student and doing this easy home based work for 3 to 4 hours a day. This job is qwe very simple to do and its regular earnings are much better than any other office type work.
        See detail here………… USA ONLINE JOBS

        1. Google pays for every Person every hour online working from home job. I have mbq received $23K in this month easily and I earns every weeks $5K to 8$K on the internet. Every Person join this working easily by just just open this website and follow instructions…

          …. for more info visit any tab this site Thanks a lot .

          Here……….. …………………Home Profit System

          1. [ PART TIME JOB FOR USA ] Making money online more than 15$ just by doing simple work from home. I have received $18676 last month. Its an easy and simple job to do and its earnings are much better than regular office job and even a little child can do this an earns money. Everybody must try this job by just use the info
            on this pages…..work92/7 online<b

      2. Google pays for every Person every hour online working from home job. I have veh received $23K in this month easily and I earns every weeks $5K to 8$K on the internet. Every Person join this working easily by just just open this website and follow instructions….. Visit Here

    2. Google pays for every Person every hour online working from home job. I have kjd received $23K in this month easily and I earns every weeks $5K to 8$K on the internet. Every Person join this working easily by just just open this website and follow instructions….. Visit Here

      1. I get paid more than $500 to $5000 per hour for working online. I heard about this job 2 months ago and after joining this i have earned easily $96k from this without having online working skills. This is what I do…… CLICKHERE

    3. [ PART TIME JOB FOR USA ] Making money online more than 15$ just by doing simple works from home. I have received $18376 last month. Its an easy and simple job to do and its earnings are much better than regular office job BYI and even a little child can do this and earns money. Everybody must try this job by just use the info
      on this page…. Visit Here

    4. [ PART TIME JOB FOR USA ] Making money online more than 15$ just by doing simple works from home. I have received $18376 last month. Its an easy and simple CGT job to do and its earnings are much better than regular office job and even a little child can do this and earns money. Everybody must try this job by just use the info
      on this page…. Visit Here

  2. Ron, can you provide the link to the study that proved the vaccine was effective at 90% WITHOUT THE SECOND DOSE?

    1. [ PART TIME JOB FOR USA ] Making money online more than 15$ just by doing simple work from home. I have received $18576 last month. Its an easy and simple job to do and its earning are much better than regular office job and even a little child can do this and earns money. Everybody must try this job by just use the info
      on this pages…..work92/7 online

    2. The link to the previous Reason article also then links to the preliminary clinical trial results at the FDA.

      I’m not a fan of this sort of ad-based footnote-baiting. And it ain’t what I envisioned the Internet becoming. But it is what it is and Ron is generally pretty good at linking to raw data that supports the assertions/conclusions he draws. So even though I haven’t read that FDA clinical trial data, I will assume that that is what it says.

  3. Never let “good enough” get in the way of perfection.

    1. On second thought, I’m going to give the FDA the benefit of the doubt. At present, I don’t have anything that says the second shot is identical to the first. If they’re different, you may not be able to double. Not sure what the increase would be in that case.

      1. JOIN PART TIME JOBS
        Google pays for every Person every hour online working from home job. I have received $23K in this month easily and I earns every weeks $5K to 8$K on the internet. Art Every Person join this working easily by just just open this website and follow instructions
        COPY This Website OPEN HERE….. Visit Here

  4. “Another important thing to remember is that vaccination may make illness less severe in people who get vaccinated and still get sick.” medical experts can’t help themselves from talking about individuals like they’re categories and vice versa. It’s not that everyone who gets vaccinated AND sick MAY randomly have less severe symptoms – some will and some won’t, depending on how similar the flu they get is to the flu they’re vaccinated against.

  5. Because the vaccine was tested using a two dose protocol. Many vaccines require two doses because while the first one is effective, the effect is not lasting. Since it was not tested with one does, we have no data to provide any confidence that one does is actually good enough. Vaccines are complicated, I trust that if one does was truly good enough, then the scientists creating the vaccine would recommend that we go to a one does protocol.

    1. Still seems to me like there is enough data to make reasonable inferences about how long one dose lasts v two doses. Every stats study (many a lot bigger than this one) I’ve managed has provided enough data to analyze a thousand different ways.

      That said – it is certainly possible that everything has become so politicized that no one will go out on a limb to test what could not have been anticipated when the study began. Even though the uncertain – the probabilistic – is exactly what stats is about (and used to be called). Even more possible is that the data isn’t at the FDA but is within the pharma/trials companies so that none of them are really able to crowdsource the whole. They’re each looking at their part of the elephant.

