Testimony By Guthrie Birkhead, M.D., M.P.H. Deputy Commissioner New York State Department of Health
Presented to
- Assembly Standing Committee on Health
- Assembly Standing Committee on Labor
- Assembly Standing Committee on Education
- Assembly Standing Committee on Higher Education
- Assembly Standing Committee on Workplace Safety
October 13, 2009
New York, New York
Assemblyman Gottfried, Assemblywoman John, Assemblywoman Nolan, Assemblywoman Glick and Assemblyman Lancman: thank you for the opportunity to testify today and present the New York State Department of Health's response to the 2009 H1N1 influenza. I am Dr. Guthrie Birkhead, Deputy Commissioner for Public Health at the New York State Department of Health.
Our response to H1N1 influenza this fall has benefited from experience with this virus last spring and summer, three years of pandemic influenza planning from 2006 to 2008, as well as our experience with the 2004 flu vaccine shortage and our general state of preparedness to deal with all hazards from weather events, to disease outbreaks, to possible terrorist events. We have learned that our response to public health problems like H1N1 is very dependent on the cooperation and joint activities of the state health department, other state agencies, local health departments, and other partners throughout the health care system. This collaboration is one of the strengths of our public health system in New York.
Last April New York Governor David Paterson directed the state health department to activate its health emergency preparedness plan in response to cases of H1N1 in NYS. This plan was developed over a number of years of pandemic planning and involves the collaboration of programs across the health department, other state governmental agencies and local public health departments. Over the past months both Governor Paterson and Commissioner of Health Daines have been involved in the response with public appearances, multiple press conferences and meetings with providers and consumers.
The primary activities during the H1N1 response have included implementation of targeted surveillance and laboratory testing activities and multiple communication strategies including a toll-free hotline available 24/7, and ongoing communications with county health departments, hospitals, clinics, doctors' offices, schools and other partners. Governor Paterson directed his agencies to develop a coordinated response and supported conduct of a series of town hall style meetings at locations throughout the State to provide in-person briefings on clinical care, surveillance, community mitigation, vaccine and education and outreach.
We learned many lessons from the spring but we still have a lot to learn. We have learned that H1N1 is not a "1918" style pandemic in terms of clinical severity. The clinical spectrum of H1N1 is more similar to seasonal flu than the flu seen in 1918. We have also learned that there is little background immunity to H1N1 in the general population. As a result H1N1 spreads rapidly in children and young adults. Pregnant women have been identified as a population at increased risk of severe complications and as a result are a priority group for vaccination. Unlike the seasonal flu, we have seen relatively little infection in the elderly population suggesting that they may have some immunity possibly as a result of past exposures. With widespread transmission, it is inevitable that some people with underlying medical conditions will experience severe illness and risk death. It is important to note that seasonal flu kills on average 2000 New Yorkers each year; we can expect H1N1 to have a similar impact.
Current H1N1 flu activity
Nationally influenza activity attributed to 2009 H1N1 viruses increased during September 2009 beginning in the southern states where school starts in early August. H1N1 is expected to continue through the fall and winter influenza season. In New York State, our surveillance systems outside New York City indicate that flu activity is starting to increase. New York's flu activity is currently classified as widespread under the CDC's classification system indicating that more than 50 percent of reporting jurisdictions indicate the presence of flu. New York's flu status has gone from sporadic to localized to regional activity to now widespread activity over the last four weeks. To date this fall, the number of people hospitalized with flu remains low but may be starting to increase. Rates of visits for influenza-like-illness are also increasing in Emergency Departments and sentinel providers. So far this fall there have been three known H1N1 associated deaths. There is at least one school district upstate with significant disease and several college campuses have reported disease with one death in a college student.
We may now be at the beginning of our third influenza season this year, the seasonal flu season last February and March, the H1N1 outbreak in May and June, and now the return of H1N1. However, we don't know for sure how the fall and winter flu seasons will unfold. A telephone survey conducted in New York City last spring found that between 6 and 10 percent of all New Yorkers surveyed had experienced influenza-like-illness. The spring flu outbreak may have been truncated by the end of school and the beginning of the warm weather season. Had the flu season continued, as it now appears it may do over the coming fall and winter months, we could possibly see up to 35 to 40 percent of the population impacted by the new flu strain - two to three times that which we experienced in the spring. The experience with flu in states in the southern part of the country suggests a surge three to four weeks following the start of the school year. We are just entering that period in New York State
It should be noted that some cities are reporting near-normal levels of flu activity for this time of year. The cities, including New York, are those that were hardest hit at the outset of the 2009 H1N1 flu pandemic. New York, which had widespread school closures in the spring, is reporting normal attendance; the same holds true for Boston and Philadelphia. One theory to explain the relative lack of flu in these cities — as opposed to the rest of the country where activity is widespread — is that the earlier outbreaks conferred enough "herd immunity" to protect them now. This theory is plausible; only time would tell whether it's accurate.
