FDA Helps Russia Improve Vaccine Program

by Food and Drug Administration (FDA)

Russia and the United States have been officially working together since last fall to help improve the childhood immunization programs of Russia and the Newly Independent States.

The program was started by the Food and Drug Administration in response to a Russian request for assistance and is coordinated and funded by the State Department and the Agency for International Development (AID).

At AID's request, FDA, U.S. vaccine, and industry engineering officials traveled to Russia and the Ukraine March 1 to 7, 1992, to confer with scientists there about immunization needs. On Sept. 30, 1992, FDA and the Assistant Secretary of Health's Office of International Health signed a participating agency service agreement with AID to assist Russia.

Under the agreement, FDA receives funds for two specific aid components the agency will provide to Russia: a regulatory control workshop and technical training, supplies, equipment, and journals.

After the Soviet Union dissolved, measles, diphtheria and polio outbreaks became more of a threat to the children of the Newly Independent States and Russia, because of low vaccination rates.

Russian doctors say that parents aren't having their children immunized because they mistakenly think the vaccines produced in Russia are causing illness and disease in their children, rather than preventing them, according to Mary K. Pendergast, an FDA deputy commissioner and senior advisor to the commissioner.

Nicolas V. Medunitsin, director of Russia's Tarasevich State Research Institute for Standardization and Control of Medical Biological Preparations, agrees.

"You all know that now, in mass media, they advocate against vaccination. Many people, even physicians, consider that vaccines are bad," Medunitsin says.

While on the AID-sponsored trip to Russia and the Ukraine, U.S. officials assessed the condition of vaccine production facilities and the need for short-term and long-term assistance.

The team reported that "the problem of vaccine quantity and quality in the nations of the former Soviet Union is complex. Currently, severe vaccine shortages exist, local production is declining, and vaccine quality is in danger of deteriorating. The choices involved in resolving the problem are equally difficult. Moreover, the crisis is immediate: The ultimate solution will not be. There are no easy answers."

The Situation in Russia

According to a 1992 United Nations Children's Fund and World Health Organization report on "Health In The Russian Federation," during the 1970s, the Soviet Union seemed to be on its way to eliminating such diseases as diphtheria, tetanus and poliomyelitis.

"However, since the early 1980s, diphtheria, and poliomyelitis incidence began to rise," the report states. "By the late 1980s, more than 80 percent of diphtheria and poliomyelitis cases reported throughout WHO's European Region came from the USSR. Diphtheria incidence in Russia reached an epidemic level in 1991 (more than 1,800 cases or a rate of 1.3 cases per 100,000 population). The main factors contributing to this increase and to the continuing diphtheria epidemic are: low level of immunization coverage with DTP (diphtheria, tetanus, pertussis) and DT (diphtheria, tetanus) vaccines among children and adolescents œthe lack of immunity to diphtheria among adults œthe adverse attitude of the health staff and general public towards immunization."

Vaccination of infants and children was required in the Soviet Union before the break-up. Since the dissolution, severe vaccine shortages have hit Russia and the other Newly Independent States. In addition, parents consider avoiding or delaying vaccinating their children to be a new-found freedom that comes with democratic rule, according to Philip Budashewitz, special programs officer of the international affairs staff in FDA's Office of Health Affairs. The UNICEF/WHO report predicts a pertussis epidemic by 1994 if Russian children are not immunized with the DTP vaccine.

The report states that the incidence of measles and polio remains low now, but unless the lack of immunization for measles is remedied immediately there will soon be increases. According to a Resources for Child Health (REACH) report, the number of polio cases jumped from 91 in 1989 to 285 in 1990. In addition, diphtheria cases continue to increase. REACH predicts about 3,000 to 4,000 cases in 1993 in Russia and the Ukraine, and up to 100 deaths. An outbreak of polio has also been reported in the Ukraine.

Vaccine Production

Before the break-up of the Soviet Union, vaccine production and immunization programs for the entire country, including the republics, was centrally controlled by the government's Ministry of Health. The ministry coordinated vaccine research and development, testing and approval, production and distribution, and the immunization programs, according to Budashewitz. The republics provided needed raw materials for vaccine production, the ministry coordinated the manufacturing process, and the finished vaccines were distributed to the republics and exported. After the break-up, the flow of raw materials for vaccine production was disrupted. In addition, the Newly Independent States must now purchase the vaccines and set up their own immunization programs.

"There is a difference between our system and the one that you are using in the USA," Medunitsin says. "The work on the investigation of all the properties of the new drugs [in the United States] is usually the responsibility of the companies. "However, our system is different. Even at the stage of the research, we [the government] control everything." Pendergast adds: "The conditions there [in Russia and the republics] are very challenging. They don't have even the basic things we take for granted, like lots of pens and paper, copy machines, fax machines, telephones, and, very importantly, access to scientific information. "The Russian scientists we met are hard-working, well- trained, and scientifically competent, and they are committed to putting out good vaccines, but they suffer under very severe limitations both in terms of the quality of production facilities they use and the age of the equipment," Pendergast says.

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