Updates:  The New Vaccines

SV's ScientiaVision line is value-priced and topic-focused to provide detailed, up-to-date information in a rapidly changing marketplace.  To help our clients remain on top of the industry after a report is published, selected vaccine news is presented below:

July 29, 2009:  Scientists at the Walter and Eliza Hall Institute have created a genetically engineered, weakened strain of malaria to be used as a live vaccine.  Plans are for the virus to undergo clinical trials in early 2010.

July 27, 2009:  Sanofi Pasteur announced that it had shipped the first doses of the 2009-2010 formulation of its Fluzone Influenza Virus Vaccine.  

July 27, 2009:  Inovio Biomedical announced that its first SynCon dengue virus DNA vaccine elicited protective antibody responses against all four distinct serotypes of dengue viruses that are transmitted from mosquitoes to humans.  The results of the study were published in the July 3, 2009, issue of Vaccine.

July 27, 2009:  GenVec announced the expansion of its contract with the PATH Malaria Vaccine Initiative, which is aimed at development of vaccines to fight malaria.  The contract is valued at approximately $2 million, and will support preclinical feasibility studies of novel adenovirus-based vaccines.

July 27, 2009:  Pennsylvania-based CSL Biotherapies began shipment of its thimerosal-free seasonal influenza vaccine to U.S. distributors for the 2009-2010 season.  CSL Biotherapies plans to deliver more than 8 million doses, with the majority in the form of single-dose, pre-filled syringes.

July 24, 2009:  The U.S. Centers for Disease Control and Prevention (CDC) strengthened its recommendations for seasonal flu vaccines, stating that all children aged 6 months to 18 years should be immunized.  CDC stressed the importance of seasonal flu vaccines in light of the H1N1 flu pandemic.

July 24, 2009:  Immunomedics announced a partnership and cross-licensing agreement with Alexis Biotech Ltd.  The partnership will develop targeted vaccines for melanoma, chronic lymphocytic leukemia, and AIDS.  The initiative will combine Dock-and-Lock conjugation technology from Immunomedics and its IBC Pharmaceuticals subsidiary with Alexis Biotech's HLA-antibody targeting technology.

July 23, 2009:  Allergy Therapeutics announced that the European Patent Office granted a technology patent relating to Allergy Therapeutics' family of MPL-based sublingual allergy vaccines.  The patent is jointly held with Corixa Inc.

July 23, 2009:  A study of GlaxoSmithKline's Typherix showed that the vaccine protects children as young as 2 years of age from typhoid fever, with a protection rate of 80% among children under the age of 5.  Protection was 56% for children aged 5 to 14, and 46% for those 15 and over.  The overall protection rate was 61%, and seems to confer herd immunity when enough people are vaccinated to slow the spread of the disease.

July 22, 2009:  CSL began clinical trials of its H1N1 vaccine in the start of a seven-month trial with 240 volunteers.  CSL became the second Australian firm to start human trials of an H1N1 vaccine.

July 22, 2009:  California-based REGiMMUNE announced that it entered into a collaboration with Astellas Pharma to develop a new vaccine-platform technology.  The proposed technology will combine Astellas's screening and development capabilities with REGiMMUNE's immune liposome technology.

July 22, 2009:  Novavax announced that it has selected a final respiratory syncytial virus (RSV) vaccine candidate to advance further into preclinical trials. 

July 22, 2009:  Australian firm VAXINE Pty. Ltd. announced that it has begun human clinical trials with a candidate H1N1 influenza vaccine.  The vaccine is utilizes recombinant protein technology combined with the company's Advax adjuvant system.  VAXINE started trials on July 20 with 300 volunteers.

July 21, 2009:  Canadian biotechnology company Medicago announced a partnership agreement with Genopole biopark (Evry, France) to build a commercial facility to manufacture both pandemic and seasonal influenza vaccines.  The facility will be located on Genopole's existing site in France and will utilize Medicago's Proficia plant-based manufacturing platform and Medicago's virus-like particle technology.  

July 20, 2009:  South Africa announced the launch of  clinical trials for an AIDS vaccine.  The AIDS vaccine marks the first AIDS vaccine created by a developing country with assistance from the United States.  Trials in 36 volunteers will begin in South Africa this month; trials in 12 volunteers in Boston started earlier in the year.