New York State tracks and evaluates flu prevalence and severity using a multi-faceted reporting system. Five different reporting mechanisms are used to track the flu including an electronic clinical laboratory reporting system which feeds laboratory reports of H1N1 directly to the state; hospital reporting of emergency department visits for influenza-like-illness and hospitalized influenza cases; reports by physicians of patient visits for influenza like illness at selected offices around the state; deaths associated with influenza like illness; and prescriptions filled for antiviral medications. The results of this reporting system are on the Health Department website with statistics updated each week.
H1N1 Vaccine Efficacy and Safety
One of the remarkable aspects of the H1N1 influenza response has been the development of vaccines to prevent it. Influenza A (H1N1) 2009 monovalent vaccines have been developed by the five manufacturers of seasonal flu vaccine. The production and licensure of the H1N1 vaccines are being done by exactly the same methods as the seasonal vaccines. One hundred million Americans are vaccinated each year with seasonal flu vaccines, so the safety and efficacy of the process is well defined. FDA licensure has been on the basis of standards developed for vaccine strain changes for seasonal influenza vaccines, adherence to manufacturing processes, product quality testing, and lot release procedures developed for seasonal vaccines. The age groups, precautions, and contraindications approved for the influenza A (H1N1) 2009 monovalent vaccine are identical to those approved for seasonal vaccines. The only difference between the seasonal and 2009 H1N1 influenza vaccines is the viral antigens contained in the vaccine, which also do vary from year to year as the seasonal vaccine changes. The only other difference is that clinical trials have been done on the H1N1 vaccines to establish the dosing requirements. Clinical trials are not typically done for the seasonal vaccine. So we actually know more about the characteristics of the H1N1 vaccine than we do the seasonal vaccine from these trials.
Preliminary data from the clinical trials indicate that the immunogenicity and safety of these vaccines are similar to those of seasonal influenza vaccines. An immunogenicity study of an inactivated influenza A (H1N1) monovalent vaccine manufactured by CSL Limited demonstrated a safety profile consistent with results from studies of the seasonal influenza vaccine manufactured by CSL Limited. Studies of other seasonal inactivated influenza vaccines found that rates of adverse events were not significantly different from placebo injections except for arm soreness and redness at the injection site. Vaccine safety data are reviewed by both the manufacturers' quality assurance staff and by the FDA. Only when all testing is completed and approved are the vaccines released for distribution.
Clinical trials in children coordinated by the National Institutes of Health reported preliminary results of a study among children aged 6 months--18 years which found safety results to be similar to those observed for seasonal influenza vaccine.
To assure that the safety of the H1N1 vaccine, New York is participating in expanded federal programs to monitor any possible adverse outcomes through a nationwide reporting system known as VAERS (vaccine adverse event reporting system) as well as through a program using managed care data on large populations to conduct follow up of vaccinated persons and a separate CDC-sponsored program to report Guillian-Barre Syndrome cases.
Availability of supplies and H1N1 vaccine distribution
There are currently 4 companies that are fully licensed by the FDA (the 5th is in process) to make the 2009 H1N1 vaccine, the same as for seasonal flu. Med Immune, which makes the inhaled live, attenuated influenza vaccine, Novartis, sanofi pasteur and CSL Limited, which make inactivated influenza vaccine, which is administered through an injection.
The CDC estimates that between now and the end of November there will be over 80 million doses of flu vaccine made available to states throughout the nation for redistribution to localities, health care providers and others as appropriate. The vaccine and supplies being made available by the Federal Government are being dispensed in weekly allotments that vary in size between 1.5 million and 4 million doses each week. States and cities were able to place their first orders for the 2009 H1N1 vaccine on Wednesday September 30th. By October 2nd, 2.4 million doses of live attenuated 2009 H1N1 vaccine were available for ordering with more vaccine becoming available for ordering in the coming days and weeks.
