(CIDRAP News) The US Food and Drug Administration (FDA) has approved a high-dose seasonal influenza vaccine for elderly people, whose aging immune systems may not respond effectively to flu vaccines intended for younger people.
The vaccine, Fluzone High-Dose, made by Sanofi Pasteur, contains four times as much antigen (active ingredient) as standard seasonal flu vaccines. The FDA and the company announced its approval Dec 23.
(CIDRAP News) MedImmune Inc. today announced a recall of leftover doses from 13 lots of its nasal-spray H1N1 vaccine because of a slight loss of potency, but the company said those who received doses from the affected lots don't need to be revaccinated.
The company and the US Food and Drug Administration (FDA) said there are no safety problems with the recalled doses.
(CIDRAP News) The nation is reaching a new milestone in its fight against pandemic flu, with the number of vaccine doses expected to reach 100 million by the end of the week and nearly half of states opening up immunization to anyone who wants it, federal officials said today.
(CIDRAP News) Novartis's pandemic H1N1 flu vaccine generated stronger immune responses when it was combined with an adjuvant than when used alone, though both formulations yielded good results, according to a report published by the New England Journal of Medicine.
(CIDRAP News) Sanofi has recalled four lots of its prefilled syringe pandemic vaccine for children ages 6 months through 35 months after its post-distribution monitoring found that antigen content dropped slightly below required levels, a problem that federal officials say isn't linked to any safety concerns.
(CIDRAP News) New ways of producing influenza vaccine that would free the process from long-standing problems are on the horizon, federal officials said today, but they added that scientific and regulatory hurdles will slow the products' movement past licensure and into the market.
(CIDRAP News) A second seasonal influenza vaccine made by Novartis was approved recently by the US Food and Drug Administration (FDA), and the company said some doses may reach the market this flu season.
(CIDRAP News) – The era of cell-based influenza vaccine production in the United States seemed to move closer today as Novartis unveiled its new, nearly billion-dollar manufacturing plant in Holly Springs, N.C., but onshore production and marketing of cell-based vaccines remains a few years away.