Vaccine Update

Novavax Inc.’s new swine flu vaccine that is produced using genetically engineered virus-like particles (rather than being grown inside chicken eggs like traditional flu vaccines) has prompted an immune response in patients during a mid-stage study. The company is currently conducting a larger, 3,500- person study of the vaccine, which can be grown in weeks instead of months using the traditional method.

GlaxoSmithKline PLC struck a deal with Intercell AG, an Austrian company, to develop vaccines delivered through a patch, a technology that health professionals hope could help expand the use of vaccines. The U.K.-based Glaxo will pay for access to the technology and marketing rights to patches used by travelers to guard against diarrhea and pandemic flu.

Giving a vaccine through a scratch on the skin (scarification) triggers a stronger immune response than injected vaccines, say researchers at Brigham and Women’s Hospital, who also found that scarification requires 100 times less vaccine to prompt an immune response. Scarification was first used nearly two centuries ago to give the first smallpox vaccinations, but today, nearly all modern vaccines are given via injection. The study was published in the 17 issue of Nature Medicine.

The Food and Drug Administration approved a high-dose influenza vaccine, Fluzone High-Dose, for people 65 and older. The vaccine, which is produced by Sanofi Pasteur, was designed to produce a stronger immune response and better protect older adults against the seasonal flu. It will be available in the fall of 2010 in advance of the next flu season.

BiondVax Pharmaceuticals Ltd. of Israel has successfully completed the clinical phase of its second Phase I/II clinical trial of the company’s Multimeric-001 universal flu vaccine. Initial results show that the vaccine is safe and well-tolerated, causing no severe or serious adverse events.

The FDA has approved Pfizer Inc.’s Prevnar 13 pneumococcal 13-valent conjugate vaccine. Prevnar 13 is indicated for active immunization of children 6 weeks through 5 years of age for the prevention of invasive disease caused by 13 Streptococcus pneumoniae.

According to a new report from the Institute of Medicine, which identifies priority areas for updating the National Vaccine Plan, the U.S. lacks immunization protection against several serious illnesses. The revised plan should include a strategy to accelerate development of high-priority vaccines, and should emphasize the importance of expanding funding for safety research and monitoring. It also will include the development of a national communications strategy to clarify the importance of vaccines and bolster public confidence in the immunization system.

Scientists seeking to understand how to make an AIDS vaccine have found the cause of a major roadblock. Originally, scientists thought that B cells (one of the first lines of defense against infection) are simply not able to “see” the HIV virus. But, instead, researchers have now found that, in mice, plenty of early stage B cells are produced, but most are destroyed because the immune system sees them as a potential threat. Researchers plan on using this new mouse model to test ways to teach the immune system to enable the production of B cells containing a rare but potent, broadly neutralizing human antibody that is able to block HIV infection.

GlaxoSmithKline has launched a program in the U.S.to provide free vaccines to adults ages 19 and older who don’t have health insurance and whose income totals no more than $27,075 for a single person or $36,425 for a couple. The program will cover low-income adults who meet eligibility requirements. The free vaccines include shots for hepatitis A and B, tetanus, diphtheria and whooping cough. The company’s cervical cancer vaccine, Cervarix, also will be included for women between the ages of 19 and 25.

The FDA has approved the human papillomavirus (HPV) vaccine Cervarix for use in girls and youngwomen ages 10 to 25 to help prevent cervical cancer. Manufactured by GlaxoSmithKline, Cervarix targets two HPV strains, HPV 16 and HPV 18, which are leading causes of cervical cancer.

The federal government in Canada has approved the HPV vaccine Gardasil for boys and men ages 9 through 26, the same age range as its approval in girls and women. The Public Health Agency of Canada is reviewing the data from studies of the vaccine and will make a recommendation to the provinces based on their findings.

A new vaccine shows promise for protecting young children from malaria. GlaxoSmithKline’s vaccine, which uses an immune system blocker called an adjuvant, targets the malaria parasite as it is actively infecting red blood cells and causing fever and illness. This blood-stage vaccine acts at a later stage in the malaria parasite’s life cycle than Glaxo’s experimental vaccine Mosquirix.

The Vaccine Research Center at the National Institute of Allergy and Infectious Diseases has posted a new confidential screening form to help interested people determine if they are eligible to volunteer to participate in clinical studies of potentially life-saving vaccines. The form can be accessed at www3.niaid.nih.gov/Volunteer/volunteerEligibility.htm.