NAFDAC rules out fresh clinical trial on COVID-19 vaccine

The National Agency for Food and Drug Administration and Control has said there will be no need to conduct a local clinical trial on the proposed N400bn vaccines before administering them on Nigerians.

NAFDAC said the vaccines have been approved by the World Health Organisation and it may not be necessary to conduct a fresh one.

It, however, said it would subject vaccines, which the Federal Government may likely spend N400bn to procure, to proper revalidation before administering them on Nigerians.

NAFDAC’s Media Consultant, Sayo Akintola, told PUNCH, “Once the vaccine arrives, a sample will be taken to the lab for a test. Once its safety and efficacy are certified by NAFDAC, it will be administered on Nigerians. We don’t expect anything to be different though.

“The truth is that once a vaccine is approved by the WHO, it is assumed that it has passed through some preliminary stage of the trial. It is a known fact that for the WHO to sanction a vaccine, it must have gone through a series of trial here and there,” he said.

Although he said NAFDAC’s evaluation of the vaccine would not be rigorous mainly because it’s not a new vaccine, Akintola noted that its efficacy and safety needed to be ratified.

He stated, “It is just for ratification. There is nothing on drugs or vaccines you will do without the consent of WHO. It is also expected that the regulatory body in each country would do its work in tandem with the WHO standard.”

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