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Some patients may need second flu shot, government says Vaccines given to high-risk people may not have been strong enough to do much good Web posted December 18, 1996
By Lauran Neergaard
Nobody knows if the 1.5 million to 2 million high-risk patients thought to have received the less potent vaccine really are at greater risk from influenza than some 70 million other Americans vaccinated against the disease this year.
But the Food and Drug Administration decided to err on the side of caution and write doctors that their most vulnerable patients - not healthy people - might need another dose.
``It's not that there's no protection. It's a moderately lowered level,'' FDA Commissioner David Kessler said. ``We don't believe it's a major risk.''
And because vaccine supplies now are dwindling, the FDA emphasized that doctors should give first priority to any high-risk patient who hasn't yet had a flu shot over anyone being considered for a second shot.
Four companies make flu vaccine. Only 11 batches of one company's shot - Parke Davis' Fluogen - are in question.
Parke Davis recalled those batches last month upon discovering the protection against the Nanchang flu, a new strain of the usually harsh Type A flu that is hitting the country, wasn't as potent as thought.
The Centers for Disease Control and Prevention studied elderly nursing home residents in New York and found those who got the recalled vaccine produced 39 percent fewer flu antibodies, immune cells that fight off disease, than nursing home residents who got another manufacturer's vaccine.
Generally, the more antibodies someone has, the better the protection. While the CDC cannot say whether those people still have enough antibodies to ward off Type A flu, it joined the FDA's recommendation that doctors consider revaccinating such patients.
``It is precautionary,'' said Parke Davis spokesman Stephen Mock.
A separate CDC study of healthy young health-care workers found no difference in antibody levels between the recalled and more potent vaccines - leading doctors to emphasize that healthy people, who aren't at risk for flu complications anyway, do not need a second shot.
Each year some 20,000 people, mostly the elderly and people with chronic medical conditions, die of complications from influenza.
No flu shot offers 100 percent protection - many vaccinated people just suffer a milder bout than they could have expected without the shot. And there's no guarantee a second shot would boost protection, the government warned.
Doctors can check their patients' records for the recalled vaccine lots: 00176P, 00276P, 00576P, 00586P, 00676P, 00686P, 00786P, 00886P, 00966P, 00986P and 01066P.
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