Fallout in Congress on Vaccine Shortage
WASHINGTON, Oct 13 – September was fading away when Stephen Ostroff, a senior official of the National Centers for Disease Control and Prevention, sat in front of the Senate Special Committee on Aging and said, “October is the best month to get the flu vaccine, so let’s all roll up our sleeves and get vaccinated.”
Little did Ostroff and the CDC know that in October the country would face its worst flu vaccine shortage crisis ever.
On Tuesday, only two weeks after Ostroff’s team assured Congress that a record 100 million doses would be on hand nationwide to face this season’s influenza season, Rep. William Delahunt (D-Cape Cod) and 70 other House Democrats sent a letter to President Bush urging him to take emergency steps to ensure that flu shots would be provided for the most vulnerable, “the infants and the elderly.”
How did the country go from the biggest flu vaccine order to the biggest vaccine shortage?
After last year’s aggressive influenza season—when more than 100 infants died and 200,000 adults were hospitalized—the CDC decided to contract for the 100 million doses. The order went directly to the only two companies licensed by the Food and Drug Administration: California-based Chiron and Aventis Pasteur, a French company that manufactures flu vaccine in Pennsylvania.
Federal health officials had increased the number of doses from 83 million to 100 million because they didn’t want to face the same long lines that formed in flu clinics last year after a small shortage occurred.
For the 2004-05 influenza season, Chiron had negotiated to put about 50 million vaccine doses on the market. Aventis Pasteur would produce about 52 million, of which 4 million would go to a stockpile at CDC headquarters to be used in December –“if shortages occurred,” Ostroff told Congress.
On Oct. 5, with the flu vaccination season already in progress, the CDC was informed that British regulators had shut down Chiron’s manufacturing plant in Liverpool after finding several batches of contaminated vaccines.
The abrupt closing of the plant meant none of the doses Chiron had committed to supply would be delivered.. Suddenly, the bulk of the nation’s vaccine supply was cut in half.
A federal grand jury is investigating Chiron’s failure to supply the vaccine. The U.S. attorney in New York has issueda subpoena to the company, according to a regulatory filing posted by the company on Tuesday.
The shortage caught the government by surprise, officials said, even though in late August they learned of the contaminated batches and were told by Chiron that its supply would suffer some delay.
After learning of the shortage last week, the CDC, which tracks flu epidemics, quickly issued guidelines on who should receive priority in getting the vaccine. The center also urged state programs, public and private clinics and supermarkets to follow the “honor code” and to dispense the flu shot only to infants 6 to 23 months old, seniors 65 years and older, and adults with chronic diseases.
But Aventis by then had started shipping its supplies. By last week 30 million doses of its vaccine were sent to its clients. Aware of the shortage, people formed long lines to get a shot of the scarce vaccine. The majority of providers followed the CDC guidelines, but in some states the shortage prompted price gouging.
The American Society of Health-System Pharmacists, for example, said on Wednesday that doctors were being visited by opportunistic vendors who offered the flu vaccine for as much as 10 times the normal price.
Julie Gerberding, the director of the CDC, said Tuesday that price gouging was “immoral” and called for state-by-state prosecution of those who were profiting from the shortage.
The 70 House Democrats who called up on the President to take emergency steps to respond to the shortage, also called for a federal investigation of flu vaccine price gouging. “This is not a state-by-state issue, it’s a federal issue,” said Steve Schwadron, spokesman for Delahunt.
Delahunt’s office spokesman also accused the Bush Administration of “not paying enough attention” to the crisis and claimed “every day of inaction exacerbates the problem,” he said.
The letter called on the government to gather all the unused vaccine in the market and redistribute it to the neediest. “People are in panic, they are scared, and that is not right,” Schwadron said.
On Tuesday, the CDC unveiled a two-phase plan that would redirect the 22.4 million unshipped doses of Aventis vaccine to the neediest patients and to those states that were heavily reliant on the Chiron vaccine.
Gerberding said that initially 14.2 million doses will go to pediatricians, long-term care facilities, Veterans Hospitalsand state programs.
Massachusetts could benefit some from this reallocation; 462,000 doses, or 73 percent of its publicly contracted supply, was to have come from Chiron.
The CDC will keep 8.2 million doses to be distributed after the flu season starts to areas where the disease is more prevalent or where a large percentage of the high-risk population has not received shots.
But Gerberding acknowledged that not everybody in need of a flu vaccine will get one this year.
With the flu season just beginning, and “with isolated cases in the New York-New Jersey area,” according to CDC spokeswoman Christine Pearson, the agency is asking patients to seek medical help, when they get the first symptoms, “since there will be plenty prophylactic medicines available,” Gerberding said.
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