Nasal swine flu vaccine recalled over potency

Posted December 22, 2009
Updated December 23, 2009

— Drugmaker MedImmune is recalling nearly 5 million doses of swine flu vaccine because the nasal spray appears to lose strength over time, federal health officials announced Tuesday.

The vaccine recall is the second this month caused by declining potency and comes as public health officials urge millions of Americans to get vaccinated against swine flu.

The action affects more than 4.6 million doses, but the vast majority have already been used, according to the Food and Drug Administration. Agency officials said the vaccine was strong enough when it was distributed in October and November.

"The slight decrease in potency is not expected to have any effect on the protective effect of the vaccine," said Norman Baylor, director of the FDA's vaccine research office. "We are not recommending revaccination."

The North Carolina Division of Public Health was notifying county health departments and other health care providers across the state that received 113,700 recalled doses of the nasal mist vaccine, officials said in a statement.

“We see this as a preventive measure to ensure the vaccine we are giving to the public is going to protect them against the H1N1 virus,” said Beth Rowe-West, head of the division's Immunization Branch.

The agency is looking into the problem but said it's not uncommon for vaccines to lose strength over time. MedImmune's vaccine has a recommended shelf life of about four months. The company has about 3,000 doses in its warehouses but does not know how many remain in the field, according to the FDA.

Last week, vaccine maker Sanofi Pasteur recalled hundreds of thousands of swine flu shots for children because tests indicated those doses lost some strength. Most of those doses had already been used, too.

Maryland-based MedImmune, a subsidiary of London-based AstraZeneca PLC, voluntarily recalled 13 lots of its vaccine, "due to a slight decrease in potency" discovered through routine quality control testing, said spokesman Tor Constantino.

"It's not a safety concern. People who have received doses from the affected lots do not need to be revaccinated. The doses were well within potency specification," he said.

Swine flu vaccine has been available since early October, and since then manufacturers have released over 111 million doses for distribution in the U.S. MedImmune makes the only nasal spray version, which can be used by healthy people ages 2 to 49.

Only in recent weeks have state authorities lifted restrictions on who can get vaccinated. Previously the vaccines were reserved for high-risk patients, including pregnant women and schoolchildren.

In a telephone news conference on Tuesday, Dr. Anne Schuchat of the federal Centers for Disease Control and Prevention estimated that 60 million Americans have received swine flu vaccine, and said intense monitoring for side effects has not turned up any safety concerns.

"We are not seeing any worrisome signs," she said.

The vaccine supply has increased so much in recent weeks that she urged parents of children 10 and younger to get them a second dose, because studies show this age group needs two for optimal protection.

Flu activity has slowed, but "it's not gone," Schuchat said. "None of us know what the weeks and months ahead will bring in terms of influenza activity, and it's very important not to become complacent."

The first wave of the swine flu pandemic began in April, when the strain was discovered. A larger wave started in the late summer and is declining. Infections are now widespread in 11 states, down from 48 in late October.

A new Harvard poll released Tuesday finds that concern about swine flu has waned along with the number of new cases being reported.

Only 40 percent of people now say they are concerned that they or a family member will get sick from swine flu during the next year. That's down from an earlier poll in September, when 52 percent said they were worried about swine flu.

The new poll found that most parents who sought vaccine for their children were able to get it. However, more than one-third of respondents said they did not plan to seek it for their kids.

The Harvard School of Public Health polled more than 1,600 adults on Dec. 16 and 17.

Also on Tuesday, a 13-year-old dog in suburban New York was confirmed as the first known case of swine flu in a dog. The pet apparently caught the virus from his owner. The CDC's Schuchat said that animals can carry and spread flu viruses, but such cases are rare and people should not be afraid to enjoy their pets. A few cats and ferrets have also been diagnosed with swine flu.


AP Medical Writer Marilynn Marchione reported from Milwaukee.


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  • for_shame Dec 28, 2009

    people should not be afraid to enjoy their pets

  • dbcooper41 Dec 24, 2009

    good thing they fast tracked this stuff to market(note:sarcasm). the ptb said this was just like any other flu vaccine so there was no need for additional testing. apparently it's not "just like" the rest.

  • wattsun Dec 23, 2009

    Read between the lines.

  • todmax Dec 23, 2009

    So they recall them after they lose potency over time huh? Why not just put an expiration date on them? I'm glad I live in a country that can get us something on a mass scale, even if some are not the several hundred percent potency wanted. People still suffer and die all over the world from diseases we are immunized against as children and have pretty much forgotten about.

  • momeeee Dec 23, 2009

    How much are we paying for all these vaccines that are not right?

  • Titus Pullo Dec 23, 2009

    Anybody surprised? This product was rushed to market without sufficient testing. It is questionable if it is at all efficacious.