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Drug Maker Seeks Approval for Chicken Pox Vaccine

January 28, 1994

BETHESDA, Md. (AP) _ A vaccine for chicken pox, long awaited by parents, moved a step closer to market Thursday.

An advisory committee to the Food and Drug Administration decided the experimental vaccine has proven safe and effective for use by all Americans, children and adults.

The Food and Drug Administration still must approve the vaccine.

The panel stopped short of recommending immediate FDA approval of the vaccine, saying some questions remained unanswered, including whether to give children one shot or two and whether it could be given at the same time as children get their measles immunizations.

″It will save lives, lives that are precious and can never be replaced,″ said Rebecca Cole, a North Carolina woman who has fought for approval of the vaccine since her 12-year-old son died of chicken pox in 1988.

Chicken pox afflicts about 4 million people a year, mostly children. Typically, it’s a nuisance disease, keeping bump-covered children out of school and their parents out of work for about a week. Some doctors have contended a vaccine is unnecessary.

But chicken pox can be deadly in infants, adults and people with immune problems. It kills up to 90 people a year and hospitalizes another 9,000.

A chicken pox vaccine has been used in high-risk children in Japan for 20 years with no known ill effects and for almost 10 years there in healthy children. Japanese figures show only 1 or 2 percent of the vaccinated children contract chicken pox.

Merck & Co. is seeking FDA approval to market in the United States a chicken pox vaccine called Varivax, which is made of the same strain of chicken pox virus that the Japanese vaccine uses.

As with any vaccine, it has some mild side effects, typically redness or swelling of the vaccine site, said Merck scientist Dr. Jo White.

Merck officials produced studies of 11,000 people who had received the vaccine. The few who later contracted chicken pox got very mild cases, company officials said.

The advisory committee said Merck proved the vaccine was effective over the short term but may not protect adequately for more than four or five years.

″The need for booster shots has not been determined,″ said the FDA’s Dr. Phillip Krause. The advisory committee agreed and said the government and Merck should immediately study whether everyone would need a booster shot.

Merck officials say anyone over age 12 would need two shots in order to be protected.

Another question about the vaccine is whether it affects how many people get shingles, a very painful rash caused when the chicken pox virus continues to live within its victims and resurfaces as shingles decades later.

The FDA has not set a date to consider whether to approve the vaccine, but officials said privately it could come soon. The Centers for Disease Control and Prevention is poised to approve guidelines for use of the vaccine next month.

Merck officials said the vaccine would be in doctors’ offices six weeks after FDA approval.

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