Covid vaccines: FDA will approve updated ones without requiring clinical trials!
The news had already leaked in early July, but now the confirmation arrives. The Food and Drug Administration (FDA), the US drug regulator, will not require the conduct of clinical trials for the approval of updated anti-Covid vaccines to the latest variant. The go-ahead is therefore expected this week, despite the human experimentation not over. The US agency intends to use data available from other sources, such as research carried out on laboratory mice.
FDA commissioner Robert Califf tweeted:
The evidence tells us that current Covid mRNA vaccines, given to millions of individuals, are safe.
The authorization of serums without prior human testing is similar to the method adopted by the FDA to approve flu vaccines annually. However, some members of the scientific community have expressed doubts about the acceleration of the US regulator.
Paul Offit, FDA adviser and director of the vaccine center at Philadelphia Children's Hospital:
I feel uncomfortable thinking that we will administer tens of millions of doses to people based on data from experiments in mice.
According to Offit, the comparison with flu vaccines would not stand up. There are too many differences, especially as regards mutations and levels of protection.
In any case, the FDA does not seem willing to organize a further meeting with the scientific advisors, and the final authorization of the updated sera now seems only a formality. Califf said decision makers had already voted last June in favor of adding the string "omicron" to Covid vaccines until now authorized on a conditional basis.
For some reason, the US drug regulator has unbridled trust in drug companies. Over the years, the FDA has profoundly changed its structure, particularly as regards funding, which once came entirely from taxes paid by taxpayers. The structure has now changed and a substantial part of the organization's funds now flow from the companies it should regulate. We are talking about 46% of the agency's total budget, 2.8 billion dollars that come from the fees paid by companies to present their products.
Meanwhile, Moderna has begun clinical trials in humans with the updated vaccine, while Pfizer is expected to start in early September. But the results will not be available before the looming autumn vaccination campaigns, already anticipated by the ministers of health, for example in Germany.
William Schaffner, a professor of medicine at Vanderbilt University Medical Center, told the Wall Street Journal:
If we wait for the results of the clinical trials, we will have vaccines in the spring."This is just an update of the vaccine we have used so far.
In short, why wait for annoying and long clinical trials, when vaccines can now be developed within a few weeks? The watchword is: "Trust us".
References:
https://newsofcanada.net/latest-covid-boosters-roll-out-before-human-testing-is-complete/
The FDA initially banned Aspertamine in the 80's, then after a couple years I think they gave it the coveted approval, and despite the initial concerns, it seems they diminished and completely evaporated simply by the passage of time..
FDA gets good founds from compagnies like Pfizer, guess how neutral can they be
Fuck @spaminator - u got an upvote from me :D
Have a wonderful wednesday <3