Clinton Vows to Keep Vaccine Initiative : Health: Administration officials defend program brought into question by GAO. They say effort to boost immunization rates can start on time.

The Clinton Administration vowed Tuesday to press ahead with its embattled preschool vaccination initiative even as lawmakers released a congressional report raising fundamental questions about the program.

“This is no time to reverse course,” Health and Human Services Secretary Donna Shalala said at a news conference called to respond to the report by the General Accounting Office, Congress’ investigative arm. “Congress and the President have set a course and our goal is within reach.”

The GAO report questioned whether the Vaccines for Children program could begin on time, assure the integrity of highly sensitive vaccines and achieve its goal of boosting immunization rates by expanding the distribution of free vaccine. Four members of Congress who released the assessment promised to seek to delay the start of the program or scrap it entirely.

But a short time later, a phalanx of senior Administration officials defended the $500-million-a-year plan and expressed confidence that they can meet the Oct. 1 starting date. The program would expand the purchase of discounted vaccines and distribute nearly one-third of the nation’s supply through a single facility in New Jersey.

Top officials from Health and Human Services and the General Services Administration acknowledged that the new program is behind schedule and that it will not be “glitch-free” or fully operational in 73 days.

Nonetheless, they said that delaying implementation would impose a hardship on states counting on the new program, could lead to higher prices for vaccines and would undercut momentum in the effort to inoculate young children against such diseases as measles, mumps, hepatitis and polio.

“We will have in place all necessary systems to order, purchase and deliver vaccine in a safe and efficacious way,” said Dr. David Satcher, director of the federal Centers for Disease Control and Prevention. “We are confident that we will be ready to go.”

The dueling congressional and Administration news conferences--during which all parties maintained that their prime concern was to immunize at least 90% of all children by the age of 2--were the first round in what looms as a three-day struggle over the immediate fate of the vaccination program.

Sen. Dale Bumpers (D-Ark.), a longtime immunization advocate, said that the Administration would be “foolish in the extreme” to proceed on schedule. When the Health and Human Services spending bill for the fiscal year starting Oct. 1 comes before the Appropriations Committee today, he said he will propose legislation to prohibit funds from being spent on the program until a later date or until congressional concerns have been allayed.

Bumpers also plans a hearing Thursday on the GAO report, at which Administration officials plan to testify.

The new program, which was touted by President Clinton as his first domestic policy initiative, will provide free vaccines to private physicians to immunize Medicaid recipients who are children, uninsured children and Native Americans. In addition, children whose insurance does not cover vaccines will be eligible if they get their shots at a federally approved community health center or rural clinic.

Under the plan, doctors in each state will place vaccine orders with state agencies, which will approve and forward them to the CDC. The agency will then transmit them to manufacturers or to a distribution center in Burlington, N.J., operated by the GSA.

Vaccines may be shipped from manufacturers directly to doctors and public health clinics or from the warehouse to the states, which would then distribute them to local doctors and clinics. Currently, private doctors and states can order vaccines directly from manufacturers.

The GAO report noted that all those covered under the new program already can receive free vaccinations from public health clinics and that most recent studies “indicate that vaccine cost is not an important barrier.” The auditors said that the new program is likely to benefit only children without insurance who will now be able to get their shots from private doctors.

More important impediments, the GAO said, include education of physicians in private practice and at public clinics, the availability of public health facilities and the “lack of knowledge and awareness of the vaccine schedule on the part of parents.” Administration officials said that they are addressing these factors as well.

The GAO said that only four of 15 contracts with pharmaceutical manufacturers to buy vaccines at discounted prices have been awarded, that states have only begun to enroll private physicians in the program and that accounting mechanisms are lacking to detect misuse, fraud or abuse. The agency also expressed concern that the government does not have enough time before Oct. 1 to develop and test packaging and shipping systems, and computer hardware and software for tracking vaccines.

The biologicals, which must be refrigerated at specific temperatures or frozen during shipping and storage to retain their potency, will be handled by the GSA, which has never transported such pharmaceuticals.