Vaccine Production for H1N1 Falls Short of Estimates as Pediatric Death Toll Rises

by Brendon Nafziger, DOTmed News Associate Editor | October 20, 2009
Swine flu poses
threat to young people
If you've asked your doctor about the swine flu vaccine (not to be confused with seasonal flu) you probably heard that the government is working on it and we don't know when to expect the serum.

According to the Centers for Disease Control's weekly report, around 30 million doses of the H1N1 vaccine will be available by the end of the month, around 10 or 12 million doses short of their original estimate.

The CDC says the shortfall came about because of both low antigen yield for the vaccine and the necessity of rigorous safety testing to limit side effects.

"We are not cutting any corners in the safety of the production of this vaccine or the testing and oversight of the vaccine and it's very important to us that this process be done carefully and safely," Anne Schuchat, M.D., assistant surgeon general and director of the National Center for Immunization and Respiratory Diseases at the CDC, told reporters during CDC's Friday flu briefing.

Deaths of children under 18 from the disease reached 86 last week, according to CDC, a grim statistic matched by news that flu-like illnesses accounted for around 6 percent of all doctor visits -- a number unusually high for October.

Quest gets another H1N1 test approved for emergency use

As part of its effort to fast-track flu-related products to market, the FDA has granted emergency use authorization to Quest Diagnostics Simplexa H1N1 test. The test, which runs on a 3M cycler, looks at a specific part of the 2009 swine flu gene that distinguishes it from other influenza viruses.

According to Quest, the test can come up with results in about an hour. "Faster turnaround time can aid in clinical management of the patient and allow hospitals to segregate infected patients from other high-risk individuals," John G. Hurrell, Ph.D., vice president and general manager of Focus Diagnostics, the Quest subsidiary that developed the test, said in a release from the company.

Simplexa is the second emergency go-ahead Quest has received this year from the FDA. In July, a similar H1N1 test got an EUA. That, and Simplexa's EUA, will expire when FDA declares the emergency over or when they see fit to revoke it.