You will have heard the new buzz about mRNA Covid vaccines: plug-and-play — and speed’s the thing.

Plug new genetic material into a fixed delivery vehicle, and the vaccine is ready to play against the latest covid variant. It’s the biotech equivalent of mixing Pez candies in an old dispenser; keep the peppermint but now add the sour green apple. 

The technology is truly astounding, yet something else is needed to beat even the Warp Speed of the initial mRNA-vaccine launches: Skim over that tiresome testing. 

Parents especially should catch up with what’s going on. At the pace things are moving, plug-and-play could be a part of their kids’ lives for years to come, with little regard for parents’ wishes.

READ MORE — Richard Koenig: Those new Covid vaccines — what’s Big Bird thinking now?

Plug-and-play is debuting as the currently predominant omicron BA.4/BA.5 variants deflate the more extravagant claims made for covid vaccines early on. (“If you get vaccinated, the virus stops at you.” Remember that one?) The wizards in the labs of Pfizer and Moderna have rapidly responded with plug-and-play, or “bivalent,” vaccines that encode antibody-engendering spike proteins like those found in BA.4/BA.5 variants as well as in an ancestral strain of the virus. 

Now, follow along: To secure the initial authorizations of their first-generation vaccines, Pfizer and Moderna each had enrolled tens of thousands of people in clinical trials seeking to demonstrate clinical benefit. But subsequent clearances for ever younger populations then rested on not much more than a showing of higher levels of antibodies. It might have been thought that regulatory rigor at the Food and Drug Administration could slump no further. 

Why slow clearances by waiting for test results in any human subjects at all? Speed!

Let’s focus on the data from Pfizer. It wouldn’t be entirely right to say, as some critics have, that the initial emergency-use authorization for the company’s bivalent turned on a showing of higher antibodies in only eight mice. Fairness demands counting them all — a grand total of sixteen mice, the eight jabbed with the bivalent and, for comparison, another eight jabbed with the original, primary-series vaccine. 

(Human subjects, it’s true, had been used to test antibody-production following tests of an experimental bivalent directed at an earlier variant, BA.1, but the clinical relevance of those results was questioned. Even the FDA doesn’t profess that an antibody equivalent of protection has been established. BA.1, in any case, is history.) 

That first clearance of the BA.4/BA.5 bivalent and a follow-on clearance since then now cover the population for everyone from the elderly down through age five, and Pfizer wants to bring that lower limit to six months. Remember, these are emergency authorizations. 

So is it still okay to ask: What’s the emergency? By now the great majority of young people have been infected if not also vaxxed and likely retain some measure of natural immunity. Even during the first year of the pandemic, when fewer kids had any immunity and a more lethal form of the virus than omicron was circulating, the covid-mortality risk for the healthy population eighteen and under appears to have been less than one in a million, well lower than the suicide rate.

Nor are safety concerns going away, especially the cardiac issue for teenage boys. “Troublingly,” Anish Koka, a Philadelphia cardiologist, has written, “the more you look for myocarditis after vaccines, the more you find it.” He was referring to a study in Thailand indicating asymptomatic injury to heart cells. Since then a report from Japan has pointed toward possibly higher risk for adults as well as teens.

The future of plug-and-play? It may hold potential to tweak vaccines for those who need them. For now, though, it has been co-opted by the still manic, if faltering, campaign to vax and vax again.

But for parents here is the more pressing news. Last week the Centers for Disease Control and Prevention made clear that it intends to put covid vaccines on its Childhood Vaccination Schedule — effectively extending an invitation to states and school boards to impose school-entry vaccination mandates. The decision whether to vax kids would slip from the control of parents who don’t go shopping for schools that respect their autonomy. 

What will “fully vaccinated” come to mean? How often would, say, kids aged five to eleven need to be boosted? To judge from a big study from New York, protection for those kids since the arrival of omicron peters out in little more than a month. Is anybody ready to contend the BA.4/BA.5 bivalent would obviate the need for monthly boosters? Those sixteen mice are beginning to look seriously consequential. 

Now imagine the politics involving parents who resist. As things stand today, the parents of only 39 percent of kids ages five to eleven have seen fit to get them vaxxed with as much as a single jab. 

Post-launch, Pfizer has reported that the BA.4/BA.5 bivalent raises antibody levels by day seven after administration to human subjects — Homo sapiens, no less! But by how much did antibodies rise? As of now, that’s undisclosed. For how long? Unsaid. Clinical relevance? Anybody’s guess. 

Why even ask? The Biden administration is committed to buying 105 million doses. Pfizer has been shipping for weeks. 

The future of plug-and-play? It may hold potential to tweak vaccines for those who need them. For now, though, it has been co-opted by the still manic, if faltering, campaign to vax and vax again without much thought as to who really benefits and who is put at too much risk. Nearly anybody who can stick out an arm will do.

Damn mice.

Richard Koenig is the author of the Kindle Single No Place To Go, an account of efforts to provide toilets during a cholera epidemic in Ghana.

2 thoughts on “Richard Koenig: Beating Warp Speed — plug-and-play Covid vaccines zip past regulators”

  1. Disgraceful! The most recent FDA approval was based on the results of a truncated study of lab mice. The real data will be generated by the population’s experience. Where is the rush for the J&J vaccine produced the traditional method? Not enough cash floating around Washington for that?

  2. WHO CARES.

    Never got the clot shot, never will.

    Sheeple will line up, sleeves rolled, and excited to do, “their part to save lives.”

    …..Let em.’

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