FDA Recalls a Weak Batch of Vaccine

The Food and Drug Administration announced Tuesday that it has recalled a batch of weakened flu vaccine and urged doctors to revaccinate those at high risk of flu complications who received it, including the elderly and those with chronic heart or lung diseases.

Healthy people should not attempt to get a second shot, the FDA stressed.

Federal health officials are unsure whether the 1.5 million to 2 million high-risk individuals who received the weakened vaccine are in any more danger than the 75 million other Americans who have been vaccinated against influenza this year. But they said that they decided not to take any chances.

“This is preventive public health,” said FDA Commissioner David A. Kessler.

Also, because vaccine supplies are dwindling and it is late in the flu season, physicians should give first priority to high-risk individuals who have not been vaccinated this year, the FDA said.

About 20,000 persons--most of them 65 and older or suffering from chronic medical conditions--die annually of flu complications.

No flu vaccine offers complete protection against this annual scourge of winter, which typically is characterized by headache, fever, respiratory congestion, muscle aches and fatigue. But such vaccinations often can result in a milder case or prevent the onset of serious complications.

The sub-potent vaccine, Fluogen, was manufactured by the Parke-Davis division of the Warner Lambert Co. Individuals who need to know if they received the recalled product should contact their physicians, the FDA said.

While physicians are not required to keep records of which vaccine is used, most do so voluntarily. Four companies make flu vaccines.

Last month, 11 lots of the Fluogen vaccine were voluntarily recalled because of decreased potency of the influenza A/Nanchang component of the vaccine, the FDA said. At that time, based on available information, neither the FDA nor the federal Centers for Disease Control and Prevention believed it necessary for anyone to be vaccinated again.

However, after the recall, the CDC compared blood samples taken from 86 elderly nursing home residents who had received the vaccine from recalled lots to blood samples of 86 other nursing home residents who had received vaccine from another manufacturer.

They found moderately low levels of antibodies to the influenza A/Nanchang component of the recalled vaccine, the FDA said. Generally, the higher the level of antibodies, the greater the degree of protection against illness.

In comparison, a study of generally healthy young health care workers who received Fluogen from recalled lots did not show any difference in levels of protection from those who received shots from non-recalled lots.

This year’s vaccine was designed to protect against three different influenza strains, B/Harbin, A/Texas, and A/Nanchang. The problem involves only A/Nanchang.

The recalled lots of the vaccine also provide some degree of protection, even against A/Nanchang, the FDA said. The lot numbers of the problem vaccine have been identified as: 00176P, 00276P, 00576P, 00586P, 00676P, 00686P, 00786P, 00886P, 00966P, 00986P, and 01066P.

Parke-Davis has directed all distributors, clinics and physicians to stop using these lots and return them to the company.

Three other manufacturers produce flu vaccine in this country, including Connaught Laboratories, Inc. (Fluzone); Evans Medical Ltd. (Fluviron); and Wyeth Labs, Inc. (Flushield). These products are unaffected by the recall.