July 17, 2009:  AlphaVax announced completion of process development and preclinical immunogenicity studies of its H1N1 influenza vaccine.  Studies showed protective antibody levels after a single dose, with responses increased 8-fold after a second dose at 3 weeks.  AlphaVax plans to have material manufactured for clinical trials by the end of July 2009.

July 14, 2009:  ImmunoVaccine Technologies entered into an exclusive agreement to license seven cancer antigens from Immunotope.  The antigens target breast, ovarian, and prostate cancers.  ImmunoVaccine Technologies will combine the antigens with its DepoVax delivery platform to create DPX-0907, a therapeutic vaccine.  ImmunoVaccine plans to fast-track DPX-0907 into Phase I clinical trials within the next six months.

July 14, 2009:  The U.S. Government is committing more than $800 million to buy more of the two key ingredients used to make H1N1 vaccine.

July 14, 2009:  Wyeth's Prevenar 13-valent pneumococcal vaccine received its approval, which was awarded by the Chilean Ministry of Health.

July 14, 2009:  Merck KGaA stated that it is completely convinced its therapeutic cancer vaccine Stimuvax will work and initiated Phase III trials for use of Stimuvax in breast cancer.

July 14, 2009:  Again stating that the new H1N1 virus is "unstoppable," the World Health Organization gave vaccine manufacturers a full go-ahead to produce H1N1 vaccines and stated that healthcare workers should be the first to be vaccinated.

July 13, 2009:  Inovio Biomedical Corporation announced that its SynCon H1N1 DNA vaccines elicited protective antibody responses to H1N1 virus in 100% of pigs immunized in a two-dose regimen.

July 12, 2009:  Israeli firm NasVax Ltd. announced that it had closed on purchasing 100% of the shares of Protea Vaccine Technolories, another Israeli company.  In June 2009, Protea announced a research and licensing agreement with GlaxoSmithKline for Protea's pneumococcal proteins to be used in a Streptococcus pneumoniae vaccine.

July 12, 2009:  U.S. Department of Health and Human Services Secretary Kathleen Sebelius stated that the U.S. Government will spend another $1 billion on ingredients for an H1N1 vaccine.

July 9, 2009:  Addressing government leaders at a swine flu summit, Kathleen Sebelius, Secretary of the U.S. Department of Health and Human Services, stated that an H1N1 vaccine should be ready for distribution in mid-October and warned that the impact of H1N1 may worsen in the fall with a more severe form of the virus.  Sebelius said that the government would announce $350 million in preparedness grants on Friday:  $260 million for state health departments and $90 million for hospitals.

July 9, 2009:  The U.S. Food and Drug Administration (FDA) completed a review of PharmAthene's proposed development plan for SparVax next-generation recombinant protective antigen (rPA) anthrax vaccine.  According to PharmAthene, the company is not required to make any significant changes to its plan, and the company expects to recommense contract negotiations with the Biomedical Advance Research and Development Authority (BARDA).  PharmAthene is developing SparVax under the U.S. Department of Health and Human Services' intent to acquire 25 million doses of an rPA for the Strategic National Stockpile.  PharmAthene's contract to develop SparVax was issued by the National Institutes of Health, but was transferred to BARDA on April 1, 2009.

July 8, 2009:  A study published in the July 8 issue of JAMA shows that both infants receiving two doses of 7-valent pneumococcal conjugate vaccine and infants receiving three doses of the vaccine carried a reduced rate of pneumococcal microorganisms that cause pneumonia and other infections.  

July 8, 2009:  Vical announced that its TransVax therapeutic DNA cytomegalovirus (CMV) vaccine produced positive results compared with placebo at the 4-month interim analysis during a Phase 2 trial.  The trial is scheduled for completion in the fourth quarter of 2009, with final data available expected to be available during the first half of 2010.

July 7, 2009:  Vical announced that it will report Phase 2 trial results for its TransVax therapeutic DNA vaccine on July 8, 2009.  TransVax is intended to prevent cytomegalovirus (CMV) reactivation and disease among immunosuppressed stem cell transplant recipients.  Results will be presented in a news release and conference call/webcast.  The call will include Vical management, as well as CMV and organ transplant expert Mark D. Pescovitz, M.D., who is Professor of Surgery and Microbiology & Immunology, and Vice Chair of Research in Surgery at the Indiana University School of Medicine.

July 7, 2009:  California-based Neugenesis Corporation announced that it will collaborate with PATH to develop Neugenesis's NeuBIOS protein production platform for making seasonal and pandemic influenza vaccine.

