H1N1 vaccine: What physicians can do with leftover doses

Internist Fred Ralston Jr., MD, has a common problem -- hundreds of influenza A(H1N1) vaccine doses are sitting in the refrigerator of his Fayetteville, Tenn., practice.

"The last dose we administered was in April. We've had no interest [in the vaccine] since then," said Dr. Ralston, president of the American College of Physicians.

The federal government estimates that as many as 40 million H1N1 doses expired as of June 30. Millions more are languishing in refrigerators in doctors' practices across the U.S.

As health professionals prepare for the start of the 2010-11 influenza season, doctors want to know how they should dispose of expired H1N1 vaccines, as well as what to do with doses that are unused but still valid.

States and the federal government have established programs for physicians to dispose of expired immunizations safely.

Under the federal government's voluntary Central Vaccine Recovery Program, physicians shipped expired H1N1 vaccine doses, at no cost, to a facility contracted with the Dept. of Health and Human Services and the Centers for Disease Control and Prevention, said HHS spokesman Bill Hall. The vaccine doses were crushed and then incinerated.

Doctors were urged to return expired H1N1 vaccine doses through the federal program in May, but will have another chance this fall to dispose of expired doses, the CDC said.

Ancillary supplies provided by the federal government, including needles, syringes and containers, should not be returned through the program.

Each state also has particular recommendations and requirements for physicians who want to dispose of expired H1N1 vaccine doses themselves.

The Minnesota Dept. of Health, for example, recommends that health professionals dispose of empty vials and syringes without needles in the normal trash. Thimerosal-free vaccines in single-dose vials, prefilled syringes and nasal sprays also can go in the normal trash. Empty syringes with needles go in a sharps container. The department mandates that multidose vials of H1N1 vaccine be placed in a hazardous waste container.

Physicians should hold on to H1N1 vaccine doses that haven't expired until a sufficient quantity of seasonal vaccine is available in their area, Hall said. When an adequate supply arrives, the unused H1N1 vaccines can be disposed of through the voluntary federal program or by following state guidelines.

The seasonal vaccine will include a pandemic 2009 H1N1 virus, as well as an A/Perth/16/2009 (H3N2)-like virus and a B/Brisbane/60/2008-like virus.

Projections show that manufacturers will produce about 170 million seasonal flu vaccine doses for the U.S. market. They expect to begin shipping the trivalent vaccine to health professionals by the end of August or in early September, according to Mary Anne Jackson, MD, pediatric infectious disease specialist at Children's Mercy Hospitals and Clinics in Kansas City, Mo.

Dr. Jackson, a member of the American Academy of Pediatrics Committee on Infectious Diseases, recommends that physicians begin immunizing all patients age 6 months and older against the flu as soon as they receive the seasonal vaccine. She said immunizations should continue as long as the virus is circulating and vaccine is available.

In the meantime, doctors should reserve their remaining H1N1 doses that have not yet expired for patients who are traveling to the Southern Hemisphere, according to infectious disease specialists. That particular region is in the midst of its influenza season.

In the U.S., there is currently little H1N1 and seasonal flu activity, according to the CDC.

"Although there were many doses of vaccine that went unused, it was much more appropriate to have been prepared for the worst-case scenario than to have had too few doses," Hall wrote in an e-mail to American Medical News.

Unused H1N1 vaccine

Since the start of the pandemic in the spring of 2009, about 162 million H1N1 vaccine doses have been distributed to the public, and approximately 90 million were administered, Hall said.

Of the remaining vaccine doses, an estimated 40 million expired as of June 30. The expiration dates are set by the Food and Drug Administration, and they indicate the time after which there are insufficient data to show the vaccine is safe and effective, said FDA spokeswoman Shelly Burgess.

The 31 million to 32 million doses that are not yet expired have varied expiration dates, most of which extend into 2011, Hall said. If all of those vaccines go unused, about 44% of the public's total H1N1 vaccine supply will not have been administered.

On the other hand, most of the 114 million doses of the 2009-10 seasonal influenza vaccine that were distributed to health professionals have been used, Hall said. Officials attribute the higher-than-normal seasonal vaccine rate, in part, to concern about the H1N1 virus. In many doctors' offices, seasonal influenza vaccine was available before the H1N1 vaccine.

Infectious disease experts agree that the amount of unused H1N1 vaccine is disappointing. But they insist that the current 40 million figure of expired vaccines is not outrageous.

"In a typical year, it's not at all unusual for us to discard 20 million doses of seasonal influenza vaccine. [Forty million] is not in any way extraordinary," said William Schaffner, MD, infectious disease specialist at Vanderbilt University School of Medicine in Nashville, Tenn.

Contributing to the current H1N1 vaccine surplus was uncertainty about the severity of the virus, and how many vaccine doses each person would require. Initially, the government assumed that most people would need two doses of the vaccine, said Harry Keyserling, MD, professor of pediatrics with a specialty in infectious disease at Emory University School of Medicine in Atlanta.

Clinical trials later revealed that adequate immunity largely could be achieved after one dose. The exception is children younger than 10, for whom the CDC recommends two doses of the H1N1 vaccine.

Vaccine manufacturing delays due to antiquated technology also were a problem. Many physicians received H1N1 vaccine after the virus peaked in their state. The result was a supply of vaccine that patients no longer wanted.

Experts don't know what to expect from the upcoming season, and they hesitate to speculate on whether flu vaccine will be shipped out as early as manufacturers predict. "Influenza is a very fickle virus," Dr. Keyserling said. "And each season is different and impossible to predict."