      1. [FOR USA ] Making money online more than $15k just by doing simple work from home. I have received $18376 last month.AMs Its an easy and simple job to do and its earnings are much better than regular office job and even a little child can do this and earns money.
        Everybody must try this job by just use the info on this page….. Home Profit System

      2. There is enough data to know that one dose will be effective for 3 to 5 months. That is suffiecnt to make a problem of vaccine logistics far less stressing and provide less pressure on socially manipulated prioritization schemes.

    2. That’s not the point. The FDA said it would approve any vaccine with more then 50% success; one does is 90% effective and ought to be approved as a single dose.

      1. The sooner this pandemic is under control, the sooner citizens will be free and the state will be obligated to give up its “temporary” powers. Why would they work to give up such a useful tool?

  6. There is no point in talking about the J&J vaccine, based on an adenovector until the phase 3 trials are over.

    Production of antibodies says very little about how effective they will be in the population under actual conditions.

    J&J will also be testing a two dose regimen.

    Everyone is pushing this as fast as they can. Give it a rest Ronald. You have not written a thing about the science behind this nor published a link to explain to people about how these things work.

    People out there getting information from Twitter and Facebook have many misconceptions which you could help to clear up. In fact you are making things worse.

    1. >>misconceptions

      Yeah, like the misconceptions that this is like other vaccines or that we know there are no long-term risks from its administration? Those need to be cleared up.

    2. Actually he is not making matters worse and members of the influence JASON committee that the government has sought advice from have suggested exactly the same procedure with the two approved vaccines.

  7. What likely would have made more sense is to have batches of the vaccines made earlier, rather than waiting for them to be approved.

    since a) they obviously were and b) on the slim chance they weren’t, they could have been thrown away. Would it have been a waste of money? Yes, but still a better use of money than much of what was in the “relief” bills.

    1. I am sure they thought about that. The fact that they had so much ready to go this fast is simply amazing. I have never seen anything like it.

    2. They had massive quantities made before approval. Yes it was a bit of a gamble, but that was a business risk they were willing to take.

      1. Good to remember here that this was less of a gamble because of Operation Warp Speed. The companies had the techniques to make the vaccine and they knew the best way to attack Corona viruses. Operation Warp Speed provided a faster review process (essentially letting manufacturers cut in line). And, to your point, a guaranteed market for a successful product. The government reduced the gamble.

        1. Yay Trump!

          1. If it’s really a matter of cutting in line, why yay Trump? That would mean that these got to market faster because others got to market slower. I thought it was actually a matter of cutting red tape, but if not then it’s no cause to celebrate.

            1. At best if that’s the case it’s like mailing everyone a check by borrowing on the Treasury account — only not as good, because doing that at least gets money into private hands as opposed to leaving that credit in government’s hands.

              1. [FOR USA ] Making money online more than $15k just by doing simple work from home. I have received $18376 last month.HGb Its an easy and simple job to do and its earnings are much better than regular office job and even a little child can do this and earns money.
                Everybody must try this job by just use the info on this page….. Home Profit System

            2. Um, we kind of needed the Covid stuff before most of the other stuff in the FDA’s line. Letting Covid vaccines cut in line isn’t a long term solution, but in the short term it absolutely makes sense.

    3. or just open the shit up to the free market and let companies charge whatever they want. isnt this a libertarian site?

  8. Let’s say, for the sake of argument, that Ronald Bailey, who surely has an awesome social network, ran this by one of the most distinguished members of FDA’s outside expert vaccine advisory council, who loved it from a biological standpoint but isn’t willing to go public.

    I think the problem then is that Americans have too little faith in legitimate government experts to be on board when they change their mind, as open-minded scientists do. And doesn’t this magazine, and web site, in a tiny way, contribute to that loss of trust?

    Of course, experts often need to questioned. Some of this might be best put aside during a pandemic. And at any time, how much to trust experts when you don’t have the ability and/or time to pour over the research literature to make an independent judgment, is a big question.

    If Mr. Bailey does know of what he speaks, a country where there is a higher level of social trust, than is present in the United States, should try it. I just don’t think the public here will stand for that change in direction after being told for so long how our drug approval model is sacrosanct.

    If our family doctor tells me to skip the second shot, whether for purely medical reasons, or just to make it available to someone else who may need it more, I will gladly do so. Her I trust.

    1. i should be allowed to use whatever drugs i choose and and anyone is willing to sell to me for a fee i am willing and able to pay. government should be 100% out of the picture.

