Who Should Not Be Vaccinated against Influenza

These are categories of people who should not be vaccinated without first consulting a physician:

• Children less than 6 months of age (influenza vaccine is not approved for this age group).
• People who have a moderate-to-severe illness with a fever (they should wait until they recover to get vaccinated.)
• People who developed Guillain-Barré syndrome (GBS) within 6 weeks of getting an influenza vaccine.
• People who have had a severe reaction to an influenza vaccination.
• People who have a severe allergy to chicken eggs.

Who Should Get Vaccinated against Influenza

In general, anyone who wants to reduce their chances of getting the flu can get vaccinated. However, it is especially recommended for people who are at high risk of having serious flu complications or people who live with or care for those at high risk for serious complications. During flu seasons when vaccine supplies are limited or delayed, these are priority groups for vaccination:

1. Children aged 6 months up to their 19th birthday
2. Pregnant women
3. People 50 years of age and older
4. People of any age with certain chronic medical conditions
5. People who live in nursing homes and other long-term care facilities
6. People who live with or care for those at high risk for complications from flu, including:
a. Health care workers
b. Household contacts of persons at high risk for complications from the flu
c. Household contacts and out of home caregivers of children less than 6 months of age (these children are too young to be vaccinated)

When to Get Influenza Vaccine Shot

Timing and duration of influenza seasons vary. Yearly influenza vaccination should begin in September or as soon as vaccine is available and continue throughout the influenza season, into December, January, and beyond. While flu outbreaks can happen as early as October, most of the time flu activity peaks in January or later.

Flu Vaccine Types

Currently pharmaceutical companies produce two types of vaccines:

• The “flu shot”— an inactivated vaccine (containing killed virus) that is given with a needle, usually in the arm. The flu shot is approved for use in people older than 6 months, including healthy people and people with chronic medical conditions.
• The nasal-spray flu vaccine — a vaccine made with live, weakened flu viruses that do not cause the flu (sometimes called LAIV for “live attenuated influenza vaccine” or FluMist®). LAIV (FluMist®) is approved for use in healthy* people 2-49 years of age who are not pregnant.

About 2 weeks after vaccination, antibodies that provide protection against influenza virus infection develop in the body. Each vaccine contains three influenza viruses-one A (H3N2) virus, one A (H1N1) virus, and one B virus. The viruses in the vaccine change each year based on international surveillance and scientists’ estimations about which types and strains of viruses will circulate in a given year.

Patent for Universal Influenza Vaccine Approach

Vical Incorporated (Nasdaq:VICL) announced today the issuance of U.S. Patent No. 7,537,768 covering the use of influenza virus gene sequences in a universal vaccine that could provide protection against circulating seasonal strains as well as emerging pandemic strains of influenza viruses.

Vical has patented a new influenza vaccine approach based on portions of the virus which are much more consistent between strains than the constantly changing conventional vaccine target, hemagglutinin (HA), and which are highly conserved even between seasonal and potentially pandemic emerging strains. Vical’s DNA vaccine technology can induce both antibody and T-cell immune responses against the target portions of the virus, potentially providing a level of protection not available with conventional influenza vaccines. In addition, a vaccine based on this approach may have the potential to provide protection against future pandemic threats from new strains of influenza viruses.

The new ‘768 patent covers the composition and use of gene sequences encoding highly-conserved influenza proteins-nucleoprotein (NP) and ion channel protein (M2)-which were optimized for use in human vaccination. These gene sequences were derived from common portions of proteins from influenza strains in circulation over a ten-year period. The sequences were then codon-optimized for human expression to provide the greatest level of influenza protein output per vaccine dose. The resulting NP and M2 DNA components could be used in a universal influenza vaccine with the potential to protect against a broad range of circulating or emerging influenza strains. This patent adds to Vical’s family of patents in the United States and in other key regions based on the company’s discovery that administering genetic sequences such as DNA or RNA into the body, without the use of viral delivery vehicles, may cause expression of the proteins encoded by the genetic sequences.

About Vical
Vical researches and develops biopharmaceutical products based on its patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases. Potential applications of the company’s DNA delivery technology include DNA vaccines for infectious diseases or cancer, in which the expressed protein is an immunogen; cancer immunotherapeutics, in which the expressed protein is an immune system stimulant; and cardiovascular therapies, in which the expressed protein is an angiogenic growth factor. The company is developing certain infectious disease vaccines and cancer therapeutics internally. In addition, the company collaborates with major pharmaceutical companies and biotechnology companies that give it access to complementary technologies or greater resources. These strategic partnerships provide the company with mutually beneficial opportunities to expand its product pipeline and address significant unmet medical needs.

