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Non-Safety Related Voluntary Vaccine Recall
Dear Students, Staff and Faculty,
A Non-Safety Related Voluntary Recall of Certain Lots of Sanofi Pasteur H1N1 Pediatric (0.25 mL, for 6-35 month olds) Vaccine in Pre-Filled Syringes has been issued. If you recieved your H1N1 Vaccination at the KSU Health Clinic you can disregard this message. THIS DOES NOT EFFECT ANY OF THE VACCINE GIVEN AT KSU.
Summary: As part of its quality assurance program, Sanofi Pasteur, Inc., performs additional routine, ongoing testing of influenza vaccines after the vaccine has been distributed to health care providers to ensure that vaccines continue to meet required specifications.In recent testing of the amount of antigen in its influenza A (H1N1) monovalent vaccine, Sanofi Pasteur found four distributed lots of singledose, pre-filled syringe pediatric (0.25 mL.) vaccine with antigen content lower than required potency levels. The manufacturer is conducting a non-safety related voluntary recall of these affected lots of vaccine.
Background: After performing these tests, Sanofi Pasteur notified the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) that the antigen content in one lot of pediatric syringes that had been distributed to providers was later found to have dropped below a pre-specified limit. As a result of this finding, Sanofi Pasteur tested additional lots and found that three other lots that had been distributed also had an antigen content that had fallen below pre-specified limits. This means that doses from these four vaccine lots no longer meet the specifications for antigen content.
Recommendations: While the antigen content of these lots is now below the specification limit for the product, CDC and FDA are in agreement that the small decrease in antigen content is unlikely to result in a clinically significant reduction in immune response among persons who have received the vaccine. For this reason, there is no need to revaccinate persons who have received vaccine from these lots .
Providers are being asked to return any vaccine to the manufacturer in the following lots that remains unused to the manufacturer:
- 0.25 mL pre-filled syringes, 10-packs (NDC # 49281-650-25, sometimes coded as 49281-0650-25):
- 0.25 mL pre-filled syringes, 25-packs (NDC # 49281-650-70, sometimes coded as 49281-0650-70):
These lots were shipped in November and are intended for children 6 months through 35 months of age. Sanofi Pasteur will send directions for returning unused vaccine from these lots to providers.
All vaccines are thoroughly tested prior to release and shipping to determine that they meet all manufacturer and FDA standards for purity, potency and safety. The affected vaccine met all specifications at the time of release. CDC and FDA have determined that there are no safety concerns for children who have received this vaccine. Sanofi Pasteur has discontinued distribution of the 0.25mL syringes of H1N1 pediatric vaccines.
The drop in antigen content below the required specification that is described here is specific to Sanofi Pasteur’s pediatric H1N1 monovalent vaccine in 0.25 mL pre-filled syringes. The same vaccine packaged in other forms, such as 0.5 mL pre-filled syringes for older children and adults and multidose vials, continue to meet specifications.
The antigen content in the affected lots of vaccine is only slightly below the specification limit. The slightly reduced concentration of vaccine antigen found in retesting these lots is still expected to be effective in stimulating a protective response. There is no need to re-administer a dose to those who received vaccine from these lots. However, as is recommended for all 2009 H1N1 vaccines, all children less than 10 years old should get the recommended two doses of H1N1 vaccine approximately a month apart for the optimal immune response. So, children less than 10 years old who have only received one dose of vaccine thus far should still receive a second dose of 2009 H1N1 vaccine.
For children 6 months of age and older, vaccine is available in multidose vials. The vaccine in multidose vials is safe and effective vaccine for children. One difference between vaccine in pre-filled syringes and the multidose vials is that the multidose vials contain a preservative (thimerosal) to prevent potential contamination after the vial is opened. The standard dose for this preparation for administration to infants 6-35 months old is the same as for the pre-filled syringes, 0.25 mL. For healthy children at least 2 years of age, the nasal spray (live, attenuated influenza vaccine) is also an option. The nasal spray vaccine is produced in single units that do not contain thimerosal.
