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Where the Vaccine Race Stands

Where the Vaccine Race Stands

You can expect to hear a lot about vaccine breakthroughs soon, but don’t get too excited.

On October 22, the FDA will have its last pre-election Vaccine Products Advisory Committee meeting. Members face extraordinary White House pressure to announce a vaccine breakthrough. They will likely comply in some form, however out in the real world we are many months away from even the least effective vaccines, and probably more than a year from a broadly available vaccine with lasting, reliable immunity. Regardless what happens in vaccine research, we will not bring this pandemic under control in the near future without a coordinated, sustained response from the US government.

All of the near-term vaccine candidates share some characteristics. None are expected to deliver protection better than about 30-50% effectiveness, less than the protection offered by wearing a mask. Duration of protection will probably be unknown even as the vaccines are distributed on a mass scale, but no one is initially expecting protection resistance to last more than a few months. It is unclear at this point whether any long-duration protection (more than seasonal) will ever be possible.

This means a vaccine will not be a get-out-of-covid-free card. Just as with polio, measles and other diseases, eradication will depend on a sustained program of preventative measures, testing and tracing, augmented with vaccines. Even if we somehow get a remarkably effective vaccine with a multi-year duration, we will continue to live in the Shithole Republic of Cootystan until our government takes the necessary steps toward eradication.

Where do the leading vaccine efforts stand and what do they offer? They are ranked below by their anticipated delivery dates:

Moderna

Federal Backing: $2.5bn

Storage Temp: -4F

Requires two shots 28 days apart

Phase 3 results expected any day

Moderna has been the noisiest competitor in the vaccine race and the one that seems most willing to play ball with the Administration. They issue sparkling press releases every time a trial participant has a healthy bowel movement. As a startup betting the enterprise on this moon-shot, they’re the company who should probably be least trusted.

The super-frigid storage requirement for their vaccine contributes to their need to be first-to-market. They won’t sell much of this stuff once a stable, single-shot, refrigerator-stable vaccine is available. Their test subjects have experienced pretty consistent side-effects, but none have so far been serious enough to interrupt the trial.

Early reports from Moderna highlight the challenge all the competitors face. It’s not clear how much antibody is necessary to generate protection, how long those antibodies can be maintained, or which secondary immune processes might be key to longer lasting protection. All the vaccine manufacturers will know by the time the first wave of products reach market will be expected antibody levels, predicted duration, and a profile of likely side effects.

Moderna’s big hope is to be the choice for immunizing front-line health care workers and others in greatest need, patients who can be vaccinated en masse from single locations with excellent infrastructure (hospitals, prisons, police stations, military bases, etc). They’ve already secured $8bn in government guarantees, based on hitting expedited targets. That’s likely to be the last money they’ll see from this project, but they’re hoping the gloss of being first will carry them through subsequent projects.

Pfizer/BioNTech

Federal Backing: $1.95bn

Storage Temp: -94F (can survive at refrigerator temps for 2 days)

Requires two shots 21 days apart

Phase 3 results expected any day

Pfizer is the manufacturer in tightest competition with Moderna to ride the President’s pre-election vaccine hype. Like Moderna, Pfizer’s candidate will require super-cooled storage and a booster, largely eliminating hope that it could be widely distributed to the public. That means they need to win the battle to immunize early-vaccine candidates like hospital workers or risk missing the COVID payday entirely.

They intend to release data from their Phase 3 trial in time for the FDA’s big meeting next week, but those meddling scientists are threatening to rain on Pfizer’s parade. A group of scientists and ethicists circulated a letter urging the company to hold off until late November before submitting an FDA application. There hasn’t been time to collect the recommended two months of safety data after the boosters, but locked in a race with Moderna, Pfizer can’t afford to wait.

If the FDA makes some announcement next week about the availability of a vaccine from either Moderna or Pfizer, be very skeptical. It’s unlikely anyone outside the trial will receive their first needle job before December, and likely almost no one outside high-risk institutional candidates will ever see it. These early candidates probably only deliver a modicum of additional protection to a few people at highest exposures. For the rest of us, the race goes on.

