H1N1 Anniversary Marks Infectious Disease Quandary, Montefiore's Response
Image: Stephen G. Baum, MD
Image: Belinda E. Ostrowsky, MD
The H1N1 flu pandemic has marked its one-year anniversary, with the first cases reported by the Centers for Disease Control and Prevention (CDC) in late April 2009. Initially called swine flu, H1N1 spurred a national panic that virtually halted travel to Mexico, sent sales of hand sanitizer and antimicrobial cleaners soaring, and created hours-long vaccine lines at health departments and clinics. A year later and largely faded from the headlines (only about 2,500 H1N1-related deaths have been confirmed, compared with 36,000 deaths annually from seasonal influenza), H1N1 provided a snapshot of the nation’s current infectious disease dilemma.
Vaccine Technology, Production Behind the Curve
The first batches of H1N1 vaccine were shipped in early October 2009, but substantial amounts were not available until well after several major outbursts of the flu had occurred and it had been declared a national emergency. Antiquated production techniques (90% of the world’s vaccines are grown in chicken eggs) were a primary reason for the delay, with low pharmaceutical funding and increased regulatory requirements adding to the lag. “In this era we should be inventing molecular methods for vaccine production,” said Stephen G. Baum, MD, Professor of Medicine (Infectious Diseases) and of Microbiology and Immunology. “Without an economic stimulus, newer and better ways to make vaccine will remain experimental.”
One of the swine flu shot manufacturers, Novartis, accelerated production by making the vaccine in cells rather than eggs and using an adjuvant (chemical booster) known as MF59. However, MF59-enhanced vaccines are yet to be approved in the United States due to limited data on their safety when used on pregnant women and young children.
Providers Slow to Adopt, Feeding Public Fear
A recent CDC report disclosed that a third of the “priority candidates” (children, young adults, pregnant women, and healthcare workers) and less than a quarter of U.S. residents overall were vaccinated during the 2009-2010 season. Only 90 million of the 162 million vaccine doses produced actually reached peoples’ arms and noses.
Even as its production trailed H1N1 outbreaks, the vaccine was criticized as having been rushed. Despite evidence that it was made with a time-tested method (egg-based vaccine production is over 50 years old), evaluated in thousands of volunteers and FDA approved, and contained negligible mercury levels in its preservative thimerosal, skepticism prevailed. “The public’s fear factor wasn’t adequately addressed,” Baum said. “More facts were needed as to why the vaccine was safe, including the reality that a H1N1 strain would have been included in the seasonal flu shot had time permitted.”
A Silver Lining for Montefiore
When H1N1 outbreaks began, Montefiore Medical Center established a multidisciplinary task force of emergency department physicians, pediatricians, primary care doctors, and infectious disease specialists who met regularly—as often as daily in the height of the crisis—to monitor potential swine flu issues, communicate with the Department of Health, and formulate a multi-pronged plan of attack for worst-case scenarios.
"H1N1 presented an opportunity for us to cement relationships and put algorithms into place that will serve us well if and when a more serious situation occurs," said Belinda Ostrowsky, MD, Assistant Professor of Medicine (Infectious Diseases) and Montefiore's antimicrobial steward. “It provided a good practice run for protocols we hopefully will never have to use.”
Antimicrobial Resistance Poses More Danger
Viruses have the innate ability to change their outer coat (antigenic drift) and rearrange their underlying gene structure (antigenic shift), emerging in a form unrecognizable to the immune system and conveying resistance to current drugs. "Our biggest problem in infectious disease is that the bugs become resistant much quicker than we can develop drugs, and we are going to run out of options," said Baum. "The ones we have now are good but we need more drugs that viruses will have trouble resisting."
Overuse of antibiotics and antimicrobial agents to treat secondary complications, such as pneumonias or bacterial blood stream infections, creates additional risk, according to Ostrowsky, whose stewardship program advises practicing physicians throughout the Montefiore network on judicious use of antimicrobial drugs.
As 71 million unused doses of the vaccine await expiration on warehouse shelves, better understanding and awareness are imperative in alleviating future flu panic. “Unfortunately, last year’s experience with H1N1 will probably discourage people from receiving vaccination this year because the predicted extent and severity of disease did not materialize,” Baum said. “However, H1N1 antigens are now included in the seasonal vaccine and this should make more people willing to accept vaccination—the very best way of preventing what can be a life-threatening illness.”