For More Information:
• For Questions and Answers related to the withdrawn vaccine see http://www.cdc.gov/h1n1flu/vaccination/syringes_qa.htm
• Call CDC’s toll-free information line, 800-CDC-INFO (800-232-4636) TTY: (888) 232-6348, which is available 24 hours a day, every day.
KSU Health Clinic
Dear Students, Staff and Faculty,
A new shipment of H1N1 vaccine will be available in the Village Walk-In Clinic as of Monday November 23 at 8AM. The vaccine will be administered on a FIRST-COME, FIRST-SERVED.
The vaccine will be given only to:
- Current KSU students
- Current KSU staff members
- Current KSU faculty.
All members of the KSU community wishing to be immunized must present a KSU student or KSU employee, faculty or staff I.D. card reflecting their KSU identification number in order to receive the vaccine.
Please keep the following in mind when coming to be immunized:
- This is an injectable vaccine
- Please dress appropriately – we must be able to access your upper arm to the shoulder. The immunization will be given in a public setting.
- The immunization is FREE
- The Vaccine being given is an attenuated vaccine. It is physiologically impossible to contract H1N1 from this immunization.
- The vaccine being given contains no preservatives, no thimerosal, and no mercury.
- If you are unable to be immunized on Monday November 23, 2009 please watch for information on the Health Clinic web site for when and where the vaccine wil be available again.
Department of Strategic Security & Safety
Recommended responses to influenza for the 2009 – 2010 academic year
Recommended strategies under current flu conditions (similar severity as in Spring/Summer 2009)
Returning to work or school after an influenza like illness
- The CDC currently recommends that it is safe to return to work or school when your temperature has remained below 99.5 for 24 hours without taking any medication that contains medications that reduce fever.
Facilitate self-isolation of residential students with flu-like illness
- Those with flu-like illness should stay away from classes and limit interactions with other people (called “self-isolation”), except to seek medical care, for at least 24 hours after they no longer have a fever, or signs of a fever, without the use of fever-reducing medicines. Some people with influenza will not have fever; therefore, absence of fever does not mean absence of infection. They should stay away from others during this time period even if they are taking antiviral drugs for treatment of the flu. (For more information, visit http://www.cdc.gov/h1n1flu/guidance/exclusion.htm.)
- Review and revise, as needed, policies, such as student absenteeism policies and sick leave policies for faculty and staff, that make it difficult for students, faculty, and staff to stay home when they are ill or to care for an ill family member,. Do not require a doctor’s note to confirm illness or recovery. Doctor’s offices may be very busy and may not be able to provide such documentation in a timely way.
- If possible, residential students with flu-like illness who live relatively close to the campus should return to their home to keep from making others sick. These students should be instructed to do so in a way that limits contact with others as much as possible. For example, travel by private car or taxi would be preferable over use of public transportation.
- Students with a private room should remain in their room and receive care and meals from a single person. Students can establish a “flu buddy scheme” in which students pair up to care for each other if one or the other becomes ill. Additionally, staff can make daily contact by e-mail, text messaging, phone calls, or other methods with each student who is in self-isolation.
- If close contact with others cannot be avoided, the ill student should be asked to wear a surgical mask during the period of contact. Examples of close contact include kissing, sharing eating or drinking utensils, or having any other contact between persons likely to result in exposure to respiratory droplets.
- For those who cannot leave campus, and who do not have a private room, IHEs may consider providing temporary, alternate housing for ill students until 24 hours after they are free of fever.
- Instruct students with flu-like illness to promptly seek medical attention if they have a medical condition that puts them at increased risk of severe illness from flu, are concerned about their illness, or develop severe symptoms such as increased fever, shortness of breath, chest pain or pressure, or rapid breathing.
Promote self-isolation at home by non-resident students, faculty, and staff
- Non-residential students, faculty, and staff with flu-like illness should be asked to self-isolate at home or at a friend’s or family member’s home until at least 24 hours after they are free of fever, or signs of a fever, without the use of fever-reducing medicines.
- Review, and revise if needed, sick leave policies to remove barriers to faculty and staff staying home when they are ill or caring for an ill family member. For students, consider altering policies on missed classes and examinations and late assignments so that students’ academic concerns do not prevent them from staying home when ill or prompt them to return to class or take examinations while still symptomatic and potentially infectious.
