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Update: Where the Vaccine Race Stands

Update: Where the Vaccine Race Stands

This is an update to an October 13 post on the status of vaccine production.

Trump promised us a vaccine by Election Day. To no one’s surprise he failed. There’s a chance however that a few front-line health care workers and emergency responders could be getting the first of a two-shot Moderna or Pfizer vaccine regimen by the end of the year. A few million more could be covered by about February.

Starting roughly February or March, a relatively cheap, single-shot vaccine with excellent efficacy, perhaps well over 70%, may be available to the general public. It’s beginning to look like we might be able to resume most normal activities in the developed world, though probably with some remaining precautions like masks, by next summer.

With at least three vaccines now completing stage 3 trials with 90%+ efficacy, there remain two serious concerns. None of these vaccines have been through truly large or long-duration testing. We might still discover troubling side effects, especially for the candidates using more novel techniques. Second, we have no data whatsoever on how long the disease-resistance might last. Question marks about duration will keep us masked up probably through the end of next year at the earliest.

Finally, a vaccine alone will not eradicate the disease. Flare-ups will continue. People who received only one shot of a two-shot regimen will misunderstand their immunity, act stupid, get sick and spread the disease to yet-unvaccinated and perhaps unwary populations. Mutations of the virus may evade certain vaccine strains leading to outbreaks. Vaccines are a powerful weapon, but eradication will require us to use that weapon in conjunction with others to chase it down and destroy it, a project likely to take years if not decades.

Notice the global nature of this campaign. Those who complain that “socialized medicine” will destroy innovation will soon be benefiting from vaccine campaigns led by French, German, Swedish, and British organizations. In fact, it’s likely that the first widely distributed vaccine in the US will come from a German effort, Pfizer, that deliberately avoided the Trump Administration’s rattletrap “Warp Speed” campaign.

Don’t miss the impact of immigration on the vaccine campaign. Turkish immigrant to Germany, Ugur Sahin, is leading Pfizer’s vaccine research. If the US manages to land a candidate in the first round of vaccines we’ll owe this achievement in part to Moderna’s co-founder Noubar Afeyan, an Armenian immigrant from Lebanon. Johnson & Johnson’s Chief Science Officer responsible for their vaccine push is the Belgian, Paul Stoffels. Novavax’s effort is lead by Nita Patel, an immigrant to the US from a small farming village in Gujarat. Frankly, it’s hard to find a native-born American engaged in this effort apart from the marketing directors, or the senior executives in the news for dumping stock.

Finally, Smithsonian Magazine has an interesting piece explaining why the recombinant RNA vaccines require such extreme cold storage.

Moderna

Federal Backing: $2.5bn

Storage Temp: -4F, but refrigerator-stable for up to a month

Requires two shots 28 days apart

Phase 3 completed. FDA submission pending.

Moderna claims their vaccine is 94.5% effective in a press release, based on a 30,000 person study. FDA submission is still a few weeks away. Side effects were rare and minor. Data from their study has not been either publicly released, or submitted for scientific review or publication. This is true of all the candidates and it poses some concerns. Moderna’s vaccine should cost around $25 per shot (x2).

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 completed. FDA submission this month.

Pfizer has filed for an Emergency Use Authorization from the FDA for its vaccine. This is likely to be approved in early December. In a press release Pfizer claims its vaccine is 95% effective. Assembly centers have been set up in Belgium and Michigan, with distribution centers in Milwaukee and Germany. They need a highly complex distribution infrastructure to keep them cold. They are bypassing the US government’s distribution program managed by McKesson.

The German government has set up its own distribution infrastructure for Pfizer’s vaccine, with millions of doses already purchased and staged across the country ready to be released. Pfizer’s vaccine is expected to cost around $20/shot (x2).

Johnson & Johnson

Federal Backing: $1.5bn

Storage Temp: Refrigerator stable

Single dose, no booster

J&J is expecting to seek approval by February. For Americans, this is still the one we’re most likely to receive. If results are good, we could start seeing broad distribution as early as March.

AstraZeneca/Oxford

Federal Backing: $1bn

Storage Temp: Refrigerator stable

Potentially a single dose

Phase 3 trials completed. WHO submission likely in days.

Today AstraZeneca released summary data indicating that their vaccine candidate was up to 90% effective under some dosing options. The vaccine will require a booster (second shot). The UK government already has about 4m doses stored, with another 40m under production. AstraZeneca has contracts to deliver 2bn doses by next summer. No word yet on when they will seek EUA from the US FDA. They are, however, filing for an “Emergency Use Listing” from the WHO immediately.

Novavax

Federal Backing: $1.6bn

Storage Temp: Refrigerator stable

Two injections

Started Phase 3 on September 24 in the UK.

Data expected early next year. Early trials outperformed the other contenders, but this is a small company, most of it acquired from a Swedish pharma maker. They lack the manufacturing and testing heft of many of the competitors, a drag on their efforts.

Sanofi/GSX

Federal backing: $2.1bn

Storage Temp: Refrigerator stable

Two injections

Started Phase 3 on September 3.

