Vaccine recall sparks parental fears

TRENTON - Pediatricians rushed to stock up on a crucial baby shot yesterday, a day after one of the nation's top vaccine manufacturers announced it was recalling 1.2 million doses and suspending production indefinitely.

Meanwhile, worried parents were calling doctors' offices to ask whether their children are safe if they recently got the Hib vaccine, which protects against meningitis, pneumonia and other life-threatening and disabling bacterial diseases.

Parents were told there's virtually no chance of anything but swelling and redness around the injection, which would have happened within a week; there have been no such reports.

But health officials are still scrambling over how to address the shortage, caused by a sterility problem at a Merck & Co. vaccine factory in West Point, Pa.

"This one's a huge challenge," said Dr. Lance Rodewald, head of immunization services at the Centers for Disease Control and Prevention.

Rodewald said that before the vaccine was introduced in the mid-1980s, there were about 20,000 U.S. cases a year of invasive Hib. Hib is for Haemophilus influenza type B, which can cause brain damage, deafness and death.

Rodewald said the CDC and other medical groups are weighing options to stretch the supply of Hib vaccine from the only other manufacturer, Sanofi Pasteur, and waiting to hear whether it can boost production or shift some doses here that normally would be sold overseas. He hopes to have recommendations next week.

The American Academy of Pediatrics is advising its 60,000 members to try to order now from Sanofi Pasteur, and if they run short, to delay the booster shot usually given at 12-15 months.

Merck, based in Whitehouse Station, N.J., supplies about half the 14 million doses of Hib vaccine used in the U.S. each year. It said that besides the doses recalled - roughly four months of production - it has quarantined nearly a year's worth of other, possibly suspect doses and doesn't expect to supply any more until at least next October. That means roughly two years of its normal production is unavailable.

"The math doesn't look good," said Dr. Kathy Moore, a solo practitioner in Tyler, Texas. "There's going to be a problem real fast."

Dr. Herschel Lessin, a partner in the seven-office Children's Medical Group in the Poughkeepsie, N.Y., area, said all but a handful of the Hib doses in their stock were included in the recall.

"This pretty much wipes us out," he said.

Lessin and other doctors said Sanofi Pasteur is saying at best they can get up to 50 doses per office - for now.

"It may not be adequate," said Dr. Michael Segarra of North Brunswick Pediatrics in New Jersey, which lost a third of its stock to the recall.

Dr. Kenneth Polin of Town and Country Pediatrics in the Chicago area, said he expects rationing and told his staff "to order massive quantities right now." But it was already too late, and they could place only a small order.

Polin and some other doctors who have long bought their Hib vaccine from Sanofi Pasteur were hoping to get priority over Merck's customers.

Sanofi Pasteur spokeswoman Donna Cary said the company, a unit of Paris-based drugmaker Sanofi-Aven tis SA, is trying to provide for doctors' immediate needs but is limiting them to a "reasonable" 30-day supply. She said call volume was up 45 percent yesterday.

Merck has said it initiated the recall as a precaution because a routine test in October found bacterial contamination on production equipment. None has been found in vaccine so far.

The company quarantined all doses of Hib vaccine produced since the last "clean" sterility test, in November 2006. Further investigation showed the most likely cause of the problem was a manufacturing change made in July 2006, so it recalled all doses made between July 2006 and November 2006. Those recalled doses were distributed beginning in April.

"There absolutely is going to be a severe shortage," said Dr. Jill Stoller of Chestnut Ridge Pediatrics in Woodcliff Lake, N.J. "Vaccines should be made by the government and distributed by the government," not the free market. *