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Swine Flu Test Submitted to the FDA

Osmetech (LSE:OMH) has submitted a request to the US FDA for Emergency Use Authorization (EUA) for its Respiratory Pathogen Test Panel test to be used to screen for the swine flu virus. Osmetech’s Respiratory Pathogen Test Panel test, which is expected to be launched as a research use only (RUO) product next quarter, detects and differentiates between 18 common bacterial and viral infections, including the Influenza A virus and its H1N1 subtype. Osmetech is currently developing an extension to the Respiratory Pathogen Test that will differentiate this H1N1 subtype between the human and swine forms of the virus.

Osmetech Respiratory Pathogen Test Panel test has been adapted from QIAGEN’s QIAplex-based respiratory viral test for use on Osmetech’s eSensor XT-8 molecular diagnostics system, under the terms of an agreement signed in September 2008.

James White, Chief Executive, Osmetech plc, said:

“We believe that our test is ideally suited for fast and reliable screening of Influenza A virus types, including the swine flu strain which is currently a major pandemic concern. The test will be run on our eSensor XT-8 platform, which is a small, portable and easy to use platform that has the potential to enable testing to occur in numerous locations.”

About Osmetech plc
Osmetech plc is an AIM-listed public company on the London Stock Exchange. The Company is a fast developing, international diagnostics business with operations in Boston and Pasadena in the US, serving the high growth molecular diagnostic market targeting hospitals and reference laboratories. Osmetech has a strong portfolio of over 200 issued and pending patents and has launched its first generation eSensor 4800 platform, an electrochemistry-based array system, together with an FDA cleared in vitro diagnostic test for Cystic Fibrosis carrier detection. Osmetech’s second generation platform, the eSensor XT-8 received FDA 510(k) clearance in July 2008 together with our eSensor Warfarin Sensitivity Test. These products are now being marketed in the U.S. together with a 2C9 Genotyping Test for drug metabolism and a Cystic Fibrosis carrier detection test which are both available for research use purposes only. In April 2009, Osmetech signed a five-year distribution agreement with Fisher HealthCare, a part of Thermo Fisher Scientific, whereby Fisher HealthCare will distribute Osmetech’s eSensor XT-8 instrument platform and molecular diagnostic tests and consumables in the U.S. The eSensor XT-8 System is designed to support a broad menu of tests and Osmetech has scheduled for commercial launch a number of further tests including: extended warfarin panel with the proprietary 4F2 marker, venous thrombosis (Factor II, Factor V Leiden and MTHFR) and the RESPLEX II respiratory pathogen assay in-licensed from Qiagen. The System provides accurate results while minimizing technician involvement and its features compare favorably to those of other molecular detection systems. Its ease of use, readily interpretable results, speed and low maintenance are particularly suited to the needs of the decentralizing market.

FDA Approves New Influenza Vaccine Production Facility

The U.S. Food and Drug Administration (FDA) today announced that it has approved a new manufacturing facility used to produce influenza virus vaccines. The facility is approved for seasonal influenza vaccine production and could be used for the production of vaccine against the new 2009 H1N1 influenza strain.

As part of its overall pandemic influenza preparedness efforts, the FDA meets with vaccine manufacturers to guide the efficient establishment of influenza vaccine facilities that comply with agency requirements. The agency promptly reviews applications and manufacturing supplements that could increase both the number of manufacturers and the overall supply of vaccine.

The facility, located in the United States, is owned and operated by sanofi pasteur, which manufactures Fluzone Influenza Virus Vaccine. This new facility will greatly increase sanofi pasteur’s production capability.

“This approval represents an important step towards increasing the availability of influenza vaccines,” said Karen Midthun, M.D., the FDA’s acting director of the Center for Biologics Evaluation and Research.

“Increased manufacturing capacity for influenza vaccine is critical to our preparedness for an influenza pandemic,” said Jesse Goodman, M.D., M.P.H., the FDA’s acting chief scientist and deputy commissioner for scientific and medical programs. “This action also enhances the ability to produce and provide vaccines to protect the public from seasonal influenza, still estimated to cause more than 30,000 deaths per year. Thanks to strategic investments by the federal government and proactive efforts and engagement by the FDA and the vaccine industry, our nation’s preparedness has come a long way over the last five years.”

