The FDA has approved GlaxoSmithKline’s Hiberix vaccine to prevent a disease caused by Haemophilus influenzae type b in children. The company said that it has received accelerated approval for Hiberix as a booster dose in children aged 15 months to four years due to the shortage of the vaccine protecting infants from Hib. Hib is a severe and potentially deadly bacterial infection that can cause meningitis. The vaccine is expected to be available within a few weeks.

MedImmune has licensed the use of its proprietary reverse genetics technology by a Hungary-based manufacturing and research firm, Omnivest, to develop new vaccine strains for the production of non-live vaccines for influenza in humans. The technology enables generation of viruses such as influenza from segments of DNA. It requires the manufacturers to work only with segments of genome of the virus and not directly with highly infectious strains. Before this, MedImmune has licensed the technology to CSL Limited (Australia), sanofi pasteur, Novartis, GlaxoSmithKline and BIKEN (Japan).

A recent research carried out jointly by scientists from the universities of Bristol and Harvard has shown the way in which immune system can detect and destroy the bacterium, pneumococcus. It paves the way for the development of a novel vaccine for the prevention of diseases like meningitis and pneumonia that are found in both children and adults. Many infections start because of the carriage of this bug in the nose.  The existing vaccines for these diseases are not suitable for use in poorer countries as they are too expensive. Immune cells called TH17 cells have been identified as beneficial in killing this bug.

Novavax Inc. declared that its candidate for the vaccine against pandemic influenza virus-like particle (VLP)  has shown favorable results for the second stage of the Phase I/IIa of the human clinical trial. The vaccine candidate, which does not include an adjuvant, induced robust neutralizing antibody titers across all three doses tested. Avian influenza, the disease that the vaccine will prevent, emerged in humans in 2005 in Indonesia. 81% of  the 135 documented human cases have been fatal. The safety report for the trial is pending, but no adverse case has been reported.

Brazil and Paraguay have received 6 million doses of the Stamaril yellow fever vaccine from Sanofi Pasteur, the vaccines division of Sanofi-Aventis. About 30,000 people die every year from yellow fever in Africa and South America. Sanofi Pasteur is the only yellow fever vaccine supplier to the UNICEF.

Photo by thejourney1972

Data from a pediatric Phase II study of the Japanese encephalitis vaccine, IC51, which is being produced by Intercell and Biological E, demonstrates the impressive safety and immunogenicity profile of the product. The results support Intercell’s development plan for Southeast Asia and pave the way for late-stage development and licensure in late 2009 or early 2010.

In the clinical trials being conducted by Iomai Corp., patients were showed to be effectively protected from the bird flu disease by a single dose of the company’s vaccine, along with a skin patch. According to the company, 73% of the patients participating in the trial demonstrated sufficient immune response to the disease.

New data related to GlaxoSmithKline’s CERVARIX(R) demonstrates that the cervical cancer candidate vaccine provides significant protection for women against the four most common cancer-causing human papillomavirus types. The vaccine gives protection for nearly six and a half years, which is the longest duration of protection reported to date. During this period, the vaccine showed 100% efficacy in preventing precancerous lesions due to cancer-causing virus types 16 and 18 as well as provided substantial protection against infection caused by virus types 31 and 45.

Novartis has opened a new research institute in Siena, Italy. The Novartis Vaccines Institute for Global Health (NVGH) has a nonprofit mission of developing vaccines for diseases prevalent in developing countries. The institute aims at addressing the unmet vaccine needs of developing nations by researching new vaccines specifically for these countries.