President Biden confidently declared last week that there would be enough Covid-19 vaccine delivered to the U.S. government by the end of May to vaccinate every American.
But predictions about vaccine availability have repeatedly been proven wrong. How confident should Americans be this time? The short answer: somewhat.
There is no doubt that the U.S. is moving from a time of vaccine scarcity, when there is not enough vaccine to go around, to one of vaccine surplus, when it will be far easier for people who want a Covid vaccine to receive one. By early summer, barring a manufacturing catastrophe, there should be enough vaccine for every American.
But the math behind Biden’s pledge that the U.S. will have enough supply to vaccinate roughly 260 million by the end of May depends a great deal on new, more aggressive timelines from Johnson & Johnson. A closer look at administration and industry statements also suggests officials know this. Even if J&J misses the goals stated by it and the administration, it is likely the supply would hit this 260 million figure.
The March 2 announcement was based not only on current expectations of supplies from vaccine manufacturers Moderna and the partnership of Pfizer and BioNTech, but on expectations that the U.S. will have 100 million doses of the newly authorized vaccine from Johnson & Johnson by the end of May.
J&J is able to deliver more sooner in part because of an agreement under which Merck will help manufacture its vaccine, but also due to other steps taken by the company and the administration.
In its press release announcing the new timeline, the Department of Health and Human Services said its plan will allow the administration to accelerate the delivery of J&J’s vaccine doses “from 100 million doses by the end of June to at or near 100 million doses by the end of May.”
There is, of course, a difference between “at” and “near.” And in its own statements, J&J seems to hedge its commitment as well.
When asked about the May time frame last week at a Washington Post virtual event, J&J CEO Alex Gorsky responded, “That’s our goal.” Then, he added: “Our engineers and our scientists are working hand in hand with the Merck supply chain as we speak to make this possible.”
Explaining the reason for his optimism, however, Gorsky spoke of “if” not “when.”
“The reason for optimism is that if we can achieve this distribution of several hundred million additional doses during this time frame, we are going to be at a point where there will be enough doses available for every American that can realistically be vaccinated.”
In a statement, J&J reiterated: “In partnership with the U.S. Government, we are aiming to deliver nearly 100 million doses by the end of May.” But to have just enough for every adult, J&J would need to deliver only 6o million of those 100 million doses.
A Biden administration official told STAT that J&J did tell the administration the timeline is reasonable, in part because of other steps the administration took. The administration is using the Defense Production Act to help the company obtain needed materials, such as single-use bags for the vaccine. It has helped locate teams of experts who can be on call at factories to quickly troubleshoot any manufacturing problems. Biden said that he also pushed J&J to move to a 24/7 production schedule.
All of those steps should move up the timeline, whether or not the 100 million doses arrive by May 31 or some come straggling in in June.
What the Biden administration isn’t doing, the official said, is counting potential doses that could come from vaccines that still haven’t been authorized. Results of a U.S. trial of AstraZeneca’s vaccine, which has been cleared in other nations based on studies conducted in the United Kingdom, South Africa, and Brazil, are expected any day. Novavax, a small Maryland biotech firm, has shown positive results for its vaccine from studies conducted in the U.K. and South Africa. It says it has been discussing whether the Food and Drug Administration would consider reviewing those results, which could lead to the vaccine being authorized in May. It is also conducting its own U.S. study. If either vaccine were cleared, it would increase supply further and faster. Even if neither happens, Pfizer/BioNTech and Moderna are due to together deliver enough for another 100 million people by the end of July.
That could mean a major turnaround in the way that both U.S. officials and the general populace think about vaccines. In the coming months, we’re likely to go from having to determine who gets a limited supply of shots to distributing vaccines to every American and convincing the millions of people who are hesitant to be vaccinated to roll up their sleeves.
Once again, the hardest part is likely ahead.
About the Author Reprints
In early March the FDA should have authorized the Novavax vaccine after the J&J vaccine.
They are the only 2 US made vaccines that have been tested against the B.1.1.7/British, B.1.351/South African, and the P.1 and P.2/Brazilian variants(B.1.1.28 lineage) with proven results in people, not in a lab. These variants have now been shown to have immune escape/resistance to antibodies. Existing/acquired immunity to previous(or local) variants does not protect from them, re-infection is likely with more fatal outcomes.
