Repetitively arrayed vaccines could save the world: Now let us experiment

The current regulatory regime is written in blood - lessons learned from decades of harm caused by insufficient caution.

If I understand the author, they're calling for a decrease in the level of regulatory caution so they can be allowed to experiment on the population. I'm not sure I'm comfortable with that. Can this research not be done within the current regulatory regime?

I find the article meandering, but still learned about a few interesting things like what “repetitively arrayed vaccines” are:

> The basic idea is that rigidly repetitive molecular structures — such as the repetitive surfaces of some types of virus particles — can reliably provide an exceptionally strong trigger for antibody-producing B cells. The exceptional performance of the HPV vaccine, which is composed of empty virus-like particles self-assembled from 360 copies of the HPV coat protein, is a spectacular fulfillment of Bachmann’s prophecy.

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> The Walter Reed vaccine arrays SARS-CoV-2 Spike proteins on a repetitive platform called ferritin. I was ejected from the trial when FDA officials dictated that people who had received the newly released Moderna or Pfizer vaccines couldn’t be allowed to volunteer. I found the regulatory edict incomprehensible. The key question a Phase I trial of a second-generation Covid vaccine needs to answer is whether the vaccine is safe to use as a booster dose.

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> This past January, I again attempted to vote with my arm by asking to be enrolled in a Phase III trial of ABNCov-2, which uses a repetitive SpyCatcher platform Bachmann helped develop. Two weeks prior to my attempt to enroll in the trial, regulators inexplicably dictated that only people over age 65 could be eligible.

> Another repetitively arrayed vaccine, SKYCovione, was designed by Neil King and David Baker at University of Washington. SKYCovione was authorized for use in South Korea in June 2022, but Korean regulators devastatingly hobbled it by only allowing it to be used as a first dose. There’s basically nobody left in that category in Korea, so only a few thousand people received the improved vaccine.

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> Update: In April 2023, a trial of a vaccine where the “stalk” domain of influenza HA is repetitively arrayed on ferritin provided yet another convincing confirmation of the breadth and durability of antibody responses to Bachmann immunogens (Widge et al).