Vaccine recalls, delays prompt discussion at NVAC meeting

March 2008

WASHINGTON — Government and industry must work in tandem to get vaccine supplies back on track, according to a speaker at the National Vaccine Advisory Committee meeting, held here last month.

“Merck, as we well know, reported supply issues in November 2007 with regard to its Haemophilus influenzae type b vaccine and thereafter initiated a recall of the product in December 2007,” Angela K. Shen, MPH, said. Merck officials have said that although sterility tests hadn’t found any contamination of the manufacturer’s Hib conjugate (PedvaxHIB) and Hib combination (Comvax) vaccines, some lots could have been contaminated.

Merck officials also reported supply issues for its hepatitis A vaccine and shipping delays for the monovalent varicella vaccine, according to Shen.

Shen, of the National Vaccine Program Office, Department of Health and Human Services, addressed these and other disruptions, as well as the efforts made to resolve them, during her presentation at the NVAC meeting.

Response to shortages

“Industry responded to these disruptions,” Shen said. “With regard to Hib, Sanofi Pasteur was able to supply the U.S. market for the primary series only [for the first part of 2008] and is currently reviewing its supply forecast for later on this year. With regard to hepatitis A vaccine, GlaxoSmithKline is able to cover the U.S. demand as needed.”

Additionally, Merck addressed the demand for varicella vaccine and anticipates that the measles-mumps-rubella-varicella vaccine (ProQuad) will be available in 2009. Sanofi Pasteur addressed a supply issue for single-dose vials of yellow fever vaccine through its supply of five-dose vials, according to Shen.

On the government side, an ad hoc interagency group consisting of the CDC, the FDA, the Department of Health and Human Services and partners was created in 2003 to address supply shortages for Vaccines for Children Fund vaccines.

This group works to provide guidance to providers during vaccine supply disruptions and closely monitors vaccine demand while managing the existing supply.

NVAC also took measures to address the issue of vaccine disruptions through the establishment of two stakeholder workshops in 2002 and 2005.

During the first of these workshops, members identified both immediate and contributory factors to the supply disruptions of 2001, which resulted in significant shortages of routinely administered vaccines against eight of 11 vaccine-preventable diseases, according to Shen. The 2005 meeting was dedicated to addressing progress since the previous meeting.

Issues identified

The stakeholders identified five major issues they felt were important to strengthening the U.S. vaccine supply; the first was providing incentives like tax relief to manufacturers to maintain current involvement and encourage new manufacturers to join the market.

Another issue addressed was streamlining authority to ensure safe and effective vaccines, according to Shen.

“One of the problems cited in this workshop was that there are evolving standards for different national regulatory entities,” she said. “One of the solutions is to streamline FDA regulations and increase funding for the Center for Biologics Evaluation and Research, such that the center can engage in its mission to [perform] expedited reviews … and harmonize regulatory requirements.”

Stakeholders also discussed strengthening liability protection, where concerns included maintaining effectiveness of the vaccine injury compensation program and vaccine safety research not receiving adequate funding.

According to Shen, the group’s solutions included strengthening legislative language and using a portion of the trust fund for vaccine safety research.

The fourth issue dealt with vaccine of stockpiles. The stakeholders said the problem was the Securities and Exchange Commission’s ruling on revenue, which states that revenue is not generated until the vaccine is removed from the stockpile for use.

“The solution proposed was to modify revenue recognition rules,” Shen said. “There was a federal resolution of this issue, in which the Securities and Exchange Commission provided an interpretation in December 2005 that essentially states that revenue can be recognized if companies disclose certain accounting and financials.”

Understanding the value of vaccines was the final issue identified. The problem, according to Shen, is that misinformation regarding vaccine safety confuses parents in their decision making about vaccines. The solution to that issue involved increasing public awareness of vaccine value, emphasizing an understanding of the complexity of vaccine development and manufacturing, associated costs and insurance reimbursement.

Shen closed the presentation with several questions to NVAC members with the goal of stimulating discussion on how to best mitigate future supply shortages.

These included what NVAC’s role in supply issues should be, how the committee felt they could best address limitations in emergency use authorization if they chose to do so and whether stockpiles were appropriate for non-VFC vaccines.

For more information:

• Shen AK, Baylor N. Current vaccine supply disruptions. Presented at: the National Vaccine Advisory Committee meeting; Feb. 5-6, 2008; Washington.