State-owned lab has special niche in vaccine research

Vaccine shortages sometimes lead to thoughts of publicly owned manufacturers. Massachusetts has been there and still does that.

By Susan J. Landers, amednews staff. Nov. 17, 2003.

Washington -- A fortuitous legacy in Massachusetts' history has left the state with the only publicly owned, federally licensed manufacturer of vaccines and other biologic products in the nation -- long after other states abandoned similar facilities.

The presence of the 109-year-old nonprofit Massachusetts Biologic Laboratories continues to benefit the state, the nation and maybe even the world, given the facility's recently reported advance toward developing a SARS vaccine.

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As private companies drop out of the vaccine manufacturing business because of low profits, Massachusetts maintains this part of the public health safety net -- thanks to its labs. Two years ago, for instance, the facility's ability to produce tetanus vaccine spared Massachusetts from facing the sudden shortage that plagued the rest of the nation's physicians.

Ultimately, the facility not only supplied tetanus vaccine within state lines but to other places as well.

"We were able to step up to the plate, increase our manufacturing and essentially help meet the need by delivering two million doses outside of Massachusetts," said Donna Ambrosino, MD, the director of the laboratories and a professor of pediatrics at the University of Massachusetts Medical School in Worcester.

Med school takes over

In 1997, the Massachusetts Legislature transferred operations of the biologic laboratories from the state Dept. of Public Health to the U. Mass. Medical School. But the mandate of the labs under their new sponsorship by the university remained to "maintain their public purpose, preserving their ability to compete in an increasingly competitive marketplace and maximize their value to the Commonwealth."

In light of that legislative charge, the biologic laboratories are expanding. Construction began last spring on a second facility about a mile from the first in the Boston suburbs. The new building is scheduled to open in 2005 and to include a state-of-the-art aseptic filling line.

Massachusetts' nonprofit laboratory began work on a SARS vaccine immediately after the outbreak.

The Massachusetts facility has also survived while similar state-run operations were forsaken by virtue of its ability to support itself with funding from licensing royalties, grants and contracts.

Years ago, the labs introduced diphtheria, pertussis and tetanus vaccines into statewide use and pioneered such products as respiratory syncytial virus immune globulin, the first drug to protect infants and toddlers from serious complications of respiratory viruses.

The facility also develops and manufactures drugs for orphan diseases, those that affect fewer than 200,000 people in the United States.

Pitching in on SARS

"We think Massachusetts is lucky [to have the facility] because of the vaccines that are supplied, but we think the nation is lucky because the real goal is to develop more orphan products," said Dr. Ambrosino.

One example is the labs' work on a SARS vaccine. "It's hard for a for-profit company to put a whole lot of money into SARS right now not knowing for sure how much the disease will mean to the world year-in and year-out," she said.

"Whereas for us we didn't want to waste a whole year of development waiting to see what kind of a commercial issue it was," Dr. Ambrosino said. "Rather, we immediately jumped in starting work to try to develop a product. It's that type of resource that makes it important to have a nonprofit national capacity."

The work on a SARS vaccine is being carried out with Medarex Inc., a biopharmaceutical company with locations in New Jersey and California.

Researchers from Medarex and the Massachusetts laboratories announced at an October meeting of the Infectious Diseases Society of America that they had neutralized the SARS virus in nonhuman tissue culture.

The finding was accomplished using antibodies from genetically engineered mice immunized with a protein the SARS virus uses to infect cells.

"We've got mice producing the right antibody, so we hope it's only a matter of time before we isolate the one cell that will become the basis for a monoclonal antibody to prevent SARS in individuals exposed to the illness," said Dr. Ambrosino.

Despite the advances spearheaded by her labs, Dr. Ambrosino doesn't think it is realistic to use the Massachusetts facility as a model for similar government-run vaccine centers.

The federal government has been on such a quest for some years.

The federal government "has looked at different models to allow the nation to meet special needs that aren't commercially viable, and frankly all the models have yet to come to fruition," said Dr. Ambrosino.

The most similar federal-run lab is housed at the new Vaccine Research Center at the National Institutes of Health in Bethesda, Md., but that lab is focusing on developing an effective AIDS vaccine. However, if such a vaccine is found, the center expects that it would be manufactured off-site.

Massachusetts is lucky to have an established infrastructure and unique capabilities that have been built upon over the years, said Dr. Ambrosino. "It would be hard to start anew."