H1N1 Vaccine Distribution
Each week New York State (like all states) is provided a number of doses that are available to us to order. In general we expect to receive approximately 6 percent of the national allotment based on our population. To date we have placed orders requesting our full allotment and have provided direction to the CDC regarding where the vaccine is to be shipped. Our initial ship-to sites focused on hospitals, local health departments and federally qualified health centers – in an effort to assure that all persons in New York State who fit into one of the CDC's Advisory Committee on Immunization Practices (ACIP) defined priority groups have access to vaccine as quickly as possible.
The ACIP defined the following five populations as priority groups for vaccination against H1N1: pregnant women, persons who live with or provide care for infants aged <6 months (e.g., parents, siblings, and daycare providers), health-care and emergency medical services personnel, persons aged 6 months--24 years, and persons aged 25--64 years who have medical conditions that put them at higher risk for influenza-related complications. Individuals in these groups are either at higher risk of complications associated with the flu or are more likely to come into contact, and possibly infect, persons at high risk of complications.
These five target groups comprise an estimated 159 million persons in the United States and 10 million people in New York State. Using season flu vaccination rates as a guide, which indicate that 20 to 40% of eligible persons actually present for vaccination, we estimated that we would need at least 4 million doses of H1N1 to reach all New Yorkers who fall into one of the priority groups.
To ensure distribution of vaccine in the most efficient and effective manner the Governor directed the New York State Department of Health to begin the process with initial shipments to all hospitals in the State, to all local health departments (outside of New York City) and to all Federally Qualified Health Centers outside of New York City. Following this initial push we will provide vaccine based on orders submitted by providers who have agreed to vaccinate individuals beginning with those in the defined priority groups.
The first orders, placed two weeks ago were delivered last week. Initial availability of vaccine was limited and included 91,000 doses of LAIV upstate. LAIV is used for 1) healthy kids 2-24 years old and 2) healthy adults 25-49 who are health care workers or who care for children under 6 months. Factors that we have and will continue to take into account when filling orders for H1N1 include: geographic distribution to ensure statewide coverage; per capita allocation amounts (to be equitable in distribution); ability of providers to access target groups; input of local health departments and targeting based on the specific type of vaccine available and the most appropriate target audience.
Additional orders for 113,400 doses of vaccine were placed last week that are expected to arrive at designated sites this week – bringing the total number of H1N1 vaccine doses ordered to date to 204,000. This is only the beginning of what is expected to be available with substantial supplies of H1N1 vaccine being available starting this week and next. We anticipate that by early November, most providers who want to order vaccine will be able to do so. Additional vaccine will roll out through November, December and into January. One of the critical messages we need to convey is that as this vaccine is just now being produced, people and providers need to be patient as we do our best to ensure that vaccine is first delivered to those in the priority groups.
The State Department of Health developed a system to pre-register all providers in the state who are interested in receiving vaccine. This pre-registration process asks that the provider indicate how many people they anticipate vaccinating and how many of these individuals are in each of the targeted groups – information that will be critical in assuring that vaccine is properly targeted. Eventually we anticipate that all New Yorkers who wish to receive the vaccine will have an opportunity to do so.
To date 4000 providers have pre-registered representing a range of specialties and provider types including private practice physicians, hospitals, local health departments, federally qualified health centers, pharmacies, colleges and universities, public health clinics, substance abuse treatment clinics and Indian health providers. We anticipate that additional providers will register over the coming weeks. We are also aware that there are providers who continue to be concerned with the safety of the vaccine and as a result are reluctant to register and participate in our vaccination efforts. We will continue to work with our partners in the health care community including professional organizations to educate providers as to the safety of the vaccine and the importance of vaccine as a mechanism to assure public health.
Techniques to prevent the spread of the flu
Vaccination is the most effective way to prevent influenza. The next most effective measure is to avoid contact with other people and to stay home from work or school when you are sick. As we have noted throughout our printed materials and public outreach campaigns, it is best to stay home when you are ill to prevent further disease transmission. Health care settings are no different than any other setting where vaccination is the most effective method of preventing influenza. This forms the basis of our Health Care Worker mandate for flu vaccination.
The use and availability of N-95 face masks is a notable concern for many health care workers. It is particularly important for those workers who may be exposed to the flu virus during procedures when aerosols are produced. A recent study published in the Journal of the American Medical Association, the first randomized control trial of its kind to study the use of N95 masks compared with surgical masks by nurses for routine patient care, found no difference in influenza infection rates in health care workers during the 2008-2009 flu season, 22-23 percent in both groups. This suggests that N95 masks by themselves may not provide any additional protection in routine patient care settings. The most remarkable finding of this study was that only 30% of the nurses in either group were vaccinated.
