Alex Manes, 16, takes part in the pediatric portion of the H1N1 influenza vaccine trial conducted this summer at Vanderbilt. Todd Mathis, L.P.N., administers the injection. (Photo by Joe Howell)
Is the H1N1 vaccine safe for both adults and children?
After two months of testing in thousands of adults and children, including 300 at the Vanderbilt Vaccine Research Program (VVRP), the H1N1 vaccine is approved and ready to be distributed to millions of people.
Testing for the vaccine progressed without a hitch, despite early reports in the media that brought up old concerns.
Back in 1976, a rare neurologic side-effect was linked with the swine flu vaccine, although no cause and effect relationship was ever found.
While it is routine to watch for every concern, side effects for the H1N1 vaccine were expected to be similar to side effects from any flu shot… and they were, researchers say.
“Clinical trials show that the H1N1 vaccine caused some arm pain and tenderness, but many participants stated that this was less than seen with the seasonal influenza vaccine given each year,” said Buddy Creech, M.D., M.P.H., assistant professor of Pediatric Infectious Diseases.
While there are reports the H1N1 flu may actually be a milder infection than the other seasonal flu circulating right now, Creech says any flu could be bad news in the wrong person.
“If people think they don’t need the vaccine, they should keep in mind that the vaccine also can help prevent flu from spreading to the people around them – friends, family, co-workers. Since flu can be very serious for some people, influenza vaccination is a great way to protect our communities,” Creech said.
Kathryn Edwards, M.D., Sarah H. Sell Chair in Pediatrics, director of the VVRP and principal investigator of the vaccine trials, said an important question for researchers was how much vaccine would be enough to protect adults and children.
The data suggest that adults will only need one 15 mcg dose of vaccine, but that children younger than 10 years of age will likely need two 15 mcg doses. This is similar to what is seen with the usual seasonal influenza vaccine.
These VVRP investigators are also conducting similar studies of H1N1 vaccines in pregnant women. Pregnant women have been reported to have more difficulty this year with H1N1 infections than other seasonal influenzas in past years.