Study finds quadrivalent FluMist vaccine more effective than traditional inoculations
ST. LOUIS — An intranasal vaccine that includes four weakened strains of influenza could do a better job in protecting children from the flu than current vaccines, research released Tuesday by St. Louis University found.
Before each influenza season, scientists predict which strains of flu will be circulating and make a trivalent vaccine that includes three strains of influenza — two of influenza A and one of influenza B. The ability to add another strain of influenza B without compromising the vaccine’s ability to protect against the other three strains will allow scientists make a better vaccine, noted Robert Belshe, professor of infectious diseases at St. Louis University School of Medicine and the corresponding author of the research article.
“The bottom line is adding another strain to make a quadrivalent vaccine improves our ability to protect against flu and doesn’t reduce the body’s immune response to the other strains,” Belshe said. “It should bring us better protection because there’s less guess work than in the standard trivalent vaccine.”
Children are more susceptible than adults to influenza from one of the B strains, which change less often than A strain viruses. Some winters, influenza B viruses cause most of the flu in children and significant infection in adults, Belshe said.
Preventing flu in children is key to protecting the entire population. “We think the most important way for flu to spread is through school-aged children,” Belshe said.
In the 1980s, influenza B split into the two circulating lineages of virus, which have evolved into viruses that are quite different. Some years both B viruses or the B strain that doesn’t match the vaccine circulate, which means the vaccine doesn’t protect people from getting the flu.
“There are these two very different strains of influenza B that don’t cross protect. Vaccinating against one strain of influenza B does little to protect against the other,” Belshe said. “It has not been possible to predict which strain has circulated. In the last 10 years, we predicted right five times. So you can flip a coin and do as well.”
Previously, manufacturers had not had the capacity to produce a vaccine that protects against four strains of flu, but that is no longer the case, Belshe said.
The researchers tested versions of the FluMist vaccine, which is sprayed in the nose and contains live flu viruses that have been attenuated or weakened so they don’t cause infection. The intranasal vaccine is made by MedImmune.
The nasal spray vaccine was tested in about 2,300 children between ages 2 years and 19 years. The children were randomized to receive one of three vaccines: a vaccine containing four strains of influenza — two of influenza A and two of influenza B — or one of two vaccines that contained both influenza A strains and one of each of the influenza B strains. Researchers looked at the safety and antibody response to both influenza A and B viruses in children of different age groups who were vaccinated.
Those children who receive vaccine containing four strains of flu had as robust of an immune response as those who received the vaccine that contained three strains. In addition, Belshe noted no clinically significant difference the safety of the vaccines, which were well tolerated.
“We saw stuffy noses, which we know is associated with FluMist, and an occasional low grade fever, which is similar to other childhood vaccines,” Belshe said.
On Feb. 28, the U.S. Food and Drug Administration approved MedImmune’s quadrivalent flu vaccine for use in people between the ages of 2 years and 49 years. The vaccine could be ready for use during the 2013-2014 influenza season, pending a recommendation from the Advisory Committee on Immunization Practices, a group that advises the Centers for Disease Control and Prevention about vaccination issues.
An injected flu vaccine designed to protect against four strains of flu — instead of the current three — also is in the works, Belshe said.
Findings were published electronically ahead of print in the Pediatric Infectious Disease Journal.
FDA advisory committee to review OTC availability of HIV test in May
BETHLEHEM, Pa. — OraSure Technologies on Wednesday announced that the Food and Drug Administration’s Blood Products Advisory Committee will consider making its OraQuick Rapid HIV-1/2 test available over the counter on May 15.
At the meeting, OraSure will present its consumer-usage studies — approximately 5,800 subjects were enrolled and tested in this phase across 20 states, the company said, which helped identify more than 100 previously undiagnosed individuals.
"There is an urgent need for additional testing options to identify individuals who are HIV- positive, link them to care and reduce transmission of the virus," OraSure president and CEO Douglas Michels said. "Our belief is that the availability of an easy-to-use, accurate in-home HIV test will enable more people to learn their presumptive HIV status so that they can receive necessary care and support."
According to the Centers for Disease Control and Prevention, there are approximately 1.2 million people in the United States who have HIV and despite current HIV testing options, approximately 240,000 of them are unaware of their status. It is estimated that those undiagnosed are responsible for up to 70% of the approximately 50,000 new HIV infections occurring each year in the United States. The CDC recommends all people ages 13 to 64 years be offered an HIV test in healthcare settings, with more frequent testing for people at higher risk.