Little news. They appear to be focusing on the global, and particularly the developed country markets. No indication of intent to seek an EUA from the US FDA at all.

Russian and Chinese Programs

Still no published data on efficacy and total immunizations in both countries have lagged. Both countries skipped Stage 3 testing, opting instead to just start immunizing the general population. Several months into the program only about a million Chinese have been immunized. While the Russians have crowed about the effectiveness of their Sputnik V vaccine, with reported efficacy numbers mirroring the towering margins you see from a Putin election victory, they also have lagged in administering their vaccine. Only about 10,000 have been vaccinated in the past few months. There are some serious concerns about possible problems with the method used for the Russian vaccine, which was connected with a disastrous HIV project in the past. If there’s a vaccine to avoid, it’s the Russian one.

14 Comments

  1. This is an excellent summary, but I feel like it’s missing something important. Where’s the part where you talk about strategies you’d like to see to make sure that blue states get all the vaccines and the red states don’t? I mean, the best way to stop the Confederacy before it starts is to make sure that millions of people that live there get sick and either die or become permanently crippled, right? That’s what you want, isn’t it?

  2. Bobo, I hope everything goes well for you. Isolation sucks but I applaud your commitment to public safety.
    I’m actually more frustrated with the reasons our testing options are limited than the tests themselves. I don’t have a science background but read as many quality sources as possible to understand what is happening. There is an interesting, very successful testing experiment underway in Liverpool, England that is utilizing antigen rapid tests weekly (or more often if symptoms present) to surveil the population on a regular, ongoing basis. The theory is that testing frequency is more valuable than accuracy in early identification of covid infection in large groups. The backstop remains the gold standard PCR if positive results present from the rapid tests but the emphasis is on early detection and quick results.

  3. > It’s likely to be something we just do in certain public settings for a long time.

    For certain values of “we”. I mean the Magaheads who are already screaming about infringement on their liberty will definitely not, and some other people who don’t understand that there is still a risk will go along with them.

    My plan is to mask until daily new cases in the US fall from six digits to two and I’ve been vaccinated. And maybe mask up for shopping in flu seasons anyway. But once I feel safe to go back to the gym (as above) I don’t think I’m going to wear a mask there. Maybe I’ll see how it feels.

  4. A note of caution–BIG caution: “It’s beginning to look like we might be able to resume most normal activities in the developed world, though probably with some remaining precautions like masks, by next summer.”

    A very large minority of Americans have proved themselves incapable of the simplest calculations of self-preservation when it requires a modicum of self-discipline. “Masks? Distancing? Don’t you DARE interfere with my freedom!”

    It’s as though 100 million of our citizens are too stupid to live without somebody MAKING them protect themselves. So how well will we be protected against that stupidity when those 100 million, plus another 100 million who are not stupid, but are just hopeful because they got a shot, start acting like it’s 2009 again?

    And that even ignores the fact that your mask protects me a lot more than it protects you. How will you (not you, Chris, but those 100 million random you’s out there) be convinced that you need to continue to wear your mask after you’ve gotten your shot, because you could still transmit the invisible death even after you can’t suffer from it yourself?

    1. Making matters worse, it isn’t clear yet that the immunity gained from vaccine will prevent vaccinated individuals from transmitting the virus. With other vaccines, vaccinated individuals can in rare cases shed the virus for some length of time. We have no idea yet how likely/unlikely that may be with these vaccines.

      1. My understanding is that reinfection with covid (or another close strain of coronavirus), is exceptionally rare. To date, only five cases of covid reinfection have been authoritatively confirmed in the world, which offers some reassurance to those who contract the virus but does not speak to your point about shedding the virus post-vaccination.

      2. I have not been able to find research from epidemiologists and virologists about whether people who have had covid can transmit the virus. Most doctors are telling people who have been infected that they can’t contract it again or expose other people to it. The devil is in the details which are sparse. I appreciate the challenges scientists and medical professionals have in trying to responsibly answer these questions. The necessary focus has been on treatment and vaccine development which is understandable, given the utter failure of this administration to contain and coordinate testing and achieve public compliance . Fundamentally, more time is needed to collect and aggregate data before immunity duration can be accurately determined .

      3. Hi, Mary.

        I was tested last week due to experiencing symptoms, including a complete loss of taste and smell for one day and a somewhat elevated temperature.

        For the life of me, I don’t understand how any public health official could make any decisions in the aggregate based on the test I had: 80% accuracy for covid, flu1 and flu2. I’m still isolating because 20% chance of infecting someone is not small. And false positives are relatively common, said the PA I spoke with.

        What poor tools our medical professionals have been given.

  5. Great summary of covid vaccines. I had not considered the continued need for masks following vaccination due to the unknown duration of immunity. I need to start ordering my masks in larger quantities.

    One minor correction: Pfizer did not accept US funding for R&D, but did accept purchase guaranteed funding. To my knowledge, they were the only vaccine developer who self-funded research.

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