July 7, 2009:  Final analysis of the large-scale efficacy trial of GlaxoSmithKline's Cervarix cervical cancer vaccine are published in The Lancet.  The study was the largest of any cervical cancer vaccine and involved 18,644 women.  The study showed that Cervarix is highly effective in protecting against human papillomavirus (HPV) types 16 and 18, and provides cross-protection against HPV types 31, 33, and 45, constituting protection against the five most common cancer-causing viruses.  Cervarix comprises a novel adjuvant (AS04) designed to deliver high and sustained levels of antibodies in order to provide long-term protection against HPV 16 and 18.  Cervarix has been approved in 97 countries, with licensing applications submitted in over 20 additional countries, including Japan and the United States.

July 7, 2009:  It was announced that researchers at the South Texas Center for Emerging Infectious Diseases and the Department of Biology at the University of Texas at San Antonio have genetically engineered a live, attenuated vaccine against San Joaquin Valley Fever (coccidioidomycosis), which is caused by the Coccidioides fungus.  The vaccine was shown to successfully protect mice against Valley Fever.

July 6, 2009:  Theraclone Sciences and the International AIDS Vaccine Initiative announced that they are expanding their discovery program for HIV antibodies.

July 1, 2009:  CSL is getting ready to begin clinical trials of an H1N1 vaccine.  The trials will take place in Adelaide, Australia, and calls for trial participants to receive two injections of the vaccine three weeks apart.  The trial is expected to begin in mid-July and is a step toward CSL's fulfilling a commitment to the Australian Department of Health and Ageing to supply up to 10 million people with an H1N1 vaccine.

July 1, 2009:  The U.S. Food and Drug Administration (FDA) has asked Novartis for more information on Novartis's Menveo vaccine to prevent meningitis.  Following the request, Novartis said that it does not expect the FDA to rule on approval of Menveo until 2010.

July 1, 2009:  The World Health Organization stated that a study showed that tuberculosis vaccine can cause death if administered to babies with HIV.

June 30, 2009:  Vical announced that its A/H1N1 vaccine produced robust immune responses in 100% of vaccinated mice and rabbits after a two-dose vaccine regimen.  At least 75% of the vaccinated animals met or exceeded the protection threshold after a single dose.  Vical is now trying to secure external funding in order to advance to large-scale cGMP manufacturing of the vaccine for human clinical trials.

June 30, 2009:  Inovio Biomedical announced that it has established a collaboration with the National Microbiology Laboratory of the Public Health Agency of Canada and the University of Pennsylvania to evaluate Inovio's DNA H1N1 vaccine candidates.

June 30, 2009:  Vical announced that its H1N1 vaccine elicited positive immune response in preclinical trials.

June 29, 2009:  Biovest International, a subsidiary of Accentia Biopharmaceuticals, announced that its BiovaxID personalized therapeutic anti-cancer vaccine is now available on a compassionate use basis in Europe.  BiovaxID will be supplied by idis Limited to healthcare professionals in Europe for treatment of follicular non-Hodgkin's lymphoma and possibly for other B-cell blood cancers.

June 26, 2009:  Creato Flu GmbH announced that it is working on an innovative approach to develop an orally delivered, broad-spectrum influenza vaccine that is expected to be effective against all types of influenza virus.

June 26, 2009:  The U.S. Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) voted to include Intercell's Ixiaro Japanese encephalitis vaccine on an updated recommendation list for travelers to countries in Asia where the disease is endemic, as well as for Americans living in high-risk areas.

June 26, 2009:  Radiant Research announced that it is recruiting subjects for trials of H1N1 vaccine and establishing operational plans for those trials.

June 25, 2009:  Sanofi Pasteur announced that it has increased its supply of Hib-containing vaccines.  Beginning July 1, 2009, the U.S. Centers for Disease Control and Prevention will reinstate its recommendation for a booster dose after 12 months of age.  Sanofi Pasteur continues to be the sole supplier of Hib vaccine to the U.S. market, as it has been since 2007.

June 25, 2009:  The U.S. Centers for Disease Control and Prevention announced that it plans to reinstate booster shots of Hib vaccine to protect children against bacterial meningitis.  The booster shot was dropped in 2007 due to supply shortages caused by a recall by Merck.  Sanofi Pasteur has increased production of Hib vaccine, and the increase is expected to generate sufficient vaccine to allow for reinstatement of the Hib booster shot for children aged 12 to 15 months in July 2005.  

