The Gaithersburg-based biotech firm MedImmune Inc. will resume production of its nasal-spray influenza vaccine and deliver an additional million doses by early January, the company and federal officials announced yesterday.
The company had previously announced it would make 1 million more doses from components left over from this season's original production run of 1.1 million. With the additional amount announced yesterday, MedImmune's total offering this season will be about 3 million doses.
The nation's total flu vaccine supply will reach about 61 million doses this season, Health and Human Services Secretary Tommy G. Thompson said last night in a telephone news conference.
The government hopes to get about 2 million more doses from Canadian suppliers and is negotiating with three European countries to try to get unused vaccine. Lester M. Crawford, acting head of the Food and Drug Administration, said one of the countries was France but would not name the others.
The U.S. supply of flu vaccine this winter had been expected to be about 100 million doses. Early this month, however, one of two suppliers of the traditional injectable vaccine, Chiron Corp., announced that the 48 million doses slated for U.S. distributors had been impounded by British regulators because of bacterial contamination of some lots made at its plant outside Liverpool.
Thompson stressed that much of the remaining injectable vaccine -- all made by Aventis Pasteur, the only other flu-shot manufacturer -- has not yet been sent to clinics, hospitals and doctors' offices. Officials of the Centers for Disease Control and Prevention are working with Aventis to redirect its unshipped supplies to high-priority groups and to places that had ordered mostly from Chiron and are now without any vaccine.
"Everybody thinks it's all out there, it's all been shipped. It hasn't," Thompson said. "We're going to have about 24 million doses of vaccine that will be shipped in the next seven weeks. And then there will be an additional 2.6 million doses in the first weeks of January."
Thompson said people who cannot find vaccine now will probably be able to find it over the next two months. "We want them to be persistent but not stand in line," he said.
The 2.6 million doses to which Thompson referred is the amount Aventis said earlier this week it could make from leftover material from its regular production run and a small amount of new vaccine virus it will grow over the next month.
MedImmune's FluMist is a "live" virus vaccine that grows in the nose, stimulating immunity. The FDA has given MedImmune permission to market the vaccine only to healthy people ages 5 to 49. The main target groups for vaccination are children ages 6 months to 23 months, people older than 65 , and those between ages 2 and 65 with chronic illness.
FluMist, however, can be used by some high-priority groups outlined by the CDC, specifically health care workers younger than 49 who have direct contact with patients, and day care workers and household contacts of children younger than 6 months. However, people who have close contact with AIDS patients and others with impaired immunity should not get the live vaccine, experts say.
After Chiron announced it would not be able to supply its flu shots, federal health officials asked MedImmune if it could produce even more than its expanded production run of 2.1 million, and the company has been looking at ways to do so, said Bill Pierce, an HHS spokesman.
In an interview last night, chief executive David M. Mott said he did not know when MedImmune concluded it could make a million more doses, but that he informed HHS officials yesterday afternoon that it was possible.
Only hours earlier, in an 8 a.m. conference call with financial analysts, MedImmune executives had repeated earlier statements that they expected to sell 1 million to 2 million doses this season. They made no mention of an effort to produce the extra million doses.
"Basically, this came to fruition today," Mott said, adding that he had not misled investors because the extra production does not change the company's financial projections.
Also yesterday Bill Frist (R-Tenn.), the Senate majority leader who is also a surgeon, said members of Congress who got flu shots in his office were either following federal guidelines or their own doctors' recommendations, the Associated Press reported.
Frist was responding to criticism that his Senate office had provided vaccine to lawmakers for two days after CDC asked that only people in the high-priority groups get the shots.
Senate Minority Leader Thomas A. Daschle (D-S.D.), meanwhile, yesterday called for an investigation into the planning and coordination of vaccine procurement by HHS agencies.
A campaign aide for Vice President Cheney, responding to inquiries made earlier in the week, said, "The vice president gets a flu shot at the recommendation of his doctor every year because of his history of heart disease. It would be irresponsible of the vice president not to follow the recommendations of his doctor and the CDC."
Staff writers Michael Rosenwald and Michael Laris contributed to this report.