    2. Look the suggestion in NOt very radical, it just says in stead of administering dose two, 5 weeks later, instead administer dose two 3 to 4 months later. Everyone still gets the two doses while dose one is still effective. but the overall rollout into the population is faster

  9. You can’t sue Pfizer or Moderna if you have severe Covid vaccine side effects. The government likely won’t compensate you for damages either

    https://www.cnbc.com/2020/12/16/covid-vaccine-side-effects-compensation-lawsuit.html?&qsearchterm=Pfizer

  10. This is idiotic.

    Lots of phase 3 trials fail.

    What happens when a single dose isn’t enough? How long will it take to figure that out?

    And then what happens when the booster shots are too late and don’t generate the efficacy at 6 months they do at 6 weeks?

    1. Then we’ve gotta produce a zillion more doses. In the meantime, maybe the temporary immunity in most of the population slows the transmission significantly? Seems like it would still be a positive outcome.

      1. Or covid mutates and the vaccine no longer works.

        Underdosing with antibiotics allows many bacterial infections to become resistant to those antibiotics.

        Underdosing with antivirals works the same way.

        Should we really be playing games with a vaccine? So we can end up with resistant viruses that need three or more injections to be effective?

  11. Think beyond stage one.

    The people at highest risk of death are a small population.

    If you encourage everyone who wants the vaccine to take the vaccine, then you advance the false, damaging belief that life should be shut down till the FDA approves vaccines and everyone takes vaccines.

    The truth is that going forward, everyone would do better to have access to frequent, fast tests for those in contact with people at highest risk of death; and to make rapid, widespread exposure to the virus be the norm for everyone else.

    Vaccine exposure is guaranteed to be understood less than virus exposure, and therefore of extremely-limited usefulness apart from for the population of people who are at highest risk of death.

  12. https://www.bmj.com/content/371/bmj.m4826

    “The study, published in the New England Journal of Medicine,1 found that vaccine efficacy between the first and second doses was 52% (95% credible interval 29.5% to 68.4%), with 39 cases of covid-19 in the vaccine group and 82 cases in the placebo group.”

    To be confident of efficacy, we’d have to have enough numbers to trust our statistics extrapolating from the first weeks after the first shot. But look at that confidence interval for the entire time between first and second.

    The figure Mr. Bailey quotes is, I believe, from looking at data shortly after the second shot, assumed to be so soon after that any effect can’t be the second one yet but must still be the first building up. It’s plausible and comes from someone with credentials.

    “Quantity has a quality all its own”, and for a contagious disease getting twice as many people resistant could do us good. I’d be more comfortable if we collected actual data to support the decision. If we discover that two months after a single shot the people get a third as many spreadable cases, we’ve hit the jackpot. If we discover that a booster six months later works just as well, also wonderful.

    Tl;dr. We’ve carefully and at great expense collected the wrong data to address this policy question.

  13. Hey,
    Such an amazing article.You would love to see my http://www.bisexual-orgies.net/
    site as well.

    Thanks once again.

    1. I hesitate to look at your site as I fear not everyone is wearing a mask and social distancing.

      1. Is it okay if the gathering is outdoors?

        1. [ PART TIME JOB FOR USA ] Making money online more than 15$ just by doing simple work from home. I have received $18376 last month. Its an easy and simple job to do and its earnings are muche better than regular office job and even a little child can do this and earns money. Everybody must try this job by just use the info
          on this page…..work92/7 online

  14. Do you want to earn cash online from your living room, easily work with a laptop for a few hours a day, earn 550-650 euros a day and get paid every week by deciding on your working hours? it is all true and completely changed my life. Read More.

  15. The sorry facts are that the decision is not scientific, but rather political in nature. No political as in Republican/Democrat, but bureaucratic politics.

    You are completely correct in that the CDC and FDA lack courage and imagination. They also only “Follow the Science” if it suits their objectives. The CDC and FDA need to be gutted/eliminated or at least scaled back.

  16. Or we could just cut the single dose in half and have 4x as many doses which is still pretty good.

    1. Add some water, and boom! 8X

    2. Your suggestion is based on no experimental data.

    3. Sometimes you say things that are so stupid it makes me wonder if you’re being provocative or just stupid.

    4. So you’re the guy that made my Margarita last night.

  17. “…hyper-cautious FDA regulators…”

    If you think that this is about caution, I have some land in Florida for sale you might be interested in buying. It’s not about caution, it’s about power, plain and simple. The entire FDA needs to be disbanded and a replacement agency put in its place, with the most important change being that nobody above the level of janitor from the old FDA be allowed anywhere near the new agency. The past year has clearly shown that the FDA has ossified beyond any hope of reform or change, and this ossification is both deep and widespread.

