Because the influenza vaccine issue directly affects nurses and their patients, ANA has been monitoring the issue, and has been involved in shaping policy and legislation, both with regard to this year’s shortage and in terms of ongoing manufacturer supply chain and related public health and safety issues. A member of the National Nursing Immunization Network, ANA representatives regularly participate in meetings with the Department of Health and Human Services (HHS), the Centers for Disease Control and Prevention (CDC) and other governmental bodies that oversee and regulate the issue.
ANA Position
ANA strongly recommends that nurses and all other health care providers who have direct patient contact be vaccinated against the flu virus – even in times of flu vaccine shortage – because they are in an influenza high-risk group that is among those the CDC has recommended receive early flu vaccination.
ANA is especially adamant about nurses receiving vaccinations in part because, according to the CDC, fewer than 38 percent of health care professionals have received immunizations against the flu virus. ANA believes this is an alarmingly high percentage and one that is totally unnecessary, especially given health care professionals’ categorization as an influenza high-risk group, their access to the vaccine and their daily contact with patients, many of whom also are in flu high-risk categories.
Also, even though the 2004-2005 flu season has been mild so far, ANA maintains that nurses and patients – and particularly persons who have HIV/AIDS, are immuno-compromised or in other high-risk groups – get vaccinated against the flu in order to prevent any late-season outbreaks of the virus.
In addition, ANA is collaborating on and advocating for strategies that will negate future shortages such as the one seen in the 2004-2005 flu season with its other partners in the policy arena.
Update
On Dec. 22, 2004, the Centers for Disease Control and Prevention recommended that states with an adequate supply of the flu vaccine roll back restrictions beginning Jan. 3. The revised guidelines include persons over age 50 – down from age 65 – and people in other high-risk groups, including nurses.
On Jan. 27, 2005, the Centers for Disease Control and Prevention (CDC) announced the immediate release 3.1 million doses of flu vaccine in the government’s emergency reserves to vaccine maker Sanofi Pasteur (i.e., formerly Aventis Pasteur) for distribution and sale to health care providers. For each dose of the vaccine sold, the government will receive a credit toward next year’s flu vaccine stockpile, according to CDC officials. Health care providers will receive a refund from the company for any unused doses and will only be charged for shipping. The agency said it also would make limited amounts of flu vaccine normally reserved for low-income and Native American children under the Vaccine for Children program available to state health departments for use by others where demand for the vaccine for program-eligible children has been met. For the complete announcement, see www.cdc.gov/od/oc/media/pressrel/r050127.htm.
As of late January 2005, surpluses of the flu vaccine existed in some states (Alaska, California, Colorado, Kansas, Massachusetts, Michigan, Minnesota, Nebraska, New Mexico, New York, North Carolina, Oklahoma, Oregon, South Dakota, Utah, Wisconsin and Wyoming, according to the Association of State and Territorial Health Officials). As a result, these states lifted all vaccination restrictions. However, a few states were still encountering spot shortages of the shots.
2004-2005 Shortage Situation
Although the flu vaccination was in short supply in the fall, additional doses of GlaxoSmithKline (GSK) influenza vaccine have since been authorized for use under an Investigational New Drug (IND) application by the Food and Drug Administration (FDA). As a result, the Department of Health and Human Services (HHS) announced Dec. 6 the purchase of 1.2 million doses of the vaccine to distribute to areas most in need, with up to 4 million doses available from the company. In addition, the federal government set up a distribution database designed to track available flu vaccine supplies and transfer them to locations still experiencing shortages).
The doses of the vaccine, known as Fluarix, were made available in addition to the existing supply of 61 million doses of licensed influenza vaccine, which included about 58 million doses of Aventis injected vaccine and 3 million doses of FluMist nasal spray.
The additional doses of Fluarix vaccine were distributed by the Centers for Disease Control and Prevention (CDC), based on the determination of communities most in need. Because Fluarix is not licensed for use in the United States (but has been approved by the Eurpoean equivalent of the FDA), it is required that the vaccine be administered under an IND – meaning that patients who are offered the Fluarix vaccine must sign an informed consent form that acknowledges they are aware of the potential adverse effects associated with the investigational vaccine. Sponsors of INDs must monitor the use of the investigational vaccine, maintain records, control the supply of the product, provide periodic reports to the FDA and make sure informed consent is obtained.
Concerns for Nurses
During the flu vaccine shortage in the fall, the Centers for Disease Control and Prevention (CDC) were recommending that health care workers who do not work with immuno-compromised patients receive the FluMist, a live, attenuated influenza vaccine. However, ANA voiced concern that such a vaccine carries the potential for shedding the vaccine virus, resulting in possible person-to-person transmission of it. While the CDC’s Advisory Committee on Immunization Practices (ACIP) has stated that it is not necessary for health care workers to be furloughed for a period of time after receiving FluMist, ANA and others questioned this recommendation by pointing out that the science behind it is minimal.
Related Concerns
In addition, ANA, citing concerns over preserving adequate funding for childhood vaccines, signed on to a Dec. 17 letter sent to HHS urging the federal government not to use money that was intended for general vaccinations for children under the CDC’s National Immunization Program 317 funds to pay for experimental flu vaccines for adults (Read letter http://nursingworld.org/readroom/thompson.pdf). That letter was followed by a similar letter to HHS Secretary Tommy Thompson on Dec. 21 from the Senate Subcommittee on Labor, Health & Human Services, Education and Related Agencies and additional letters from the U.S. Senate and House of Representatives on Dec. 22.
