Tag: FDA

Why Is the Gates Foundation Funding the UK’s Medicines Regulator?

Tina Marie (Ms. Cat)

Why Is the Gates Foundation Funding the UK’s Medicines Regulator?

“Safety in a world of user fees” is of paramount concern, concluded Lexchin. That was was back in 2017. Four years on, we are in the biggest health crisis of our lifetimes and the tasks performed by medicines regulators are more important than ever. New experimental vaccines and therapeutic treatments are rolling off the line in record time. But they’re also being authorised in record time — in some cases despite scant evidence of benefits (e.g., Remdesivir). And they’re earning record profits for their manufacturers. At the same time, promising repurposed off-patent medicines that do not offer lucrative financial returns are largely being ignored or are even being demonised by our medicines regulators.

Does the FDA think these data justify full approval of Covid Vaxx?

Tina Marie (Ms. Cat)

Does the FDA think these data justify full approval of Covid Vaxx?

Prior to the preprint, my view, along with a group of around 30 clinicians, scientists, and patient advocates, was that there were simply too many open questions about all covid-19 vaccines to support approving any this year. The preprint has, unfortunately, addressed very few of those open questions, and has raised some new ones.

Unfortunately, it was just given full approval by the FDA.

The FDA just fully approved Pfizer’s COVID-19 vaccine in a move that could lead to more vaccinations

Tina Marie (Ms. Cat)1 Comment

The FDA just fully approved Pfizer’s COVID-19 vaccine in a move that could lead to more vaccinations

The shift to full approval could persuade some vaccine-hesitant people in the US to get the shot. A common talking point among skeptics of the COVID-19 shots has been that they’re not fully approved and are technically experimental medicines under emergency OKs. Pfizer’s vaccine winning standard approval directly addresses that concern.

No, it won’t, because they were fast-tracked! All they care about are profits!

He said the fast-track decision appeared more political than scientific since it skipped the usual formal advisory committee meeting and did not fully account for the reports of deaths and disabilities suffered by people after being vaccinated.

Senator Ron Johnson

‘No need to rush’: Senator warns of FDA’s shortcuts to full approval of COVID-19 vaccine

Tina Marie (Ms. Cat)1 Comment

‘No need to rush’: Senator warns of FDA’s shortcuts to full approval of COVID-19 vaccine (Archived)

“I see no need to rush the FDA approval process for any of the three COVID-19 vaccines. Expediting the process appears to only serve the political purpose of imposing and enforcing vaccine mandates,” Mr. Johnson wrote in the letter, a copy of which was obtained by The Washington Times.

…

U.S. Surgeon General Vivek Murthy told “Fox News Sunday” that moving the Pfizer vaccine from “emergency” to “full approval” would make mandates more appealing.

…

Former FDA Commissioner Scott Gottlieb, who is on the Pfizer board of directors, also said the full approval will prompt more vaccine mandates.

Related:

Gottlieb’s Pfizer Announces $1.95 Billion Deal with Feds for COVID-19 Vaccine

Just hours before the Pfizer vaccine news became public, Gottlieb appeared on CNBC’s Squawk Box to explain that any vaccine will need to be administered on an annual basis.

Source.

Some more notes that I made, about Gottlieb and the coronavirus, in March 2020.

Federal Vaccine Program Hasn’t Helped Those Whose Lives Were Altered by COVID-19 Shot

Tina Marie (Ms. Cat)

Federal Vaccine Program Hasn’t Helped Those Whose Lives Were Altered by COVID-19 Shot

A national vaccine court has paid out billions to families who could prove their kids were injured by vaccines. But there’s only a skeletal program for the rare victims of covid vaccination, raising concerns as the pressure for mandated shots grows.

Federal Vaccine Program Hasn’t Helped Those Whose Lives Were Altered by COVID-19 Shot

Related:

Why won’t the US medical establishment “believe women”? Covid-19 vaccines do not warn about menstrual disruption

Pfizer CEO to Public: Just ‘Trust’ Us on the Covid Booster

Tina Marie (Ms. Cat)

Pfizer CEO to Public: Just Trust Us on the Covid Booster

Pfizer announced its global phase 3 trial on a third dose in mid-July. That trial’s completion date is in 2022. Phase 3 results generally are required before regulatory approval.

“We are confident in this vaccine and the third dose, but you have to remember the vaccine efficacy study is still going on, so we need all the evidence to back up that,” Jerica Pitts, Pfizer’s director of global media relations, said Monday. The financial stakes are enormous: Pfizer announced in July that it expects $33.5 billion in covid-19 vaccine revenue this year.

…

The White House has added to the mixed messaging: Spokesperson Jen Psaki confirmed that the U.S. will buy an additional 200 million doses of the Pfizer-BioNTech vaccine for inoculating children under 12 and for possible boosters.

Why won’t the US medical establishment “believe women”? Covid-19 vaccines do not warn about menstrual disruption

Tina Marie (Ms. Cat)1 Comment

Why won’t the US medical establishment “believe women”? Covid-19 vaccines do not warn about menstrual disruption

As the National Institute for Health (NIH) stated in May 2021: “While anecdotal first person reports of menstrual changes in response to SARS-CoV-2 vaccines exist, these associations, and their long-term consequences, have not been investigated in a rigorous or systematic manner. Clinical trials for the Pfizer, Moderna, and Johnson & Johnson SARS-CoV-2 vaccine seem to have collected last menstrual period (LMP) data (to exclude current pregnancies), but have not collected menstrual cycle outcomes post-vaccine.”