Johnson & Johnson

Federal Backing: $1.5bn

Storage Temp: Refrigerator stable

Single dose, no booster

Phase 3 trials started September 21, results likely in December

J&J is the leading candidate for a broadly distributed vaccine. It will need only conventional refrigeration and be delivered in a single shot. Unfortunately, this trial was paused yesterday due to a subject displaying an unspecified serious side-effect. That’s not unusual, but lost time takes a toll. If others begin showing similar symptoms this promising candidate could be out of the race.

That said, J&J are vaccine veterans, running with an established, conventional vaccine technology. They won’t be first to market with a vaccine, but they might still be first with a vaccine capable of mass, cheap distribution.

AstraZeneca/Oxford

Federal Backing: $1bn

Storage Temp: Refrigerator stable

Potentially a single dose

Phase 3 trials started in August

AstraZeneca had been the leading contender to bring a broadly distributable vaccine to market first, but they took a hit in September when some subjects developed serious side effects. Testing resumed after a week delay on September 14, but their effort may be dragged by the need for further statistical analysis. It is not clear when they will release Phase 3 results.

Novavax

Federal Backing: $1.6bn

Storage Temp: Refrigerator stable

Two injections

Started Phase 3 on September 24 in the UK

Novavax has produced the most promising early results, delivering higher antibody levels than early candidates like Moderna with few side effects. They are lagging well behind Johnson & Johnson in the race to be the mass-distributable leader, the one you’re most likely to receive, but they might make up the gap with quality. With Phase 3 results just getting started, we may not see results before the end of the year.

Sanofi/GSX

Federal backing: $2.1bn

Storage Temp: Refrigerator stable

Two injections

Started Phase 3 on September 3

Sanofi is developing two vaccine candidates. This one, in partnership with GSX, uses conventional technology to develop what would be an easily mass-distributed vaccine. Since they aren’t in the horserace to be first to market, they’ve published little detail about their trials so far. They expect to be able to deliver vaccines by early-next year.

Russian and Chinese Programs

Russian and Chinese citizens are already receiving COVID vaccines. It may not be helping them.

These countries are out ahead because they skipped the whole Phase 3 mass testing process, instead turning their citizens into the test subjects. As one might expect, neither government has been forthcoming about the details of their vaccines or reported much helpful data on efficacy, duration or side effects.

When the Russians published some limited trial data, analysts noticed anomalies so crude as to be hilarious, including patients listed with duplicate test result values. Similarly, initial data published on a limited basis from Chinese studies was less than impressive, with antibody levels quickly declining. The advantages of an authoritarian regime in terms of central command and speed seem to be outweighed by the burden on science imposed by fear and intimidation.

What does this mean? Whatever the FDA announces under pressure from the Administration next week will have little or no impact on our lives. If the early candidates experience success, then some front-line workers might start getting a vaccine that’s difficult to mass-deliver and produces very limited protection as soon as January. If the leading, most readily deliverable candidates sail through testing, ordinary people may be able to get a vaccine with roughly 50% efficacy and seasonal (multi-month) protection by late spring of 2021. That’s if all works well.

In a more realistic world, it will be late 2021 before we get a vaccine that is readily distributed, safe, delivering high effectiveness with coverage lasting a year or more. By the then, the candidate may be an inhaled vaccine we aren’t even discussing today. Across 2021, we will only make significant progress against the pandemic by also doing the things we needed to do in 2020.

31 Comments

    1. Aaron Dow

      Actually, the thing about a Potemkin Village is that it’s supposed to HIDE the bad things happening in a country, but what happens if literally every single person aware of the Potemkin Village’s existence knows it’s a Potemkin Village? Like that’s the strangest thing about the modern era of political propaganda, is that it’s done reflexively and with the broad strokes but with no sense of detail or belief anyone will fall for it.

      Someday there may actually be a Wikipedia entry for Foxconn Factories DEFINED as Potemkin Villages that everyone knows everyone knows is a Potemkin Village.

      1. Aaron Dow

        Sorry, I’m still reading the article and despite the tragedy of lost opportunities and well-being in such sections a

        ” Into the gap between appearance and reality fell people’s jobs, homes, and livelihoods.”

        nevertheless, the entire farce is more hilarious than Spaceballs.

