CDC, States Reaching Out for Help Administering H1N1 Vaccine
Interested FPs Can Contact Local Health Agencies Proactively
The CDC and state health departments are reaching out to physicians in numerous specialties, including family medicine, in preparation for the fall influenza season with the expectation that vaccine for the novel influenza A (H1N1) virus will be available by mid-October.
At a July 9 H1N1 Flu Preparedness Summit in Bethesda, Md., HHS Secretary Kathleen Sebelius, together with Department of Homeland Security Secretary Janet Napolitano and Education Secretary Arne Duncan, announced plans for a voluntary novel influenza vaccination program this fall.
Pascale Wortley of the CDC's Immunization Services Division said in an interview with AAFP News Now that in addition to public health vaccination clinics, family physicians, obstetricians, pediatricians and internists will play a role in administering the vaccine, along with clinics in retail stores, pharmacies and workplace settings.
Five manufacturers are in the process of producing H1N1 vaccine under contracts with the HHS. Jesse Goodman, M.D., M.P.H., director of the FDA's Center for Biologics Evaluation and Research, said July 17 in a joint media briefing with CDC officials that clinical trials are expected to start soon.
If the vaccine is deemed to be safe and effective, the CDC will distribute it to states based on relative population figures; states then will distribute it to public health agencies and private practices.
"As far as we know, just about every state plans on engaging their private providers, although there's always an exception to the rule," Wortley said. "A lot of places really welcome the involvement of the private sector. All of the people who normally administer the seasonal influenza vaccine are people they're interested in recruiting, including family physicians."
Wortley said states likely will turn to physicians who are members of the CDC's Vaccines for Children, or VFC, program, but she added that "non-VFC providers are clearly going to be part of this." A little less than half of AAFP members participate in the VFC program.
Wortley said states are in the process of contacting professional medical organizations to recruit physicians who want to be involved in administering the vaccine. Physicians also can be proactive by contacting their local public health agencies.
Vaccine for the novel influenza A (H1N1) virus will be provided to physicians at no charge, as will syringes, needles, sharps containers and alcohol swabs.
Meanwhile, America's Health Insurance Plans has indicated to the CDC that insurance companies will provide reimbursement for administration of the vaccine.
The CDC has issued an overview to professional medical organizations (3-page PDF; About PDFs) that summarizes many aspects of preparing for H1N1 vaccinations.
Wortley said storage capacity could be an issue for private practices, because seasonal flu and the novel virus are expected to be circulating at the same time.
Pascale Wortley of the CDC's Immunization Services Division said in an interview with AAFP News Now that in addition to public health vaccination clinics, family physicians, obstetricians, pediatricians and internists will play a role in administering the vaccine, along with clinics in retail stores, pharmacies and workplace settings.
Five manufacturers are in the process of producing H1N1 vaccine under contracts with the HHS. Jesse Goodman, M.D., M.P.H., director of the FDA's Center for Biologics Evaluation and Research, said July 17 in a joint media briefing with CDC officials that clinical trials are expected to start soon.
If the vaccine is deemed to be safe and effective, the CDC will distribute it to states based on relative population figures; states then will distribute it to public health agencies and private practices.
"As far as we know, just about every state plans on engaging their private providers, although there's always an exception to the rule," Wortley said. "A lot of places really welcome the involvement of the private sector. All of the people who normally administer the seasonal influenza vaccine are people they're interested in recruiting, including family physicians."
Wortley said states likely will turn to physicians who are members of the CDC's Vaccines for Children, or VFC, program, but she added that "non-VFC providers are clearly going to be part of this." A little less than half of AAFP members participate in the VFC program.
Wortley said states are in the process of contacting professional medical organizations to recruit physicians who want to be involved in administering the vaccine. Physicians also can be proactive by contacting their local public health agencies.
Vaccine for the novel influenza A (H1N1) virus will be provided to physicians at no charge, as will syringes, needles, sharps containers and alcohol swabs.
Meanwhile, America's Health Insurance Plans has indicated to the CDC that insurance companies will provide reimbursement for administration of the vaccine.
The CDC has issued an overview to professional medical organizations (3-page PDF; About PDFs) that summarizes many aspects of preparing for H1N1 vaccinations.
Wortley said storage capacity could be an issue for private practices, because seasonal flu and the novel virus are expected to be circulating at the same time.