  18. Hey,
    Such an amazing article.You would love to see my kubet
    site as well.

    Thanks once again.

  19. Everyone I know who was young had corona wu flu for 3 days or less.
    That would be my 21 years old daughter and my fellow doctors 25 year old son.
    My 91 year old father in law, and my 76 year old brother and his 71 year old wife were all actually sick for a week and had a prolonged recovery.
    All are fully recovered now.
    I got the vaccine as they gave it to all our O R and E R staff.
    In the future they are going to look back at the hysteria surrounding this virus and wonder, just like we wonder at the hysteria around the war of the worlds radio broadcast.
    Now that there is a vaccine and the end of the current crisis is in sight, I hear reports about mutated virus is from England.
    Just like the “murder hornets “, this is a way to continue the hysteria and the tyranny.

    1. 320k dead

      that is not hysteria

      and you are no doctor

  20. Hospitals in LA near or at full capacity. Running low on O2, covid patients require high volumes of O2.

    https://www.latimes.com/california/story/2020-12-25/l-a-county-hospitals-running-dangerously-low-on-oxygen-supplies-as-er-units-are-overwhelmed

  21. In answer to that actual question posed by the author:

    The companies have to request it

    I mean sure, the first dose has proven to be 90 effective for years….oh, wait, no it hasn’t

    A science writer is not a scientist, but they ought to do their own self argument before publishing

    1. Okay, well Brett Weinstein and Heather Heying, bona fide biologists, have also considered this possibility and they thought it was worth consideration as well. And in any case, my body, my choice. If I want to buy a single-dose vaccine, that is none of the government’s business.

      1. It is expected that a number of people will not show up for a second dose especially if they had side effects from the first one.

    2. “science writer is not a scientist”
      Neither is Your governor, nor is CA’s Public Health Office who want to prioritize vaccination based on race.

      1. The public health director is a doctor and must be by law. In CA it is currently Tomas Aragon MD PhD.

  22. Or try the free market. Sell to the highest bidder. Incentivize the drug companies to make more, faster. Bazillionaires and charities could buy up doses to help the poor.

    1. It is not about that at this point. There is more than enough money. The geeky white coat types, and there are not many of them at this level, they are not pure profit driven. That is not altruism they are driven by different motives.

      Sports analogy. You can offer $100 million more to LeBraun. You might be able to get him to switch teams but he is already playing at his peak ability. What he wants is not more money. He wants to win.

  23. The most I think about this, the better it sounds for saving both lives and businesses. We know that one dose of a mRNA vaccine, provides substantial protection. And we know that a second dose of a mRNA vaccine, as currently formulated, is more reactogenic than the first. Ronald Bailey explained it better than I can.

    And there is a day coming up that would be perfect for the pivot — January 20, 2021.

    I hope that Joe Biden has an open-minded virus transition team internally debating this now.

    Caveats:

    1. Joe Biden was not elected to be dictator. But he can, on day one, second experts to advise states, and individuals, about second dose timing.

    2. Late January is close to when more results are expected for the Oxford and Janssen adenovirus vaccine. If they are even partially available on, say, January 19, and more positive than now seems likely, the benefit of taking the risk Bailey proposes would be less. But if it seems that adenovirus vaccines are less effective than mRNA, the case for the Bailey pivot strengthens. You then can take the Oxford or similar just as tested, or just one dose of the other kind, and everyone who wants some protection gets it much more quickly. The alternative may be no authorization for the second rate vaccines (or no one, in a country like the U.S., willing to take them), and a dreadfully long period of vaccine shortage.

    1. The Oxford vaccine has a big advantage worldwide because it does not require the ultra cold storage. I saw they were talking about combining it with the one developed in Russia which targets different parts of the virus to see if that improves efficacy.

      There is also the one developed in China which looks promising.

  24. Yes, in india the Oxford vaccine is coming soon, But there are some issues with this.

  25. Kubet hay KU Casino là nhà cái đẳng cấp hàng đầu châu Á hiện nay với nhiều dịch vụ hấp dẫn như: cá cược thể thao, bóng đá, casino online, xổ số lô đề online, game bắn cá, slot games, nổ hũ … Tham gia tại Kubet ngay để trải nghiệm một sân chơi đẳng cấp thực sự. Bạn sẽ được tham gia các trò chơi hấp dẫn như tại các Casino hàng đầu Thế giới.
    https://kubet77.pro/

Please to post comments

Comments are closed.