Meredith Hodnock
๐ค SpeakerAppearances Over Time
Podcast Appearances
Vijay monitored his patients for nearly two years, but then the study was out of his hands.
Finally, after months of needles and months of waiting, the people of Lyme got their answer.
The study results were published in the New England Journal of Medicine in July 1998.
66 people in the placebo group got Lyme disease that year, compared to 16 cases in the fully vaccinated group.
With over 10,000 patients, this wasn't the biggest of studies, but it was a perfectly respectable phase three trial, showing that there were no major side effects over the 20 months that the patients were monitored.
Most symptoms from the vaccine, as reported by the study, were a sore arm, a little fever, nothing a few days, and some ibuprofen didn't resolve.
Vijay was a lead author on the paper, with scientists from some of the biggest research universities in the country.
He contributed to textbooks and helped educate doctors around the world about Lyme disease.
And with the study over, Vijay took on a new role, advocacy.
In 1998, Vijay and other sponsor representatives for the drug company went to a holiday inn in Bethesda, Maryland, to present the vaccine study to an FDA advisory committee.
This meeting lasted all day, going into the weeds of the study design, the efficacy results, the safety data.
Vijay shared what he had learned about the many faces of Lyme disease, how it could look like so many different things.
Then the coordinating investigator of the vaccine study, Dr. Alan Steer, shared some new findings of his own.
He's the one that first discovered that Lyme disease came from ticks decades before.
And he'd been studying Lyme on his own, apart from the vaccine trial.