‘Serious Doubt’ About COVID-19 Vaccine Safety After Forced Release of 15,000 Pages of Clinical Trial

[Elderberry]

Epoch Times by Tom Ozimek 7/21/2023

‘Serious Doubt’ About COVID-19 Vaccine Safety After Forced Release of 15,000 Pages of Clinical Trial Data: Legal NGO

Conservative public interest advocacy group Defending the Republic (DTR) has obtained almost 15,000 pages of Moderna’s COVID-19 vaccine clinical trial data, claiming the data show an “utter lack of thoroughness” of the trials and calls the vaccine’s safety into “serious doubt.”

As a result of successful Freedom of Information Act (FOIA) litigation against the U.S. Food and Drug Administration (FDA), the group recently announced it had obtained—and is releasing—nearly 15,000 pages of documents relating to testing and adverse events associated with “Spikevax,” Moderna’s COVID-19 vaccine.

Since 2022, the group has been involved in litigation against the FDA relating to the production of data submitted by Moderna in support of its application to federal regulators for approval of its vaccine.

As a result, the FDA agreed to produce around 24,000 pages of the Moderna records by the end of this year, with the 15,000 pages being the first instalment.

The records, some of which relate to adverse events related to the vaccine, include important information related to the safety profile of Spikevax, which was first authorized for emergency use in the United States in December 2020 and in January 2022 received full approval for adults.

“The public can be assured that Spikevax meets the FDA’s high standards for safety, effectiveness and manufacturing quality required of any vaccine approved for use in the United States,” Acting FDA Commissioner Dr. Janet Woodcock said in a statement earlier this year.

But the new data call this view into question. The advocacy group says that the tens of thousands of pages of clinical trial data released by the FDA supports the conclusion that there is “serious doubt” about both  the safety of Spikevax and the FDA’s standards for approval.

Neither Moderna nor the FDA immediately responded to a request for comment.

More: https://www.theepochtimes.com/article/serious-doubt-raised-about-covid-19-vaccine-safety-after-forced-release-of-15000-pages-of-clinical-trial-data-5414614

[Elderberry]

Moderna Spikevax Trial Data Show Serious Adverse Events and Death

UIncoverDC By Wendi Strauch Mahoney -July 24, 2023

Moderna Spikevax trial data show serious adverse events (SAEs) and death according to the first tranche of 13,685 pages of Moderna documents released Tuesday in response to a Freedom of Information Act (FOIA) filed by Defending the Republic (DTR). The documents are related to Moderna’s trials of the COVID-19 vaccine marketed as Spikevax. DTR filed a lawsuit in June 2022 against the U.S. Food and Drug Administration (“FDA”).

According to DTR’s announcement, “DTR filed its FOIA lawsuit after the FDA denied the expedited production of Moderna COVID-19 records.” DTR states the FDA felt there was “no compelling need or urgency for the public to review this information.” In 2021, the FDA originally requested 55 years to “complete a FOIA request for data and information on the approval of Pfizer-BioNTech’s COVID-19 vaccine, Comirnaty.” The FDA later (Dec. 2021) “doubled down” and asked for 75 years to release Pfizer documents.

DTR’s agreement with the FDA stipulates the “production of approximately 24,000 pages of some of the most important records submitted by Moderna in support of its Biologics License Application (BLA). The FDA agreed to produce the remaining 10,000 pages “on a monthly basis, to be completed no later than December 31, 2023”, a total of 23,751 pages.

Internist and biological warfare epidemiologist, Dr. Meryl Nass, is on the advisory board for the Children’s Health Defense. She believes the information in the Moderna documents parallels the findings in the Pfizer clinical trial documents, also made available by DTR in a searchable format. Nass told The Defender the adverse side effects “likely were vaccine side effects.”

“Both the preclinical (animal) studies of Moderna and of Pfizer revealed skeletal abnormalities in the offspring of vaccinated mice and rats at higher-than-normal rates and revealed vaccine components traveled throughout the body into all organs.

Both the Pfizer and Moderna trial data in humans reveal concerning deaths and side effects that were attributed to other causes, but likely were vaccine side effects.”

Nass speculates that the rush to produce vaccines (Operation Warp Speed) may have contributed to what she believes was the FDA’s failure to “proper[ly] review” the clinical data.

More: https://www.uncoverdc.com/2023/07/24/moderna-spikevax-trial-data-show-serious-adverse-events-and-death/