Date: Fri 23-Apr-1999

Publication: Hea

Author: KAAREN

Quick Words:

FDA-Lyme-immunization-LYMErix

Full Text:

HEALTH MONITOR: FDA Approves First Lyme Disease Vaccine

BY ANDREA ZIMMERMANN

After more than a year of trials, the FDA has approved the world's first Lyme

disease vaccine which is designated for people aged 15-70 who frequent areas

infested by Borrelia burgdorferi-infected ticks. Manufactured by SmithKline

Beecham Biologicals, the immunization is given in a series of three

injections. Although the FDA approved the vaccine to be administered over a

year's period, area hospitals and local physicians offer an accelerated

series, because Lyme disease "season" is upon us.

"We are in an endemic area and studies showed the vaccine did not adequately

protect a person until the third shot," says Jennifer Holloway, MD, an

internist who is in practice with Peter Licht, MD, in the Newtown Professional

Center. The doctors offer a three-month series of vaccines.

Between 1982 and 1996, more than 99,000 cases of Lyme Disease were reported to

the nation's Centers for Disease Control. In 1996, Connecticut had the highest

rate of reported cases (91.5 per 100,000 population). Danbury Hospital was one

of the trial sites for the vaccine; now, it also offers the series.

"Unlike typical vaccines, LYMErix can fight the bacterium while the germ is

still inside the tick, before the patient becomes infected. When the tick

sucks a vaccinated person's blood, it will ingest the antibodies, which can

neutralize Lyme germs inside the tick," reported Charles Henderson in Vaccine

Weekly last January.

Average cost for the vaccine is $65 per shot; in addition, one office visit

fee may be charged. The first two shots in the series are given one month

apart; the third is at 12 months from the first vaccine. If an accelerated

course is chosen, patients can complete the schedule within two to three

months. (The latter course has not been studied extensively and is not yet

approved by the FDA.) The vaccine is genetically engineered and cannot cause

Lyme disease; it does not contain any bacterial products.

It is unknown how long the vaccine will protect and when, if any, booster is

needed. Also, the FDA cautions the vaccine does not prevent all cases of Lyme

disease. The vaccine has an efficacy against confirmed Lyme disease of 50

percent after two shots and 78 percent after three. (These numbers reflect

results of trials where the vaccine was administered between January and April

-- before the height of transmission season.) Against asymtomatic infection,

two injections are reported to be 83 percent effective and the full-series 100

percent effective.

"I am hopeful we can prevent Lyme in many people by this vaccine," says Dr

Holloway. "But it's not foolproof."

The physician encourages people to learn about the vaccine, evaluate their

risks for infection, and then make their own decisions about whether or not to

have the vaccine. The reason Dr Holloway is not encouraging all of her

patients to have the vaccine is because the long-term side-effects are not

known. Usually, Lyme disease can be cured with antibiotics, but left untreated

the disease can severely damage the nervous system and heart. And there are

instances where some people experience residual chronic Lyme, says Dr

Holloway. Those suffering from advanced arthritis caused by Lyme are not

candidates for the vaccine, she added. But others who have previously been

infected can reap the same benefits as those who have not.

Adverse reactions to the vaccine include flu-like symptoms, myalgias,

arthralgias, rash, joint and muscle pain, and possible redness and swelling

around the site of vaccine injection. The side effects usually appear and

vanish within the first four days after injection. Most insurance companies

cover the cost of the vaccine series, although Medicare does not, says Dr

Holloway.

Now that the FDA has approved the vaccine, SmithKline Beecham will conduct a

study in New England to obtain further safety data on its product, and do

animal testing to establish a pregnancy registry. Right now, the vaccination

is available only through physicians. Recommendations for the use of the

vaccine are being developed by the Advisory Committee for Immunization

Practices.

But even if you have the new Lyme vaccine series, don't drop your guard. Both

physicians and LYMERix manufacturers suggest you continue to take the

following traditional precautions. And remember to protect children; they are

not yet candidates for the vaccine and, according to Connecticut state lab,

those five to nine years old are most likely to contract Lyme disease.

Wear long pants and tuck pant legs into socks. Also, tuck your shirt into your

pants. Wear clothes made of tightly-woven materials.

Pull back long hair.

Wear a hat.

Avoid sitting directly on the ground. Use a light-colored blanket which has

been treated with repellent.

Spray clothes and exposed skin with a repellent containing DEET (read cautions

first)

Avoid walking in brushy areas.

Clear tall grass or brush from your property.

Inspect clothing and skin every 3-4 hours when you are outside (also check

pets). When you come in, inspect your body thoroughly for ticks.

Wash "outdoor" clothes in hot water and dry on high.

Shower immediately after coming inside.

Infected ticks must be attached to the skin for 24 hours to transmit Lyme

disease, according to Dr. Holloway. If you are not certain how long a tick has

been attached to the skin, many local health departments will send suspect

ticks removed from humans to the state lab for testing.

For more information on the Lyme Disease vaccine, contact your physician,

health department, or visit the LYMErix Web site at www.lymerix.com.