Information on the Availability of Vaccines against Anthrax, Plague and Smallpox

In Germany, vaccines against the pathogens of anthrax, plague and smallpox neither have a marketing approval nor are they available at short notice (see additional information, page 4). The Paul-Ehrlich-Institut at Langen near Frankfurt am Main has once again investigated whether such vaccines can be received from outside Germany. The result of this investigation is attached to this press release

If such vaccines are utilised in compliance with the regulations stipulated by Section 79 of the German Drug Law (exceptional regulations in times of crises), the Paul-Ehrlich-Institut would immediately be in a position to carry out the required tests for efficacy, quality and safety of the vaccines. In exceptional situations and times of crisis, too, it must be guaranteed that the vaccines designed to protect the vaccinee from a dangerous illness bear no health hazards for him or her. For instance, no healthy individuals should be harmed as a result of pure precautionary measures.

For further information on the appropriate pathogens, their symptoms, diagnostic possibilities or ways of treatment, please contact the central information office for biological weapons at the RKI

+49 1888 754 3430

More information on these illnesses is also available on the internet at the RKI (only in German)

Enclosure:

Availability of Vaccines and Sera Against Potential Biological Weapons

1. Anthrax (Bacillus anthracis)

Country	Type of vaccine or serum	Approval status	Availability
UK	Inactivated vaccine	Approved in the country of manufacture	Currently not available
USA	Inactivated vaccine	Approved in the country of manufacture	Currently not available
CAN	Inactivated vaccine	Approved in the country of manufacture	Currently not available
RUS	Live vaccine	Approved in the country of manufacture	Possibly available
RUS	Antiserum from horse (IgG horse Anthraxin)	Approved in the country of manufacture	Possibly available

2. Plague (Yersinia pestis)

Country	Type of vaccine or serum	Approval status	Availability
USA	Inactivated vaccine	Approved in the country of manufacture	Currently not available
CAN	Inactivated vaccine	Approved in the country of manufacture	Currently not available
RUS	Live vaccine	Approved in the country of manufacture	Possibly available

3. Botulism (Clostridium botulinum)

Country	Type of vaccine or serum	Approval status	Availability
DE	Antiserum from horse (botulism antitoxin, trivalent (Types A, B, E))	Approved in Germany	Available in small quantities
CH	Antiserum (botulism antitoxin, trivalent (Types A, B, E))	Approved in the country of manufacture	Possibly available
UK	Toxoid vaccine (Types A-G)	Not approved	Clinical testing stage
USA	Pentavalent toxoid vaccine (Types A, B, D, E, F)	Not approved	Clinical testing stage
USA	Monovalent toxoid vaccine (Type F)	Not approved	Clinical testing stage
USA	Antiserum (Botulism antitoxin, trivalent (Type A, B, E))	Approved in the country of manufacture	No longer manufactured
RUS	Trivalent toxoid vaccine (Type A, B, E)	Approved in the country of manufacture	Possibly available
RUS	Antiserum from horse (botulism antitoxin, trivalent(Type A, B, E))	Approved in the country of manufacture	Possibly available

4. Smallpox (Variola)

In Germany, smallpox vaccinations were carried out up to the mid-seventies of last century. The last method used was in the form of an MVA pre-vaccination followed by a vaccination with live smallpox vaccination (strain: Elstree). The marketing approval for these vaccines formally expired in late 1991.

Resuming the manufacture in Germany is possible in principle.

Various organisations still have remaining stocks in varying quantities. The most important ones include:

WHO: ~ 500.000 doses

Centers for Disease Control and Prevention (Atlanta, USA) ~ 14 Million doses (Dryvax of Wyeth, NYCBOH-Stamm)

In the past few years, the Swiss serum and vaccination institute at Bern made available individual doses for laboratory purposes and for the vaccination of researchers (Strain: Lanciy, production: 1980, annual efficacy testing.

Additional information:

In early November 2001, the Federal Government purchased 6 million doses of small-pox vaccine as an emergency reserve. This vaccine is not designed to vaccinate major parts of the population as a preventive measure. The vaccine has been made available within the framework of risk prevention, i.e. the unlikely event of biological warfare by means of small-pox viruses. The vaccine would then offer the possibility of carrying out selected vaccinations including vaccinations of infected persons, contacts of infected persons as well as health care professionals.

5. Marburg-, Ebola- and Lassa Virus

No vaccines are available for Marburg, Ebola and Lassa virus infections world-wide. The results obtained with experimental vaccines are encouraging. A statement concerning future availability of these vaccines would be too preliminary.

Antisera from horse against Ebola and Marburg virus are approved in Russia and possibly available.

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