Federal Officials Testify at Senate Hearing About Factors Behind Flu Vaccine Shortage
In testimony during a Senate Special Committee on Aging hearing, FDA Acting Commissioner Lester Crawford on Tuesday said that the federal government's regulation process and flu vaccine manufacturers' concerns about liability have discouraged some companies from entering or staying in the vaccine market, which could have contributed to a national flu vaccine shortage this year, USA Today reports (Rubin, USA Today, 11/17).
On Oct. 6, California-based Chiron -- which is one of two flu vaccine producers for the United States -- announced that contamination found during the manufacturing process at a facility in Liverpool, England, caused the British Medicines and Healthcare Products Regulatory Agency to suspend the plant's manufacturing license. As a result, Chiron will not ship any flu vaccine doses to the United States this season. U.S. officials expected to have about 100 million flu vaccine doses this year.
France-based Aventis Pasteur has provided the United States with 56 million flu vaccine doses, and Maryland-based MedImmune provided about three million doses of the nasal-spray flu vaccine FluMist (California Healthline, 11/15).
Crawford called the current vaccine production method -- which relies on chicken eggs to grow the virus -- "laborious," and he said it could "get us in trouble" (Meckler, AP/Las Vegas Sun, 11/16). Because of the use of chicken eggs, flu vaccine production "inherently starts with a high amount of contamination," according to the Contra Costa Times.
Crawford confirmed that serratia bacteria found in nine of Chiron's 100 flu vaccine lots manufactured in Liverpool led U.S. inspectors to declare Chiron's entire supply unsafe (Silber, Contra Costa Times, 11/17). Crawford also said that lower-than-expected funding from Congress for vaccine research this year put the agency "in an incredibly vulnerable spot" by limiting the development of other flu vaccine manufacturing technologies (Heil, CongressDaily, 11/17).
HHS this year requested $100 million for such research and received $50 million. Crawford said the funding could be used to develop a cell-based flu vaccine manufacturing system, in which scientists would genetically engineer strains of the flu virus and grow the strains in human or monkey cells. Unlike the chicken egg method, which requires an incubation period, cell technology production could be maintained "indefinitely" and boosted when necessary, according to the AP/Las Vegas Sun (AP/Las Vegas Sun, 11/16). Crawford noted that improving the manufacturing process might not result in more companies entering the market (CongressDaily, 11/17).
Committee Chair Larry Craig (R-Idaho) said, "The $100 million's in the budget" for next year. Craig's aides said the funding must first pass budget negotiations but added that legislators are expected to approve it (AP/Las Vegas Sun, 11/16).
Crawford said FDA could not have known before its inspection in October -- after British regulators suspended Chiron's license -- that all the flu vaccine Chiron produced for this season was contaminated. Chiron in August told FDA officials that some vaccine lots were contaminated; however, Crawford said it was necessary for the company to complete the manufacturing process before regulators could determine if all the lots were affected (Contra Costa Times, 11/17). He said that FDA regulators after Chiron's announcement conducted "one of the most in-depth inspections that anyone has ever done" (Rubin, USA Today, 11/17).
Crawford said that FDA in February or March will conduct a "comprehensive inspection" of Chiron's Liverpool plant to evaluate the company's efforts to remedy the manufacturing problems (Schmidt/Rubin, USA Today, 11/17).
Further testimony and discussion on FDA documents related to the shortage are expected Wednesday at a House Committee on Government Reform hearing, which could "reveal whether the FDA was at fault and waited too long to conduct its on-site investigation," according to the Times (Contra Costa Times, 11/17).
Sen. Ron Wyden (D-Ore.) criticized the expediency of FDA's response to the shortage. He said, "It seems like getting good vaccine out to the public is 'Public Health 101.'"
Craig, who is cosponsoring a bill related to flu vaccine production with Sen. Evan Bayh (D-Ind.), said, "We can't wait until Congress is in full swing in February to address next year's challenges. By then it will be nearly too late" (CongressDaily, 11/17).
Chiron might not be able to remedy the problems in its manufacturing process before vaccine production must begin in March to prepare for next year's flu season, USA Today reports. Chiron CEO Howard Pien on Wednesday is expected to update a congressional committee about progress at the company's Liverpool plant.
John Savopoulos, vaccine analyst for Datamonitor, said that if Chiron does not produce flu vaccine next year, there will be another national shortage.
National Institute of Allergy and Infectious Disease Director Anthony Fauci said, "It's going to be a close call for Chiron." Fauci also said that government officials are considering protecting flu vaccine manufacturers against liability, implementing tax incentives to encourage more manufacturers to develop the vaccine and purchasing unused flu vaccine doses from manufacturers.
If Chiron does not manufacture vaccine next year, officials for Canada-based ID Biomedical said the company could supply the United States with eight million to 12 million traditional flu vaccine doses. Aventis could supply the United States with 75 million traditional flu vaccine doses, and MedImmune could supply as many as 10 million doses of FluMist (Schmidt/Rubin, USA Today, 11/17).