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Dr. Janet Englund played a dual role in the effort to prevent H1N1.

H1N1 #2 220x130 The new strain of H1N1 flu virus that appeared in the spring of 2009 caught the country’s healthcare system off guard. With the seasonal flu vaccine already in production, a second vaccine needed to be developed as fast as possible.

Dr. Janet Englund played a dual role in the nation’s response to the H1N1 pandemic. She helped determine priority groups who would get the vaccine earliest and also helped test the vaccine’s safety and potential effectiveness in children.

Englund, a pediatric infectious disease specialist at Seattle Children’s, has been studying how to improve vaccines for children for a number of years and is one of the country’s leading authorities on influenza and children. As a member of the national Advisory Committee on Immunization Practices (ACIP), she helps determine which vaccines should be routinely administered to the public. In addition, she helps develop new and improved vaccines against infectious diseases by serving on one of the nation’s eight regional Vaccine and Treatment Evaluation Units (VTEU).

Who to vaccinate first?

H1N1 220x130When the new strain of H1N1 was identified in May, the challenge facing Englund and the rest of the medical community wasn’t figuring out how to produce a vaccine. The challenge was how to make it available to people before flu season started that fall. The ACIP held an emergency meeting in July to prioritize who should get the first doses of H1N1 vaccine, based on their level of risk.

“It was thought early on that it might be a contentious meeting,” Englund says, “but there was good agreement about which groups of people should be offered the vaccine first. That’s probably because we were able to base our decision on data from the initial spring outbreak rather than on opinions. That’s not always the case.”

As the ACIP was making its decisions, drug manufacturers were racing to make test vaccines from a seed vaccine generated by the Centers for Disease Control (CDC). Once the test vaccines became available, the VTEUs performed much of the testing.

2009’s sole focus: testing H1N1 vaccine

The National Institutes of Health (NIH) created the VTEUs in 1962 to conduct clinical trials of vaccines in response to emerging public health concerns. Over the last four decades, they’ve conducted hundreds of studies leading to new vaccines for diseases ranging from avian flu to pneumococcal infections. In that sense, their work on the H1N1 vaccine was nothing new.

“We’re studying new vaccines all the time,” Englund says. “The difference was that we had to drop everything else we were doing and focus entirely on testing the H1N1 vaccine.”

Children’s, Group Health Cooperative and the University of Washington make up the only VTEU on the West Coast. Together, they enrolled 1,000 people in seven H1N1 studies involving a variety of populations. The most pressing question was whether one dose of vaccine would be sufficient to protect people from the virus.

“The timeline was really compressed for this,” says Dr. Lisa Jackson, a senior investigator with the Group Health Research Institute and leader of the VTEU here. “Enrollment normally occurs over weeks and months, but we were doing it in a matter of days. It was extraordinary, but we faced a national emergency.”

Englund led a pediatric study that enrolled 118 children ages 6 months to 17 years. “We’re fortunate to have someone with Janet’s experience on our team,” Jackson says. “She’s a worldwide expert in viral respiratory infections in general and influenza in particular.”

VTEU investigators reviewed data from the six-week studies in real time rather than waiting until the studies concluded. The results showed that one dose of the vaccine was enough to protect adults and children over age 10.

“By demonstrating that we didn’t need to give two doses, we effectively doubled the amount of vaccine that would be available starting in October 2009,” Englund recalls.

Looking back, the response to the H1N1 pandemic proved that vaccines can be made available to the public much faster than is typically the case, Englund says. “Some steps in getting a new vaccine to the public are potentially unnecessary, and we should consider reducing them,” she says.

“The response to the H1N1 pandemic proved that vaccines can be made available much faster than is typically the case. Some steps in getting a new vaccine to the public are potentially unnecessary.”
~ Dr. Janet Englund