NAFDAC begins examination of Johnson & Johnson, Russian vaccines

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

This development is the first step to approving the vaccines for use in Nigeria as  the dossiers would allow those in authorities to  find out  whether the vaccine is fit for human consumption or not.

The Director-General of NAFDAC, Prof Moji Adeyeye, made this known yesterday.

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.

This is happening after a month that Nigerians received COVAX largest shipment of Astrazeneca Covid vaccines.

The Federal Government, however, last week, directed all states administering Covid-19 vaccines  to stop immediately they have exhausted half of the dosage given to them.

The move, it was learnt, became necessary due to a shortage of the AstraZeneca vaccine on the international market caused by a surge in the demand for the vaccine including in India which is experiencing a second wave of Covid-19.