Flu vaccine produced at ‘Cantacuzino’ banned by ANM


Test results indicated a very high concentration of endotoxins. Health Minister notified SRI. Ponta sent the Body of Control to the Cantacuzino Institute.

The National Agency for Medicines and Medical Devices (ANM) has banned the marketing of the flu vaccine produced by the Cantacuzino Institute, after test results showed a large concentration of endotoxins that can cause adverse side-effects like fever, rigors, and very rarely anaphylactic shock when administered, Mediafax informs.
According to Marius Savu, President of ANM, 400,000 doses of flu vaccines were issued this season by the Cantacuzino Institute and samples were taken for conformity analyses. Late last year, ANM informed the Institute that the vaccine could not be commercialized because the level of endotoxins exceeded the allowed limit. Nonetheless, the Cantacuzino Institute conducted another test and asked ANM to perform another check-up analysis. Both the test and the check-up concluded the product did not comply with regulations, Marius Savu said. In turn, ANM also sent samples to the French Agency for Medicine, who released a public statement on January 31, saying the vaccine was not in accordance with the norms. Results indicated the flu vaccine produced by Cantacuzino had over 3,000 units/ml of endotoxin, a much higher quantity compared to the maximum of 100 units allowed for authorized products. The French Agency conducted a second confirmatory test with the same results and submitted the findings to ANM in the middle of last week. Subsequently, ANM sent the Cantacuzino Institute an official notification and informed the Health Minister and the PM that the flu vaccine does not comply with the norms and cannot be marketed, Savu explained.
3,000 units of endotoxins is a normal value for flu vaccines in the U.S., but it is considered too high in Europe. The fact that the doses produced by the Cantacuzino Institute were not commercialized proves safety and quality standards are upheld in Romania, Prof. Dr. Adrian Streinu Cercel, Manager of ‘Matei Bals’ National Institute of Infectious Diseases in Bucharest, stated.
SRI and PM’s Body of Control keep an eye on the institute
In reply to a question about the possibility of a deliberate contamination of the flu vaccine produced by the Cantacuzino Institute, Eugen Nicolaescu, Minister of Health, stated Saturday that he received information to support this fact from “immediate outside sources to the Institute, through various channels.” “I have asked SRI to help us in this respect,” Nicolaescu added. The day before, the Health Minister referred to existing suspicions of “ill-intent” in every stage of the flu vaccine production process. When asked if measures will be taken regarding the 400,000 doses of flu vaccine that could not be commercialized, Nicolaescu said, “If they are found guilty, yes.”
The situation was also brought to the Prime Minister’s attention, who sent the Body of Control to the Cantacuzino Institute after ANM banned the marketing of the flu vaccine.
However, a press release issued by the Ministry of Health shows the flu vaccine produced by Cantacuzino was tested on 62 persons aged between 20 and 80 during the clinical trials phase, with minor registered side-effects similar to those of patients treated with the import vaccine. Prof. Dr. Emanoil Ceausu, manager of ‘Victor Babes’ Infectious and Tropical Diseases Hospital in Bucharest, said the possibility of anaphylactic shock following the administration of the flu vaccine is “slightly exaggerated,” since this side-effect never occurred in patients with typhoid fever of cholera treated with immunization products that contain hundreds of thousands of endotoxin units.