Aventis, CDC Officials Announce Distribution Plan for Unshipped Flu Vaccine Doses
Aventis Pasteur this week will divert 22.4 million unshipped doses of the flu vaccine to areas that serve high-risk patients and areas with the most severe vaccine shortages, CDC officials said Tuesday, the AP/Las Vegas Sun reports (Neergaard, AP/Las Vegas Sun, 10/12). California-based Chiron, which produces half of the U.S. flu vaccine supply, informed U.S. health officials last week that it would not ship any influenza vaccines this year after British regulatory officials suspended for three months the license of Chiron's Liverpool, England, plant, which manufactured flu vaccine for the United States. Britain's Medicines and Healthcare Products Regulatory Agency said it was suspending the company's license because of the factory's "issues with systems and processes," according to Chiron Chair and CEO Howard Pien.
The plant manufactures Chiron's entire supply of flu vaccine for the United States. Prior to Tuesday's announcement, the United States expected to have 100 million doses of flu vaccine, up from 87 million last winter. Now, federal health officials expect to have about 56 million doses produced by Aventis and another one to two million doses of nasal flu vaccine spray manufactured by Maryland-based MedImmune. Following Chiron's announcement, a panel of experts convened by CDC issued new, temporary guidelines for flu vaccinations that say those most in need of vaccination should be inoculated first. Under the new recommendations, high-priority groups include all people ages 65 years and older; people between the ages of two and 65 who have chronic illnesses; pregnant women; nursing home residents; children taking aspirin; health care workers; those who have close physical contact with infants younger than six months; and infants ages six months to 23 months. CDC data show that an estimated 95 million adults and children -- nearly one-third of the United States' population -- fall into the high-risk category (California Healthline, 10/12).
Under CDC's new plan, Aventis' diverted doses will be distributed in at least two stages. About 14.2 million doses will be shipped in the next six to eight weeks to hospitals, long-term care facilities, elder-care facilities and private pediatric health care providers (Glanz, Washington Times, 10/13). Of those doses, 11.8 million will go to institutions that originally ordered them because they cater to high-risk populations. Organizations that ordered the remainder of the 14.2 million doses will be asked to reassess their minimum needs (McKenna, Atlanta Journal-Constitution, 10/13).
Meanwhile, the remaining 8.2 million doses will not be shipped until it becomes clear which areas of the country have the most severe shortages, which is partly dependent on which areas are hit hardest by the flu (Washington Times, 10/13). Of those, 4.5 million doses have been committed to a CDC stockpile (Niedowski, Baltimore Sun, 10/13).
CDC Director Julie Gerberding said that more information on when and where shipments will arrive will be available later in the week (AP/Las Vegas Sun, 10/12). Officials intend to "share information electronically" with pharmacies, doctors, Veterans Affairs officials and others in an effort to "track the progress of the flu virus," the Washington Times reports (Washington Times, 10/13). Health officials also plan to "keep tabs" on which states have little or no vaccine, track where the flu hits hardest and determine where people are filling flu-related prescriptions, Gerberding said (Vedantam, Washington Post, 10/13).
According to the Journal-Constitution, CDC plans to map the high-risk groups "using electronic tools developed for bioterrorism detection." Ensuring that state health departments receive at least 50% of the vaccine they originally ordered is "one of the first priorities," the Journal-Constitution reports (Atlanta Journal-Constitution, 10/13). Aventis plans to ship vaccine through December, according to Aventis United States President Damian Braga. As part of the plan, CDC will order up to 50 million doses of rimantadine treatment, an antiviral medication used to treat the flu virus. CDC also has a supply of Tamiflu, an antiviral drug used to treat and prevent the flu "on a short-term basis," the Sun reports (Baltimore Sun, 10/13).
Successful implementation of the CDC plan will require "unprecedented collaboration" from the public, Gerberding said (Anstett, Detroit Free Press, 10/13). Gerberding called healthy people who voluntarily forgo immunization "public health heroes" (Gorner, Chicago Tribune, 10/13). However, she acknowledged that even if the plan is implemented properly, some high-risk patients will not receive vaccinations. "We're sorry for the people who need flu vaccine and may not be able to get it this year." She added, "We say, be patient, but also be persistent" (Washington Post, 10/13). Gerberding added that the agency "will take every step that we can to get an equitable distribution of vaccine as quickly as we can" (AP/Las Vegas Sun, 10/12).
Voluntary rationing has been conducted "on the honor code," according to the Sun. "We have used this strategy before with significant success, and we're so far seeing very good evidence that it's working this time out, too," Gerberding said (Baltimore Sun, 10/13). In the meantime, Gerberding advised that people in the high-risk category "seek medical attention early and determine with your clinician if you should take prophylactic drugs or treatment drugs if you're sick with influenza" (Chicago Tribune, 10/13). Gerberding noted that the situation "probably will not make everybody happy" (Washington Post, 10/13). Braga said, "We have had to address market shortages in the past, and we've found that our customers, when presented with the information, are very ... willing to take part" (Atlanta Journal-Constitution, 10/13). CDC spokesperson Christine Pearson said that it is "impossible" to predict the severity of the upcoming flu season. "Basically, flu by its nature is extremely unpredictable. So, before a season, we can never say with any certainty when it will start, how long it will last or how bad it will be," Pearson said (Markley, Houston Chronicle, 10/12).