Citing clinical studies conducted by OraSure, the CDC noted the OraQuick oral fluid test correctly identified 99.3% of people who were infected with HIV (sensitivity) and 99.8% of people who were not infected with HIV (specificity). The Food and Drug Administration expects clinical laboratories will obtain similar results.
The OraQuick rapid HIV test for use with blood was waived under the Clinical Laboratory Improvements Amendments of 1988 in January 2003, and waived for use with oral fluid in June 2004. A waived test can be used in any facility with a CLIA certificate, rather than only in traditional laboratories. As such, a waived test can be used in many non-clinical settings.
Such was the case last summer when Walgreens teamed with Greater Than AIDS on a national awareness campaign around HIV/AIDS in the United States, to distribute informational resources and specialized HIV-related services at more than 300 Walgreens pharmacies in affected communities.
At these specialized pharmacy locations, Walgreens had pharmacists on hand to offer one-on-one medication counseling and other support services that provide customers living with HIV/AIDS and their families with compassionate, confidential care. Free rapid oral HIV testing was available at select Walgreens with technical support and guidance from the Centers for Disease Control and Prevention and test kits from OraSure Technologies.
State and local health departments and community-based organizations in the local markets conducted the tests and providing pre- and post-test counseling.
That means this could be the first switch application that could significantly benefit from a pharmacist or nurse practitioner intervention in the wake of last month’s FDA public meeting on expanding the switch paradigm. One of the concerns associated with an OTC HIV test is the availability of counseling following a positive/false positive result. The OraQuick Rapid HIV point-of-care test produces results in 20 minutes — and if that 20 minutes transpires in a pharmacist or nurse clinician consultation room a person finding out that they are HIV positive would have immediate access to a healthcare professional.
To review the OraQuick Advance package insert, a product presently available to clinicians, click here.
Americans buying supplements even as they tighten their belts
WASHINGTON — More than two-thirds of Americans (71%) reported the economy has not affected their household’s purchasing habits of dietary supplements, according to a survey released Wednesday by the Council for Responsible Nutrition.
The CRN study is in line with a special report in AdAge magazine titled “The New Necessities: What Products and Services Can Consumers Not Live Without?,” citing a study by advertising agency Leo Burnett which studies the impact of consumer "wants" versus "needs" in a down economy. In a diagram of wants versus needs, vitamins were listed as something that consumers couldn’t bear to cut back on, which was on par with car insurance, routine car maintenance, mobile phone service and household repairs.
“What’s interesting about our survey findings and those of Leo Burnett is that, even in the midst of trying economic times, dietary supplements are not something consumers are willing to sacrifice," CRN SVP communications Judy Blatman said. "While they certainly are looking for ways to save money, they clearly know the value of using dietary supplements to promote overall health and wellness,” she said. “Given the ongoing debate about health care in America, it’s encouraging to see consumers taking proactive steps, such as incorporating dietary supplements into their health regimen.”
The remaining respondents (29%), however, reported that the economy has impacted their household’s purchasing habits of supplements. The study asked specifically how it affected their purchasing habits, and only 7% of Americans report they have stopped purchasing supplements altogether because of the economy.
Still, overall use of dietary supplements is on the rise with 69% of all Americans reporting that they use supplements, up from 66% in 2010. For the 3-in-10 of consumers whose supplement purchasing habits have been affected by the economy, many are engaging in a variety of money saving tactics, including buying fewer supplements as a means to save money; buying supplements only when they are on sale; and purchasing less expensive supplement brands.
The CRN survey also found that the supplement purchasing habits of those ages 55 years and older were least affected by the trying economy, with 78% of that group indicating as such, followed by consumers ages 18 years to 34 years (70%) and those ages 35 years to 54 years (65%). Gender didn’t appear to be a factor.
The 2011 CRN Consumer Survey on Dietary Supplements was conducted Aug. 25 to 29, 2011 by Ipsos Public Affairs and funded by CRN. The survey was conducted online and included a national sample of 2,015 adults ages 18 years and older from Ipsos’ U.S. online panel. The survey has been conducted annually since 2000.