There is growing urgency to get more vaccines to locations where the variants are known to be spreading with large populations that had large numbers of fatalities so far during the pandemic. Instead there is foot dragging and indecisiveness – demands for more trials and data for Novavax. This means production of the Novavax vaccine with simpler storage and handling requirements(when compared to Pfizer or Moderna) is stuck in bureaucratic limbo, when it should have already entered the production and distribution phase this month.
Interesting. J&J has just told the EU it likely will not meet its expected vaccine deliveries in the second quarter of 2021… AstraZeneca has, until now delivered less than 10% of its scheduled deliveries to the EU. The EU is one of the biggest exporters of COVID vaccines currently. It is interesting to see the negative comments about the vaccine situation in the US, when in Europe I expect we will not be vaccinated before the end of the year.
The U.S. health administration is still being stubbornly moronic in its response to COVID-19.
1) 1,700+ people a day dying yet they STILL insist on U.S. trials of Novavax and AstraZeneca when we have strong evidence from well run international trials PLUS REAL WORLD EVIDENCE of overwhelming efficacy and safety (in the case of Astra Zeneca)! Needless to say this is not just incredibly insulting to other nations’ health regulators but an appalling dereliction of duty in the midst of a pandemic.
2) STILL insisting on only 3 and 4 weeks dosing gaps between Pfizer and Moderna shots respectively when the REAL WORLD evidence from the UK conclusively shows 90+ percent of protection is derived from the first shot after c3-4 weeks and immunity levels are still very strong at 12 weeks pre booster. This means TENS of MILLIONS more people could have been given effective protection (plus dramatically reduce onward transmission) zinstead of dosing up people with a second dose for little additional protection. The U.S. approach is equivalent to a search and rescue team spending half their helicopter flight hours winching in a portion of the survivors of a shipwreck who have already had life vests and life rafts thrown to them while flying blithely over others still struggling without any flotation devices as they drown!
3) Still no urgency re variants. It is c6 months since the UK variant with N501Y first emerged (first genomic evidence is from early September) yet we still aren’t in safety trials of a variant booster?! There seems to be ZERO urgency re variant boosters WHATSOEVER!
Yes to all these things, and several more items you didn’t include:
1) Endless handwringing over giving shots to the underserved and people of color. I get that vaccine supplies are limited, but each day a dose of vaccine sits on a shelf while people debate equity a person dies. Speed is much more important than distribution equity amongst groups, and every person vaccinated protects someone else.
2) Vaccine wastage – we have seen instances of people being fined and even prosecuted for giving doses to the wrong sorts of people for the wrong reasons. Hence the vaccine is not used and spoils. Or CDC rules of discarding vaccine vials after five doses, when a sixth dose is usually included.
3) We keep confusing infections rates with death and hospitalization rates, when only one of the two needs to be addressed first. Focus the vaccine on those most likely to be hospitalized of die (everyone over 55). Stop fooling about “food handling workers” and “First line responders”. I know a 30 year old message therapist that was one of the first to get vaccinated because she is a “health care worker”. She has virtually zero chance of hospitalization or death. It’s just idiotic.
Have to agree with you on thise points too Big D.
Hard to understand how health care administrators cannot understand the simple concept of an exponential function.
They need to do everything in their power to get shots in arms NOW. Over 20m doses sitting in storage unused.
SIMPLY NOT ACCEPTABLE.
Open vaccination to EVERYBODY over 55 and or with a co-morbidity until all the stockpile is gone. People who have to wait another week or two for their second shot will be just fine.
I’m in the last group in PA and they can’t even get half of the 1A people vaccinated. By the time I get both my shots the new variants will already be dominant. People won’t stop traveling and are still spreading the new variants globally. We won’t get anywhere near immunity as a populace. They will be required to produce large quantities of newly developed vaccine all the time and we’ll be constantly rolling up our sleeves. This Covid disease represents a fundamental change in human evolution. A new era of super viruses capable of mutation more rapid than anything they’ve ever seen before. They’re observing Covid adapt and change to various treatments in such dramatic fashion that it might suggest to science fiction writers that the virus has a sentient intelligence. In the UK they were giving a treatment and saw the virus adapt. They changed the treatment and the virus mutated again in the same patient into another new variant that killed them. It’s more contagious and hides better than typhus. And causes secondary diseases they’ve never seen before. It’s like something from another planet. What was 2 main variants is now at least 14. In another year there could be a hundred different active strains capable of mutating into something worse. I don’t think the human race is going to ever get past this. It’s a permanent monster at our doors.
