NAFDAC begins exams of Johnson & Johnson, Russian COVID-19 vaccines

The National Agency for Food and Drug Administration and Control (NAFDAC) has received the dossiers for Pfizer, Johnson & Johnson and the Russian Sputnik V vaccines.

This is the first step to approving the vaccines for use in Nigeria.

The Director-General of NAFDAC, Prof Moji Adeyeye, said this on Saturday.

Adeyeye said, “We have three other dossiers that we are working on now. These are Sputnik V, J&J and Pfizer-BioNTech. We will be announcing our decisions as soon as we finish the review of each dossier.”

A registration dossier of a pharmaceutical product is a document that contains all the technical data (administrative, quality, nonclinical and clinical) of a product to be approved, registered and marketed in a country.

It consists of data proving that the drug has quality, efficacy and safety properties suitable for the intended use, additional administrative documents, samples of finished product or related substances and reagents necessary to perform analyses of finished product. – Punch.

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