COVID-19 Vaccine(Janssen)

TUCSON, Ariz., June 02, 2025 (GLOBE NEWSWIRE) -- Endocrine effects that may result from vaccination are deceptively subtle at their onset. Hence, robust and sensitive pharmacovigilance is needed to discover them, writes Jane Orient, M.D., in the summer issue of the Journal of American Physicians and Surgeons . As of Mar 20, 2023, more than 13 billion COVID-19 vaccine doses had been administered worldwide. Vaccine proponents argue that with such huge numbers of vaccinations, a clear signal for endocrinological complications should be detected by current vaccine surveillance. This has not occurred, but not necessarily due to the absence of adverse endocrine events, Dr. Orient writes. There are two approaches to surveillance, she explains: the adverse events of special interest (AESI) method and organ systems-based surveys. The AESI approach focuses on a few events selected based upon their severity, biological plausibility, and previous association with vaccines. Organ systems-based surveys examine systematically any potential side effects that could affect vital organs. The article summarizes the major vaccine safety monitoring systems, including: the U.S Vaccine Adverse Event Reporting System (VAERS), the EU’s EudraVigilance System, the Vaccine Safety Datalink (VSD), V-safe, and the Biologics Effectiveness and Safety System (BEST). These systems rely on the AESI approach due to its low cost and simplicity. However, this method is neither sufficiently robust nor sensitive to detect subtle signs of initial endocrine side effects, Dr. Orient writes. “In fact, one can argue that overreliance on this method can guarantee that virtually none of the endocrine complications of COVID-19 vaccine will be detected.” Induction of autoimmunity is a well-recognized mechanism for vaccine adverse effects. The cause of many endocrine conditions, including diabetes mellitus and thyroid, adrenal, and pituitary diseases, involves autoimmune mechanisms as well. Unsurprisingly, there are published case series and reviews demonstrating association between vaccinations and endocrine disorders, Dr. Orient states. Those phenomena are overlooked by the AESI approach because it lacks needed sensitivity. “A potential disaster of yet undetected endocrine side effects of the vaccine is likely unfolding surreptitiously,” she concludes, and “clinicians need to have a high index of suspicion for this problem in their patients.” The Journal of American Physicians and Surgeons is published by the Association of American Physicians and Surgeons (AAPS) , a national organization representing physicians in all specialties since 1943. Contact: Jane M. Orient, M.D., (520) 323-3110, janeorientmd@gmail.com Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

NEW YORK, NY, USA and MAINZ, GERMANY I May 28, 2025 I Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced that they have submitted a regulatory application to the European Medicines Agency (EMA) for approval of COMIRNATY ® for the 2025-2026 season, targeting the LP.8.1 strain. The submission follows the recommendation by the EMA’s Emergency Task Force (ETF) to update the COVID-19 vaccine composition for the coming season to target the LP.8.1 strain. The COVID-19 vaccines by Pfizer and BioNTech are based on BioNTech’s proprietary mRNA technology and were developed by both companies. BioNTech is the Marketing Authorization Holder for COMIRNATY ® and its adapted vaccines in the United States, the European Union, the United Kingdom, and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. AUTHORIZED USE IN THE EU: COMIRNATY ® ▼ has been granted standard marketing authorization (MA) by the European Commission to prevent coronavirus disease 2019 (COVID-19) in people from the age of 6 months. The vaccine is administered as a single dose in people 5 years of age and older, and as a three-dose series, in infants and children from 6 months to 4 years who have not had COVID-19 with the first two doses given three weeks apart, followed by a third dose given at least 8 weeks after the second dose. Adults and adolescents from the age of 12 are given 30 micrograms per dose; children aged 5 to 11 years are given 10 micrograms per dose; infants and children aged 6 months to 4 years are given 3 micrograms per dose. Additional doses may be administered to individuals aged 5 years and older who are severely immunocompromised in accordance with national recommendations. The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has completed its rigorous evaluation of COMIRNATY, concluding by consensus that sufficiently robust data on the quality, safety and efficacy of the vaccine are available. In addition, COMIRNATY has also been granted standard MA for three adapted vaccines: COMIRNATY Omicron XBB.1.5, which contains mRNA encoding for the spike protein of the Omicron XBB.1.5 subvariant of SARS-CoV-2, COMIRNATY JN.1, which contains mRNA encoding for the spike protein of the Omicron JN.1 subvariant of SARS-CoV-2 and COMIRNATY KP.2, which contains mRNA encoding for the spike protein of the Omicron KP.2 subvariant of SARS-CoV-2. COMIRNATY Omicron XBB.1.5, COMIRNATY JN.1 and COMIRNATY KP.2 may be administered as a single dose regardless of prior vaccination status in people aged 5 years and older. Children from 6 months to 4 years of age may have one or three doses depending on whether they have completed a primary vaccination course or have had COVID-19. There should be an interval of at least 3 months between administration of COMIRNATY Omicron XBB.1.5, COMIRNATY JN.1 or COMIRNATY KP.2 and the last prior dose of a COVID-19 vaccine. About Pfizer: Breakthroughs That Change Patients’ Lives At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com . In addition, to learn more, please visit us on www.Pfizer.com and follow us on X at @Pfizer and @Pfizer News , LinkedIn , YouTube and like us on Facebook at Facebook.com/Pfizer . About BioNTech Biopharmaceutical New Technologies (BioNTech) is a global next generation immunotherapy company pioneering novel investigative therapies for cancer and other serious diseases. BioNTech exploits a wide array of computational discovery and therapeutic modalities with the intent of rapid development of novel biopharmaceuticals. Its diversified portfolio of oncology product candidates aiming to address the full continuum of cancer includes mRNA cancer immunotherapies, next-generation immunomodulators and targeted therapies such as antibody-drug conjugates (ADCs) and innovative chimeric antigen receptor (CAR) T cell therapies. Based on its deep expertise in mRNA development and in-house manufacturing capabilities, BioNTech and its collaborators are researching and developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global and specialized pharmaceutical collaborators, including Duality Biologics, Fosun Pharma, Genentech, a member of the Roche Group, Genevant, Genmab, MediLink, OncoC4, Pfizer and Regeneron. For more information, please visit www.BioNTech.com . SOURCE: BioNTech