Day 578: SpikeVax or StrikeVax?

Here at PlagueBlog we intended to report on the extra-metalness of SpikeVax, now shown to make twice as many antibodies as the less-metal-named Comirnaty. But the news overtook us that two vaccine leaders are leaving the FDA, apparently in protest of the Biden administration's recent foray into deciding who should get boosters and when.

A former senior FDA leader told Endpoints that they’re departing because they’re frustrated that CDC and their ACIP committee are involved in decisions that they think should be up to the FDA. The former FDAer also said he’s heard they’re upset with CBER director Peter Marks for not insisting that those decisions should be kept inside FDA. What finally did it for them was the White House getting ahead of FDA on booster shots.

FDA’s former acting chief scientist Luciana Borio added on Twitter, “FDA is losing two giants who helped bring us many safe and effective vaccines over decades of public service.”

“These two are the leaders for Biologic (vaccine) review in the US. They have a great team, but these two are the true leaders of CBER. A huge global loss if they both leave,” Former BARDA director Rick Bright wrote, weighing in on the news. “Dr. Gruber is much more than the Director. She is a global leader. Visionary mastermind behind global clinical regulatory science for flu, Ebola, Mers, Zika, Sars-cov-2, many others.”

Here in Massachusetts, cases were up almost a fourth of a percentage point today, after a dip down to a fifth daily since Thursday's high.

Day 574: Kids Still Unaffected

Despite some hand-wringing at The Atlantic, children remain statistically unaffected by COVID. Emily Oster (perhaps best known for Cribsheet: A Data-Driven Guide to Better, More Relaxed Parenting, from Birth to Preschool) has been blogging about the data to the end of reassuring freaked-out parents. As of her latest post, COVID is still barely even the flu for children:

The million dollar question: Does Delta change this? It is not completely clear. People, including the CDC Director, have cited more hospitalizations among children in heavily affected areas as evidence that Delta might be worse for kids. However, with more cases, we expect more hospitalizations. We saw this rise in pediatric hospitalizations last winter, as well, without Delta. Seeing more cases is different from saying that delta increases the hospitalization rate. There is also an increase in RSV in young children in many of the same areas COVID is spreading widely, complicating the analysis.

I would argue, though, that what we do know suggests the risks are in the same range. That the narrative that this is a new virus which is tremendously more dangerous for children is just simply not supported by the data.

Massachusetts cases were up a quarter of a percentage point yesterday, our biggest one-day jump since mid-April.

Day 570: Comirnaty

As rumored, the FDA approved Pfizer's COVID vaccine, Comirnaty, today, but only the first two jabs for those over 15. The rest of the protocol remains experimental, as does Moderna's far more pronounceable SpikeVax. The side effects of myocarditis and pericarditis, mainly in boys, got special attention.

P.S. Massachusetts cases were up about a seventh of a percentage point on Monday. (This number is derived from the merged weekend data and not indicative of much.)

Day 566: Vexxed by the Unvaxxed

One-time skeptic and ongoing editor-in-chief of Skeptic magazine Michael Shermer recently wrote an article for Quillette about how vexxed he is by vaccine skeptics. After confessing to scolding an employee for her skepticism, he goes into the usual irrelevant risk analogies (yes, the vaccine is less risky than driving, but so is COVID itself), superficial political analysis (no, being pro-life doesn't automatically make you pro-vaxx anymore than it makes you anti-death-penalty), and conflation of vaccination against diseases of childhood with mass adult vaccination against a disease that barely affects children. Vaccine reluctance was summed up much better by a commenter (aptly pseudonamed Sane World):

There may be a fourth reason, not mentioned by the author, why people hesitate to get vaccinated. After the numerous drastic coercive measures of the last twenty months, many of which were previously unknown in liberal western democracies, some people may simply be tired of constantly being persuaded, exhorted, pressured, lied to, incited, coerced, bullied, humiliated, denounced, threatened, criminalized, and punished into submission to an increasingly totalitarian mode of government.

On the irony front, the governor of Texas has come down with COVID. Despite having just tested positive, being vaccinated, and showing no symptoms, he's being treated with Regeneron.

Massachusetts cases were up to a new local high of a fifth of a percentage point yesterday. Our governor remains uninfected.

P.S. Cases were up a fifth of a percentage point again on Thursday, and rumor has it that the Somerville city council Board of Health voted to put us back under the mask (indoors).

Day 563 Retrospective: Booster Shots

The New York Times reports that the Biden administration [sic] is recommending a booster shot of all three US vaccines after 8 months. At least they're waiting for the FDA to approve such a move, but it's unclear why a more relevant agency (the CDC, or at least the Surgeon General) is not doing the recommending. PlagueBlog would prefer medical advice on the matter as opposed to political advice, nor are we the only ones with doubts:

The regulatory path for additional shots is not entirely clear. Pfizer-BioNTech filed data to the F.D.A. on Monday that it said showed the safety and effectiveness of a booster shot. But the data was preliminary, from Phase 1 of a clinical trial. Moderna is on a similar track, exploring the safety and efficacy of both a half-dose and a full dose as a third shot.

The World Health Organization has called for a moratorium on booster shots until the end of September, saying available doses should be used to help countries that are far behind in vaccinations. But Israel is already offering third shots to those at least 50 years old.

Massachusetts cases were up a seventh of a percentage point on Monday. Our governor remains anti-mask, but is permitting cities and towns to gin up their own mask requirements.