U.S. Smallpox Vaccine Plan Hampers Drug Company Bidding, Industry Representatives Say
By David Francis
Global Security Newswire
WASHINGTON - The U.S. Health and Human Services Department this week issued a draft request for proposals for the next-generation smallpox vaccine for the Strategic National Stockpile (see GSN, May 3).
Industry lobbyists say the Project Bioshield contract for development and production of Modified Vaccinia Ankara (MVA) discourages larger drug companies from bidding because it calls for producing only 20 million doses. Most larger companies lack the capacity to produce vaccine, and would see little economic incentive in seeking the contract unless the number of requested doses was larger, lobbyists said.
The sources contend this contradicts congressional proposals for Bioshield II legislation, which is aimed at attracting larger players to the vaccine anufacturing business with financial and other incentives.
Lobbyists said it is unusual for the department to ask for comments on a proposal before it is issued and that large pharmaceutical companies would probably ask that the number of doses in the contract be increased.
Companies are likely to seek a contractual guarantee to produce at least 50 million doses, said attorney John Clerici of McKenna Long and Aldridge, a law firm representing vaccine manufacturers.
Any profit gained from a 20-million dose contract would not match the investment in vaccine production infrastructure, Clerici said.
The contract does not specify how much would be paid per dose, but gives the
government the option of purchasing 60 million additional doses after delivery and Food and Drug Administration approval of the initial batch of vaccines.
The contract in its current form also makes it difficult for smaller companies to bid, as storage and manufacturing requirements are hard for small companies to meet, Clerici added.
A second industry lobbyist, who asked to remain anonymous because of close ties to vaccine manufacturers, agreed that the scope of the administration's request discourages large drug companies from bidding.
The bid request "is drafted to scare away big [pharmaceutical and biotechnology] companies," the source wrote in an e-mail. "The RFP first solicits 20 million doses of the vaccine, which may be awarded either 10 million doses each for two companies or 20 million doses to one company. Then, it gives the government the sole option later to acquire up to an additional 60 million doses of the vaccine. The draft RFP does not commit the government to ever exercise that option."
The Health and Human Services Department believes the new recombinant vaccine would cause fewer post-vaccination adverse reactions than Dryvax, the currently licensed smallpox vaccine.
The source questioned why the department, acknowledging smallpox as a threat, would not simply request 80 million doses.
"HHS is playing cat and mouse with this crazy option" to purchase an extra 60 million doses, the source wrote. "I thought Bioshield was supposed to create a guaranteed market so that more companies would be attracted and bid. This is someone's idea to confuse and provide uncertainty to industry ... except perhaps for some small start-ups that are willing to gamble the entire[ty] of their companies and roll the dice."
Comments on the draft proposal are due on May 31.
U.S. Senate proposals - one introduced by Republican leadership, another by Senators Joe Lieberman (D-Conn.), Orrin Hatch (R-Utah) and Sam Brownback (R-Kan.) - would provide incentives, such as liability shields and patent exclusivity, to encourage big drug makers to enter the vaccine market.
Senator Richard Burr (R-N.C.), chairman of the Senate Health, Education, Labor and Pensions Committee's bioterrorism preparedness subcommittee, plans to review the bills in a series of hearings this summer. Burr has pledged to consider both bills before combining them into a single piece of legislation.
The smallpox contract would be the fourth under Bioshield, which has $5.6 billion available for developing biological weapon countermeasures over the next decade. The Health and Human Services Department has awarded contracts to VaxGen for an unlicensed recombinant anthrax vaccine, BioPort for its licensed anthrax vaccine and Fleming and Co. for a radiation countermeasure.
Global Security Newswire
WASHINGTON - The U.S. Health and Human Services Department this week issued a draft request for proposals for the next-generation smallpox vaccine for the Strategic National Stockpile (see GSN, May 3).
Industry lobbyists say the Project Bioshield contract for development and production of Modified Vaccinia Ankara (MVA) discourages larger drug companies from bidding because it calls for producing only 20 million doses. Most larger companies lack the capacity to produce vaccine, and would see little economic incentive in seeking the contract unless the number of requested doses was larger, lobbyists said.
The sources contend this contradicts congressional proposals for Bioshield II legislation, which is aimed at attracting larger players to the vaccine anufacturing business with financial and other incentives.
Lobbyists said it is unusual for the department to ask for comments on a proposal before it is issued and that large pharmaceutical companies would probably ask that the number of doses in the contract be increased.
Companies are likely to seek a contractual guarantee to produce at least 50 million doses, said attorney John Clerici of McKenna Long and Aldridge, a law firm representing vaccine manufacturers.
Any profit gained from a 20-million dose contract would not match the investment in vaccine production infrastructure, Clerici said.
The contract does not specify how much would be paid per dose, but gives the
government the option of purchasing 60 million additional doses after delivery and Food and Drug Administration approval of the initial batch of vaccines.
The contract in its current form also makes it difficult for smaller companies to bid, as storage and manufacturing requirements are hard for small companies to meet, Clerici added.
A second industry lobbyist, who asked to remain anonymous because of close ties to vaccine manufacturers, agreed that the scope of the administration's request discourages large drug companies from bidding.
The bid request "is drafted to scare away big [pharmaceutical and biotechnology] companies," the source wrote in an e-mail. "The RFP first solicits 20 million doses of the vaccine, which may be awarded either 10 million doses each for two companies or 20 million doses to one company. Then, it gives the government the sole option later to acquire up to an additional 60 million doses of the vaccine. The draft RFP does not commit the government to ever exercise that option."
The Health and Human Services Department believes the new recombinant vaccine would cause fewer post-vaccination adverse reactions than Dryvax, the currently licensed smallpox vaccine.
The source questioned why the department, acknowledging smallpox as a threat, would not simply request 80 million doses.
"HHS is playing cat and mouse with this crazy option" to purchase an extra 60 million doses, the source wrote. "I thought Bioshield was supposed to create a guaranteed market so that more companies would be attracted and bid. This is someone's idea to confuse and provide uncertainty to industry ... except perhaps for some small start-ups that are willing to gamble the entire[ty] of their companies and roll the dice."
Comments on the draft proposal are due on May 31.
U.S. Senate proposals - one introduced by Republican leadership, another by Senators Joe Lieberman (D-Conn.), Orrin Hatch (R-Utah) and Sam Brownback (R-Kan.) - would provide incentives, such as liability shields and patent exclusivity, to encourage big drug makers to enter the vaccine market.
Senator Richard Burr (R-N.C.), chairman of the Senate Health, Education, Labor and Pensions Committee's bioterrorism preparedness subcommittee, plans to review the bills in a series of hearings this summer. Burr has pledged to consider both bills before combining them into a single piece of legislation.
The smallpox contract would be the fourth under Bioshield, which has $5.6 billion available for developing biological weapon countermeasures over the next decade. The Health and Human Services Department has awarded contracts to VaxGen for an unlicensed recombinant anthrax vaccine, BioPort for its licensed anthrax vaccine and Fleming and Co. for a radiation countermeasure.
