Flu Vaccine Delay Raising Concerns

N E W Y O R K, Sept. 13, 2000 -- Infectious disease specialist Dr. Steven Mostow is worried.

Usually, by this time of year, says Mostow, director and dean of outreach at the University of Colorado Health Sciences Center, in Denver, hospitals, nursing homes, doctors and visiting nurses in Colorado would have received much of their supply of a million or so flu vaccine doses. But this year, they haven’t.

“This is probably one of the worst delays of flu vaccine I have seen in my 34 years of practice,” Mostow says. “I am afraid the flu is going to hit before enough vaccine becomes available. Tens of thousands of more people across the country might die this year because of the delay.”

All across the nation, health care professionals are bracing for late shipments of the vaccine that protects against the A and B strains of influenza. While some are taking a cross-their-fingers attitude, others, like Mostow, fear the worst: If the vaccine arrives later than the start of flu season, more people will get sick, emergency rooms will become burdened and more people could die.

In response, flu-prevention education programs and contingency plans to help the most vulnerable are kicking into gear across the country.

Difficulty Growing Virus

Flu vaccine production slowed down this year because the four manufacturers of the product in this country experienced difficulty in cultivating the A Panama (H3N2) strain, a new type of virus in the vaccine’s mix. The Food and Drug Administration’s regulatory action against two of the vaccine’s manufacturers, Parkedale Pharmaceuticals, of Rochester, Mich., and Wyeth-Ayerst, of Marietta, Pa., also set production back.

As a result, the Centers for Disease Control and Prevention in Atlanta is telling the public to expect flu vaccine shipments later than usual this year, and is advising health care professionals to defer mass vaccination programs until mid-November. Many places typically start vaccinating in late September and mid-October. The agency first made the announcement about the delay in late June, but very little has changed in terms of more information since then.

The agency also is telling health officials to first treat those most susceptible: the elderly, the immunocompromised, such as patients with AIDS or those who are undergoing chemotherapy, and people with cardiovascular and pulmonary problems.

“This year is not an ordinary one and we will need to triage the flow of vaccines to the most needy population,” says Dr. Arnold S. Monto, professor of epidemiology at the University of Michigan School of Public Health, Ann Arbor. “Manufacturers, companies, government and academia will have to work together to ensure the vaccine when available gets appropriately distributed.

Regulatory Woes, Too

Manufacturers are keeping vague about shipments. King Pharmaceuticals, of Bristol, Tenn., the parent company of Parkedale, has not yet disclosed when it will ship the vaccine, says spokesman Kyle Macione. The company has cornered 15 percent of the U.S. flu vaccine market.

King Pharmaceuticals has completed five of the eight actions FDA required of it, is manufacturing vaccine and is working on the final three actions, he says. The actions dealt with quality control and contamination. “Our goal is to provide distribution in a timely manner,” Macione says.

Wyeth-Ayerst spokesman Douglas Petkus, whose company supplies 27 million doses, or approximately a third of the market, is telling clients to expect shipment in four to six weeks and is working with the FDA about the agency’s concerns regarding vaccine manufacturing and plant renovation. His firm normally ships in August, he says.

Len Lavenda, spokesman for Aventis Pasteur, a vaccine manufacturer in Swiftwater, Pa., that supplies about 50 percent of the market, says he’s concerned the Parkedale and Wyeth-Ayerst situation may actually lead to a shortage this year. His company is beginning to ship some vaccine now, but most will arrive in late November, he says.

Medeva Ltd., of Wayne, Pa., the fourth leading vaccine manufacturer could not be reached for comment.

“It is still unclear the extent of the delay and potential shortfall,” says FDA spokesman Lawrence Bachorik, a sentiment echoed by the CDC. Both agencies are working closely with the manufacturers to address the problem.

Health Care Response

Such uncertainty worries Christine Nutty, infection control practitioner at Western Baptist Hospital, in Paducah, Ky. She says her supplier, Aventis Pasteur, will not be shipping vaccine to her 376-bed hospital with 1,400 employees until mid-November.

“We usually start our program of vaccinating employees at the hospital now,” Nutty says. “Our peak flu season is November-December. The problem is that someone might get vaccinated at the time the vaccine comes and still get the flu because it takes two weeks or so after the shot for immunity to kick in.”

Nutty explains it is difficult enough to get people in early for the vaccine, but after Thanksgiving it becomes even harder because of the holidays.

Nutty says her hospital has an emergency staffing plan in place that uses all personnel if necessary. Two years ago, when a flu vaccine shortage also occurred, they needed the additional staffing for all of January. “We will see,” she says.

Less fearful, however, is Susan Slavish, a registered nurse and infection control officer with the Queen’s Medical Center, a 530-bed hospital in Honolulu, Hawaii. Aventis Pasteur told her hospital’s pharmacy it was shipping vaccine this week. “If we get it when they say they will send it, we will only experience a slight delay in immunizing our employees and the high-risk in the hospital,” Slavish says. “But we usually start vaccinating about now.”

Holding Their Breath

Likewise, Kevin Teale, communications director for the Iowa Department of Public Health, says county health departments in his state are handling many phone calls from the public about the vaccine, but are holding their breath.

“We usually don’t see the flu season until after Christmas, so even if we get it after Thanksgiving and we can convince people to come in then, we’ll do well, ” Teale says “It might be like the Y2K bug problem. No one will remember it by March. Things are iffy now, but they can change very rapidly.”

His agency is calling upon the drug store chains to be selective as to who gets vaccine, if they are able to obtain it before others in the health community. The public, he says, also should be advised to wash their hands more often to prevent the spread of the virus. And if someone is feeling ill, he or she also should not go to work or school.

Mostow, though, remains apprehensive. He is telling doctors across the state to start purchasing diagnostic kits that quickly test for the flu, so any outbreaks can be monitored. He also is advising them to use the four antiviral drugs currently on the market as a preventive in the high-risk population, even though only two have FDA clearance for prophylaxis.

“Most states don’t have a disaster plan for flu,” Mostow says. “This year we have a new strain, possibly no vaccine. It is going to test how we all respond.”

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