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The FDA-approved lung cancer drug osimertinib (sold under the brand name Tagrisso) slashes the risk of death by 51% for certain patients whose cancer is caught early, according to new trial data. “This should be the new standard of care for these patients,” Nathan Pennell, co-director of the Cleveland Clinic Lung Cancer Program, who wasn’t involved in the drug’s development, said in a statement for the American Society of Clinical Oncology. The drug: Lung cancer is the second-most common cancer in the world, with 2.2 million new diagnoses every year. The vast majority fall into a category called “non-small cell...

In recent months, COVID-19 vaccination in the U.S. has “slowed to a crawl” as an increasingly distrustful public says “no thanks” to primary shots and boosters. Still, U.S. public health agencies continue to authorize, approve and recommend COVID-19 vaccines — even for infants.On Tuesday, advisors to the Centers for Disease Control and Prevention (CDC) — perhaps believing they can reverse the slowdown in “vaccine uptake” and without admitting to the ravages caused by the Pfizer/BioNTech, Moderna and Johnson & Johnson (J&J) shots — unanimously recommended the “Novavax COVID-19 Vaccine, Adjuvanted.”The U.S. Food and Drug Administration (FDA) last week granted Novavax...

Several companies in the race for a coronavirus vaccine have stumbled upon a new and unexpected hurdle: activists protesting the use of a substance that comes from sharks in their products. The oily compound, called squalene, is churned out by shark livers and has immunity-boosting powers, which has led several companies to use it as an ingredient in vaccines. A group called Shark Allies has mounted a campaign calling on the Food and Drug Administration and other regulatory bodies to halt the sourcing of the compound from sharks, warning that mass distribution of a coronavirus vaccine could require harvesting tissue...

The Food and Drug Administration (FDA) announces that it has approved Fluad, the first seasonal influenza vaccine containing an adjuvant. Fluad, which is manufactured using an egg-based process, is formulated with the adjuvant MF59, an oil-in-water emulsion of squalene oil. The study showed that Fluad induced antibody levels that were comparable to the levels induced by Agriflu [i.e., no better.] Fluad was approved using the accelerated approval regulatory pathway, which allows the FDA to approve products for serious or life-threatening diseases based on evidence that the product has an effect on an outcome that is reasonably likely to predict clinical...

Just a week after it emerged that the German armed forces was getting a different kind of A/H1N1 vaccine to the general population, Der Spiegel magazine reports that the government will also get special treatment. The general population will be offered the GlaxoSmithKline vaccine, called Pandemrix, which contains a new booster element, or adjuvant, as well as a preservative containing mercury. Controversy has grown around the rapid licensing of the GSK vaccine – and a similar one being made by Novartis. Critics said not enough testing had been conducted before European licensing authorities rushed an approval. Chancellor Angela Merkel, her...

The coming swine flu vaccination campaign is expected to begin in October. But with vaccine safety tests being fast-tracked under “public health emergency” rules and the use of some questionable ingredients, many health experts are warning about a myriad of risks associated with the vaccine and the importance of being educated. “Right now, you need to become educated about vaccination, influenza, vaccine risks and the public health laws in your state,” warned Barbara Loe Fisher, the president of the National Vaccine Information Center. “You need to find out what your rights and options are under new public health laws that...

a Department of Safety Research on Biologics, National Institute of Infectious Diseases, Gakuen, Musashimurayama, Tokyo 208, Japan b Department of Bacteriology, Kinki University School of Medicine, Osakasayama, Osaka 589, Japan c Animal Production and Grassland Division, Japan International Research Center for Agricultural Sciences, Tsukuba, Ibaraki 305, Japan Received 5 December 1996; Revised 20 January 1997; accepted 21 January 1997. Available online 12 December 1997. Abstract Effects of calcium phosphate and aluminium hydroxide adjuvants with different physical properties were examined in guinea pigs for local histopathological reactions, electron-microscopical changes of macrophages and adjuvanticity on total IgG antibody response to subcutaneously administered...

For decades, scientists have known that they can make vaccines much more efficacious by adding aluminum compounds, but they never knew why. Now, a study reveals how, on a molecular level, these helpers spur the production of antibodies. The finding may help researchers develop better vaccines. Many vaccines contain adjuvants, nonspecific agents that help jolt the immune system into action. "Alum," a term referring broadly to aluminum hydroxide and several aluminum salts, has this effect, as was accidentally discovered in the 1920s. It has been widely used in human vaccines since the 1950s, and it's still the only adjuvant allowed...