A virus does not have intelligence.
That said, the other part of this comment about this pandemic being a significant change for humanity is spot-on. It’s going to continue to mutate and cause issues for years. While things will be better, people are likely to be in for a rude awakening if they think that they will be able to (or want to) gather for Christmas dinner next year.
The bigger problem is that we’re close to the point where it will be very cheap for anyone to perform gain of function experiments and intentionally release viruses that are far worse than this one. Imagine starting with norovirus and engineering it to have 50% mortality.
A lot more manufacturing capacity needs to be prepared, particularly with mRNA platforms, and better simulations need to be prepared, to be able to rapidly ring vaccinate against potential future threats. The current vaccines were created in days but took months to manufacture and test, which could lead to the extinction of the human race if the next disease is more serious than COVID-19.
Thank you, as usual… the right information at the right time from STAT. We can now re-focus on distribution and equity…
I love Stat, but I think any discussion of “vaccines” needs to address the fact we have growing indications the Brazilian P1 and South African B1351 variants will not be stopped by what we are using.
In other words, we have great vaccines for the first wave virus but it is still uncertain those are vaccines for the second wave.
Hopefully, they will work, at least a bit – but in Manaus they had a huge outbreak in 2020, and now, less than a year later, a brand new one, some claim worse than the first, with P1. That variant clearly reinfects people who were sick recently -is there any reason to think vaccines will stop it? I can find no clear indication they will. Data seems to show, at the least, much lower efficacy against both those variants than they have against the first one.
Some reports are, P1 is more contagious and more deadly -if so, when it gets here in large numbers, we may well have a worse epidemic than we had in 2020 and early 2021. We know it will infect people who were sick already -so natural immunity will not stop it – we have reason to think vaccines will not stop it – so if it is more contagious, more people will get it. If it is more pathogenic, more people will be severely ill and die (with the caveat, maybe treatments being developed will be very effective, better than what we had in 2020/early 2021 -to me that seems like a reasonable HOPE).
@Steve White
The Pfizer and the Moderna vaccines work against all variants, including P1 – https://www.nejm.org/doi/full/10.1056/NEJMc2102017?query=featured_home
There are a couple of more papers that say pretty much the same thing. If anything, the South African variant is more of a concern but even in this case, vaccine-elicited antibodies are still able to neutralize it (though Pfizer and Moderna are working on a potential booster, if it will become needed).
Importantly, even if antibody neutralization is impaired, vaccine-elicited T-cell
response is instrumental in protecting us from severe disease, as evidenced by the Johnson & Johnson Phase 3 trial results in South Africa (lower vaccine efficiency, in protecting from symptomatic Covid but no cases of severe disease). The viral T-cell binding sites are plenty (many more than antibody binding sites) and those have barely been touched by viral evolution:
https://www.biorxiv.org/content/10.1101/2021.02.27.433180v1.full
TLDR: Vaccines are protective against all circulating variants for the moment and most importantly protect us from severe disease.
Exactly.
What if the vaccines are not effective in stopping the disease, but reduces hospitalization and death from it to near zero? Isn’t that still a “cure”? That seems to be the case, even with the variants.
Without operation warp speed’s success deaths would be rising worldwide
Careful, Geoff. There are certain things that you are not allowed to say. And giving Trump credit is a big no no. You don’t want to trigger the woke brigade, do you?
There’s also a bit of wiggle room. There are 285 million Americans 18 or older, and some can’t or won’t be vaccinated. So doses for 260 million that, barring catastrophe, will be available should handle it.
No, it is 250 mil over 18 and 70% of that is 175mil. It should be done by the end of April.
And death and hospitalization rates should crash to near zero by the end of this month.