FDA Approves 2009-10 Seasonal Influenza Vaccine
FDA officials announced July 20 that the agency has approved the seasonal influenza vaccine for 2009-10.
According to the CDC, 5 percent to 20 percent of the U.S. population develops influenza each year, leading to about 200,000 hospitalizations and 36,000 deaths.
The elderly, young children and people with chronic conditions are considered at high risk for complications. Vaccination also is important for health care workers to protect patients from infection and to stop spread of disease to other health care professionals.
CDC officials have said the seasonal flu vaccine will be available in August or September -- earlier than usual -- to clear the way for vaccinations for the novel influenza A (H1N1) virus. That vaccine is expected to be available beginning in mid-October, pending FDA approval.
According to the CDC, 5 percent to 20 percent of the U.S. population develops influenza each year, leading to about 200,000 hospitalizations and 36,000 deaths.
The elderly, young children and people with chronic conditions are considered at high risk for complications. Vaccination also is important for health care workers to protect patients from infection and to stop spread of disease to other health care professionals.
CDC officials have said the seasonal flu vaccine will be available in August or September -- earlier than usual -- to clear the way for vaccinations for the novel influenza A (H1N1) virus. That vaccine is expected to be available beginning in mid-October, pending FDA approval.
Capacity could be especially challenging for physicians who care for young children and pregnant women, because H1N1 vaccine for those high-risk groups will be in single-dose syringes. Prefilled syringes eliminate the need for preservatives, but they also will take up more space in refrigerators than the multidose vials intended for other population groups.
The H1N1 vaccine likely will require two doses, which could well raise issues about supply and prioritization. HHS already has released guidance for pandemic vaccine allocation, (26-page PDF; About PDFs) but Wortley said the CDC's Advisory Committee on Immunization Practices, or ACIP, probably will recommend changes when it meets July 29 in Atlanta.
Robert Parkinson Jr., president and CEO of Baxter International Inc., said July 16 during the company's quarterly earnings call that yields from H1N1 vaccine seed strains provided by the World Health Organization are proving to be a challenge for all manufacturers, including Baxter.
Baxter has orders for 80 million doses of the new vaccine, but Parkinson said the company will not deliver "anything even remotely close to that" by fall.
Parkinson's comments, as well as those of other manufacturers, have prompted reports in the mainstream media that H1N1 vaccine supplies would be insufficient in the fall. Some media outlets also have speculated that the United States, which relies chiefly on foreign manufacturers for flu vaccine, would be in a dire position if supplies are low worldwide.
However, Anne Schuchat, M.D., director of the CDC's National Center for Immunization and Respiratory Diseases, said during the July 17 media briefing that she was not concerned about manufacturers backing out on HHS contracts and added that yield issues were taken into consideration in the agency's planning.
The H1N1 vaccine likely will require two doses, which could well raise issues about supply and prioritization. HHS already has released guidance for pandemic vaccine allocation, (26-page PDF; About PDFs) but Wortley said the CDC's Advisory Committee on Immunization Practices, or ACIP, probably will recommend changes when it meets July 29 in Atlanta.
Robert Parkinson Jr., president and CEO of Baxter International Inc., said July 16 during the company's quarterly earnings call that yields from H1N1 vaccine seed strains provided by the World Health Organization are proving to be a challenge for all manufacturers, including Baxter.
Baxter has orders for 80 million doses of the new vaccine, but Parkinson said the company will not deliver "anything even remotely close to that" by fall.
Parkinson's comments, as well as those of other manufacturers, have prompted reports in the mainstream media that H1N1 vaccine supplies would be insufficient in the fall. Some media outlets also have speculated that the United States, which relies chiefly on foreign manufacturers for flu vaccine, would be in a dire position if supplies are low worldwide.
However, Anne Schuchat, M.D., director of the CDC's National Center for Immunization and Respiratory Diseases, said during the July 17 media briefing that she was not concerned about manufacturers backing out on HHS contracts and added that yield issues were taken into consideration in the agency's planning.
Related ANN Coverage
CDC's Advisory Committee Gives Thumbs-up to New Antiviral Recs
Agency Gearing Up for Possible H1N1 Vaccine Distribution
(7/1/2009)
CDC's Advisory Committee Gives Thumbs-up to New Antiviral Recs
Agency Gearing Up for Possible H1N1 Vaccine Distribution
(7/1/2009)
