Drastic Measure? Officials Consider Early Roll-Out of Swine Flu Vaccine

Aug. 25, 2009— -- The government appears to be moving forward with an early roll-out of a vaccine against the H1N1 swine flu virus – even as trials to determine its safety, efficacy and proper dosage are still under way.

On Tuesday, Dr. Ann Schuchat, director of the CDC's National Center for Immunization and Respiratory Diseases, confirmed that the government will request that manufacturers "fill and finish" batches of the vaccine in 15-microgram doses in order to put some doses of the vaccine into vials for shipment so they could be available as early as mid-September. The measure was one of the recommendations laid out in a report by the President's Council of Advisors on Science and Technology (PCAST) released on Monday.

"We certainly feel that based on everything we know about seasonal influenza and H1N1... the risks of the disease are much higher than the risks of the vaccine," Schuchat said during a CDC press conference on the vaccine on Tuesday.

Some infectious disease experts said that given the circumstances, the plan is warranted.

"I think this is a good idea if it can be done," noted Dr. D.A. Henderson, former director of the Office of Public Health Emergency Preparedness for the Bush administration and currently an infectious disease specialist at the University of Pittsburgh Medical Center. "The only problem is that the individual may receive a less potent vaccine that will be less effective. Is it better to have this than no vaccine at all? I think so."

But others said the early roll-out could be premature. "I am very skeptical of finishing vaccine before we know the appropriate dose to be included in each inoculation, before immunogenicity studies are complete or before safety assessments have been finished," said Dr. William Schaffner, chair of the Department of Preventive Medicine at Vanderbilt University School of Medicine in Nashville, Tenn., and a proponent of influenza vaccination.