News for hackers. Stuff that matters.
Re:FDA Authorizes Moderna, Pfizer-BioNTech Bivalent Covid-19... by incrudible on Wednesday August 31, 2022 @07:33PM (#32669718)
Sure, why not inject a pharmaceutical with indeterminate benefit and a minor risk of heart injury of unknown etiology, on an annual basis. Scrutinizing the methodology and motivations of the people responsible is totally uncalled for.
Re:FDA Authorizes Moderna, Pfizer-BioNTech Bivalent Covid-19... by throwaway13909 on Wednesday August 31, 2022 @08:42PM (#32670293)
The overwhelming benefit weighed against a negligible risk is exactly the reason for the FDA authorization.
Re:FDA Authorizes Moderna, Pfizer-BioNTech Bivalent Covid-19... by incrudible on Thursday September 01, 2022 @05:33AM (#32674058)
Really? Can you show me the "overwhelming benefit" of a first or second booster on this chart?

https://ourworldindata.org/grapher/united-states-rates-of-co...

Looks like more like a rodeo to me. Younger age groups aren't even tracked.

Re:FDA Authorizes Moderna, Pfizer-BioNTech Bivalent Covid-19... by nikolay on Wednesday August 31, 2022 @10:32PM (#32671181)
It is not negligible - there is enough data already. The benefits depends on age (above 40) and comorbidities. Given we have a decently working antiviral and monoclonal antibodies, the vaccine has little appeal today. Vaccinating healthy kids will be damned in the very immediate future once this administration is gone!
Re:FDA Authorizes Moderna, Pfizer-BioNTech Bivalent Covid-19... by dudeDDRrulez on Thursday September 01, 2022 @02:22PM (#32680760)
I think you misspelled “unknown” and it came out as “overwhelming”.

All jokes aside, the only benefit of this booster was seen in wildly inconsistent antibody levels of 8 mice. It has never been tested on humans.

Re:FDA Authorizes Moderna, Pfizer-BioNTech Bivalent Covid-19... by origin_path on Thursday September 01, 2022 @04:53AM (#32673776)
The FDA have seen several highly placed regulators quit in disgust because the approval process for vaccines became so corrupt during COVID.

https://www.ft.com/content/af8da7d4-43ea-41d6-90ee-f959b3675...

"Two top scientists who recently announced their retirements from the US drug watchdog have criticised the policy of giving most people Covid-19 booster vaccinations, just days before the Biden administration plans to start doing so.

Philip Krause and Marion Gruber, who resigned from the Food and Drug Administration two weeks ago, are among the authors of a scathing critique of widespread booster shots, which was published in The Lancet on Monday.

The article, which argues that the scientific evidence does not yet justify giving most people third shots of messenger RNA vaccines, offers an insight into the internal tensions in the Biden administration that were ignited by the White House’s sudden decision to back the booster plan."

FDA approval no longer means anything. Did they even do a trial at all this time? For Omicron boosters they accepted trials with tiny sample sizes, in which "not getting sick" wasn't actually the outcome they tested for (because the vaccines would have failed). Instead they only looked for antibody generation. Judging from the press release the answer is no: the authorization cites the "totality of available evidence" including evidence from other vaccines that aren't the one they authorized. They also talk about the "extensive safety data" which is all far worse than would have been tolerated for any vaccine in the pre-COVID era.

But sure, if you want to go on trusting the Experts™ then go right ahead. Please for the love of god don't try to inflict your naivety on everyone else though!

Re:FDA Authorizes Moderna, Pfizer-BioNTech Bivalent Covid-19... by jrockway on Wednesday August 31, 2022 @07:48PM (#32669858)
What do you think their motivations were?
Re:FDA Authorizes Moderna, Pfizer-BioNTech Bivalent Covid-19... by incrudible on Wednesday August 31, 2022 @07:51PM (#32669888)
Money, as well as the prospects of further money down the line.
Re:FDA Authorizes Moderna, Pfizer-BioNTech Bivalent Covid-19... by nikolay on Wednesday August 31, 2022 @10:33PM (#32671191)
I'm sure Pfizer will be happy treating ED later on - both those who got COVID-19 and those who didn't but get vaccinated and get injured.
Re:FDA Authorizes Moderna, Pfizer-BioNTech Bivalent Covid-19... by jrockway on Thursday September 01, 2022 @11:02AM (#32677320)
Your claim is that the COVID-19 vaccine causes ED? What's the mechanism?
Re:FDA Authorizes Moderna, Pfizer-BioNTech Bivalent Covid-19... by nikolay on Thursday September 01, 2022 @04:54PM (#32683041)
Yes, both the disease and the vaccine cause vasculitis, which is linked to ED. Of course, not all vaccinated get vasculitis, because not all the vaccine ends up in the blood stream of the vacinated, but for a good portion of them it does and it's a well-documented fact already. That's why in Germany and Austria they recommend giving the vaccine shot using the classical appraoch with aspiration. Many European dotors have been sounding the alarm for well over a year now!