FDA Helps Russia Improve Vaccine Program : Part 2

by Food and Drug Administration (FDA)

(Page 2 of 2)

Teams of international vaccine experts that have visited Russian vaccine production facilities since 1992 have found the facilities substandard and ill-equipped to produce safe, sterile and potent vaccines in accordance with good manufacturing practices, according to Pendergast. They also found that scientists at the Tarasevich Institute, which controls the quality of the vaccines, do not have the equipment and facilities necessary to do their jobs. And that's where FDA comes in.

FDA's Assistance

FDA has already delivered the first component of aid pledged in the September 1992 agreement: the regulatory control workshop. The agency presented the workshop in Moscow last May 17 to 21, on the regulation of medical products and foods in the United States. The week-long workshop was attended by more than 230 scientists, administrators and manufacturers from Russia, Belarus, Georgia, Kazakhstan, Latvia, Lithuania, Estonia, Tadjikistan, and the Ukraine. "Basically, we told them what we do and what we don't do and how we do what we do," Budashewitz says. "We looked at what we do from the pre-market standpoint, the production standpoint, and the post-market standpoint ... and discussed FDA's regulatory control role in each of those phases."

For example, on the first day, workshop participants heard about the history of FDA and the roles of corporations, consumers, medical professionals, and government in the U.S. system. During the remaining days, FDA officials concentrated on the agency's role in pre-market, production, and post-market regulation of vaccines, blood products, drugs, medical devices, and foods. They discussed testing, approval, quality assurance, post-market monitoring, surveillance, and enforcement responsibilities.

"What we're doing is helping the Russians help themselves. We're helping them develop a system that will work for them, given our experience," Budashewitz says. Michel Kabruf, a representative from Belarus at the workshop says, "Belarus is now a new state, a young state ... and, of course, we will have to build up the system from the very beginning, from nil. ... The lessons that we have learned in these five days will be very useful for all of us." Under the second component of the agreement, FDA is providing technical training for up to 16 Russian scientists from the Tarasevich Institute over the next year and a half. This training, now under way at FDA's Center for Biologics Evaluation and Research, gives the scientists "hands-on" experience with regulation, quality control, and monitoring of vaccine production.

"We're trying to teach them how to do quality control monitoring so that they're in a position to determine for themselves the quality of the vaccines they make," Pendergast says.

FDA will also provide just over $110,000 in vaccine testing equipment, laboratory supplies, and scientific journals to the Tarasevich Institute.

"We were told there's really only one copy of journals to be shared by all scientists," Pendergast says, "because journals have to be purchased with hard currency and there are lots of other needs for hard currency." Budashewitz adds: "We'll be giving them two-year journal subscriptions. It sounds like very unimportant stuff, but journal subscriptions are probably one of the most cost- effective ways to transfer the most current scientific knowledge."

Six Russian scientists from vaccine-developing facilities also will be trained in quality control procedures in the center's laboratories. The scientists are coming here from the Mechnikov Enterprise for the Production of Medical Biological Preparations, which produces diphtheria, tetanus and pertussis vaccines; the Institute of Poliomyelitis and Viral Encephalitis, which produces oral polio vaccines; and D. Mazai, which makes measles and mumps vaccines.

Assistance Benefits

Both Pendergast and Budashewitz are enthusiastic that FDA's aid will lead to long-term benefits for Russia and the Newly Independent States.

"These vaccines are relatively inexpensive to produce and administer, but the benefits to public health are overwhelming," Budashewitz says. "We'll be helping them save their children's lives."

Pendergast adds: "We will help provide them with information on new scientific techniques that maybe they have not had an opportunity to train in, provide them with new equipment to help them work, and provide an opportunity for their scientists to meet our scientists and to begin the process of collaboration."

FDA will benefit as well. "On our side, I think the benefit is, principally, that we will have the opportunity to work with them," she says. "Russian scientists have long been important in vaccine work. They helped test the very first Sabin polio vaccines that are now very widely used in this country." Pendergast feels that the scientific exchange and collaboration will benefit the United States and Russia, as well as the rest of the world.

"Epidemics do not know national boundaries," she says. "We have committed to be part of global efforts to eradicate polio by the year 2000. To the extent we can help the Russians eradicate their polio, we are furthering that global effort." And to the extent that other childhood diseases are controlled in one part of the world, they are brought closer to world-wide control.

About the Author

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FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.