Risky business? Corporate sector gets H1N1 pandemic vaccine before hospitals

Hospitals wrestle with tight supply of H1N1 vaccine

When this pandemic influenza season eases and there is time to ponder lessons learned, here's one question on the top of the list: Why did some corporations, such as Goldman Sachs and Citigroup, obtain vaccine before hospitals?

Delays in production of H1N1 vaccine left many hospitals with few doses, which were reserved for high-risk patients and their health care workers. Other health care workers had to wait for vaccine to become available. Yet some state and local health departments provided vaccine to workplace-based vaccine clinics in the corporate world.

"Hospitals were highly prioritized by the majority of states," Anne Schuchat, MD, director of the Center for Disease Control and Prevention's National Center for Immunization and Respiratory Diseases, told reporters at a briefing. But she defended the use of workplace-based clinics as a way to reach an at-risk population, such as pregnant women and caregivers of young children. "The key thing is to vaccinate as many people in the groups as effectively as possible. Sometimes, focusing on putting the vaccine in the path of where people will be is the strategy," she said.

CDC director Thomas Frieden, MD, sent a letter to state and local health departments urging them to target vaccine only to priority groups, including pregnant women, health care workers, caregivers of infants less than 6 months old, children and adults with underlying health conditions such as asthma and diabetes, and people under 25.

"While vaccine supplies are still limited, any vaccine distribution decisions that appear to direct vaccine to people outside the identified priority groups have the potential to undermine the credibility of the program," he said in the letter. "... I ask each of you to review your plans immediately and work to ensure that the maximum number of doses is delivered to those at greatest risk as rapidly as possible."

As of mid-November, CDC estimated that 8 million children under the age of 18 had been ill with novel H1N1 influenza, 36,000 hospitalized, and 540 children had died in the first six months of the pandemic. Among adults 18 to 64 years of age, CDC estimated there were 12 million cases, 53,000 hospitalizations, and 2,900 deaths. Fewer people 65 and older were affected; CDC estimated about 2 million cases, 9,000 hospitalizations and about 440 deaths.

Meanwhile, hospitals were forced into a tight prioritization mode for novel H1N1 vaccine and revealed weaknesses in the process of producing flu vaccine.

By the end of October, despite pronouncements from the Centers for Disease Control and Prevention that about 27 million doses had been delivered to states, some hospitals still had no vaccine. Others had only partial orders plus the FluMist nasal spray, which is contraindicated for people 50 or older as well as pregnant women or those with underlying medical conditions — the very people who are at high risk for complications from the flu.

"It creates a nightmare because you are taking care of ill patients with H1N1 in the hospital and you can't protect your staff," says Chris Horan, RN, FNP-C, COHN-S/CM, MSN, director of employee health at Athens (GA) Regional Medical Center.

The Athens hospital finally received 1,000 doses of injectable H1N1 vaccine on Oct. 29 and immediately began vaccinating in priority areas, including the emergency department, urgent care clinics, maternity and the special care nursery, and intensive care units.

Meanwhile, the hospital had only received half of its seasonal flu vaccine, with no word as to when the remainder would arrive.

"We are working very closely with the manufacturers and the states and the private sector to make vaccine available as quickly as it's produced," Schuchat said. The H1N1 vaccine was not growing as well as had been hoped, leading to slower production, she said.

Frieden cited unprecedented demand for seasonal flu vaccine. "The projected total of 114 million doses may not be enough to meet the demand," he said in a briefing. "This year looks like it will be the highest ever uptake of seasonal flu vaccine," he said.

Slow-grow for flu vaccine

Influenza vaccines are notoriously problematic. They must be grown in eggs, so slow growth means slow production. Vaccine delays or shortages occurred in 2000, 2001, 2004 and 2005.

This fall, as vaccine manufacturers focused on processing H1N1 vaccine, production of seasonal vaccine became secondary. A new push for mandatory vaccination of health care workers lost steam in the midst of supply delays. New York State Department of Health, for example, suspended its emergency rule requiring the state's health care workers to receive both influenza vaccines.

"These circumstances set up a dynamic where health care personnel covered under the regulation might compete for vaccine with persons with underlying risk factors for adverse outcome of influenza infection," Health Commissioner Richard F. Daines, MD, said in a letter to hospital administrators.

"In a situation where the choice to vaccinate is between health care personnel and persons at risk, I have always held that patients take precedence," he said. "Maintaining the health care personnel vaccination requirement would delay persons in need from being vaccinated. For these reasons, I have determined that there will not be sufficient supplies of either vaccine to meet the intent of the regulation in the 2009-2010 influenza season."

New York state will pursue a mandatory rule for future influenza seasons, he said.

Some health care systems or hospitals have backed off the mandatory approach. Marshfield (WI) Clinic had planned to require unvaccinated health care workers to wear surgical masks during the flu season, but then decided to allow employees to decline the vaccine due to medical or religious reasons or "personal conviction."

Ironically, the concerns about H1N1 and the tight supply helped boost demand for the shots. By the end of October, the Marshfield Clinic vaccinated about 75% of its employees with seasonal vaccine — then ran out. About 50% had received H1N1, including priority areas such as urgent care, the laboratory and radiology and at-risk workers, such as pregnant employees, says Bruce Cunha, RN, MS, COHN-S, manager of employee health and safety.

In setting priorities, he considered the clinic's day-to-day needs: "What are the critical functional areas? What areas do we absolutely need to protect to keep functioning so we can take care of patients?"

Hope for future in cell-based technology

The ultimate answer to influenza vaccine shortages lies in new, cell-based technology. "(W)e acknowledge the limitations of the old manufacturing sites and technologies for influenza vaccines to rapidly respond to the needs of a pandemic," Andrin Oswald, CEO of Novartis Vaccines and Diagnostics of Cambridge, MA, said in a statement.

Novartis initially had a yield of just 23% of that seen with typical seasonal flu vaccines. A new seed virus produced a higher yield, though still 63% of normal. Meanwhile, Novartis planned to open the nation's first cell-based flu vaccine manufacturing facility in Holly Springs, NC, by the end of November. It would be fully operational by the end of 2010, the company said.

"Cell culture (and the related approach, production of recombinant protein in insect cells), offer some significant advantages in terms of ease of production and scale-up," says John Treanor, MD, chief of the division of infectious disease at the University of Rochester (NY) Medical Center and professor of Medicine, and of Microbiology and Immunology at the University of Rochester.

"These process changes don't solve all of the issues in getting from a new strain to a finished product in less than six months, but they probably will save some time and also be less susceptible to disruptions related to the supply of embryonated eggs," he says.

However, Frieden cautioned not to expect the new flu vaccine technology any time soon. "We do hope and need to have better vaccine production methods but they're not ready yet," Frieden said. "This is an investment in the future."