"Quite good news": Phase one of Moderna vaccine trials shows patients produced more antibodies than infected people did

‘Bout time we had some good news on COVID around here.

Although … there was actually some good news this morning that went by the boards, when 3M and MIT announced they’ll be partnering on an antigen test for coronavirus that should be available later this year. Antigen tests are cheap and simple and produce results within minutes, no more complicated in some cases than applying a sample to a piece of treated paper and seeing whether it reacts. 3M thinks it can manufacture several million tests per day once this is off the ground. Say goodbye to all the stuff you’ve been reading lately about supply-chain shortages and long delays in getting test results.

There was good news on Friday too. It wasn’t a randomized clinical trial so the results here aren’t being viewed as definitive, but Gilead has observed that severely ill patients treated with remdesivir appear meaningfully more likely to survive than patients who don’t receive it. That had been an open question after the first trials of the drug, which showed faster recovery times for remdesivir patients than for others but no clear death benefit. If Gilead is right then maybe we have a partial explanation for why the number of deaths has remained considerably lower in hot-spot states than in New York this past spring.

We’re going to need all the good news we can get as fall approaches:

As for the vaccine, scientists reported in the New England Journal of Medicine today that phase one of Moderna’s innovative mRNA product does what it’s supposed to do. The sample was small — it’s just phase one, although phase two is ongoing and phase three is set to start soon — but if it’s antibodies you want, it’s antibodies they’ve got.

After the first vaccination, antibody responses were higher with higher dose (day 29 enzyme-linked immunosorbent assay anti–S-2P antibody geometric mean titer [GMT], 40,227 in the 25-μg group, 109,209 in the 100-μg group, and 213,526 in the 250-μg group). After the second vaccination, the titers increased (day 57 GMT, 299,751, 782,719, and 1,192,154, respectively). After the second vaccination, serum-neutralizing activity was detected by two methods in all participants evaluated, with values generally similar to those in the upper half of the distribution of a panel of control convalescent serum specimens. Solicited adverse events that occurred in more than half the participants included fatigue, chills, headache, myalgia, and pain at the injection site. Systemic adverse events were more common after the second vaccination, particularly with the highest dose, and three participants (21%) in the 250-μg dose group reported one or more severe adverse events.

Note the bit about side effects. All 29 patients who received the 100-μg or 250-μg dose reported an “adverse” event (fatigue, chills, headache, myalgia, pain at the injection site) after the booster shot; in fact, the side effects at the highest dose were considered serious enough that Moderna’s since abandoned the 250-μg shot and moved ahead with the 100-μg one instead. But minor side effects are a small price to pay for immunity to COVID, and there should be immunity based on the level of antibody titers produced. See that number in the excerpt for the 100-μg dose — 782,719? By way of comparison, the number of titers detected in people in the control group who’d been infected with coronavirus and then recovered was 142,140. “The rapid and robust immunogenicity profile of the mRNA-1273 vaccine most likely results from an innovative structure-based vaccine antigen design, coupled with a potent lipid-nanoparticle delivery system, and the use of modified nucleotides that avoid early intracellular activation of interferon-associated genes,” says the NEJM report. I’m … not entirely sure what that means, but I think it means Moderna’s vaccine is able to keep the body cranking out antibodies because it eludes defense mechanisms that might otherwise interrupt the process.

Anyway, Fauci’s pretty excited:

“This is really quite good news,” Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said in an interview Tuesday. NIAID co-developed the Moderna vaccine and led the study.

“The gold standard of protection against a viral infection is neutralizing antibodies,” he added. “And the data from the study, small numbers as it may be, are pretty clear that this vaccine is capable of inducing quite good [levels] of neutralizing antibodies.”…

Researchers, however, still don’t know what level of a neutralizing immune response would be needed to guard against either infection or severe disease, and for how long a vaccine could provide such protection.

That’s the big mystery right now, made bigger by the fact that ominous reports keep trickling in about antibody levels in recovered patients dropping precipitously not long after infection. That’s not a total disaster: We also get some immunity from our T-cells and B-cells, and so long as the vaccine provides enough antibodies to immunize us for some extended period — six months? two years? — we can always get revaccinated periodically. (It would make herd immunity much harder, though, since it would require a huge share of the population to get vaccinated repeatedly. Convincing people to get vaccinated even once is challenging enough.) Until then, even those who’ve beaten the disease once already may be at risk of reinfection this fall, with one doctor telling Vox recently that he suspects he’s seen a patient who had the disease, beat it, then got it again.

The only silver lining there, according to a New York vaccinologist, is that subsequent infections should lead to less severe illness. “If you’re reinfected after some time, it would be an attenuated disease. It will be not as severe as the first time because your B and T cells remember the virus and react quickly,” he told Business Insider. There’s also a silver lining to the increasingly grim outbreak being experienced in states like Arizona, California, Texas, and Florida right now. Namely, a population in which the virus is spreading freely is fertile testing ground for a vaccine trial. One of the worries for European vaccine-makers is that they might not be able to get conclusive results about their vaccines’ efficacy because there’s not a high enough risk of getting infected in Europe at the moment. No problem with that here in the U.S. of A!

I’ll leave you with this clip of Fauci, another choice soundbite about whose advice the public should trust. Oh, and read this too and answer your exit question: What the hell are we doing?

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