How Health Care Settings, Schools and Workplaces Are Implementing These Steps
Under the direction of Governor Paterson the New York State Department of Health in collaboration with other state agencies, has developed numerous resources intended to assist health care providers, schools and businesses with the implementation of procedures to help prevent and reduce the spread of the flu. These resources include model polices regarding attendance and sick leave at places of employment; the preparation of contingency plans for operating during the flu season when many staff may be out either sick themselves or out caring for sick family members and how schools and businesses can communicate guidance on flu prevention and care provided by the CDC and by NYSDOH to their employees. The State Health Department has worked closely with the State Education department not only to provide guidance regarding best practices for assuring a healthy school environment and for minimizing transmission between students and staff but also by encouraging vaccination for students and employees. We have provided detailed guidance on how best to ensure proper facilities and supplies to ensure good hand hygiene and respiratory etiquette and to ensure that schools, health care facilities and workplaces are cleaned routinely.
Education, Outreach and Prevention - NYS Government Activities
NYSDOH has and continues to provide information about 2009 H1N1 flu through a variety of channels, intended to maximize our "reach" to target audiences. Last April Governor Paterson directed the State Health to establish an H1N1 call center; this call center has been available 24/7 to answer questions from concerned individuals. More recently we have established a vaccine call center for providers to place orders for vaccine over the coming weeks.
As the 2009 school year approached Governor Paterson asked that NYS agencies proactively reach out to communities and individuals throughout the State to provide education; to answer questions and to assure that all New Yorkers had access to the most comprehensive and up to date information available. Between July and September 38 briefings and educational sessions were conducted for groups throughout the State. There are an additional 14 trainings under development for October, and additional meetings, webinars and teleconferences are planned with agencies, unions, health care workers and others who express an interest in these sessions.
To date, approximately 2,100 planning and preparedness partners have participated in educational sessions and briefings including state agencies, hospitals, local health departments, long term care facilities, community health centers, home care and hospice staff, schools and universities and business groups.
To ensure ongoing access to updated information and to assure that local health departments are provided all the resources necessary to respond to 2009 H1N1 in their communities NYSDOH holds weekly teleconferences with representatives of Local Health Departments to provide informational updates, to answer questions and to solicit recommendations from the field. Weekly calls are also convened with hospitals and long-term care providers and we have reached out to health plans and to individual physicians. For example we have worked with the American College of Obstetricians and Gynecologists to identify the best ways to get crucial H1N1 information to pregnant women and their health care providers and to develop materials for dissemination.
Over the past several weeks we have refined and updated our comprehensive H1N1 website. This website which is continually evolving to reflect new and updated information and resources includes information for consumers and health care providers, along with information for the media. Many website materials are—or soon will be—available in English and Spanish as well as other languages.
Public education activities are ongoing. Working with the Governor and other state agencies the health department is engaging in a mass media campaign to educate people about ways to reduce their chances of getting or spreading the flu. A 2-week radio buy was timed to coincide with back-to-school. Messages stressed the importance of vaccination, hygiene, and staying home if you're sick. A television Public Service Announcement (PSA) with a similar message has been distributed statewide and is getting good airplay. A radio PSA featuring a pregnant woman explaining why she will get H1N1 vaccine is being taped this week and will begin to air shortly.
Later this month the Department will begin an advertising campaign posted on mass transit, in many parts of the state. Interior bus cards will encourage individuals in priority groups to "Go to the head of the line." The Department has and will continue to provide thousands of H1N1 informational materials free-of-charge to Local Health Departments, health care providers, employers and community groups.
As response efforts to the current pandemic intensify, education and training will shift from didactic, regional meetings, to a series of weekly phone calls and webinars. Presentations and informational sessions will continue to be updated weekly; materials will continue to be developed to meet identified needs and will be distributed through multiple channels and mechanisms. Similarly we will respond to outbreaks, to any identified trends in specific populations; to any reports of resistance to medication and to any adverse reactions to vaccine.
Governor Paterson has asked us to remain vigilant and flexible as this is an evolving situation. We have activated our emergency response system and have mechanisms, procedures and protocols ready to implement in the event of a surge requiring much more intensive activities and interventions on the part of the State. Throughout we will continue to communicate and coordinate with our partners throughout the State and the nation to ensure that our response is successful in reducing the number of persons ultimately infected and for those infected, a swift and easy recovery.
Thank you.