The FDA has interacted with the company throughout the regulatory process to help ensure compliance with applicable requirements.

The bulk manufacturing facility will be used for the production of Fluzone, sanofi pasteur’s egg-based influenza vaccine.

Sanofi Pasteur is located in Swiftwater, Pa.

Multi-Faceted H1N1 Influenza Diagnostic Systems

Evogen, Inc., a molecular diagnostics company, is developing multi-faceted capabilities to address the air-monitoring, detection and diagnosis of Influenza A H1N1, or Swine Flu, in addition to several prevalent flu types.

Evogen’s molecular PCR diagnostic test is capable of rapidly and specifically detecting H1N1 pandemic Influenza, utilizing HyBeacons® technology. The test can be implemented on PCR equipment currently used in laboratories globally or can be operated on Evogen’s EvoCyclerTM HD12, a rapid, portable, affordable PCR platform designed specifically for field use, when and where needed.

The EvoCycler HD12, utilizing HyBeacons tests, provides High Definition PCR results in a simple-to-use molecular diagnostic system that can be implemented at the “front line” in this global pandemic. In addition, Evogen’s validated air-sampling systems designed for airborne pathogen collection may be effective in determining if the Influenza virus is present in the air and not just on surfaces. The combination of air samplers, the EvoCycler HD12 instrument and HyBeacons tests can be used as an integrated system to meet public health needs or used separately with other commercially available technologies. Additionally, tests for the full Influenza spectrum, Flu A, Flu B, Avian Flu (H5N1), Swine Flu (H1N1) and others are available to enable flu related diagnosis.

“HyBeacons is a novel PCR chemistry able to more effectively detect multiple pathogen strains than other commonly used chemistries. This feature is critical to infectious disease detection for pathogens such as Influenza where a strain could shift to a highly pathogenic strain,” said Sean Reineke, Evogen’s President and CEO. “The EvoCycler HD12 is an ideal platform for bringing diagnostic capabilities to the time and place of need, given its portability, low cost and ease-of-use. In addition, our air sampling solutions are deployed in over 1,000 locations worldwide as part of pathogen detection systems. Evogen is focused on delivering tailored systems specifically designed to enhance the decentralization of molecular diagnostics in a variety of fields, moving the capability for detection out to where it is needed. We are positioned to assist organizations involved in the front-line of detection for infectious disease, biodefense or environmental monitoring applications.”

Evogen will request the U.S. Food and Drug Administration (FDA) to grant an Emergency Use Authorization for the specific H1N1 pandemic strain PCR test for use on a variety of platforms including the EvoCycler HD12 instrument as clinical testing is completed. Additionally, Evogen is seeking partners globally interested in validating the platform with currently existing technologies to ensure the most effective and affordable combinations are available to health care professionals, governments and military organizations.

High Definition PCR
High Definition PCR is enabled through the combination of HyBeacons assays operating on the EvoCycler HD12, an innovative instrument that combines ultra-rapid PCR amplification together with detection. Designed for clinical, research, environmental and biodefense applications, the EvoCycler HD12 can simultaneously process, analyze and identify up to 12 samples in less than 30 minutes. The operator-intuitive instrument software automates key tasks, from selection of the most appropriate primers and thermal cycling conditions through to auto-calling of results. HyBeacons assays are designed to detect sections of DNA sequence with a genetic variation, crucial to specific pathogen detection. Together, EvoCycler and HyBeacons provide unsurpassed results in an easy-to-use, affordable, fieldable format.

About Evogen
Evogen, Inc. is the culmination of the merger of two leading independent companies bringing together technologies to meet the ever-evolving needs of the molecular detection and diagnostics industry. Evogen, Ltd., a U.K. molecular diagnostics company and Sceptor Industries, Inc., a U.S. aerosol collection systems company merged to form an entity uniquely positioned to provide accurate, rapid and affordable solutions globally for molecular detection and diagnostics across multiple markets, including research, clinical, biodefense, environmental and animal health. Evogen, Inc. is globally positioned with offices in Kansas City, MO., White Marsh, MD and Bath, U.K.