Injection Safety

Authorities Deem Novartis’ FLUAD Safe

Towards the end of November Italian officials prohibited the use of two batches of Novartis’ flu vaccine FLUAD after 13 deaths were reported to have taken place shortly after vaccination (8 within 24 hours). There were concerns from the AIFA that there may have been quality deficits within the two batches affected (143 301 and 142 701), however they and the ISS have deemed the vaccine safe after a series of negative results from preliminary tests.

Novartis’ Fluad Investigated After 13 Reported Deaths

The Italian medicines agency, AIFA, have suspended the use of two batches of Novartis’ influenza vaccine Fluad after the death of 13 adults, 8 of whom were above the age of 80, between the 7th and 25th of November. The suspension is a precautionary measure undertaken by the AIFA as the majority of the deaths occurred within 24 hours of after receiving the vaccine.

FDA clears syringe that prevents needlestick injuries

Exton, PA's West Pharmaceutical Services just announced that the FDA has given it 510(k) clearance for the NovaGuard Staked-needle Automatic safety system, as the push to avoid needlestick injuries gathers momentum.
The company says that the device shields the syringe's exposed needle after it has been activated and contains a tamper-evident safety mechanism to prevent early activation of the device.

The New England Journal of Medicine Publishes Results of Final Landmark Phase III Efficacy Clinical Study of Sanofi Pasteur’s Dengue Vaccine Candidate

Sanofi Pasteur, the vaccines division of Sanofi, today announced the publication of the detailed results of the final landmark phase III clinical efficacy study in Latin America in The New England Journal of Medicine.1 Overall efficacy against any symptomatic dengue disease was 60.8 percent* in children and adolescents 9-16 years old who received three doses of the vaccine. Analyses show a 95.5 percent* protection against severe dengue and an 80.3 percent* reduction in the risk of hospitalization during the study.

New vaccine generates strong immune response against hepatitis C

The vaccine was found to be very safe and well tolerated in the 15 healthy human volunteers who took part in the phase 1 safety trial.
A trial to test the efficacy of the vaccine is now underway among intravenous drug users in two sites in the USA. It is the first hepatitis C vaccine to reach this stage of clinical trials.
The aim is to see if the vaccine is able to offer any protection from infection in this group at high risk of hepatitis C compared with placebo.

Grippe : non, il n'y a pas de produits toxiques dans le vaccin

La grippe tue chaque année en France 9000 personnes âgées de plus de 65 ans. Pourtant, seuls 29% des Français prévoient de se faire vacciner cet hiver, a révélé une étude PHR-Ifop. Notamment parce qu'ils jugent ce vaccin trop risqué. "Ce n'est pas une peur de la piqûre mais une peur du produit", souligne à metronews Christophe Koperski, membre de la Fédération des pharmaciens d'officine. Vous êtes inquiet de ce qu'on vous inocule ? Voici les ingrédients du vaccin contre la grippe. 


Pfizer meningitis vaccine receives FDA approval

The U.S. Food and Drug Administration recently granted approval to TRUMENBA, a meningococcal group B vaccine produced by Pfizer, for use in people aged 10 through 25 infected with Neisseria meningitidis serogroup B.
The FDA’s Breakthrough Therapy designation and Priority Review programs reviewed and approved the drug.

WHO: Large Ebola vaccine trials could start in January

Large clinical trials that would put Ebola vaccines in the arms of thousands of West Africans may begin as early as January, depending on the outcome of small preliminary trials under way now or soon to start, a World Health Organization (WHO) official said at a press conference today.

The Psychology of Anti-Vaxers: How Story Trumps Science

Skyler Smoot, a cooing, smiling 12-week-old baby, is in danger. His brown eyes sparkle, his toes wiggle, his hands wave, but his health lies at the heart of a controversy between parents and doctors.
“I’m just afraid, you know?” his mother, Jacklyn, says. “I’m afraid of what could happen to him.”
Skyler isn’t vaccinated.

U.S. requests production plans for Ebola drug ZMapp

U.S. officials have asked three advanced biology laboratories to submit plans for producing the experimental Ebola drug ZMapp, which ran out after it was given to a handful of medical workers who contracted the disease in West Africa, government and lab officials said on Friday.
The "task order" issued on Thursday by the Biomedical Advanced Research and Development Authority (BARDA) asks that detailed plans, including budgets and timetables, be submitted by Nov. 10.