AAAS: “New Lyme disease vaccine offers protection—but falls short of trial goals.” Phase 3 trial did not meet its primary end point but developers still plan to seek approval. Previously, “there has only been one Lyme vaccine approved in the United States and its manufacturer, GSK, withdrew it from the market in 2002 after unproven concerns about side effects led to lawsuits and collapsed sales.” The new vaccine was announced in a press release this wk.
“Four doses of its experimental vaccine for Lyme disease showed greater than 70% efficacy in preventing the debilitating condition in a randomized, controlled trial of more than 9000 people.” Sounds good so far—aside from requiring 4 visits + jabs. But the problem is that “there were so few cases of Lyme among the trial participants overall that the result wasn’t statistically significant at the prespecified confidence level required to declare it a success.”
Obviously, this could “complicate their plans to seek approval for the vaccine from the U.S. Food and Drug Administration (FDA) and other regulators.” Like the first, withdrawn vaccine, the new proposed vaccine uses a surface protein found on the tick-spread bacterium that causes Lyme, but the companies Pfizer + Valneva have “engineered the protein to reduce the potentially problematic immune response GSK’s vaccine allegedly caused,” though that company did not detail the side effects seen in their trial.
Many outside scientists are reserving judgment until more information is presented, as do I. “Vaccine researcher Kathryn Edwards of Vanderbilt University Medical Center, for example, told STAT the trial’s result was “encouraging news” but added that more studies were needed and it wasn’t clear the current data would be enough to win FDA approval.
Final point: the tiny tick in the photo is the nymphal form, + is actually more likely to spread Borrelia than the adult deer tick.
