Information on the Availability of Vaccines against Anthrax, Plague and Smallpox
Joint press release of the Paul-Ehrlich-Institut and the Robert-Koch-Institut
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.
Contact:
Paul-Ehrlich-Institut
Public Relations
Dr. Susanne Stöcker, Dörte Ruhaltinger
Paul-Ehrlich-Straße 51-59
63225 Langen
GERMANY
Phone: +49 6103 77 1030
Fax: +49 6103 77 1262
Email: press@pei.de
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