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.
"We have assured both the profession and the public that the H1N1 vaccine will be evaluated with the same rigor that is applied to seasonal vaccine," he added. "We should not make vaccine available before the trials are complete and the results carefully assessed."
Amir Afkhami, assistant professor of Psychiatry and Behavioral Sciences and of Global Health at George Washington University in Washington, D.C., agreed.
"I fear that a rush towards vaccinating the population without completing trials risks leading to the harmful outcome that we witnessed during the 1976 Swine flu scare where the government advocated rapid production and vaccination of the population without adequate safeguards which led to an unexplained increase in cases of Guillain Barre syndrome amongst other complications," Afkhami said. "I think in this regard we must learn from lessons of the past and be mindful of not jumping from the proverbial frying pan into the fire by putting people's health at risk without adequate production and safety monitoring of the vaccines."
Throughout the development of the new vaccine that is aimed at offering protection against the swine flu, some have raised concerns over what they see as an effort to rush the drug through safety trials.