Oct. 7, 2009 -- At the University of Chicago Pediatric Clinic on Tuesday, Diane Brogan jumped at the opportunity to get her 6-year old son, Liam, vaccinated against swine flu when he came in for his check-up.
"They told me that it was available so I said, 'great, better safe than sorry'," Brogan said of her son receiving the nasal spray form of the vaccine. "Liam's very happy that it was not a shot," she added.
Asked how the vaccination went, Liam replied, "It tickled a lot."
In Omaha, at the Nebraska Medical Center, father Robert Wright received a similar offer for his son Rosean. Rosean, who turned 4 years old on Tuesday, got an unexpected birthday present when he was chosen as one of only a few dozen kids at Omaha's pediatric clinic to be offered the vaccine. Wright said he was "not concerned about him getting it," adding that his son was "very excited about it."
Not all parents are as confident as Brogan and Wright when it comes to the safety of the new influenza vaccine, which a select few centers across the country rolled out this week. But as the novel version of the flu continues to spread throughout most of the nation, health officials insist that the formulation is safe. Meanwhile, vaccine programs are moving forward in many states as more than 2 million doses of the nasal spray vaccine become available for use.
The U.S. Centers for Disease Control and Prevention announced Tuesday that all 50 states have ordered their allotments of available H1N1 vaccines. At least six states with widespread or regional swine flu have begun giving out the vaccine to health care workers and children between the ages of 2 and 4.
The vaccine programs have only had access thus far to the live-attenuated nasal spray, which is only suitable for healthy individuals between the ages of 2 and 49. But on Tuesday the CDC announced that the injectable form, suitable for both healthy and higher risk individuals such as infants 6 months to 2 years old, pregnant women, the elderly and those with preexisting conditions, will become available starting next week. The CDC expects to have 10 to 15 million doses of nasal or injectable vaccine available for distribution each week.
Not Yet Enough for Everyone
CDC Director Dr. Thomas Frieden said at a Tuesday briefing that the continued rollout of the vaccine will be "a little bit of a messy process," with each state being notified on a day-to-day basis how much vaccine will be made available to them. But, he added, "This is the best way to get the vaccine out as soon as it becomes available."
In his weekly briefing, Frieden emphasized the importance of the vaccine in combating this pandemic.
"At this point, swine flu has affected 5 to 10 percent; that leaves 90 to 95 percent of the population that's still susceptible," he said. "We can't predict what the future will hold, [but] we know that vaccination is our best tool to reduce the impact of flu.
"My children will get it, other public health and societal leaders and experts will get it... It's something that we have a high degree of confidence in."
First allotments of the vaccine have been small, providing enough vaccine to reach only a fraction of states' target populations. The number of high priority individuals that can be vaccinated is further reduced by the limitations of the nasal spray form of the vaccine that is currently available. The current version uses a live strain of the virus, so it is not safe for those with compromised immune systems such as young infants, the elderly, those who are pregnant, or those with asthma or respiratory illness.
As a result, facilities have been giving the vaccine predominately to eligible health care workers who come into contact with flu patients -- and in a few locations, to healthy children between the ages of 2 and 4.
In Chicago, where swine flu prevalence is widespread, Children's Memorial Hospital received 500 doses on Monday and chose to allocate them all to hospital staff. Similarly, in other swine flu hot spots such as Indiana, Minnesota, Wisconsin, Utah, Mississippi, and Virginia, shipments of vaccine have arrived and are being given to health care workers who treat flu patients.
Still, a few hospitals and clinics are expanding vaccine programs to include 2- to 4-year-old children. As of Tuesday morning, a few hundred children were given the nasal spray vaccine in Georgia, Illinois and Nebraska. Oklahoma will hold the state's first H1N1 flu clinic for schoolchildren in Newcastle on Wednesday.
'Dramatic' Need for Swine Flu Vaccine
As the number of available doses is too small to advertise the vaccine publicly, most centers are offering the vaccine to eligible children already coming in for their annual check-ups.
"There is a dramatic and pressing need at the present time" for the vaccine, said Dr. Mark Rupp, Medical Director of Epidemiology for the Nebraska Medical Center. "Our ER and some of our clinics are operating at record levels right now with a large number of patients with influenza-type illness."
Rupp added that the hospital will take and use "whatever form of the vaccine we can get our hands on. We're looking to protect people as quickly as possible."
Some Doctors and Pharmacists Holding Back on Vaccine
Not all in the medical profession are so eager to give out the nasal spray vaccine, however.
Though the Lahey Clinic in Burlington, Mass., received 500 doses of the nasal vaccine on Monday, it has yet to vaccinate anyone.
"Lahey Clinic generally prefers to vaccinate its caregivers with the injectable flu shot [instead of] the nasal spray with the live virus," said Dr. Robert Duncan, an infectious disease specialist at the clinic. "This method eliminates the risk, albeit small, of transmitting a live virus to immune-suppressed patients."
As a result, infectious disease doctors at the clinic are currently reviewing when and to whom they will give the nasal spray. This more deliberate approach runs counter to advice from Frieden. "We ask that places don't hold vaccine back, vaccinate as many people as you can," he said.
But the doctors at Lahey Clinic are not alone in their desire to more carefully approach who gets what vaccine when.
Dr. Ira Rubin, a pediatrician in Naperville, Ill., has chosen to wait for the injectable vaccine before vaccinating his patients. Though the state offered his clinic doses of the nasal spray vaccine this week, he feels that there are risks associated with the giving the spray that he would rather not take.
"I'm not worried about the vaccine itself being safe; if done properly, I have no doubt it will be safe," Rubin said. "But the average person going to a clinic may not know that they have a respiratory disease... If you gave the live vaccine to a patient with asthma, that could hurt them.
"I'm not looking to be paranoid, but there's going to be some human error."
Some Remain Skeptical of Swine Flu Vaccine Safety
Rubin added that he is concerned about the vaccine because "it's very new" and there doesn't seem to be concrete information available to clinicians as to what percentage of those vaccinated can be expected to be protected, or as to which of the four different vaccine products that will eventually be available works the best.
Others are more critical.
"The CDC and FDA have jumped the gun on this," said Zachariah Broshes, assistant professor of Pharmacy Practice at Ohio Northern University. "I will not be carrying the vaccine, nor will I administer it."
Broshes' opinion is among the minority; however, Dr. Peter Katona, an infectious disease specialist at UCLA, said that he is "getting a great deal of hesitation about vaccination, [that it] hasn't been tested properly, the flu isn't that bad anyway, it won't happen to me, et cetera. Some docs are also telling their patients not to take it."
Dr. John Treanor, an infectious disease specialist at the University of Rochester has also noticed these concerns. "The ironic thing about this is that we use more than 100 million doses of seasonal flu vaccine each year, usually containing new components, that are also not evaluated in clinical trials before licensure, and that seems to work just fine."
Dr. Tony Fauci, director of the National Institute of Allergy and Infectious Diseases, commented that just in NIH-funded clinical trials alone, these vaccines have been tested in a total of 3,009 adult, elderly, and pediatric patients, adding that many drugs are approved on the basis of studies of this size.