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.
Early Push May Not Be Warranted, Flu Experts Say
"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."
Too Early for 'Fill and Finish'?
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.
Indeed, some of the lingering fears may spring from the spike in a rare neurological condition known as Guillain Barre syndrome cases that accompanied vaccination efforts during the 1976-77 flu season. A number of medical professionals say no strong evidence exists to support the theory that the vaccine caused the neurological disorder. However, some believe that preparing the doses before the trials are complete could open the door to unexpected side effects.
"Normally to get approval for a new vaccine you must do a variety of trials to make sure the vaccine is both safe and effective and, if there are side effects, what those may be," said Bill Muraskin, professor in the Department of Urban Studies at Queens College at the City University of New York. "Even with the biggest and best trials, there is the problem that a side effect that appears rarely may not be discovered."
Push Comes Amid Sine Flu Vaccine Supply Worries
Meanwhile, with the news last month that barely more than a third of the anticipated 120 million doses of swine flu vaccine will be available by mid-October, public health experts are faced with significant pressure to ensure that vulnerable populations will have access to the shots if they are needed.
One of the biggest questions that still remains is whether recipients of the vaccine will need one or two doses to get full protection from the virus. And even then, the question of whether 15 micrograms is the proper amount of antigen to have in each shot is still an unanswered one.
"Is 15ug the correct quantity?" asked Dr. Rich Whitley, president-elect of the Infectious Diseases Society of America (IDSA). "We will need the results of the NIAID studies to answer that question, as well as whether we will need to doses of novel H1N1 vaccine."
Making the Right Move Is Crucial, Experts Warn
At stake in the debate over how quickly to push forward with swine flu vaccine efforts is not only public health, but also public opinion, Muraskin warned.
"We have in this country a major anti-vaccine lobby and movement that is not confined to the lunatic fringe, but increasingly includes upper middle class groups," he said. "It is vital not to give these people ammunition.
"If the public health authorities skip any key step in the normal vaccine approval process they are setting themselves up for a real attack by the anti-vaccine forces if there are significant side effects and the flu is no more severe than what they are now predicting."