But until the COVID-19 panicdemic — and no, that’s not a typographical error; panic was really the disease — we had serious clinical trials. In the late 18th century, Edward Jenner, having heard how dairy workers seemed immune to smallpox, devised a clinical trial.
In May 1796, Edward Jenner found a young dairymaid, Sarah Nelms, who had fresh cowpox lesions on her hands and arms. On May 14, 1796, using matter from Nelms’ lesions, he inoculated an 8-year-old boy, James Phipps. Subsequently, the boy developed mild fever and discomfort in the axillae. Nine days after the procedure he felt cold and had lost his appetite, but on the next day he was much better. In July 1796, Jenner inoculated the boy again, this time with matter from a fresh smallpox lesion. No disease developed, and Jenner concluded that protection was complete.
That was a clinical trial with one subject, but, thanks to the politicization of COVID-19, it might be a larger clinical trial than one today:
FDA expected to authorize new Covid boosters without data from tests in people
The lack of human data means officials likely won’t know how much better the new shots are — if at all — until the fall booster campaign is well underway.
By Berkeley Lovelace Jr. | Tuesday, August 30, 2022 | 4:09 PM EDT
The updated Covid vaccine boosters, a reformulated version targeting the BA.5 omicron subvariant, could be available around Labor Day. They’ll be the first Covid shots distributed without results from human trials. Does that matter?
Because the Biden administration has pushed for a fall booster campaign to begin in September, the mRNA vaccine-makers Pfizer-BioNTech and Moderna have only had time to test the reformulated shots in mice, not people. That means the Food and Drug Administration is relying on the mice trial data — plus human trial results from a similar vaccine that targets the original omicron strain, called BA.1 — to evaluate the new shots, according to a recent tweet from the FDA commissioner, Dr. Robert Califf.
That could be a potentially risky bet, experts say, if the shots don’t work as well as hoped.
Note that my source was NBC News, not some evil reich-wing blog!
Of course, the Biden Administration wants to get this in people’s bodies almost immediately:
Biden Team Aims for Omicron-Targeted Shots in Arms by Labor Day
- Reformulated vaccines due to ship next week if cleared
- US will have between 10 and 15 million doses initially
By Josh Wingrove | August 26, 2022 | 11:33 AM EDT
The Biden administration plans to begin offering next-generation Covid-19 booster shots as soon as the Labor Day weekend, according to people familiar with the matter, aiming to stave off a fall surge in cases of the disease.
Food and Drug Administration regulators are expected to clear the use of Covid-19 vaccines reformulated for omicron variants next week, the people said. They asked not to be identified ahead of an official announcement.
The so-called bivalent vaccines are designed to better protect against subvariants of the virus that are now dominant in the US, BA.4 and BA.5. The shots are poised to begin shipping next week and can be administered after Centers for Disease Control and Prevention clearance.
A CDC advisory panel hearing is set for Sept. 1 to 2 to discuss the issue, the people said. CDC Director Rochelle Walensky has the final say and could sign off as soon as next week.
That timeline sets up the potential for a smattering of shots as soon as the Labor Day weekend beginning Sept. 3, with broader availability in the following week or two, the people said. The US will have between 10 and 15 million doses initially available, one of the people said, out of a total order of 171 million doses.
So, President Biden and his minions want people to start taking a vaccine which has never been tested on humans starting this coming weekend. And while there’s no word, at least yet, of an attempted federal mandate, we have previously noted how Mayor Jim Kenney (D-Philadelphia) — who wouldn’t wear the mask his city’s public schools have mandated for students while visiting a school — is finally getting his wish and firing the 68 remaining unionized city employees who have refused to take the existing COVID-19 vaccines. Will the Mayor, along with other big city mayors who have done the same things he has, try to force people to take the newest vaccine, the one not tested on humans?
Also see: The New York Times: California Approves Bill to Punish Doctors Who Spread False Information About COVID Vaccines
But even that is becoming questionable. As we have previously noted, there is strong evidence that a lot more people have had the virus at some point, in line with acting Food and Drug Administration head Commissioner Janet Woodcock having told the Senate Health, Education, Labor and Pensions committee, last January, that she expected that, eventually, almost everyone would contract the virus. Celebrity doctor Anthony Fauci said that COVID-19 would infect “just about everybody.” This was during the BA.1 variant’s primacy, and two months later, the American Medical Association warned that the then-new BA.2 subvariant could be “30% to 60% more transmissible” than BA.1. While playing Blondie’s One Way of Another, we noted that BA.4 and BA.5 are gonna get ya, get ya, get ya, get ya! Yale Medicine also said that BA.4 and BA.5 appear to be more transmissible.
With the advent of at-home testing for COVID-19, we do not know how many people have tested positive for the virus and never reported it. After all, if reporting that you have contracted the virus would subject you to restrictions, there would doubtlessly be those who did not feel sick enough to stay home and subject themselves to self-quarantine. We also do not know how many people felt slightly ill, but didn’t bother to get tested, either at a clinic or at home, and we don’t know how many have contracted the virus at some point but were completely asymptomatic.
What we do know is that BA.5, while serious for a relatively small percentage of people, isn’t much more than a typical cold or perhaps the flu for most people.
Why, then, would we want to introduce an untested vaccine into millions of people, for a disease that is simply not that serious for most of the public?