Experimental Avian Flu Vaccine

NIAID Initiates Trial of Experimental Avian Flu Vaccine, Fast-track recruitment has begun for a trial to investigate the safety of a vaccine against H5N1 avian influenza, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), announced today.

Sites in Rochester, NY, Baltimore and Los Angeles will enroll a total of 450 healthy adults. The clinical sites are part of the NIAID-sponsored Vaccine and Treatment Evaluation Units (VTEU).

“While there have been relatively few cases worldwide of H5N1 avian influenza infection in humans, the public health community is concerned that the virus will develop the capability of efficiently spreading from human to human and thus create a risk for a worldwide pandemic,” says NIAID Director Anthony S. Fauci, M.D.

“NIAID has supported research on H5N1, the strain responsible for this deadly form of avian influenza, since 1997 when the first cases in humans were reported. The initiation of this vaccine trial marks a key advance in our efforts to prepare to respond to an avian flu pandemic,” adds Dr. Fauci.

Sanofi pasteur, Swiftwater, PA, manufactured the trial vaccine, which is an inactivated vaccine made from an H5N1 virus isolated in Southeast Asia in 2004. Sanofi pasteur, formerly Aventis Pasteur, was awarded a contract by NIAID to manufacture the H5N1 vaccine in May 2004.

This Phase I trial will test the vaccine’s safety and ability to generate an immune response in 450 healthy adults aged 18 to 64. If the vaccine is shown to be safe in adults, there are plans to test it in other populations, such as the elderly and children.

H5N1 avian influenza leads to severe disease in both birds and humans. Between January 2004 and March 11, 2005, there were 69 confirmed cases of and 46 deaths from H5N1 infection in humans reported to the World Health Organization. To date, there has been a small number of cases where human-to-human transmission of the virus may have occurred. However, public health experts fear that the virus may evolve into one that is more easily transmitted between people. If this were to happen, a worldwide pandemic could follow.

Influenza pandemics are global outbreaks that emerge infrequently and unpredictably and involve strains of virus to which humans have little or no immunity. H5N1 is one such flu virus strain. The last influenza pandemic swept the globe in 1968; many public health officials believe the world is overdue for another one.

The VTEUs now enrolling adult volunteers are

• University of California at Los Angeles (Joel Ward, M.D., Principal Investigator)
• University of Maryland School of Medicine, Baltimore, MD (James Campbell, M.D., P.I.)
• University of Rochester School of Medicine and Dentistry, Rochester, NY (John Treanor, M.D., P.I.)

In addition to the previous contract awarded to sanofi pasteur, in May 2004 NIAID also awarded a contract to Chiron Corporation of Emeryville, CA, to produce H5N1 vaccine for clinical trials.

NIAID is a component of the National Institutes of Health, an agency of the U.S. Department of Health and Human Services. NIAID supports basic and applied research to prevent, diagnose and treat infectious diseases such as HIV/AIDS and other sexually transmitted infections, influenza, tuberculosis, malaria and illness from potential agents of bioterrorism. NIAID also supports research on transplantation and immune-related illnesses, including autoimmune disorders, asthma and allergies. SOURCE: National Institute of Allergy and Infectious Diseases (NIAID)

FOR IMMEDIATE RELEASE Wednesday, March 23, 2005 CONTACT: Anne A. Oplinger 301- 402-1663

Centers for Medicare & Medicaid Services (CMS) hospital conditions of participation

MEDICARE PUBLISHES PROPOSED RULE UPDATING HOSPITAL CONDITIONS OF PARTICIPATION

The Centers for Medicare & Medicaid Services (CMS) today announced a proposed rule to alleviate hospitals of overly burdensome regulations and allow doctors and nurses to focus more time and energy on patient care.

The proposed rule would revise requirements in the hospital conditions of participation (CoPs) for completion of history and physical (H&P) examinations, authentication of verbal orders, securing medications, and completion of post anesthesia evaluations.

“Based on extensive input from health professionals and the health care community, we are proposing to revise some specific aspects of our regulations to provide better support of the delivery of high-quality, up-to-date care at a lower cost,” said CMS Administrator Mark B. McClellan, M.D., Ph.D.

These revisions were contained in the notice of proposed rule making (NPRM) published December 19, 1997, entitled “Medicare and Medicaid Programs; Hospital Conditions of Participation; Provider Agreements and Supplier Approval,” which contained extensive revisions to the entire set of hospital CoPs. Other changes in the hospital CoPs are coming, building on these steps to avoid unnecessary burdens while promoting high-quality care.

“To keep up with changes in effective medical practice, we believe it is in the interest of the health care community as a whole for us to move forward with these changes,” McClellan said.

The revised requirements include:

• H&P examination. The proposed requirement would expand the number of permissible practitioners who may perform the H&P and the time frame for its completion.
• Authentication of verbal orders. This regulation would require that all orders, including verbal orders, must be dated, timed, and authenticated by a practitioner responsible for the care of the patient. During a five year transition period from publication of the final rule, it would allow all orders, including verbal orders, to be dated, timed and authenticated by the prescribing practitioner or another practitioner responsible for the care of the patient. This would respond to public comments, reduce burden, and provide flexibility for hospitals in meeting the requirements for authentication of verbal orders. CMS expects that sunsetting this flexibility after a five year period is sufficient time for the adoption of changes in health care information technology to make it easy for prescribing practitioners to authenticate all of their own orders in a timely fashion. Additionally, the proposed rule states that in the absence of a State law specifying the timeframe for authentication of verbal orders, verbal orders would need to be authenticated within 48 hours. Finally, this requirement clarifies and reinforces current regulations regarding who may accept verbal orders, authentication of all orders for drugs and biologicals, and authentication of medical record entries.
• Security of Medications. This regulation requires that all drugs and biologicals be kept in secure areas, or locked when appropriate, to prevent unauthorized persons from obtaining access. This regulation addresses community concerns, provides flexibility for hospitals in determining control of nonscheduled drugs and biologicals, and is more patient-focused and outcome-oriented than the current requirement.
• Post anesthesia evaluation. This requirement permits the post anesthesia evaluation for inpatients to be completed and documented by any individual qualified to administer anesthesia. The current CoP requires that the individual who administers the anesthesia do this evaluation.

The intent of this proposed rule is to ensure that our requirements are consistent with current standards of practice, to provide hospitals and practitioners greater flexibility in meeting the needs of patients, and to reduce unnecessary regulatory burden for hospitals.

The proposed rule may be found at cms.hhs.gov. # # #

Medicare News For Immediate Release: Contact: Thursday, March 24, 2005 CMS Office of Public Affairs202-690-6145 For questions about Medicare please call 1-800-MEDICARE or visit medicare.gov. SOURCE: Centers for Medicare & Medicaid Services