June 24, 2009:  A U.S. immunization panel voted to include Intercell's Japanese encephalitis vaccine in its list of vaccines recommended for U.S. travelers.

June 24, 2009:  PepTcell Ltd. announced that it received approval to begin Phase 1b clinical trials of its HIV vaccine in the United Kingdom.  The HIV-v vaccine elicits strong B-cell and T-cell responses to regions of the virus that do not change between variants.

June 24, 2009:  A trial in the Philippines that was coordinated by the National Institute for Health and Welfare found that pneumococcal vaccine is effective in preventing severe pneumonia and reduces child deaths in developing countries.  The large-scale efficacy trial was conducted between 2000 and 2004.

June 23, 2009:  Novavax announced that preclinical study results of its investigational virus-like particle vaccine against H3N2, H1N1, and B influenza strains have been published.  The study showed that the vaccine elicited strong responses in mice and ferrets.  The vaccine is now in Phase II clinical testing.

June 23, 2009:  The U.S. Centers for Disease Control and Prevention announced that only 40% of adult asthmatics received recommended flu shots during the 2006-2007 flu season.

June 23, 2009:  The U.S. Department of Health and Human Services announced that it awarded Protein Sciences Corporation a $35-million contract to pursue advanced development of a new means for manufacturing influenza vaccine.  The contract can be extended up to five years for a total cost of around $147 million.  

June 22, 2009:  Belgium's Solvay noted that it did not secure a Dutch government contract to supply H1N1flu virus vaccine to the Netherlands because it could not supply the product within the required timeframe.

June 22, 2009:  Pevion Biotech and Bio Life Science announced that Phase I clinical trials of their virosome-based breast cancer vaccine were successful.  The vaccine, which comprises three peptide epitopes of HER-2/neu attached to virosomes, is intended to prevent tumor recurrence among breast cancer patients following treatment of the primary tumor.  The vaccine was found to be safe, well tolerated, and immunogenic for patients who were moderately over-expressing HER-2/neu.

June 19, 2009:  Geneart AG announced that it was awarded a contract by the United Kingdom to design and produce a DNA vaccine mixture against HIV.   Geneart will work with two DNA vaccine candidates that were developed by Geneart in cooperation with the Institute of Medical Microbiology and Hygiene at the University of Regensburg. 

June 19, 2009:  Avir Green Hills Biotechnology of Vienna announced that data from preclinical studies confirmed safety and immunogenicity of a new intranasal H5N1 influenza vaccine.  The intranasal technology is also suitable for swine flu vaccines.

June 19, 2009:  Sinovac Biotech receives the first order in China for supplying influenza A/H1N1 vaccine.  The order of 4 million doses is expected to be delivered by the end of September with an additional 10 million doses expected to be ordered beginning in October 2009.

June 18, 2009:  Vical has completed its second-year milestones for the RapidResponse system under a grant awarded by the national Institute of Allergy and Infectious Diseases, National Institutes of Health.  The three-year, $6-million grant focuses on development of a DNA vaccine manufacturing process that can produce several million doses of vaccine in days with low capital requirements.

June 17, 2009:  Crucell is acquiring a FlexFactory bioproduction line and multiple XDR single-use bioreactors from Xcellerex in order to more quickly produce vaccines and monoclonal antibodies.

June 17, 2009:  VaxInnate Corporation reported positive preclinical results for a recombinant swine flu vaccine that was developed in less than three weeks.

June 16, 2009:  GlaxoSmithKline (GSK) and Protea Vaccine Technologies Ltd. executed a collaboration and option agreement that grants GSK the option to obtain an exclusive license to Protea's pneumococcal proteins for development and commercialization of a universal protein-based Streptococcus pneumoniae vaccine.  The  deal calls for Protea to receive 2.4 million Euros in research and development funding, with upfront license fee and subsequent milestons payments totaling approximately 17 million Euros.  Protea would also receive royalties.

June 15, 2009:  Protein Sciences Corporation announced that it has begun manufacturing of an H1N1 vaccine.  The company estimates that it can produce 100,000 doses per week of its PanBlok vaccine.  Following bulk production, the vaccine will undergo quality tests and clinical trials.

June 15, 2009:  China’s Sinovac Biotech announced it has completed construction of its H1N1 seed bank required to produce virus antigen.  Sinovac received seed virus from the U.S. Centers for Disease Control and Prevention on June 8, 2009.

