Coronavirus: Thread

grarpamp grarpamp at gmail.com
Sun Feb 6 09:35:57 PST 2022


FDA Suddenly Scrubs Moderna Document From Website After Reporters Ask Questions

https://www.theepochtimes.com/fda-document-on-moderna-vaccine-approval-removed-from-agencys-website_4254453.html
https://www.theepochtimes.com/post-vaccination-heart-inflammation-highest-among-young-men-likely-underreported-cdc-study_4240826.html
https://www.theepochtimes.com/cdcs-advisory-panel-to-meet-on-modernas-covid-19-vaccine-following-fda-approval_4247875.html
https://www.cdc.gov/vaccines/acip/meetings/downloads/agenda-archive/agenda-2022-02-04-508.pdf
https://www.theepochtimes.com/young-men-more-likely-to-get-heart-inflammation-after-pfizers-booster-than-covid-19-study_4187228.html

A Food and Drug Administration (FDA) document explaining why the
agency approved Moderna’s COVID-19 vaccine was removed from the
agency’s website overnight.
Signage is seen outside of the Food and Drug Administration (FDA)
headquarters in White Oak, Maryland, on Aug. 29, 2020. (Andrew
Kelly/Reuters)

The Summary Basis for Regulatory Action offered more details about how
regulators reached the approval decision, and included references to
an unpublished analysis that found the rates of post-vaccination heart
inflammation were higher than any U.S. agency had found before.

After The Epoch Times reviewed the document and sent questions about
it to FDA spokespersons, it disappeared from the agency’s website.

“We are aware of the issue and hope to have the document reposted as
soon as possible,” a spokesperson told The Epoch Times in an email on
Feb. 3.

Reached by phone and asked for more details about the issue, the
spokesperson said: “I reached out to the website people. I don’t
really have any more information to tell you.”

The Epoch Times has submitted Freedom of Information Act requests for
the document and several unpublished analyses referenced in it,
including the FDA meta-analysis.

Barbara Loe Fisher, president of the National Vaccine Information
Center, a nonprofit that advocates for informed consent, told The
Epoch Times in an email that “the public has the right to review the
evidence FDA is using to license new mRNA vaccines as safe and
effective.”

“Lack of transparency only fosters distrust in government agencies
charged with protecting the public health. FDA should immediately
release all information related to the incidence of myocarditis and
other serious adverse events following mRNA COVID-19 vaccinations,
whether that information has been provided to the agency by vaccine
manufacturers or discovered through in-house analyses of additional
data collected by federal officials,” she wrote.

The FDA meta-analysis examined data of four health care claims
databases and estimated that, among males aged 18 to 25, the rate of
myocarditis following Moderna’s primary series was 148 per million
males vaccinated.

That figure is higher than other government estimates, including a
Centers for Disease Control and Prevention (CDC) analysis of reports
submitted to the Vaccine Adverse Event Reporting System. The analysis
found about 10.7 cases per million males aged 18 to 24 who got
Moderna’s first shot and 56 cases per million among those who received
Moderna’s second shot.

Myocarditis is one type of heart inflammation that people who receive
vaccines built on messenger RNA (mRNA) have experienced at
higher-than-expected rates. It also occurs among people who contract
the CCP (Chinese Communist Party) virus, which causes COVID-19.

Moderna’s shot, a type of mRNA vaccine, is administered in a two-dose
primary series. The doses are administered about a month apart.

The FDA approved Moderna’s vaccine on Jan. 31 without convening its
expert vaccine advisory panel, a growing trend for the agency.

The CDC’s vaccine advisory committee is scheduled to meet on Feb. 4 to
review data on the jab.

An agenda (pdf) for the meeting says a Moderna scientist will present
safety and efficacy data on the company’s shot, followed by CDC
researchers discussing updates on post-vaccination heart inflammation
and the benefit-risk framework in light of the most recent analyzed
information.

Researchers in the UK found in December 2021 that men under 40 were
much more likely, and females under 40 were more likely, to suffer
from heart inflammation after Moderna’s second shot than from COVID-19
itself.


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