None of Chiron's flu vaccine is safe, FDA says

Oct 15, 2004 (CIDRAP News) – Federal health officials today ruled out using any of Chiron Corporation's influenza vaccine in the United States this year, following the completion of inspections at the company's plant in Liverpool, England.

Shipment of Chiron's 48 million doses of vaccine was halted last week when the British government shut down the plant because of concerns about contamination. US officials had held out little hope that any of the Chiron vaccine could be used, and today's announcement confirmed the bad news.

"Today we're announcing that none of the flu vaccine made by Chiron for the US market is safe," Food and Drug Administration (FDA) Acting Commissioner Lester Crawford said at a news briefing late this afternoon. The announcement confirms the disappearance of nearly half of the previously projected US supply of 100 million doses.

Crawford said FDA officials who finished inspecting Chiron's Liverpool plant this afternoon found violations of "good manufacturing practices." "We did enough testing to conclude that we couldn't guarantee the safety of any of the vaccine," he said. "The contamination appears to be from the filling of the vials; that has to be done in a sterile way, and we're not sure that was the case." He said the contamination involved the bacterial species Serratia marcescens.

About a million doses of Chiron vaccine that had already been shipped to the United States probably can't be used either, Crawford said. "Our inclination and intention here is to test and retest those lots and see if some of it can be used. We are not optimistic about that and in fact do not believe it can be used," he said.

The Chiron disaster has left Aventis Pasteur as the only supplier of injectable vaccine for the US market. Aventis has produced 55.4 million doses, about 33 million of which have already been shipped to customers, according to the Centers for Disease Control and Prevention (CDC).

Because of the shortage, the CDC has recommended that healthy people forgo flu shots so the doses can be saved for people at high risk for flu complications, such as the elderly, infants, and people with chronic illness. The agency is working with Aventis to assure that the remaining doses go to those groups.

Crawford said the Department of Health and Human Services is hunting everywhere for more vaccine. "Literally every flu vaccine manufacturer in the world is being contacted, and some progress is being made," he said, without giving specifics.

The CDC said today that Aventis shipped more than 2 million doses of flu vaccine this week to providers serving high-risk groups, including the Veterans Administration, long-term care facilities, hospitals, state public health agencies, the Vaccines for Children Program, and private providers who care for young children.

"More doses of vaccine will be going out over the next 6-7 weeks so there will be more opportunity for those who need this vaccine to get it in time for this year's influenza season," CDC Director Julie Gerberding said in a news release.

Amplifying this message at the news briefing, Gerberding said, "We recommend that people not wait in long lines [for vaccine] but rather call ahead to make an appointment. . . . We have very limited flu activity in the US right now, so there is still time for us to get these vaccine doses out and for people to receive them without having to wait in long lines."

Dr. Anthony Fauci, director of the National Institute for Allergy and Infectious Diseases, urged providers not to give flu shots to healthy people in low-risk groups. "It's a numbers issue," he said. Roughly 45 million people in the high-risk groups are expected to seek flu shots, which means there are just enough doses for them, he explained.

Gerberding said the CDC has a stockpile of antiviral drugs that can help the nation cope with the vaccine shortage. "We've gotten 5 million doses of rimantadine for the stockpile. . . . We also have a stockpile of oseltamivir which would be used for treating influenza," she said. She added that the CDC will be providing more information soon and will look into whether production of antivirals can be increased.

In other developments, reports of exorbitant prices for scarce flu vaccine prompted HHS Secretary Tommy Thompson yesterday to urge states to prosecute price gougers.

"I am encouraging the attorney general of each state to thoroughly investigate reports of price gouging and prosecute those engaging in this immoral and illegal activity to the full extent of the law," Thompson said in a letter he sent to attorneys general and released publicly.

At the same time, Thompson said it was "doubtful" that the United States would be able to buy significant supplies of flu vaccine from Canada or other foreign sources, according to the Associated Press (AP) and other news services.

The FDA has been talking with two companies that sell flu vaccine in Canada and other countries and have "a few million" unsold doses, the AP reported. But the vaccines are not licensed in the United States, and Thompson said it was unlikely the producers could meet FDA requirements in time for this season, according to the report.

Thompson's comments came a day after President Bush, in the Oct 13 presidential debate, said Canadian supplies might ease the US vaccine shortage.

According to the AP, hospitals have reported distributors offering flu vaccine for as much as $100 per shot, compared with normal retail prices of $12 to $20. In his letter to attorneys general, Thompson said the CDC is collecting reports of price gouging and sharing them with the National Association of Attorneys General and state prosecutors.

One sign of the surging demand for flu vaccine came from Denver, where someone stole 780 doses from a clinic in suburban Aurora, according to a report in yesterday's Denver Post. The doses were taken from a refrigerator at Kids Aurora, a private, two-doctor pediatric clinic, the story said.

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