Between them and us stand a few small groups of nurses at select institutions around the country, including the University of Rochester Medical Center, who protect the population from such scourges.
The University is one of seven institutions that make up an elite network of centers established by the Federal government to respond to national needs in the area of infectious disease. Funded by the National Institute of Allergy and Infectious Diseases (NIAID), the seven Vaccine Treatment and Evaluation Units (VTEUs) supply the nurse power necessary to beat back or altogether prevent infectious disease. The VTEUs assess the safety and effectiveness of potential vaccines; the targets include new diseases, like bird flu; tenacious killers that re-appear every year, like the flu; and even diseases that have been wiped out in nature but could still pose a threat, such as smallpox.
In 2001, shortly after the 9/11 disaster, the nation called upon the network to see if the smallpox vaccine supply could be extended if necessary. Last year, as chickens in Asia died from bird flu, a study of an experimental vaccine was initiated.
This fall when the nation set out to prevent another flu vaccine shortage from occurring, much of the effort ended up in the hands of nurses at four of the seven VTEUs. Last week, nurses in the vaccine testing unit at the University of Rochester Medical Center wrapped up one of their busiest weeks ever, vaccinating a record 278 people in one week with an experimental flu vaccine designed to help prevent another shortage.
Other VTEUs taking part in the current flu study are at Baylor Medical College, Cincinnati Children's Hospital, and the University of Maryland. In addition, St. Louis University, University of California at Los Angeles, and Vanderbilt are all part of the NIH network.
In Rochester, people eager to get an experimental flu shot spilled over into the hallway, waiting room, and even into the lunch room that nurses relinquished for the week. Visitors found their way through a maze of corridors to the vaccine testing unit, which is on the same floor of the Medical Center as the university's children's hospital, Golisano Children's Hospital at Strong. Next to the elevators hid Oscar the Grouch, periodically popping up from his dwelling – a colorful trash can designed to entertain children – to greet the visitors on their way to get their flu shot.
Secretary Barbara Mahoney fielded more than 1000 phone calls and e-mails from people who wanted the flu shot, and she scheduled nearly 300 callers for appointments. Then a team of nurses and doctors led by Diane O'Brien, clinical coordinator of the unit, and John Treanor, M.D., professor of medicine and director of the unit, developed a system to inoculate so many volunteers quickly, so that the study results would be in on time to benefit planning for next year's flu season.
Volunteers first were screened via a telephone call to make sure they met most eligibility requirements, such as being healthy and from ages 18 to 64. Then volunteers came in for appointments, learned more about the study, filled out extensive paperwork, and were interviewed by a doctor or nurse practitioner about their health. Finally they were led to an exam room, where nurses administered the shot and drew a sample of blood. Lastly, volunteers waited for 30 minutes, munching on cookies and coffee as nurses made sure the volunteers felt well after the injection. All the volunteers are documenting their health and will return in three weeks for a final interview and another blood test to check their reaction to the shot.
"Everyone put their holiday plans on hold and worked together to do what was necessary to complete the task," says O'Brien. "It's not as if we just lined up 278 people and gave them flu shots. This had to be conducted under the same good clinical practices as any research study. The staff here is terrific – without their experience and dedication something like this couldn't be done."
Nurses on the unit who did much of the work – helping volunteers understand and fill out consent forms, doing the injections and drawing blood, briefing volunteers about how to monitor their health – include Jean Comstock, Valerie Davis, Doreen Francis, Judy Marianacci, Anne Mowrer, Pat Smith, and Mary Lou Werthman. Barb Fernaays was called away from a study on shingles to assist, while nurses Shirley Erb, Trish Koops and Gail Mowrer also helped out for the week. Nurse practitioner Carrie Nolan and Christine Mhorag Hay, M.D., also worked the week evaluating participants.
"We called on all the troops, and things couldn't have gone better," says Treanor.
Even during the influx last week, nurses continued to see participants and follow up on several other studies, including one designed to prevent genital herpes in women; two experimental vaccines against anthrax; and a study to see if a flu vaccine made from insect cells might protect people as well as vaccines made in the conventional egg-based process.
In recent years the unit has vaccinated an average of approximately 500 to 700 people taking part in a total of eight or nine studies each year. Over it's 33-year history, the unit has vaccinated well over 10,000 people in hundreds of studies. Most of the new vaccines of the last 35 years first passed muster at the University of Rochester and the other VTEUs. In addition to the diseases named above, its adversaries have included malaria, the common cold, pneumonia, tuberculosis, and a host of microbes.
"Infectious disease is an ever-present threat, and the VTEUs are crucial to helping us stay one step ahead of disease to keep us safe," says Treanor. "The work that is accomplished by these sites gets done by people who find the volunteers and get them vaccinated. Without these people, none of those studies would ever happen."