Tag: clinical trials

Item of Interest: NIH funds studies to assess potential effects of COVID-19 vaccination on menstruation

Tina Marie (Ms. Cat)

Item of Interest: NIH funds studies to assess potential effects of COVID-19 vaccination on menstruation

The National Institutes of Health has awarded one-year supplemental grants totaling $1.67 million to five institutions to explore potential links between COVID-19 vaccination and menstrual changes. Some women have reported experiencing irregular or missing menstrual periods, bleeding that is heavier than usual, and other menstrual changes after receiving COVID-19 vaccines. The new awards support research to determine whether such changes may be linked to COVID-19 vaccination itself and how long the changes last. Researchers also will seek to clarify the mechanisms underlying potential vaccine-related menstrual changes.

Related:

Researchers studying reported menstrual changes after COVID-19 vaccination

South Korea: Gov’t to review cases of menstrual problems after COVID vaccine shots

Informed consent disclosure to vaccine trial subjects of risk of COVID-19 vaccines worsening clinical disease

Tina Marie (Ms. Cat)

Informed consent disclosure to vaccine trial subjects of risk of COVID-19 vaccines worsening clinical disease

Results of the study: COVID-19 vaccines designed to elicit neutralising antibodies may sensitise vaccine recipients to more severe disease than if they were not vaccinated. Vaccines for SARS, MERS and RSV have never been approved, and the data generated in the development and testing of these vaccines suggest a serious mechanistic concern: that vaccines designed empirically using the traditional approach (consisting of the unmodified or minimally modified coronavirus viral spike to elicit neutralising antibodies), be they composed of protein, viral vector, DNA or RNA and irrespective of delivery method, may worsen COVID-19 disease via antibody-dependent enhancement (ADE). This risk is sufficiently obscured in clinical trial protocols and consent forms for ongoing COVID-19 vaccine trials that adequate patient comprehension of this risk is unlikely to occur, obviating truly informed consent by subjects in these trials.

Related:

Will covid-19 vaccines save lives? Current trials aren’t designed to tell us

Phase III trials evaluated mild, not severe, disease!

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.

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.

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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.”

Long-Term Studies Of COVID-19 Vaccines Hurt By Placebo Recipients Getting Immunized

Tina Marie (Ms. Cat)

February 19, 2021:

Long-Term Studies Of COVID-19 Vaccines Hurt By Placebo Recipients Getting Immunized

Dr. Steven Goodman, a clinical trials specialist at Stanford University, says losing those control groups makes it more difficult to answer some important questions about COVID-19 vaccines.

“We don’t know how long protections lasts,” he says. “We don’t know efficacy against variants — for which we definitely need a good control arm — and we also don’t know if there are any differences in any of these parameters by age or race or infirmity.”

H/T: This is nuts, Moderna & Pfizer intentionally lost the clinical trial control group testing vaccine efficacy and safety