Sanofi Pasteur, the vaccines division of France-based Sanofi-Aventis Group, is voluntarily recalling about 800,000 doses of H1N1 (swine) flu vaccine meant for children between the ages of 6 months and 35 months because quality assurance tests indicate the vaccine doses lost some potency.
Sanofi Pasteur, the vaccines division of France-based Sanofi-Aventis Group, is voluntarily recalling about 800,000 doses of H1N1 (swine) flu vaccine meant for children between the ages of 6 months and 35 months because quality assurance tests indicate the vaccine doses lost some potency.
After a routine stability testing, Sanofi learned that this vaccine's potency was 12% below the point where it should have been. Sanofi tested additional lots and found that three other lots that had been distributed also had an antigen content that, while properly filled at the time of manufacturing, was later measured to be below pre-specified limits.
This vaccine, which was manufactured in Sanofi’s factory in Swiftwater, PA, was distributed throughout the US. Vaccine doses with the following lot numbers are included in the recall:
• 0.25 mL pre-filled syringes, 10-packs (NDC # 49281-650-25, sometimes coded as 49281-0650-25): UT023DA, UT028DA, UT028CB.
• 0.25 mL pre-filled syringes, 25-packs (NDC . 49281-650-70, sometimes coded as 49281-0650-70): UT030CA.
According to the CDC, there is no safety concern and even though the vaccine isn't quite as potent as it is supposed to be, children vaccinated from the lots already will not need to be re-vaccinated.
This fall, the FDA approved four H1N1 flu vaccines, manufactured by CSL Limited, MedImmune, Novartis Vaccines and Diagnostics Limited, and Sanofi Pasteur. In November, the FDA approved a fifth vaccine, manufactured by GlaxoSmithKline (GSK).
Last month, GSK put on hold one lot of its Arepanrix adjuvanted H1N1 flu vaccine in Canada, following reports of a higher than usual number of adverse events.
Questions and answers related to Sanofi’s vaccine recall on CDC’s web site
GSK Issues Hold for One Lot of H1N1 Vaccine Following Adverse Events
VERAXA and Voyager to Create Combined Business for Advancing Pipeline of Next-Gen Cancer Therapies
April 23rd 2025The proposed business combination would create a publicly traded, clinical-stage biopharmaceutical company that will focus on developing a pipeline of next-generation cancer therapies.
Mastering Antibody-Drug Conjugates
December 19th 2024In this episode, we explore BIOVECTRA’s capabilities in antibody-drug conjugate (ADC) manufacturing, from complex conjugation chemistry to synthesis of highly potent payloads. We’ll also showcase how BIOVECTRA’s extensive experience in complex chemistries and specialized small molecule manufacturing gives them a unique perspective, strengthening their approach to ADC production and ensuring clients receive custom solutions across all project stages.
MHRA Approves GSK Therapy Combinations for Multiple Myeloma
April 21st 2025Belantamab mafodotin is approved in combination with bortezomib plus dexamethasone in patients who have had at least one prior therapy, and in combination with pomalidomide plus dexamethasone for those who have had a prior therapy including lenalidomide.
Tokyo University of Science Research Team Explores Improved Delivery of Antisense Oligonucleotides
April 18th 2025Using cholesterol-modified oligonucleotides, the research team aims to improve the delivery of antisense nucleotide-based therapies for treating neurodegenerative diseases and brain cancers.