        To wit, at one point Foxconn hired about 600 students at the end of 2019 to do their own homework so that they could get subsidies, then fired the students come 2020, however they didn’t pay the students enough and also withheld the paychecks they didn’t want to pay up front too long, so they didn’t even get the subsidies they wanted in the first place.

        In short, a bunch of students got paid to do their homework SORT OF. Some of them are still waiting on paychecks and probably won’t receive them.

  3. Dinsdale Pirannha

    Another thing I am curious about, and have seen very little discussion about, is manufacturing capacity of any vaccine, let alone the logistics to distribute it.

    Let’s say the two-course vaccine (initial shot plus another 28 days later) turns out to the effective one. Let’s also assume that it ends up being like the common flu, where you have to get a shot every year. Now, I realize that if Big Pharma can manufacture the common flu vaccine in huge quantities, they can with any Covid vaccine.

    But how many common flu vaccines are actually produced in a single year. (assume I am talking about the u.s. alone)? If you go with the two-course assumption, and only vaccinate the non-Maga’s, you are talking about 400 million doses. How are those doses distributed? What states get them first, as they will obviously get an enormous competitive economic advantage over other states?

    Taking it one level further, what happens if some country in Europe or Canada discovers the magic recipe first? If it is an EU country, the wisest play would be to withhold the vaccine from the u.s., russia, and china, in order to get an edge as the EU economies ramp up first.

    1. Chris Ladd

      Mass pharma manufacturing isn’t such a big challenge. The big players are already ramping up for this. Distribution will be the ugly part, complicated by the fact that the first round of vaccines will likely be the ones requiring extreme cold storage delivered in double doses, that will probably only be effective for a few months.

      Gotta think of this process in phases. That first phase will probably only touch people who work in large institutional settings. In other words, people who gather in places where they can be mass-vaccinated. Where a single delivery, under expensive controlled conditions, can reach a lot of people at once.

      Hospitals. Prisons. Airline & airport personnel (at airports). Military bases. Police and firefighters, etc, maybe even teachers/administrators. They might start getting doses as early as December, since both leading contenders have already begun manufacturing.

      That first round won’t offer much immunity or duration, and will be a pain (literally) to obtain, while carrying a higher than usual load of side effects.

      More conventional vaccines are probably only about three months behind them, one or two requiring only a single dose and most relying only on conventional refrigeration. By March we’ll probably all be lining up to get them, available first probably at hospitals and doctors offices, but within weeks probably available anywhere you get a flu vaccine. Their duration probably won’t be much longer, but their effectiveness will likely be 20% or so higher.

      Once you get to that point you could start targeting eradication. If you got about half the population vaccinated and maintained a mask mandate, you could begin contact tracing and isolation on a scale that could make a huge, rapid difference.

      By the time we see third generation vaccines late in ’21, we could be on our way to wiping this out in the developed world. That depends on a US government that takes the matter seriously, but right now we seem on track for that.

    1. Chris Ladd

      It’s interesting. Neither company has abandoned the possibility of seeking an emergency use authorization (early approval), but both have stated as of this week that they’ll push out their request until the next meeting, November. The won’t be that much farther along in their trials, and Nov would still be early by any conventional standard. With pressure and incentive they probably could have gotten under the wire, but they decided not to.

      When we look back on this election I wonder if we’ll see Trump COVID diagnosis as the place where the campaign really went off the rails. It happened right at the moment when he would have needed to be needling the drug companies, pushing and threatening them to get their vaccines on the market. He just wasn’t able to do it.

      1. Ryan Ashfyre

        Even setting aside the amazing timing of it (which will never not be jaw-dropping), I’d say so. Something about the Dear Leader being felled by COVID was the political sucker punch that sent an already flailing, broke-ass campaign into a tailspin. Not that I believe it’ll be the difference between victory or defeat, but the average 3 pt loss he suffered could prove pivotal in some key Senate races.

    1. Chris Ladd

      They’ll likely be arrested. There’s a whole body of law around election fraud, including rules on handling of ballots, that could form the basis of criminal charges and Cali don’t play.