March is typically when we see a resurgence of respiratory infections. In April and May we should see a sharp decline in the infection rates. Coupled with immunization, we are weeks from this being over. What we might see is the J&J vaccine being donated to hot spots all around the world, because if we don’t break the virus there as well, it will keep coming back. I, for one, would be happy to see 50 million doses of J&J vaccine going to Brazil, South Africa, and Mexico.
As a layman, this problem is extremely disheartening to me.
The Moderna vaccine existed in March 2020, the BIoNTech in April – it could be earlier for both, but they were being put into clinical trials by then.
We were told by the media, when it managed to divert it’s attention from the election for an instant or two – that huge supplies of the vaccine were being manufactured in anticipation of approval by FDA.
Having read this, and, to be clear, it did not in any way appear to be a press release by the previous administration – and I do not know of anyone in government, or who had been in government, raising the alarm that it was not true – it is kind of a shock to find out we have several great vaccines, apparently, but despite a YEAR of working on it – we do NOT have the vaccines as promised, and will not have them for another 3 months.
I would like to know what happened.
I respect Dr. Fauci taking risks with his own health to get out the word, (but it must be said belatedly) on wearing masks and other prophylactic measures- but as head of the infectious disease sub agency within CDC – what more important job did he and CDC have – not perhaps working alone, but certainly part of their mission – than getting us the vaccine to end the biggest epidemic in 100 years?
But this failure seems to go deeper than CDC. The medical establishment refused to use human challenge testing to test these vaccines faster. When you are going to have 100M cases, addding a few hundred or few thousand in hopes of heading off tens of millions more seems like a no-brainer, and I do not believe anyone can show, with a reasonable projection of a worst case scenario, that their refusal made sense.
And, by the way, the worst case scenario was not everyone in the human challenge test keeling over and dying, – because if that had happened, that would mean, no time would be wasted making a vaccine too dangerous to use, and the sacrifice of a few hundred people would be trivial compared to losing six months in vaccine development.
Going forward – it seems really quite incredible the companies making vaccines are not required to give precise calculations of how much vaccine they can produce, and, where necessary, be required to build additional production facilities. It seems incredible this was not required from the start. I realize there was a different President — but even if he was hostile to the idea of a government partial takeover of a private industry – where were the Dems? What did we hear from the CDC? FDA? How about all the former top health officials from Obama administration?
We should have had true crash programs to make all the vaccine we could use, and not let anything – Pharma’s proprietary secrets, or reluctance to divert resources, or build factories they would only use once – whatever it was – no one, no one, had the right to get in the way of our economic and emotional recovery.
Dr. Fauci works for NIH, not CDC. Dems were screaming plenty. Republicans were denying the extent of the problem. But all that aside, the federal government was supporting the construction of the factories. That takes time. Manufacture of mRNA requires less equipment than other vaccines. But the process is novel… and is still being made more efficient.
Thank you for the info. I had thought NIAID was a sub agency of CDC so I was wrong. But still, as head of NIAID, what more important thing did he have to do?
I can not put numbers to the failure to build for more production, but since you are defending it – do you KNOW they did all they could?
“Doing all they could”, to me, would mean looking at how much production capacity they had in the beginning, Spring to Summer of 2020, and, if it was inadequate, building more. It seems clear that did not happen. I do not think anyone can claim it did. If it had, the J&J vaccine being approved would make no difference to the vaccine efforts, which would only be limited by the inability to inject the vaccines, not by vaccine supply.
And I am not even going into vaccine supply in other countries – clearly a big problem, even in wealthy countries which have infrastructure for the mRNA vaccines.
I realize I do not have firm numbers, so I can say “Look, $2B for a new vaccine factory spent last summer would mean we get a dose for everyone by April 1 instead of June 1” – but that is because we did not have an open process where everyone could see where we were likely to have problems, and deal with it.
The drug companies need not have built vaccine production -well, they know how to do it, so they would probably have done it under government contract.
I see failure, not success, in getting the first people inoculated in December, for a vaccine which existed in March.
I would not care so much, except that it seems certain we now have a very similar situation with the variants. We will need new vaccine for them -if it takes 10 months to get them, we are in for a very bad year.
I