Vaccines

Pandemrix™ data on co-administration with annual seasonal influenza vaccine (Fluarix®)

09 November 2009, London UK -- GlaxoSmithKline (GSK) today announced the results from the clinical trial assessing Pandemrix™, GSK’s adjuvanted H1N1 pandemic influenza vaccine, administered at the same time as the annual seasonal influenza vaccine, Fluarix ® . The trial showed that co-administration of one dose of both vaccines in separate arms, induced a strong response in adults for both the H1N1 pandemic vaccine as well as the seasonal vaccine. The trial involves 168 adults aged over 60 years of age, and was designed to evaluate the tolerability and immunogenicity of the co-administration of Pandemrix and Fluarix.    » read more »

Approval marks an important milestone in the process of replacing 50 year-old egg-based flu vaccine production with modern biotechnology

November 05, 2009 -- Basel, November 5, 2009 - Novartis announced today that it received approval from the German regulatory authorities for its adjuvanted cell culture-based Influenza A(H1N1) 2009 monovalent vaccine, Celtura®. Novartis continues to pursue registration in other major countries, including Japan and Switzerland.    » read more »

November 2, 2009 -- Q. When will the 2009 H1N1 vaccine be widely available in my community?

All states and the District of Columbia have placed orders for vaccine, and more orders are expected daily. Orders are coming in throughout the day; they're being processed and shipped, and vaccine is arriving in thousands of places across the country.

The vaccine situation changes rapidly and we are slowly seeing the gap between supply and demand begin to close. Because the vaccine distribution system varies by state, the vaccine situation on the ground may differ from community to community.    » read more »

November 2, 2009 -- Healthy pregnant women mount a robust immune response following just one dose of 2009 H1N1 influenza vaccine, according to initial results from an ongoing clinical trial sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health.

“For pregnant women, who are among the most vulnerable to serious health problems from 2009 H1N1 infection, these initial results are very reassuring,” says NIAID Director Anthony S. Fauci, M.D. “The immune responses seen in these healthy pregnant women are comparable to those seen in healthy adults at the same time point after a single vaccination, and the vaccine has been well tolerated.”    » read more »

WASHINGTON, Nov. 3, 2009 – Like protective equipment issued to troops downrange, the H1N1 flu vaccine is a measure the Defense Department is taking to safeguard U.S. military forces, a defense official said today.

“We use other treatment modalities to protect people in the same way we use body armor to protect against other threats,” said Ellen P. Embrey, acting assistant secretary of defense for health affairs.

“The H1N1 vaccine was purchased specifically for our uniformed servicemembers so they could continue to perform their mission anywhere on the globe,” she continued. “And during a pandemic, that’s a real threat.”    » read more »

WASHINGTON, (11/2/09) - The Defense Department has started receiving H1N1 vaccines and will begin distributing doses in the coming weeks.

The Health and Human Services Department is distributing the vaccines, manufactured by four producers, to the department. Because rates of production vary among the manufacturers, supplies are expected to be limited initially, but to increase over time, said Ellen P. Embrey, acting assistant secretary of defense for health affairs.    » read more »

Nov 02, 2009 -- WASHINGTON — As shipments of some 3.7 million doses of H1N1 vaccine ordered by the Defense Department continue to arrive from the manufacturer, more than enough will be available for all military personnel and their beneficiaries, military medical experts say.

Navy Cmdr. Danny Shiau, division chief for the Bureau of Navy Medicine and Surgery's force health protection, and Dr. Robert Morrow, the bureau's preventive medicine programs and policy officer, took questions about the military's seasonal flu and H1N1 preparedness efforts during an Oct. 29 "DoDLive" bloggers roundtable.

Morrow explained why it has taken the primary manufacturer, Novartis, longer than expected to produce the vaccine.    » read more »

Pivotal testing of RTS,S is on track for target enrollment of 16,000 children

NAIROBI, KENYA November 3, 2009 -- A pivotal efficacy trial of RTS,S, the world’s most clinically advanced malaria vaccine candidate, is now underway in seven African countries: Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique and Tanzania. The trial, which is expected to involve up to 16,000 children, is on schedule, with more than 5,000 children already enrolled, researchers announced Tuesday at the 5th Multilateral Initiative on Malaria Pan-African Malaria Conference.    » read more »

Proposed Acquisition Of A Majority Stake In Zhejiang Tianyuan

November 04, 2009 -- Basel, November 4, 2009 - Novartis has reached an agreement to acquire an 85% stake in the Chinese vaccines company Zhejiang Tianyuan Bio-Pharmaceutical Co., Ltd. as part of a strategic initiative to build a vaccines industry leader in this country and expand the Group's limited presence in this fast-growing market segment. This proposed acquisition will require government and regulatory approvals in China.    » read more »

October 19, 2009 -- While every flu season has the potential to cause sickness and visits to the doctor, this year we face not just the seasonal flu but also the H1N1 influenza virus. For this reason, the Centers for Disease Control and Prevention (CDC) recommend that we take extra precautions to protect ourselves against the flu.    » read more »

More H1N1 Vaccine Arrives in State; Influenza Activity in New York Now Considered Widespread

October 16, 2009 -- New York Governor David A. Paterson today announced that as of October 15, New York State’s Medicaid program will provide reimbursement to Medicaid enrolled pharmacies for the administration of seasonal and H1N1 influenza vaccines by certified pharmacists to Medicaid fee-for-service enrollees 18 years and older.

Medicaid managed care and Family Health Plus enrollees will be able to access immunization services through their health plans. The Governor also reported that influenza activity in New York State is now considered widespread, with more than 50 percent of counties reporting influenza activity.    » read more »

More than 80,000 Doses Have Arrived; Thousands More On the Way

October 15, 2009 -- Connecticut Governor M. Jodi Rell today announced that vaccination clinics for the H1N1 virus – the so-called swine flu – are getting underway in Connecticut and more are expected to be scheduled over the next several weeks as shipments of the vaccine continue to arrive in the state.    » read more »

More Licensed Medical Professionals Able to Give H1N1 Flu Shot

October 14, 2009 -- SPRINGFIELD – Illinois Governor Pat Quinn today signed a public health emergency proclamation in a proactive effort to ensure there are enough certified and licensed health care professionals able to administer the H1N1 flu vaccine.

This gubernatorial proclamation allows the Illinois Department of Public Health and the Illinois Department of Financial and Professional Regulation to permit additional certified and licensed health care professionals to administer the H1N1 vaccine.    » read more »

October 6, 2009 -- New York Governor David A. Paterson today announced that the first shipments of the new H1N1 influenza vaccine have started to arrive in New York State.

“Some counties in New York received their first doses of the H1N1 vaccine yesterday,” Governor Paterson said. “More counties are receiving vaccine this week, and we expect to receive larger quantities of the H1N1 vaccine over the coming weeks. Eventually, there should be enough vaccine for every New Yorker who wants it.”    » read more »

Interim data from European studies confirm that one dose of Panenza® or Humenza® pandemic influenza vaccines induces robust seroprotective antibody response in children and adults

Lyon, France – October 8, 2009 - Sanofi Pasteur, the vaccines division of the sanofi-aventis Group (EURONEXT: SAN and NYSE: SNY), announced today that a single dose of influenza A (H1N1) 2009 monovalent vaccines, Panenza® (15 mcg dose, non-adjuvanted) or Humenza® (3.8 mcg dose, adjuvanted), administered to children (3 years of age and older) and adults induces a robust immune response, according to results from clinical trials conducted in Europe.    » read more »