In a Jan. 19, 2005, response letter, Julie Gerberding, director of the CDC, noted that the CDC “has been working with HHS to offset the use of Section 317 funds for the purchase” of the vaccine and noted that other possible solutions include reimbursement from Medicare recipients who are receiving the vaccination and a possible transfer of funds from HHS to CDC. She also promised the CDC would make public any final decisions to reallocate funds to the Sect. 317 program ( Read response http://nursingworld.org/readroom/replyimmunz.pdf).
Advocacy Activities
- Congress – ANA has endorsed The Flu Vaccination Act of 2004, a bill introduced in the U.S. Senate Nov. 17 by Sens. Evan Bayh (D-IN) and Larry Craig (R-ID) that seeks to promote effective influenza vaccination. (For the text of the bill, see http://thomas.loc.gov/cgi-bin/query/z?c108:hr.4818:.)
“The Flu Protection Act of 2004 will ensure that an adequate amount of effective flu vaccine is available every year,” wrote ANA Government Affairs Director Rose Gonzalez in a letter endorsing the bill.” If passed, this law “would help educate health care professionals and increase awareness about the importance of receiving the vaccine. And it would help the nation prepare for influenza epidemics and pandemics.”
- CDC – ANA participated in conference calls held regularly by the CDC to update the health provider community regarding the flu vaccine shortage.
- Flu Vaccine Leadership Forum – ANA participated in a Nov. 8, 2004, summit convened by the American Public Health Association and attended by 15 other health professional organizations and representatives from Member of Congress’ offices. The purpose of the meeting was to discuss the current flu vaccine shortages and identify potential recommendations that would address both the current shortage, as well as steps that could be taken to prevent such shortages from occurring in the future. Summit participants agreed that even if the 2004-2005 flu season remains mild, contingencies still should be identified and put in place, and the vaccine crisis that occurred in the fall needs to be addressed, possibly through legislative remedies, to prevent future occurrences.
ANA also spoke to the need to ensure the availability of appropriate personal protective equipment (PPE) and hospital policies that will help to prevent the transmission of the flu virus to registered nurses and other health care workers. And, ANA and other participants agreed on the need to promote flu-prevention education and flu-outbreak control measures – such as washing hands and segregating patients with respiratory illnesses – and to publicize national guidelines and best practices, such as school closings during severe flu outbreaks.
In addition, summit attendees discussed pharmaceutical issues, such as the need for federal incentives to encourage greater vaccine production and stronger antiviral medications, as well as streamlining the vaccine approval process.
- Bush Administration – In October, Mark McClellan, administrator of the Centers for Medicaid and Medicare Services, asked President Blakeney for ANA’s assistance in informing nurses and the public about the additional supply of flu vaccine. Blakeney agreed to assist CMS in distributing updates and reminded McClellan of the need to vaccinate nurses, who will be needed to care for patients, this fall and winter, including those who may suffer complications from the flu. She also asked that ANA be invited to participate in any federal-level task force that may be formed to address short-term and long-term issues arising from the current shortage.
- Kerry campaign – As concern about the shortage of vaccine and the ability to get the remaining supply to those at greatest risk grew this past fall, Sen. John Kerry released his plan to address the shortage and to avert future shortages. On Oct. 18, at the request of the Kerry campaign, ANA President Barbara Blakeney participated on a national press call to help get out the message about the need for such a plan in the wake of the current circumstances and impact on public health.
Letters and Comments
Congress and the Bush Administration – ANA’s activities in this area have included the previously mentioned letter sent to the Department of Health and Human Services on Dec. 17, 2004, urging the federal government not to use money that was intended for vaccinating children under the CDC’s National Immunization Program 317 funds to pay for experimental flu vaccines for adults and a Nov. 16 letter sent to Sens. Bayh and Craig indicating ANA’s support of the flu bill, which they introduced.
Communications Outreach and Education
Media Outreach and Response – ANA responded to media inquiries regarding the flu vaccination shortage from the Associated Press and the Wall Street Journal among several smaller news outlets early in the flu season.
Member Education/Publications – Members have been updated on the flu vaccine issue through The American Nurse (“ANA Tapped to Help Carry Out Messages About Flu Vaccine,” p.10, November/December 2004 issue) and the CMA Insider (“Some Areas Report Flu Vaccine Surplus; ANA, Congress Urge HHS to Alter Funding Source,” p. 2, January 2005 issue; “HHS Secures 1.2 Million More Doses of Flu Vaccine,” p. 2, Dec. 2004 issue; “ANA Endorses Flu Protection Act in Congress, Participates in Flu Vaccine Leadership Forum,” p. 2, November 2004 issue; “Flu Vaccine Shortage Creates Turmoil; ANA Tapped to Help Carry Out Messages,” p. 2, October 2004 issue).
Flu Resources
Media Resources and Flu News Archives
Flu General Facts
- Approximately 36,000 people die each year as a result of the flu.
- More than 90 percent of influenza-related deaths occur in people age 65 and older.
- Fewer than 38 percent of health care professionals are vaccinated against the flu. ANA hopes to counteract this alarming and unacceptably high percentage through greater education and awareness among nurses.
- Infants and young children (aged 6 to 23 months) are among many of those hospitalized for the flu, with 152 flu deaths among children in 2003-2004.
- According to the CDC, more than 50 percent of children and 43 percent of adults in priority groups received flu shots in the last quarter of 2004. Most people vaccinated were in priority groups; however, vaccination for most priority groups was somewhat lower than in years when there was not a flu vaccine shortage.
- In 2004, the first year all children 6-23 months were recommended for flu vaccination, the vaccination rate among children aged 6-23 months was up sharply from 7.7 percent in 2002 to 57.3 percent, according to the CDC.
Summaries and background information on key topics
