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PUBLIC NOTICE

26^th October, 2021

TMDA AUTHORIZES FIVE TYPES OF COVID - 19 VACCINES FOR EMERGENCY USE

1. Tanzania Medicines and Medical Devices Authority (TMDA) would like to inform its esteemed stakeholders and the general public that, it has authorized five types of COVID-19 vaccines for emergency use through its non-routine procedure of granting marketing authorization.
2. This notice is issued pursuant to section 51 of The Tanzania Medicines and Medical Devices Act, Cap 219 that mandates the Authority to authorize medicines and vaccines for use during public health emergencies of national concern.
3. TMDA has an Emergency Use Listing Procedure which is essentially a risk-based approach for assessing and listing medical products including vaccines with the aim of expediting the availability of these products during the declared public health emergencies.
4. The Authority would like to highlight to the public that, granting of emergency use of medical products does not alter the standard regulatory requirements for establishing quality, safety and efficacy required for issuing marketing authorization.
5. Therefore, the authorization of the five vaccines referred to in this notice was based on the acceptance of the safety, quality and efficacy data submitted by manufacturers to the international agencies including World Health Organization (WHO) and regional collaboration initiatives in which TMDA has participated and jointly assessed the scientific data.
6. The list of COVID-19 vaccines listed for emergency use by TMDA can be accessed by clicking here

   List of COVID-19 vaccines approved by the Authority

   SN	Name of vaccine	Manufacturer
   1	COVID-19 Vaccine Janssen (Janssen - Ad26.COV2.S)	Janseen - subsidiary of Johnson & Johnson – US
   2	Sinovac - COVID-19 Vaccine (Vero Cell), Inactivated/ CoronavacTM	Sinovac Life Science Co., Ltd., P.R. China
   3	Moderna - mRNA-1273	ModernaTX, Inc. Norwood and Lonza Biologics, Portsmouth, US.
   4	Pfizer/BioNtech - BNT162b2/COMIRNATY Tozinameran	Pfizer/BioNtech – US/Germany
   5	Sinopharm - SARS-CoV-2 Vaccine (Vero cell), inactivated (InCoV)	Beijing Bio-Institute of Biological Products Co Ltd - subsidiary of China National Biotec Group (CNBG), China

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