HHS Asks Potential Smallpox Vaccine Makers to Submit Detailed Production Information
HHS has asked drug makers to submit by Oct. 24 "detailed information" about their "capability to produce millions of doses" of smallpox vaccine, a move that highlights the government's concerns about a potential smallpox attack, the Wall Street Journal reports. In an Oct. 19 letter, HHS said that interested drug companies must "demonstrate an ability" to "develop, manufacture and deliver" up to 250 million doses of smallpox vaccine within a year. HHS has ordered more than 50 million doses from Acambis PLC, HHS Secretary Tommy Thompson announced last week that HHS plans to purchase a total of 300 million doses by the end of next year. "It will be a tough push, but I think we can make it," Thompson said. He has discussed the issue with four drug companies, including Merck & Co. and Baxter International. According to the HHS letter, the government will "bypass the standard procurement process and expedite procedures for the procurement of 250 million doses of smallpox vaccine." The government may purchase a single order of 250 million doses or separate orders of 50 million doses and has asked drug makers to provide prices per 50 million doses, the Journal reports. HHS has asked drug companies for information about their "experience in producing vaccines," planned clinical trials, FDA product licensure and "how the vaccines will be stored and shipped" (McGinley, Wall Street Journal, 10/23). Meanwhile, the Canadian government, which has stockpiled 380,000 doses of smallpox vaccine, also hopes to "increase its reserves." Canadian Health Minister Allan Rock said he told Thompson that Canada would help the United States bolster the supply of smallpox vaccine (Canadian Press/Miami Herald, 10/22). The United States has 15.4 million doses of smallpox vaccine (Kaiser Daily Health Policy Report, 10/19).
No Antibiotic Shortage, Officials Say
Meanwhile, despite concerns over a potential shortage of the antibiotic Cipro, the "most widely used drug to treat anthrax," government officials and drug makers said that "there is an ample supply of other drugs" to treat those infected with the bacteria, the New York Times reports. "We have enough supply to address the cases that exist. We are absolutely confident," CDC spokesperson Donna Garland said, adding that patients can take several generic antibiotics, including doxycycline and penicillin, to treat anthrax. According to Michael Reicher, the chair and CEO of Halsey Pharmaceuticals, "There is more than enough doxycycline and penicillin to treat all of America right now. If 30 million people decided to hoard a 60-day supply, I think the market could certainly bear it." In addition,
Generic Pharmaceutical Association spokesperson Clay O'Dell said that several generic drug makers could "probably produce ample quantities on short notice." The Times reports that drug firms have had "no difficulty in procuring enough of the raw ingredients" in doxycycline or manufacturing the drug. Health officials also said that several brand-name drugs in the same class as Cipro, such as
Bristol-Myers Squibb Co.'s Tequin and two Johnson & Johnson drugs, "could be equally effective" in anthrax treatment (Abelson/Pollack, New York Times, 10/23).