- Do not require a doctor’s note for students, faculty, or staff to validate their illness or to return to work, as doctor’s offices and medical facilities may be extremely busy and may not be able to provide such documentation in a timely way.
- Distance learning or web-based learning may help students maintain self-isolation.
- Visit http://www.cdc.gov/h1n1flu/guidance/exclusion.htm for more information on staying home while sick.
Considerations for high-risk students and staff
- People at high risk for flu complications who become ill with flu-like illness should speak with their health care provider as soon as possible. Early treatment with antiviral medications often can prevent hospitalizations and deaths. Groups that are at higher risk of complications from flu if they get sick include: children younger than age 5; people age 65 or older; children and adolescents (younger than age 18) who are receiving long-term aspirin therapy and who might be at risk for experiencing Reye’s syndrome after flu virus infection; pregnant women; adults and children who have asthma, other chronic pulmonary, cardiovascular, hepatic, hematological, neurologic, neuromuscular, or metabolic disorders such as diabetes; and adults and children with immunosuppression (including immunosuppression caused by medications or by HIV). People age 65 and older, however, appear to be at lower risk of 2009 H1N1 infection compared to younger people. But, if older adults do get sick from flu, they are at increased risk of having a severe illness.
- One of the best ways to protect against the flu is to get vaccinated against the flu. People under age 25 are one of the key groups recommended by CDC’s Advisory Committee on Immunization Practices (ACIP) to be among the first to receive the 2009 H1N1 flu vaccine. For more information, visit http://www.cdc.gov/h1n1flu/vaccination .
- Communicate with local health officials to determine where vaccine will be administered and to discuss the possibility of a vaccination clinic at the IHE.
Discourage campus visits by ill persons: Use a variety of communication methods such as e-mail, posters, flyers, and media coverage to discourage people with flu-like illness from visiting the campus or attending IHE events such as football games or concerts until they have been free of fever for at least 24 hours.
Encourage hand hygiene and respiratory etiquette of both people who are well and those that have any symptoms of flu: Emphasize the importance of the basic foundations of flu prevention: stay home when sick, wash hands frequently with soap and water when possible, and cover noses and mouths with a tissue when coughing or sneezing (or a shirt sleeve or elbow if no tissue is available).
- Establish regular schedules for frequent cleaning of high-touch surfaces (for example, bathrooms, doorknobs, elevator buttons, and tables).
- Provide disposable wipes so that commonly used surfaces (for example, doorknobs, keyboards, remote controls, desks) can be wiped down by students before each use.
- Encourage students to frequently clean their living quarters, including high-touch surfaces.
Considerations for specific student populations
- Review policies for study abroad programs, including accessing health services abroad and reporting illness to the IHE.
- Communicate plans, policies, and strategies to partner K-12 schools regarding “early/middle college” students, prospective student tours, and other K-12 students regularly on campus.
- Determine if special communication strategies are needed to meet the needs of students with disabilities.
- Remind health-care profession students to follow infection control guidance for health-care workers. Visit http://www.cdc.gov/h1n1flu/clinicians for guidance for health care settings.
Under conditions with increased severity compared to spring/summer 2009
CDC may recommend additional strategies to help protect IHE students, faculty, and staff if global, national, or regional assessments indicate that flu is causing more severe disease. In addition, local health or IHE officials may choose to use additional strategies. Although the following strategies have not been scientifically tested in the IHE setting, they are grounded on basic principles of infection control. Implementing these strategies is likely to be more difficult and to have more disruptive effects than the previously described strategies. These strategies should be considered if influenza severity increases and are meant for use in addition to the strategies outlined above.
Permit high-risk students, faculty, and staff to stay home when flu is spreading in the community
- If flu severity increases, people at high risk of flu complications may consider staying home while a lot of flu is circulating in their community. Such people should make this decision after consulting with their doctor.
- IHEs should plan now for ways to continue educating students who stay home through distance learning methods. IHEs should also examine policy accommodations that might be necessary such as allowing high-risk students to withdraw for the semester, tailoring sick leave policies to address the needs of faculty and staff, or modifying work responsibilities and locations.