In seeking additional flu vaccine supplies, HHS officials have contacted other pharmaceutical manufacturers who are not licensed to distribute flu vaccine in the United States (Atlanta Journal-Constitution, 10/13). GlaxoSmithKline on Tuesday told government officials the company has 500,000 doses of flu vaccine manufactured in Germany. ID Biomedical also offered 1 million to 1.5 million doses the company manufactured in Canada. Neither brand has received FDA approval for sale in the United States (AP/Las Vegas Sun, 10/12).
According to the Post, officials said they are "willing to explore alternate vaccine sources in Britain and Canada if there are data showing that the products are safe and effective" (Washington Post, 10/13). Gerberding said, "It's not easy to get unlicensed vaccine into the country in time to solve any problems this year. But we're not ruling anything out." ID Biomedical spokesperson Dean Linden said, "[I]t's by no means a slam dunk that we're going to be delivering flu vaccine into the United States this year" (AP/Las Vegas Sun, 10/13). Half doses of flu vaccine -- which some studies have shown provides effective protection -- likely will not be provided this season because no studies have been conducted on whether the strategy would work with this year's vaccine, according to Bruce Gellin, director of the HHS national vaccine program office (Washington Post, 10/13).
There have been "sporadic reports" of some suppliers charging "hugely inflated prices" for flu vaccine, according to the Journal-Constitution (Atlanta Journal-Constitution, 10/13). Law enforcement officials have "vowed to prosecute those trying to take advantage of the unprecedented vaccine shortage," the New York Daily News reports (Shin, New York Daily News, 10/13).
Kansas Attorney General Phill Kline on Tuesday filed suit against Meds-Stat for allegedly proposing to charge a Kansas City pharmacy $900 for a vial of the vaccine, which sold for $85 one week earlier. A vial contains 10 doses of vaccine. The lawsuit is seeking an injunction preventing the company from selling pharmaceuticals and also seeks a monetary reward (Washington Times, 10/13). A survey conducted by the American Society of Health-System Pharmacists found that 55% of 650 hospital pharmacists surveyed reported that they had been contacted by "opportunistic vendors" of the vaccine, the Newark Star-Ledger reports. Of those, about 80% reported being offered vaccine for more than four times the original market price (Seeman, Newark Star-Ledger, 10/13). Gerberding said, "This is a reprehensible thing to be doing. I think an immoral thing in this context. There's no room for this kind of behavior in an environment where we need to pull together as a country to protect out vulnerable populations" (Atlanta Journal-Constitution, 10/13).
Officials from the Department of Justice are investigating Chiron's failure to supply U.S. residents with flu vaccine, according to company officials, who announced Tuesday that they have received a grand jury subpoena, the New York Times reports. In the subpoena, New York District Attorney Zachary Carter requested documents relating to Chiron's flu vaccine and British regulatory officials' suspension of the company's license. Chiron officials would not comment on details of the investigation but said that they were cooperating fully.
Some analysts and lawyers have said they think the investigation is related to whether Chiron deceived shareholders in violation of securities laws. One week before the Liverpool plant was shut down, Chiron officials told shareholders they were "optimistic" the company could ship 46 million to 48 million doses of vaccine to the United States this winter, the New York Times reports. However, "it is possible the investigation is about something else or could even be a sort of fishing expedition to see if there has been a crime," according to the New York Times (Pollack, New York Times, 10/13). According to the Wall Street Journal, a grand jury subpoena from the U.S. attorney's office "typically implies a criminal investigation" (Tam et al., Wall Street Journal, 10/13). DOJ officials also could be investigating whether Chiron lied to a government agency, the Los Angeles Times reports. The subpoena was issued by the law firm Dorsey & Whitney, which "is known for its high-profile Wall Street probes," according to the Los Angeles Times (Peterson/Gellene, Los Angeles Times, 10/13).
Carter said, "We will have a substantial crisis of a shortfall of vaccine. There's a human impulse to believe that someone must have done something wrong and that the something wrong may be criminal in nature" (New York Times, 10/13). John Coffee, a Columbia University law professor, said, "The fact that they messed up in England and had a plant that was not acceptable does not offend U.S. criminal law normally. What may be of interest to federal prosecutors is whether false statements were made to the FDA about lab conditions, internal controls or the company's ability to meet (delivery) schedules" (Los Angeles Times, 10/13).
In written testimony delivered Friday to a government hearing on flu vaccines, Pien said, "Chiron did not at any time mislead public health stakeholders or the public. ... The results of Chiron's internal investigations confirmed our belief that our product was safe" (Wall Street Journal, 10/13). Chiron last week announced that it was reducing its expected 2004 earnings to between 35 cents and 45 cents a share from $1.50 to $1.60 a share because of the vaccine issue (Hartford Courant, 10/13).
Several broadcast programs reported on the flu vaccine shortage:
- ABCNews' "World News Tonight": The segment includes comments from Dr. Tina Dobsevage from Mount Sinai School of Medicine; Kline; and Susan Meisinger of the Society for Human Resource Management (McKenzie, "World News Tonight," ABCNews, 10/12).
- CBS' "Evening News": The segment includes comments from Gerberding and Dr. William Schaffner of Vanderbilt University School of Medicine (Kaledin, "Evening News," CBS, 10/12). The complete segment is available online in RealPlayer.
- NPR's "All Things Considered": The segment includes comments Braga and Gerberding (Knox, "All Things Considered," NPR, 10/12). The complete segment is available online in RealPlayer.