Manufacturers Already Shipping Seasonal Influenza Vaccine

CDC Issues Health Advisory as Flu Activity Increases

August 12, 2010 05:40 pm David Mitchell

Flu season( in the United States typically doesn't peak until February, but manufacturers already have begun shipping 2010-11 influenza vaccine.

Sanofi Pasteur; MedImmune; GlaxoSmithKline, or GSK; and Novartis Pharmaceuticals Corp. all began distributing their flu vaccine products by the end of July. Meanwhile, a representative for Merck and Co. Inc. said the company plans to begin distributing its Afluria vaccine, which is produced by Australian manufacturer CSL Ltd., by mid- to late August.

Anne Schuchat, M.D., director of the CDC's National Center for Immunization and Respiratory Diseases, said in an Aug. 6 letter to physicians that vaccination efforts should begin as soon as vaccine is available and continue throughout the influenza season.

The CDC's Advisory Committee on Immunization Practices, or ACIP, expanded its recommendations for annual influenza vaccination this year to include all people ages 6 months and older in whom the vaccine is not contraindicated.

The AAFP has adopted the ACIP's flu vaccine recommendations as policy.

Check Your Mailbox for Vaccination Resources

The AAFP plans to send updated immunization resources to 70,000 active members and residents this month.

The mailing includes laminated versions of the 2010 immunization schedules that were released in January, which include recommendations made by the CDC's Advisory Committee on Immunization Practices, or ACIP, and adopted by the AAFP, as well as more recent immunization updates.

Those updates address expanding seasonal influenza immunization recommendations to include everyone 6 months of age and older unless contraindicated; use of the 13-valent pneumococcal conjugate vaccine; and information about measles, mumps, rubella and varicella, or MMRV, vaccine.

The mailing also includes

  • information about the AAFP "Immunization Resources" Web page;
  • a flier stressing the importance of health care worker immunizations;
  • CDC resources to help physicians educate parents about immunizations; and
  • a letter from AAFP President Lori Heim, M.D., of Vass, N.C.

Heim said in her letter that the most important factor in a parent's decision to be immunized and to immunize his or her child is the recommendation of their doctor.

"Use the CDC resources for risk communication to ensure your patients are being properly immunized," Heim said. "We urge you to use every opportunity to immunize your patients."

The cost of printing and mailing the materials was supported by a grant from Merck & Co. Inc.

The CDC said in an Aug. 4 health advisory that there were two small localized outbreaks of influenza A (H3) in Iowa in July. The agency also received influenza A (H3)-positive specimens from 11 other states from June 20 to July 23, as well as samples positive for H1N1 influenza A and B viruses.

Antigenic characterization of the influenza A (H3) viruses received by the CDC is pending, the agency said. However, based on hemagglutin gene sequencing data from four viruses isolated from specimens, CDC officials said the viruses are expected to be antigenically similar to A/Perth/16/2009-like HN32 viruses.

According to the CDC, Perth-like H3N2 viruses were first identified last year but have not yet circulated widely in the United States. The strain, which has not been included in previous seasonal flu vaccines, is included in the 2010-11 vaccine, as is the novel influenza A (H1N1) virus that was linked to about 12,000 deaths in the United States last year.

"It is not possible in advance to know how bad an influenza season will be, and the two defenses we have are infection control practices( and vaccine," said Doug Campos-Outcalt, M.D., M.P.A., associate head of the department of family and community medicine at the University of Arizona College of Medicine, Phoenix, and the AAFP's liaison to the ACIP. "It is important to use both to the maximum."

In her letter, Schuchat stressed the importance of vaccinating people at high risk( of developing influenza complications, including pregnant women and patients with diabetes, asthma or other chronic conditions. She also said physicians with limited amounts of vaccine can still play an important role by urging patients to get vaccinated through other immunization providers, such as pharmacies and local health departments or at school and workplace clinics.

Localized outbreaks and sporadic influenza activity during the summer months are not uncommon, and the CDC offered the following advice for physicians:

  • Influenza should be considered as a possible diagnosis -- even during the summer -- when evaluating patients with acute respiratory illnesses, including pneumonia.
  • Prompt empiric antiviral treatment is recommended while results of definitive diagnostic tests are pending. If diagnostic testing isn't possible, patients with clinically suspected influenza who have illness requiring hospitalization or progressive severe or complicated illness; as well as those at increased risk for severe disease, also should receive empiric antiviral treatment.
  • Neuraminidase inhibitors oseltamivir, which is marketed as Tamiflu, and zanamivir, which is marketed as Relenza, are recommended for use against circulating influenza A (H3) and 2009 H1N1 viruses. The adamantanes -- amantadine and rimantadine -- are not recommended because of high levels of resistance.
  • Because of limited sensitivity and the possibility of false-positive results, negative results from a rapid influenza diagnostic test should not be used to guide decisions regarding antiviral treatment. Use of reverse transcription polymerase chain reaction or viral culture is recommended for laboratory confirmation.
  • Report unusual increases in febrile respiratory disease outbreaks to local and state health departments.

Despite an increase in the number of people recommended for vaccination this season, the CDC has indicated it does not expect supply to be an issue.

Sanofi Pasteur said in a July 30 news release that it expects to distribute 70 million doses of seasonal flu vaccine in the United States during the 2010-11 season.

Donna Cary, Sanofi's director of public relations, said that as of Aug. 10, the manufacturer still was accepting orders directly from physicians for multidose vials and the adult and pediatric syringe presentations of Fluzone. Unit-dose vials, however, were not available for direct order, she said. Fluzone High-Dose, the manufacturer's new flu vaccine specifically for patients 65 and older, is available for direct order in prefilled syringes.

Novartis began shipping Fluvirin on July 29 and expects to deliver about 40 million doses of the vaccine to the U.S. market this season. According to a company spokesperson, the manufacturer plans to begin shipping its Agriflu influenza vaccine, which is approved for adults 18 and older, later in the season.

As a result of the ACIP's expanded flu vaccination recommendations and increased demand resulting from the 2009 H1N1 pandemic, a Novartis representative said vaccine commitments were made earlier than usual this year, and the company is no longer taking direct orders via its website. The majority of Novartis' flu vaccine is delivered through distributors.

MedImme said in a July 23 news release that it plans to ship 15 million doses of FluMist, its nasal flu vaccine. The manufacturer suggested that physicians begin vaccinations in August and September -- months earlier than the typical start of the flu vaccination season -- to reach millions of children during appointments that already have been scheduled.

A company representative said physicians can still order FluMist directly from MedImmune sales reps. However, those orders will not be fulfilled until after the prebooked orders have been shipped.

GSK said in a July 30 news release that it plans to distribute more than 30 million doses of its flu vaccines in the United States this season. GSK began shipping its adult product, Flulaval -- which is manufactured by its subsidiary ID Biomedical Corp. -- on July 30 and said it expected to begin shipping Fluarix, which is approved for use in people as young as age 3 years, "in the next several weeks."

Merck expects to ship 7 million doses of CSL's Afluria vaccine in prefilled syringes, beginning later this month. Physicians who did not preorder still can receive vaccine through third-party distributors, a Merck representative said.

The ACIP recently recommended( that Afluria not be given routinely to children younger than 9 years old because of an increased risk of febrile seizures in children ages 6 months through 4 years and a higher incidence of reported fever in children ages 5 years through 8 years.