<small>UPDATE 1:</small> I encourage readers to also see Bone Saw’s COVID Breakthrough Deaths in Context, posted Wednesday.<small>UPDATE 2:</small> (unrelated to that diary), some paragraphs after the page-break in this diary are expanded to accommodate a few reader concerns about how experimental or not can be said mass population vaccination is with Emergency Use Authorization before the vaccine[s] are eligible for FDA Approval. (A few other commenters repeatedly insist this diary & diarist are anti-vax — nothing could be further from the truth, but I thank them for running up my comment count. ;)
Centers for Disease Control and Prevention (CDC) researchers report that more than 10,000 fully vaccinated Americans have experienced "breakthrough" COVID-19 through April 30, 2021. They note that the figures are likely an underestimate.
The 10,262 SARS-CoV-2 vaccine breakthrough infections were reported from January 1 through April 30 in 46 US states and territories. About one quarter of affected people, 27%, were asymptomatic. Two percent, or 160 people, with breakthrough infections died...
according to preliminary data, the patchiness of collection of which, say the CDC and outside experts, makes likely that the these numbers are an underestimation, the true figures much higher.
The above and below quotes and information are from a no-paywall (but you do have to register) highly readable article at Medscape (the professional arm of WebMD). It cites a study published online May 25 at the CDC’s Morbidity and Mortality Weekly Report (MMWR) (completely free to read, no registration required).
Skimming DK’s covid tag-pages, I found no reportage about breakthrough cases, so it seemed worth mentioning. The Medscape article is quite brief, remarking later:
...A majority of breakthrough cases, 63%, occurred in women. The median age of people in the study was 58 years (interquartile range, 40–74 years).
Genetic sequencing was performed on 5% of these reported cases. Nearly two thirds, 64%, of these cases involved a SARS-CoV-2 variant of concern. These variants included B.1.1.7 (UK) in 56% of breakthrough cases, B.1.427 (California) in 29%, P.1 (Brazil) in 29%, B.1.429 in 25% (California), and B.1.351 (South Africa) in 13%….
Commenter RBroach linked to Pfizer/BioNTech’s’s 18 Nov 2020 press release announcing that the final efficacy analysis in their ongoing [at that point] Phase 3 study, begun in July with 43,000+ randomized volunteers, showed their mRNA-based COVID-19 vaccine candidate meeting all of the study’s primary efficacy endpoints, allowing application for FDA Emergency Use Authorization. Pfizer/BioNTech’s clinical trials.gov page lays out the data a bit more clearly. For Moderna, this New England Journal of Medicine abstract with comparable information, and clinical trial.gov page, 30,000+ volunteers. Also in EUA use in the Us, Johnson &Johnson /Janssen. EUA status (wik)
...does not constitute approval of the drug in the full statutory meaning of the term, but instead authorizes FDA to facilitate availability of an unapproved product, or an unapproved use of an approved product, during a declared state of emergency from one of several agencies or of a "material threat" by the Secretary of Homeland Security.[1]
Some commenters are uncomfortable with the following portion of the Medscape source article (linked up top)
...The CDC needs to continue rigorous surveillance, he added, to answer: Are breakthrough infections increasing with time? Are breakthrough infections increasing with the new variants? Which vaccines are most effective against future variants?...
being interpreted, in my words, that this always meant there were going to be a greater extent of problems than with vaccines that came into wide usage following normal testing and approval protocols. Although in Phase III clinical research
it is typically expected that there be at least two successful ... trials, demonstrating a drug's safety and efficacy, in order to obtain approval from the appropriate regulatory agencies such as FDA (US), or the EMA (European Union).
I’m willing to compromise on having said :”everyone in the global population being vaccinated is ... in effect ... volunteer experimental research subjects in clinical trial phase so far as to suggest instead that EUA puts us (and most of the world) about halfway between Phase III and Phase IV (wik)?
also known as a postmarketing surveillance trial or drug monitoring trial to assure long-term safety and effectiveness of the drug, vaccine, device or diagnostic test.[1] Phase IV trials involve the safety surveillance (pharmacovigilance) and ongoing technical support of a drug after it receives regulatory approval to be sold*.[6] Phase IV studies may be required by regulatory authorities or may be undertaken by the sponsoring company for competitive (finding a new market for the drug) or other reasons (for example, the drug may not have been tested for interactions with other drugs, or on certain population groups such as pregnant women, who are unlikely to subject themselves to trials).[2][6] The safety surveillance is designed to detect any rare or long-term adverse effects over a much larger patient population and longer time period than was possible during the Phase I-III clinical trials.[6] Harmful effects discovered by Phase IV trials may result in a drug being withdrawn from the market or restricted to certain uses...
*the COVID-19 vaxxes are not being sold to Americans: our govt paid for them.
<big>Most of us doubt that EUA status should deter anyone from getting vaxxed against COVID-19;</big> there’s really no more-reliable means of protection for ourselves, families and communities. But it remains a fact to keep in mind in understanding that unanticipated outcomes may arise.
Expert commenters might like to go into greater detail, so I’ll leave it to them. My own thinking from the start, in being aware of this fact, is that I plan to go on masking and disinfecting anytime I have to be in situations where I’m within six feet of other people, even though I’m vaxxed. For their sake and beyond, as well as my own.
The conditions have not changed that brought this plague from oblivion to global death-dealing and long-haul handicapping of virtually every population on the planet. Many experts predicting this plague for over a decade also say there are more to come, viral and other kinds, some of them variants of known microbes, others utterly new, at least as far as mainstream medical technologies are concerned.
So it may be that if we consider anti-vaxxers ought not to be free to refuse the hopeful but uncertain jab, and if we consider that anti-maskers should never have been left free to spread this plague, then we’re under obligation to consider that passing what we hope to be the worst peaks does not leave free us now to just go back to how we lived before.
It may be that we all need —for our own sake— to go on making masking and hygiene methods as common here as in countries where smog and viral transmission for years have prompted those populations to make protection just part of their ordinary routines.
It may also be, of course, that everyone who can should modify lifestyle and support population control, so consumer demands don’t push further into nondomesticated places on the planet where more microbes incubate that science is far from equipped to deal with.