In Beaumont, Texas, attorneys for a whistleblower alleging violations occurred during the Pfizer–BioNTech COVID-19 vaccine clinical trial argued in federal court on March 1 that their case should advance to the discovery phase. Attorneys for the defendants—Pfizer and two subcontractors, Ventavia Research Group and ICON—tried to convince the judge to dismiss the case. If successful,…
Fate of the Pfizer Whistleblower Case to Be Decided by Federal Judge in Texas
Another Study Finds Increased Risk of Adverse Events After COVID-19 Vaccination Among Naturally Immune
People who recovered from COVID-19 have a higher risk of adverse events after vaccination, according to a new study. Health care workers who had post-infection immunity reported more adverse events after receipt of Pfizer’s COVID-19 vaccine than those without natural immunity, researchers in England said. Rachael Raw of Newcastle University’s School of Medicine and Health,…
Pfizer Says It Ended COVID-19 Vaccine Pregnancy Trial Early
Pfizer says it stopped its clinical trial analyzing COVID-19 vaccine safety and efficacy in pregnant women. The company said that enrollment in the study stopped in the fourth quarter of 2021 after health experts, including the U.S. Advisory Committee on Immunization Practices, began recommending the Pfizer-BioNTech vaccine for pregnant women. “With the declining enrollment, the study…
FDA Panel Endorses Pfizer’s RSV Vaccine for Older Adults
A panel of outside advisers to the U.S. Food and Drug Administration (FDA) voted to endorse a vaccine from Pfizer for respiratory syncytial virus (RSV) on Tuesday. The majority vote to endorse Pfizer’s product brings it closer to potentially becoming the first approved vaccine for RSV for older adults in the United States. The FDA had…
FDA Finds Rare Neurological Disorder Is a ‘Potential Risk’ With Pfizer Vaccine
The Food and Drug Administration (FDA) said two people who received Pfizer’s respiratory syncytial virus (RSV) vaccine during a clinical trial were subsequently diagnosed with a rare neurological disorder known as Guillain-Barre syndrome. Briefing documents (pdf) released on Feb. 24 ahead of an upcoming meeting of the Vaccines and Related Biological Products Advisory Committee flagged…
FDA Finds Rare Neurological Disorder Is a ‘Potential Risk’ With Pfizer RSV Vaccine
The Food and Drug Administration (FDA) said two people who received Pfizer’s respiratory syncytial virus (RSV) vaccine during a clinical trial were subsequently diagnosed with a rare neurological disorder known as Guillain-Barre syndrome. Briefing documents (pdf) released on Feb. 24 ahead of an upcoming meeting of the Vaccines and Related Biological Products Advisory Committee flagged…
FDA Finds Rare Neurological Disorder Is ‘Potential Risk’ With Pfizer RSV Vaccine
The Food and Drug Administration (FDA) stated that two older adults who received Pfizer’s respiratory syncytial virus (RSV) vaccine during a clinical trial were subsequently diagnosed with a rare neurological disorder known as Guillain-Barré syndrome. Briefing documents (pdf) released on Feb. 24 ahead of this week’s meeting of the Vaccines and Related Biological Products Advisory…
Protection From New COVID-19 Vaccines Drops Sharply Within Months: CDC
February 24, 2023
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The new COVID-19 vaccines provide a boost to protection against hospitalization but that shielding wanes within months, according to unpublished data presented on Feb. 24. A bivalent Pfizer or Moderna booster increased protection against hospitalization initially by 52 percent, but that protection dropped to 36 percent beyond 59 days, U.S. Centers for Disease Control and…
Previously Undisclosed COVID Vaccine Agreements Between Pfizer and Israel Released
Previously disclosed agreements regarding the sale of COVID-19 vaccines between Pfizer and the Israeli Ministry of Health were revealed to the public for the first time on Feb. 20. The documents include the Confidential Disclosure Agreement that was signed on July 12, 2020; the Binding Term Sheet signed on Nov. 13, 2020; the Manufacturing and…
Hearing on Pfizer Clinical Trial Violations Set to Take Place
A hearing is scheduled to take place in a legal case brought by a whistleblower who confirmed that violations occurred during the Pfizer-BioNTech COVID-19 vaccine clinical trial. The company Ventavia failed to properly report adverse events and keep all participants blinded, according to internal communications revealed by Brook Jackson, the whistleblower. Pfizer paid ICON, a clinical…
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