Increase social distances:
- Explore innovative ways to increase the distances between students (for example, moving desks apart or using distance learning methods). Ideally, there should be at least 6 feet between people at most times.
- Consider whether to suspend or modify public events such as films, sporting events, or commencement ceremonies.
Extend the self-isolation period: If flu severity increases, people with flu-like illness should stay home for at least 7 days after the onset of their symptoms, even if they have no more symptoms. If people are still sick after 7 days, they should stay home until 24 hours after they have no symptoms. See information above for self-isolation in different types of housing.
Consider suspending classes
- IHE and health officials should work closely to balance the risks of flu in their community with the disruption that suspending classes will cause in both education and the wider community.
- Use multiple channels to communicate a clear message about the reasons for suspending classes and the implications for students, faculty, staff, and the community.
- Reactive class suspension might be needed when IHEs cannot maintain normal functioning.
- To decrease the spread of flu, CDC may recommend preemptive class suspension if the flu starts to cause severe disease in a significantly larger proportion of those affected than occurred during the spring/summer 2009 outbreak.
- If classes are suspended preemptively, large gatherings (for example, sporting events, dances, commencement ceremonies) should be cancelled or postponed.
- IHEs with only nonresidential students should consider whether they can allow faculty and staff to continue use of their facilities while classes are not being held. This may allow faculty to develop lessons and materials and engage in other essential activities.
- IHEs with residential students should plan for ways to continue essential services such as meals, custodial services, security, and other basic operations for students who remain on campus. When possible, dismiss students who can get home – or to the home of a relative, friend of the family, or host family – by private car or taxi. International students and others without easy access to alternative housing should stay on campus, but increase the distance between people as much as possible.
- The length of time classes should be suspended will vary depending on the goal of class suspension as well as the severity and extent of illness. IHEs that suspend classes should do so for at least five to seven calendar days. Before the end of this period, the IHE, in collaboration with public health officials, should reassess the epidemiology of the disease and the benefits and consequences of continuing the suspension or resuming classes.
Deciding on a course of action
CDC recommends a combination of strategies applied early and simultaneously. Strategies should be selected a) based on trends in the severity of disease, virus characteristics, feasibility, and acceptability and b) through collaborative decision-making with public health agencies, IHE faculty and staff, students, students’ families, and the wider community. CDC and its partners will continuously look for changes in the severity of flu-like illness and will share what is learned with state and local agencies. However, states and local communities can expect to see a lot of differences in disease patterns from community to community.
Every IHE has to balance a variety of objectives to determine the best course of action to help decrease the spread of flu. Decision-makers should identify and communicate their objectives which might be one or more of the following: (a) protecting overall public health by reducing community transmission; (b) reducing transmission in students, faculty, and staff; and (c) protecting people with high-risk conditions. Some strategies can have negative consequences in addition to their potential benefits. The following questions can help begin discussions and lead to decisions.
Decision-Makers and Stakeholders
Are all of the right decision-makers and stakeholders involved?
- Local and state health, education, and homeland security agencies
- Campus health services and mental health services
- Campus emergency managers and security staff
- Student affairs and residential life staff
- Communications staff
- Physical plant staff
- Food services staff
- Community representatives
- Students’ families
Information Collection and Sharing
Can local or state health officials determine and share information about the following?
- Numbers of and trends in outpatient visits, hospitalizations, and deaths for flu-like illness
- Percent of hospitalized patients requiring admission to intensive care units (ICUs)
- Groups being disproportionately affected
- Ability of local health care providers and emergency departments to meet increased demand
- Availability of antiviral drugs, hospital beds, staff, ICU space, and ventilators for flu patients
What does the IHE know about the following?
- Student, faculty, and staff absenteeism rates
- Number of visits to the campus health service
- Bed availability for student self-isolation
- Severity of illness among affected staff and/or students
Do you have the resources to implement the strategies being considered?
- Legal authority or policy requirements
- Communication channels
Have you determined how to address the following challenges to implementing the strategies?
- Public concern about flu
- People who do not feel empowered to protect themselves
- Lack of public support for the strategy
- Secondary effects of strategies (for example, job security, financial support, health service access, and educational progress)