What will the federal government's new regulation plan for immunizations be?

January 1, 2009

The federal government is changing the recommendations for vaccinations: what should the new ones be, and how will the changes affect your practice?

How can we have a stable supply of all the various vaccines? Where can teens get the new adolescent immunizations, if they don't see physicians often enough for all the shots? How is it feasible for pediatricians and other physicians to store vaccines for months, and not be paid until they use them?

The federal government is in the midst of a two-year (or longer) process of looking for direction in the vastly changed world of vaccines for infectious diseases.

The National Vaccine Program Office (NVPO) is nominally in charge of coordinating vaccine policy for the entire federal government. NVPO is gathering comments in order to rework the National Vaccine Plan, its first overhaul in 14 years.

Raymond Strikas, PhD, an NVPO medical advisor, said at a November conference that topics in the draft framework include maintaining and improving the current high childhood vaccine coverage, and achieving 90% coverage for adolescents.

Other topics include enhancing vaccine R&D, and enhancing applied research for new and improved vaccines. He noted, "Universal influenza vaccine is another one that we could add."

Another priority is reducing financial barriers, according to Strikas, who spoke at a "Vaccines: All Things Considered" conference in Tysons Corner, Va.

The challenges also include a stable vaccine supply, he commented, because, "We always seem to be having a shortage in the US of this, that or the other," including influenza and varicella.

"We are supposed to have a six-month stockpile of pediatric vaccines," said Strikas. But others have mentioned a problem with rabies vaccines supply, he said, and "we don't have an answer for that right now."

Potential topics also include improving the vaccine safety infrastructure, and adverse event reporting, and communications with to the public, Strikas said. Also on the radar, he said, is personalized medicine, specifically in terms of identifying people who are more at risk of an adverse event.

Beyond that, he said, the National Vaccine Injury Compensation program has been successful, and needs to continue to be so. An improvement might include an update of the list of vaccines compensated for, he indicated. Further, the official said, the nation could do a better and quicker job of disease surveillance. This would identify outbreaks faster.

The IOM committee is holding five stakeholder meetings on the plan: the first was in December. In addition, said Strikas, there will be four public engagement meetings during 2009, as well as a review by the National Vaccine Advisory Committee (NVAC).

The aim is to finish the report by the end of 2009. The work was planned to overlap into next year to allow the new administration to help write it, he said.

He told the conference that figuring out, "who is going to pay for what, and who is going to do what, and who is accountable for what, is a huge task that we need to start undertaking probably early next year."

In the meantime, Strikas said, the NVAC has developed recommendations for improving the financing of vaccines, particularly for children. The Assistant Secretary of Health will receive its final findings.

The draft of those recommendations, which went to the advisory committee in September, included:

In 2003, the IOM recommended that the federal government mandate that vaccine benefits be included in all private and public insurance plans, including Medicare, Medicaid, and the State Children's Health Insurance Program. The federal government should provide a subsidy to health plans and providers for purchase and administration, IOM said, and should offer immunization vouchers for uninsured people.

Strikas indicated there was a lot of disagreement with that report from the federal sector. The feeling was that it was not workable: "So there are some more modest recommendations that are coming out from the National Vaccine Advisory Committee."

Kathryn Foxhall is a contributing editor to Contemporary Pediatrics.