The U.S. Food and Drug Administration (FDA) has changed the end date for a key study on post-vaccination heart inflammation without notifying the public. Pfizer was supposed to complete a study on the occurrence of subclinical myocarditis, or heart inflammation, after receipt of its COVID-19 vaccine. The completion date was listed by the FDA in…
FDA Quietly Changes End Date for Study of Heart Inflammation After Pfizer COVID Vaccination
FDA Advisers Back COVID-19 Vaccine Pivot in Move Toward Annual Shot
Experts who advise the U.S. Food and Drug Administration (FDA) on immunizations were supportive on Jan. 26 of a planned pivot on COVID-19 vaccines. Members of the Vaccines and Related Biological Products Advisory Committee voted to recommend the FDA stop using the original vaccines, which only target the obsolete Wuhan strain, in favor of new bivalent…
COVID Boosters: Why Many Physicians Consider Them Unreasonable for Young People
January 25, 2023
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While the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) recommend a bivalent booster for anyone over the age of 6 months, some physicians disagree. This includes clinicians who discourage all COVID-19 vaccinations, and also those who endorse the primary shots but have reservations about boosting. Dr. Paul…
FDA Rushed Approval for Pfizer COVID-19 Vaccine to Enable Vaccine Mandates: Emails
January 25, 2023
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U.S. regulators sped up the approval of Pfizer’s COVID-19 vaccine to enable vaccine mandates, according to newly released emails. Pfizer and BioNTech asked the U.S. Food and Drug Administration (FDA) in May 2021 to approve their vaccine. Regulators said publicly that the review of the Biologics License Application would likely be done by January 2022, but…
Elevated Rate of Facial Paralysis Identified After Pfizer COVID-19 Booster in Elderly: FDA
January 25, 2023
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An elevated rate of Bell’s palsy was identified among elderly people after vaccination with a Pfizer booster shot, U.S. regulators said in a new study. The “small but statistically significant elevation” in Bell’s palsy was detected after vaccination with Pfizer’s old booster, which is no longer available in the United States, researchers with the U.S….
‘Normalization’ of Emergency Use Authorizations Concerns Health Experts
January 12, 2023
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The Food and Drug Administration (FDA) has approved an unprecedented number of emergency use authorizations (EUAs) for drugs, tests, and medical devices since the beginning of the pandemic. Between March 2020 and June 2021, more than 600 EUAs were authorized, according to Fortune. This has caused concern among healthcare professionals, with some studies claiming that…
Deadline Passes for Pfizer to Submit Results of Post-Vaccination Heart Inflammation Study to US Regulators
January 11, 2023
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The deadline has passed for Pfizer to submit the results of a study exploring the frequency of heart inflammation following receipt of the company’s COVID-19 vaccine. Pfizer was required by the U.S. and Food and Drug Administration (FDA) to conduct multiple studies on its vaccine after the FDA approved the shot in August 2021 because…
FDA Waited Months to Alert Public to Possible COVID-19 Vaccine Safety Issues, Researchers Disclose
The U.S. Food and Drug Administration (FDA) first identified possible issues with the most-used COVID-19 vaccine in early 2021 but waited months to disclose the discovery to the public, a new publication revealed. FDA researchers saw safety signals for two serious conditions among elderly persons following vaccination with Pfizer’s COVID-19 vaccine on Feb. 27, 2021,…
FDA Authorizes Updated COVID-19 Vaccines for Babies, Toddlers
December 8, 2022
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U.S. drug regulators on Dec. 8 announced emergency clearance for two COVID-19 vaccines for children as young as 6 months of age. The updated vaccines from Pfizer and Moderna are now able to be administered to younger children after previously only being available to those 5 and older, the U.S. Food and Drug Administration (FDA)…
FDA Says Ivermectin Doesn’t Work Against COVID-19 but Points to Studies That Show It Does
December 8, 2022
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The U.S. Food and Drug Administration (FDA) says a drug called ivermectin does not work against COVID-19 but links to studies that show it does, an Epoch Times review has found. The FDA’s website states, “Currently available data do not show ivermectin is effective against COVID-19.” But half of the studies to which the FDA…
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