June 15, 2009:  Researchers in Toronto said that the flu drugs Tamiflu and Relenza appear to be relatively safe in pregnant or lactating women.

June 12, 2009:  Baxter announced it is commencing full-scale production of H1N1 vaccine.  Baxter received an H1N1 strain from the U.S. Centers for Disease Control and Prevention in May and aims to deliver a pandemic vaccine in July 2009.

June 12, 2009:  Novartis produced its first batch of H1N1 vaccine and plans to begin clinical trials in July 2009.

June 12, 2009:  The World Health Organization reported that the number of swine flu cases is close to reaching 30,000, with 29,669 cases of H1N1 flu reported in 74 countries.  There have been 145 deaths worldwide.  There have been 13,217 cases in the United States and 6,241 cases in Mexico.

June 11, 2009:  The World Health Organization (WHO) declared the start of a global pandemic, raising the alert level to Phase 6, WHO’s highest designation.  The designation reflects the spread of the virus, not the severity of illness caused by the virus.

June 11. 2009:  The merger of Merck and Schering-Plough will result in the loss of 16,000 jobs.

June 11, 2009:  Wyeth’s Prevenar 13 may provide coverage against the 13 most prevalent serotypes responsible for pneumococcal disease, according to Phase III data from European clinical trials.

June 10, 2009:  CEL-SCI Corporation announced that it is expanding preclinical testing of its flu vaccine to determine whether the vaccine can target mutated versions of H1N1 swine and other flu viruses.  The vaccine was already in preclinical testing against non-mutated H1N1 flu viruses.

June 10, 2009:  Emergent BioSolutions announced that the U.S. Food and Drug Administration approved a shelf life extension of BioThrax from 3 years to 4 years.  The approval gives Emergent BioSolutions another $30 million under the company’s contract with the U.S. Department of Health and Human Services.

June 10, 2009:  GlaxoSmithKline opened its state-of-the-art, $600-million vaccines plant in Singapore.

June 9, 2009:  The U.S. Food and Drug Administration approved a label change to strengthen the warning regarding syncope—or fainting—for Merck’s Gardasil.  The new warning cautions that all vaccine recipients should remain seated or lying down and be closely observed for 15 minutes following vaccination in order to prevent falls and injuries.

June 9, 2009:  DxNA announced that it submitted a request to the U.S. Food and Drug Administration for Emergency Use Authorization (EUA) for DxNA’s GeneSTAT test for detecting H1N1 flu virus.

June 9, 2009:  GlaxoSmithKline entered into a $34 million agreement to form a joint venture with Shenzhen Neptunus Interlong Bio-Technique Co. Ltd. that will develop and manufacture influenza vaccines for the Chinese market.

June 8, 2009:  Chinese vaccine company Sinovac Biotech Ltd. Announced that it is beginning production of H1N1 vaccine, having received seed virus from the U.S. Centers for Disease Control and Prevention.

June 5, 2009:  The World Health Organization recommends rotavirus vaccine for all children, which is expected to increase sales of both Merck’s RotaTeq and GlaxoSmithKline’s Rotarix.

June 4, 2009:  Novavax signed an agreement with the Division of Microbiology and Infectious Diseases of the National Institute of Allergy and Infectious Diseases, National Institutes of Health.  The agreement calls for cooperation in evaluating a virus-like particle vaccine  against H1N1.

June 2, 2009:  Warnex announced the launch of a real-time polymerase chain reaction (RT-PCR) test to detect H1N1 flu virus, with results in as little as 8 hours.

June 2, 2009:  Researchers in Bogota, Colombia, published research showing that women aged 24-45 could benefit from vaccination with Merck’s Gardasil if they have not already been infected with HPV.

June 1, 2009:  China has implemented a program to reduce development time of H1N1 flu vaccine and aims to start producing vaccine by mid-July.

May 29, 2009:  CSL Biotherapies announced that it contracted with the U.S. Department of Health and Human Services to provide bulk Novel A (H1N1) influenza vaccine antigen.  The initial order is for $180 million, and HHS will fund clinical trials.

May 29, 2009:  U.S. Centers for Disease Control and Prevention states that H1N1 vaccine will not be ready for widespread use until October 2009, even though companies are already starting preliminary work.

May 27, 2009:  Older adults may have preexisting antibodies against H1N1 virus, according to a study in the Center for Disease Control and Prevention’s Morbidity and Mortality Weekly.  This would explain the virus’s being more prevalent among younger, healthier populations.

