Testing Criteria

The FDA wants to add new Wuhan Virus vaccine testing criteria to emergency use authorization applications—weeks after several pharma companies’ Phase III trials (the last phase requiring substantial data collection before EUA can be requested, the phase whose satisfactory completion is required before general use authorization can be requested) already have begun.

As part of the new guidelines, manufacturers seeking authorization would have to follow trial participants for at least two months after a second vaccine shot.
The new standards would also reportedly ask developers to identify a specific number of severe COVID-19 cases in patients who received a placebo in trials.

These data collection steps would be useful; however, it’s ridiculous to try to make them Critical Items for EUA. The FDA has known the structure of existing tests all along—it approved those tests’ advance into Phase III trials. If the FDA really thought these new “standards” and data collection criteria were important, it would have levied them on the original pharma companies at the time it approved their Phase III trials.

Waiting until this late date to try to add them is suspicious.

“Sharing a household with children and risk of COVID-19”

That’s the title of a medRxiv preprint (unpeer-reviewed) paper that looked at the risk to adults—in particular, Scottish NHS healthcare workers, NHS-contracted general practice service providers, and members of their households—of contracting the Wuhan Virus (my term) when they lived in households with children with ages ranging from new-born to 11 years old. Total participants numbered more than 300,000 adults and children.

The results are correlative rather than causative, but the strength of the correlation is strongly suggestive.

The risk of hospitalization with COVID-19 was lower in those with one child and lower still in those with two or more children….

And the money quote:

Conclusion[:] Increased household exposure to young children was associated with an attenuated risk of testing positive for SARS-CoV-2 and appeared to also be associated with an attenuated risk of COVID-19 disease severe enough to require hospitalisation.

That suggests, also (my conclusion; the authors didn’t address the matter), that putting children back in school (at least grade school) poses no serious risk of spreading serious illness from the virus.

The preprint abstract can be read here.

Unsafe at any Quickness

Food and Drug Administration Commissioner Stephen Hahn is being asked by some 20 Senators—Republican; no Progressive-Democrat wanted any part of this—to take the abortifacient Mifeprex or mifepristone off the market.

The senators say that based on FDA reporting the drug has resulted in the death of more than 3.7 million unborn children and two dozen pregnant women.
They also said the drug has caused at least 4,195 negative reactions in pregnant women including hemorrhaging, excruciating abdominal pain and severe, life-threatening infections.

The drug is unsafe for a significant fraction of the mothers who take the drug. It’s 100% unsafe for the 3.7 million unborn babies that have been killed with it.

Panic Over Kern County, California

Kern County, California, is in serious Wuhan Virus trouble. Or so think some journalists and the State of California.

Residents of the agriculture-rich Central Valley are falling victim to Covid-19 at the highest rates in California….

And

Kern County, which lies in the Central Valley’s southernmost part, had the highest per capita rate of new Covid-19 infections in California between July 31 and Aug. 13, averaging 56.2 new cases per 100,000 people….

Now for some context, using Alejandro Lazo’s—he’s the author of the piece at the link—own numbers.

In total, 25,888 people there have been infected and 204 have died, according to the county health department. Statewide, California recorded 601,075 cases as of Friday and 10,996 deaths.

The mortality rate in Kern, given an infection, is 0.8%

Statewide, the mortality rate is 1.8%.

Both rates are quite low (so why are Newsom and the NLMSM in such a blind panic?), but Kern looks quite a bit safer than the State at large, contrary to the tone of the article.

Go figure.

The Doctors Video

Here, through the efforts of One America News Network, is the video of facts and considered medical opinion that the amateur censors of Facebook, Alphabet (through its YouTube and Google subsidiaries) and Twitter don’t want you to see because it runs counter to their pre-written narratives.

It’s 45 minutes long and well worth every moment, whether or not you agree with their opinions, because it’s useful to get all sides of the matter. Especially if Mark Zuckerberg, Sundar Pichai, and Jack Dorsey don’t want you to see the whole story.