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More drugs pending addition to immunization roster
Source: Drug Topics
By: Kathryn Foxhall
Originally published: November 21, 2005

Much is expected to happen on the vaccine front in the next 1,000 days or so, two top vaccine experts told a session at the American Academy of Pediatrics (AAP) conference in Washington, D.C., in October.

In line with the impressive history of immunization in improving health, "the near future holds hope for the program to be raised to the next level, with the possible addition of conjugated meningococcal; Tdap; rotavirus; measles, mumps, rubella, and varicella (MMRV); and human papillomavirus vaccines to the childhood and adolescent immunization schedule." So said Larry Pickering, M.D., and Margaret Rennels, M.D. Pickering is senior advisor to the director of the Centers for Disease Control & Prevention's National Immunization Program. Rennels is professor of pediatrics at the University of Maryland. Both have been part of the AAP committee that developed Red Book recommendations on vaccinations for children and adolescents.

Among the vaccines likely to be added to the recommendations, according to experts, are:

  • Varivax, a new Merck varicella (chickenpox) vaccine, indicated for patients over 12 months. While its duration of protection is unknown, a recommendation for a second dose in children 12 months to 12 years may be coming within two years.
  • Boostrix, a recently approved GlaxoSmithKline product for protection against tetanus-diphtheria-pertussis (Tdap), for single-dose use in patients 10-18 years old.
  • Adacel, a Sanofi Pasteur Tdap product for single-dose use in persons aged 11-64.

The speakers noted that both of the new Tdap products are already in use in some practices.

  • Vaqta, Merck's hepatitis A vaccine, now approved for children 12 months and older.
  • Proquad, Merck's just-approved tetravalent vaccine for measles, mumps, rubella, and varicella.

The speakers also pointed to the news that two vaccines for different strains of human papillomavirus, which puts women at risk of cervical cancer and underlies other health problems, are due out in the not too distant future. Experts say several previous studies had indicated that the vaccines offer very good protection. They may be filed for licensure with the Food & Drug Administration at the end of this year or early next year. Then, said Pickering, FDA will have 10 months to make a decision; CDC and AAP will then make use recommendations. And there are studies in progress to determine whether these vaccines could interrupt ongoing disease at any point.

Several other vaccines are in various stages of FDA review:

  • Rotateq, Merck's three-dose vaccine against rotavirus for infants one to six months, is expected to be licensed next year. Merck is also developing a varicella zoster vaccine for adults, said Pickering and Rennels.
  • There is also very serious, late-stage consideration of a recommendation for universal hepatitis A vaccination for all children now that the age of immunization can be brought down as low 12 months, said Rennels.

Rennels acknowledged that even after vaccines are recommended by the AAP and CDC, "we know that there is enormous frustration in trying to get money into the budgets to pay for the vaccines. We know that it varies from state to state and from one third-party payer to another."

But some of the most important vaccine news is about what has not happened: There is no vaccine yet for the bird flu spreading from Asia. There has been a lot of attention to developing a vaccine for that H5N1 (bird flu) strain, noted the speakers, given the fears that if it can move easily from person to person, it could cause a pandemic. Trials have failed to come up with an effective vaccine, and, Rennels noted, the vaccine would still have to go through the normal stages for approval.

She went on to note that in a pandemic, prioritization for vaccination would depend on what age groups the virus is hitting and also on maintaining the social and economic infrastructure. She observed that the 1919 pandemic hit the adult age groups most critical to keeping society going. The Department of Health & Human Services has decided that we must prepare for the worst-case scenario and will soon finish a prioritization for vaccines and antivirals.

On the ordinary flu front this winter, the forecast is hopeful for an adequate supply of vaccine, said Pickering. With several manufacturers gearing up to make vaccines, "interest from the government, and money put into this, I hope we'll not have this problem in the future," he said.

With the large number of vaccines pending, AAP updates a table (Status of Licensure & Recommendations for New Vaccines) on an ongoing basis at http://aapredbook.aappublications.org/news/vaccstatus.pdf.

THE AUTHOR is a writer based in Maryland.



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