May 27, 2009:  Schering-Plough was notified that Johnson & Johnson has initiated arbitration in order to resolve the dispute over termination of a distribution agreement regarding Remicade and Simponi.  The dispute stems from the merger between Merck and Schering-Plough.

May 27, 2009:  Sanofi Pasteur announced it had received the new H1N1 influenza seed virus, which enabled Sanofi Pasteur to begin the production process for an H1N1 vaccine.

May 26, 2009:  The World Health Organization pre-qualifies Merck’s Gardasil, making it the first cervical cancer vaccine to receive pre-qualification.

May 26, 2009:  Sanofi Pasteur received an order from the U.S. Department of Health and Human Services to begin production of an H1N1 vaccine.  The initial order is valued at $190 million. 

May 26, 2009:  Vaxart has created an H1N1 vaccine candidate and began immune response tests in animals on May 23, 2009.  An initial batch of human H1N1 vaccine could be produced by August, with human testing to begin after safety testing in animals.

May 23, 2009:  Biotech firm Replikins Ltd. determined that the infectivity of the H1N1 virus will increase markedly and the lethality will remain relatively low over the immediate future.  Replikins made the determinations after analyzing the most recent peptide genomic sequence data.

May 22, 2009:  The U.S. Department of Health and Human Services is directing approximately $1 billion to be used for clinical studies of H1N1 vaccines that will be run over the summer and for commercial production of two potential vaccine ingredients for the pre-pandemic influenza stockpile.

May 21, 2009:  Vical announced that the company completed a prototype H1 vaccine, produced a supply of research-grade vaccine, and began immunogenicity testing in animals.  If tests are successful, the company will advance to large-scale manufacturing of the vaccine for human clinical trials that will be conducted by the U.S. Navy.

May 20, 2009:  GlaxoSmithKline offers to donate 50 million doses of pandemic flu vaccine to the World Health Organization in the event of a global flu outbreak.

May 19, 2009:  U.S. Centers for Disease Control and Prevention officials stated that they fear the new H1N1 influenza virus may mix with drug-resistant versions of seasonal flu, since H1N1 is now so widespread.

May 18, 2009:  GlaxoSmithKline and Oxford BioTherapeutics entered into a strategic alliance to develop novel therapeutic antibodies against cancer.  Oxford received an initial payment in the deal, which could be worth as much as $370 million.

May 15, 2009:  Several governments expressed in stockpiling GlaxoSmithKline’s H1N1 vaccine.

May 14, 2009:  Roche announced that its detection kit for influenza A/H1N1 virus is available for use in life science research.  Roche is filing for approval of the kit for use in emergency situations.  The kit runs on Roche’s LightCycler systems.

May 13, 2009:  Emergent BioSolutions announced it submitted a regulatory plan for its Recombinant Protective Antigen (rPA) anthrax vaccine to the U.S. Department of Health and Human Services.

May 13, 2009:  Medicago successfully expressed a new virus-like particle from the influenza A/H1N1 strain.

May 13, 2009:  SRI International announced that it will work under a contract from the Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, to screen drugs for effectiveness against H1N1 influenza A virus.  SRI will screen a library of drugs with well-characterized safety and toxicity profiles.

May 11, 2009:  Quest Diagnostics introduced a real-time polymerase chain reaction (RT-PCR) test to identify type A H1N1 influenza.  The test, offered by Quest’s Focus Diagnostics infectious disease reference laboratory, is the first testing service offered by a commercial laboratory to identify patients infected with H1N1 virus or seasonal influenza A, and differentiate between the two.

May 8, 2009:  Emergent BioSolutions launched www.BioThrax.com.

May 8, 2009:  GlaxoSmithKline announced that its Cervarix HPV vaccine produced a more powerful response than Merck’s Gardasil.

May 8, 2009:  A follow-up study of 290 women showed that the HPV 16 component of Merck’s Gardasil (Types 6, 11, 16, 18) is efficacious against HPV 16 for an average of 8.5 years after administration.

May 8, 2009:  Juvaris BioTherapeutics announced results demonstrating that its universal influenza vaccine produced robust antibody responses and complete protection against H1N1 and H3N2 in preclinical challenge models.

May 7, 2009:  The U.S. Food and Drug Administration granted priority review for Wyeth’s Prevnar 13, a 13-valent pneumococcal vaccine.

