COVID-19 Vaccine Safety and Data Integrity Concerns

by Vins

While the US Centers for Disease Control and Prevention (CDC) advocate vaccines as the best ways to protect individuals from infection and end the COVID-19 pandemic, many countries and health officials are acknowledging vaccine safety and efficacy issues, as Sheryl Attkisson and Paul Elias Alexander have reported. Furthermore, concerns about data integrity and regulatory oversight of vaccine trials have surfaced, as reported by Aaron Siri for Bloomberg Law and others.

According to the CDC, vaccine development normally takes 5-10 years, while the COVID-19 vaccines were rolled out in one year, with clinical trials completed in three overlapping phases to expedite final authorization by the FDA.

Concerns about safety issues and coverups have emerged. For example, in November 2021, the BMJ published an account of how Brook Jackson, a researcher who worked at Ventavia on the Pfizer COVID-19 vaccine trial, discovered “poor laboratory management, patient safety concerns, and data integrity issues” at her site. In September 2020, after Ventavia failed to address these concerns, Jackson emailed the US Food and Drug Administration (FDA) a list of a “dozen concerns she had witnessed,” including deviations from protocol going unreported, lack of timely follow-up with patients who experienced adverse events, mislabeled lab specimens, and targeting of Ventavia staff for reporting these types of problems. Jackson was fired that same day, the BMJ reported. In December 2020, the FDA granted Pfizer the first emergency use authorization for its COVID-19 vaccine.

“There’s just a complete lack of oversight of contract research organizations and independent clinical research facilities,” Jill Fisher, professor of social medicine at the University of North Carolina and author of Medical Research for Hire: The Political Economy of Pharmaceutical Clinical Trials, told the BMJ.

Despite CDC, FDA and NIH claims of safety and high vaccine effectiveness against COVID-19, reports of post-vaccine injuries have not been reported openly, including adverse events documented during early trials. A study published in August 2021 by the journal Trends in Internal Medicine concluded that the three types of COVID vaccines available in the US all show a “complete lack of a health benefit and even an increase in severe (adverse) events among vaccine recipients.” The study’s author, Bart Classen, wrote, “Vaccines have been promoted and widely utilized under the false claim they have been shown to improve health. However, this claim is only a philosophical argument and not science based.” He warned that mass immunization with COVID-19 vaccines was leading to “a catastrophic public health event.”

The federal government’s Vaccine Adverse Event Reporting System (VAERS) is a voluntary reporting system. According to a 2011 grant report on VAERS, between December 1, 2007 and September 9, 2020, “fewer than 1% of vaccine adverse events” were reported. Investigative reporter Sheryl Attkisson pulled together research studies from around the world to foreground “80 of the most common adverse events reported after Covid-19 vaccination.” The more common of these reported symptoms include paralysis, pulmonary embolism, thrombosis, cerebral hemorrhage, thrombocytopenia, anaphylactic/anaphylactoid systemic reactions, skin inflammation, myalgia, arthralgia, menstrual cycle disruption in women, and more. Anthony Furey of the Toronto Sun cited a report by Public Health Ontario in Canada that revealed more than 100 Canadian youth under the age of 25 had been sent to the hospital with heart complaints after vaccination.

Attkisson also cited an October 2021 report by Reuters that Sweden and Denmark paused the Moderna COVID-19 vaccine for younger groups, as have other countries including Iceland, Finland, and Slovenia.

There has not been a single payment for any COVID vaccine injury, according to November 2021 report for Forbes by Adam Andrzejewski. However, Thailand’s National Health Security Office has paid $45.65 million to settle COVID-19 vaccine injury compensation claims. Payouts were made to 12,714 people, including family members who died as a result of the vaccine, Cambodia’s Phnom Penh Post reported in March 2022.

Vaccine efficacy questions are emerging as well. Paul Elias Alexander outlined these concerns in an October 2021 report for the Brownstone Institute. According to Alexander, “evidence is pouring in about Covid vaccine efficacy. The gestalt of the findings implies that the infection explosion… may be due to the vaccinated spreading Covid as much or more than the unvaccinated.” Alexander questioned whether vaccines “with limited capacity to prevent symptomatic disease may drive the evolution of more virulent strains.”

In an August 2016 report for Science, Meredith Wadman reported that, based on data from Israel, “breakthrough” cases, where people who have previously been vaccinated come down with COVID, are “not the rare events the term implies.” Her article reported that in August 2021, 59 percent of the 514 Israelis hospitalized with severe or critical COVID-19 were fully vaccinated. Her report quoted a bioinformatician at the Israel Institute of Technology, Uri Shalit, who said, “One of the big stories” from Israel is that “‘Vaccines work, but not well enough.’”

In a January 2022 article for Bloomberg Law, Aaron Siri reported on how a group of scientists and medical researchers, Public Health and Medical Professionals for Transparency, addressed these growing concerns by suing the FDA under the Freedom of Information Act. The group’s lawsuit calls on the FDA to release documents related to the trials and licensing of the Pfizer COVID-19 vaccine. In response, the FDA asked a federal judge for permission to wait until 2096 to “disclose all of the data it relied upon to license Pfizer’s Covid-19 vaccine.” Siri’s article described the “unprecedented need for transparency” when it comes to the COVID-19 vaccines. “A majority of Americans are now mandated to receive a COVID-19 vaccine under penalty of losing a job, or worse,” Siri wrote, suggesting that we need independent scientists to review this data now—not in 75 years.

Corporate media have offered scant coverage of these issues. Reuters and Forbes published stories on vaccine injury claims. However, both articles relied on the official narrative that adverse reactions to the mRNA vaccine are rare. Fox News has openly discussed vaccine injury studies and Big-Pharma-Big Media collusion and censorship. However, none of these sources offered an independent overview of these complex issues.

Sources:

Sharyl Attkisson, “Exclusive: Covid-19 Vaccine Concerns,” Sharyl Attkisson, March 12, 2022.

Sharyl Attkisson, “Exclusive: 80 of the Most Common Adverse Events Reported after COVID-19 Vaccination,” Sharyl Attkisson, October 13, 2021.

Anthony Furey, “More than 100 Ontario Youth Sent to Hospital for Vaccine-Related Heart Problems: Report,” Toronto Sun, September 3, 2021.

Meredith Wadman, “A Grim Warning from Israel: Vaccination Blunts, but Does Not Defeat Delta,” Science, August 16, 2021.

Aaron Siri, “Why a Judge Ordered FDA to Release Covid-19 Vaccine Data Pronto,” Bloomberg Law, January 18, 2022.

Student Researcher: Karen Lopez (San Francisco State University)

Faculty Evaluators: Kenn Burrows and Amber Yang (San Francisco State University)

Review Article with Credder

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