      However, the most interesting detail of this story is that the CAGOP has been pushing these fake collection stations to their own members. In other words, they are targeting Republicans, mostly in heavily Republican areas, with a scheme that’s likely to see many GOP ballots at least delayed if not lost. This is what happens when you start believing your own conspiracy theories.

      5. mary guercio

        Bobo,
        The hideous things republicans are doing to retain power breaks my heart for America. For the people who want only an equal opportunity to live and learn, raise their families, earn a decent living. I cannot accept nor forget the greed and raw exercise of power I have witnessed since Mitch McConnell pronounced on President Obama’s inauguration his intention to deprive him of a second term and success in his first term. This is what is happening now aided by a sociopath and millions of deluded people- through any means possible. I am ashamed of what is being done in the name of politics. Ripping friends and families apart and gutting progress that has been acquired over decades and even centuries. And, for what? More disposable income for already privileged people? Depriving women of the right to control their bodies? Destruction of our courts to legislate because republicans are so out of touch with the majority of Americans they have destroyed Regular Order?

        I’m not a young nor perfect person but I have tried to contribute to making my family, my community and my country a better. It pains me to watch our country be broken.

        I don’t have the best words to say more, but this man speaks for me.

        https://thebulwark.com/a-crusade-for-something-noble/

  6. mary guercio

    The T administration has decided that it will pursue herd immunity instead of the protocol followed by every other country in the world (save Sweden). Vaccines are delayed and treatments remain in clinical trials.
    How many people will die from this newest abortive decision?

    1. Aaron Dow

      Living through the pandemic has made me happy to be a Dungeons and Dragons player.

      30% bonus roll against infection and the bonuses stack?! I’mma get me a mask. Ooo, additional 30% bonus if I take the Elixir of Moderna? Sweet! How many rounds does that elixir last? 3 months? Alright, how much does it cost?

      2. Aaron Dow

        It’s also a great gateway to finance. Where else do you find people pouring through nearly endless variations of charts looking for just that much extra edge on each dice toss, with the patience to build experience point by experience point over long periods of time?

    2. Chris Ladd

      Vaccines will make a difference. They won’t bring an end to this mess. And how much mask-wearing do you think there will be after people start getting a vaccine?

      The first generation of vaccines will let us move from pandemic to epidemic/endemic. Maybe only 60-80K deaths next year in the US. Perhaps leveling off around 30-40K consistently year to year, competing each year with the flu, but with a mounting toll of long-term disability from those with resultant chronic illness.

      Meanwhile in the Pacific Rim, countries in China’s orbit will be in a position to move past this entirely toward local eradication. That eradication will depend on heavy screening of travelers from the sad, backward places where the disease remains endemic. And the long-term health care burden from those with chronic illness will be a millstone around the neck of western economies.

      I’ll be getting a vaccine as soon as a stable, reliable one is available, but I’m not imagining that’ll bring life back to normal.

      1. Dinsdale Pirannha

        The Mexico / u.s. and Canada / u.s borders should be interesting some months after a vaccine has actually been widely distributed (if mid/late 2021 for distribution, that makes the timeline 2022). Mexico, being closer to a 3rd world nation, may not have a handle on the virus. Canada, however, will. The borders are closed to travel now.

        Imagine the situation when the tyrant says he is re-opening the borders to Canada, and Canada says “uh, no”. Further muddying the water will be the political refugees trying to get into Canada, may potentially still infected.

      2. Michael

        The common cold is primarily caused by the rhinovirus but several common cold varieties are coronavirus based. I am sure that when these coronaviruses entered the human population, the death toll was very high, but humans then were not healthy and did not live long and world travel was minimal, so it is unlikely that society put two and two together to realize the culprit. But I am sure they were pandemics then too.

        However, because it is not in the best interest of the virus to kill or cause its host to become seriously ill because that reduces the chance of spreading the virus, natural selection resulted in the coronavirus strain that merely caused mild illness to survive and result in the common cold we know today.

        I expect the same to happen with CV-19. What I don’t know however is how long that process could take. It could be decades.

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