May 7, 2009:  Scientists with the Public Health Agency of Canada completed full genetic sequencing of H1N1 swine flu.

May 5, 2009:  Life Technologies Corporation is helping accelerate detection of influenza A H1N1 by providing its Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument and its research-use-only Applied Biosystems 7500 Fast Real-time PCR System to public health laboratories across the United States and around the world to support all 50 states, the U.S. Centers for Disease Control and Prevention, and the World Health Organization.

May 5, 2009:  Tib Molbiol, Roche’s German cooperation partner, announced the development of its LightMix test to identify the influenza A H1N1 virus.  The test is optimized for Roche LightCycler systems and will initially be launched in Europe and Asia.

May 4, 2009:  The Indian firm Ocimum Biosolutions announced the launch of a research-use-only microarray-based test for H1N1 flu virus.  The company updated its custom chip probes with sequence information on the latest strain of swine flu obtained from the National Center for Biotechnology Information, National Library of Medicine, National Institutes of Health.  The U.S. Centers for Disease Control and Prevention and the U.S. Food and Drug Administration have authorized the emergency use of an RT-PCR based molecular diagnostic assay to identify cases of swine flu in the current outbreak in the US.

May 4, 2009:  Replikens Ltd.’s new synthetic peptide H1N1 is available for testing worldwide.  In April 2008, Replikens provided advance warning of an H1N1 outbreak/pandemic using the company’s patented Replikin Count genomics technology. 

April 30, 2009:  Arrayit Corporation announced it is developing a microarray-based diagnostic test to detect the H1N1 swine flu virus.  The company plans to commence mass production of its test kits within the next several weeks.  The kits will be sent to the U.S. Centers for Disease Control and Prevention for validation, then sold for emergency use to licensed clinics, laboratories, and healthcare organizations worldwide.

April 29, 2009:  The World Health Organization’s (WHO) Emergency Committee met for the third time, and raised the pandemic alert level from Phase 4 to Phase 5.  Nine countries had reported 148 cases of H1N1 influenza.

April 29, 2009:  DxNA announced that it is developing a test for the H1N1 virus for the company’s GeneSTAT pathogen detection platform.  The test will detect the H1N1 virus in approximately 45 minutes on a portable device that weighs less than 10 pounds.  DxNA anticipates having a product ready for evaluation within one to two weeks.

April 29, 2009:  Singapore-based Veredus Laboratories announced that its current VereFlu is able to detect the H1N1 swine flu virus.  The VereID Biosystem and VereFlu, launched in 2008, utilize the ST Microelectronics lab-on-chip platform.  The test integrates polymerase chain reaction (PCR) and a microarray onto a lab-on-chip platform.  The test can identify and differentiate human strains of influenza A (H1, H3, H5, H7, and H9) and B viruses, including avian flu strain H5N1, and the current H1N1 swine flu on a single test.

April 27, 2009:  The World Health Organization’s (WHO) Emergency Committee met for the second time, noting that containment of the outbreak is not feasible and elevating the pandemic alert from Phase 3 to Phase 4.

April 25, 2009:  The World Health Organization’s (WHO) Emergency Committee met, resulting in the WHO Director-General’s declaring a formal “public health emergency of international concern.”

April 24, 2009:  The World Health Organization issues its first Disease Outbreak Notice, confirming infection with H1N1 virus in the United States and Mexico.

April 24, 2009:  The Centers for Disease Control and Prevention confirms that 7 of 14 samples in Mexico contain the same virus strain found in California and Texas, and states that containment in the United States is “not very likely.”

April 23, 2009:  The Public Health Agency of Canada confirms that Mexican outbreak is of swine-origin influenza A (H1N1).

April 21, 2009:  First reports of H1N1 outbreak as the U.S. Centers for Disease Control and Prevention (CDC) alerts physicians to swine flu cases in Southern California.

April 14, 2009:  Novavax announces publication of preclinical results demonstrating that the company’s virus-like particle vaccine candidate provides protection against H1N1 Spanish flu and H5N1 bird flu strains.  The study was conducted by Novavax and scientists at the U.S. Centers for Disease Control and Prevention.

March 31, 2009:  Wyeth submitted a marketing application to the U.S. Food and Drug Administration for the use of Prevnar 13 in preventing pneumococcal disease in infants and toddlers.  Prevnar 13 is intended to provide protection against the 13 serotypes most often associated with pneumococcal disease.

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