Lyme Vaccine On Way

It is too late for this year's tick season, now in full swing, but a vaccine to help ward off Lyme disease is moving closer to reality. Two developments in the battle against the disease are promised just following summer's unofficial start this weekend.

While the public is expected to greet the news of a vaccine with cheers, some officials in medical quarters are sounding notes of caution.

On Tuesday, the Federal Food and Drug Administration will hold a key public hearing on Lymerix, a vaccine for adults against Lyme, considered endemic here, that Smith Kline Beecham Pharmaceuticals of Philadelphia has been testing since 1994. The F.D.A. must approve all medications and vaccines prescribed in this country.

Pediatric Trials

Also next week, on May 30, about 50 children in East Hampton, some as young as 4, will begin participating in a clinical trial for a pediatric version of the SmithKline Lyme vaccine. The Long Island Jewish Medical Center's pediatric infectious diseases department is doing the testing.

The vaccine will be administered in the East Hampton Medical Group office of Dr. Gail Schonfeld, a pediatrician.

SmithKline finished testing Lyme rix on some 11,000 adults in September, concluding that it was between 79 and 90 percent effective after three doses, two administered a month apart and the third a year later.

Connaught, Too

In the meantime, Pasteur Merieux Connaught of Swiftwater, Pa., has been testing a similar vaccine for adults trademarked ImmuLyme, for which it is seeking F.D.A. approval. Connaught also has plans to develop a pediatric vaccine, but has not begun trials for it.

SmithKline applied this winter for a license to market its vaccine, and its sales representatives have been visiting physicians' offices with information about distribution and "patient outreach," Richard Koenig, a spokesman, confirmed this week.

SmithKline representatives will present trial data Tuesday to an independent advisory board of about a dozen physicians, statisticians, and researchers, who will make recommendations that F.D.A. officials will consider in deciding whether to approve the vaccine. Connaught is not expected to appear, however.

Timetable Uncertain

Some had hoped for approval for SmithKline by midsummer, but those close to F.D.A. proceedings say the timetable is impossible to predict.

"The sooner we get it the better," Dr. Schonfeld said this week. The pediatrician reported seeing about 40 children a year here with Lyme disease in its early stage, plus five in later stages, which often produce Lyme-related arthritis, and about two each year in even later-stage illness involving central nervous system disorders.

Some of her young patients have required spinal taps to confirm the Lyme diagnosis; several others have had intravenous antibiotics to halt the disease's progression.

Called Early

However, Dr. Stephen Sigler, an East Hampton internist and former chief of the Southampton Hospital medical staff, said it was "too early" in the testing process for him to feel comfortable about the vaccine.

Stressing that he had not seen the data, he noted that the results were not 100-percent effective. He added that he would not give the vaccine to his own children, at least not yet.

Dr. Sigler said he was concerned that repeated doses of the vaccine, a genetically engineered recombinant outer surface protein of the spirochete known as Borrelia burgdorferi, might provoke arthritis symptoms. He also said that, since the spirochete lives in the tick, its outer surface protein could in time mutate to avoid destruction by the vaccine. This would reduce this vaccine's ability to provide protection.

Booster Shots?

Dr. John Zahradnik, who has overseen three years of Connaught's clinical trials, acknowledged that the vaccines now being made were "first-generation vaccines." After testing ImmuLyme on 10,305 adults, Dr. Zahradnik said, the vaccine was 66 percent effective after two doses, 92 percent effective after three.

The physician said it remained to be seen how many booster shots would be recommended for adults or children after the initial three inoculations, and at what intervals.

"We think it's great - another preventive tool in our arsenal," said David Weld, the executive director of the American Lyme Disease Association in Westchester.

Hard Marketing

Mr. Weld, who will attend Tuesday's hearings, said the public should keep in mind that vaccines, no matter how effective, will not wipe out the disease. He stressed that the spirochete lives within the tick, and is not spread person-to-person, as are other illnesses for which vaccines have been developed.

"I think it's pretty safe," said Mr. Weld, who said companies would be "pushing hard" to market their vaccines once they are approved. He added, however, that it could take several years before health maintenance organizations covered their cost. As of this week, company spokesmen said they had no idea what that cost might be.

The Lyme Disease Association has a Web site with current information on the treatment and prevention of the disease at: www.alda.com .

Other Illnesses

Physicians and researchers also stressed that Lyme vaccines will not be effective in preventing other tick-borne illnesses, such as Rocky Mountain spotted fever, which can come from American dog tick bites, or babesiosis and ehrlichiosis.

Lori Benincasa, a spokeswoman for the Suffolk County Health Department, confirmed that the county was a high-risk area for Lyme disease, based on the frequency of cases, adding that the Health Department would look to both the State Health Department and the Federal Centers for Disease Control in Atlanta, to provide guidelines for distribution of approved vaccines.

SUSAN ROSENBAUM