COVID-19: Experts task NAFDAC on approval of vaccines

Nigerian health experts have tasked the National Agency for Food and Drug Administration and Control (NAFDAC) to probe available COVID-19 vaccines more deeply than it is currently doing before giving approval for their use in the country.

The former National Publicity Secretary of Association of Medical Laboratory Scientists of Nigeria, AMLSN, Dr Casmir Ifeanyi charged NAFDAC to be more technical in approach, expressing concern over the manner of approval of COVID-19 vaccines.

NAFDAC, announced approval of the AstraZeneca vaccine from Korea, and the conditional approval of the Russian Sputnik V vaccine Last week.

“I saw it as a mockery the other day when NAFDAC said they are undergoing WHO accreditation and validation. My concern is that NAFDAC is not a producing facility, NAFDAC is a regulated facility. So is the accreditation and validation for vaccine production or for the purpose of the regulation? NAFDAC is not a company, it’s a regulatory agency.

“I think NAFDAC is too much in hurry to approve the Russian vaccine that is largely questioned by the World Health Organisation, WHO. Sometimes when you rush to do things you make mistakes. I expect NAFDAC to be technical in approach.

“The approval of various types of vaccines by NAFDAC especially those not currently available in the country is questionable. Is this approval based on clinical evidence validation of these vaccines in the country, or the approval is just based on literature review?

“If it’s on literature review, it is unacceptable because of individual variation. So I will want NAFDAC to come clean as to how they made this approval. They should also publish the scientific evidence justifying the approval because we do not have that in the public domain yet,” he added.

According to Ifeanyi, NAFDAC should go beyond relying on what the manufacturers present to give approval.

The NAFDAC approval of the Russian COVID-19 vaccine might be that there is a programme by the Russian government to give the vaccine to Nigeria, otherwise it is not in the front line of vaccines that can use, it is not even in the vaccine portfolio for EU vaccine passport.

Ifeanyi explained that it was important for Nigeria not to leave its gate too widely open by such arbitrary approvals.

“A time will come that the government would hands-off treatment of Covid-19, leaving the patients to care for themselves, and individuals would be bringing in all types of vaccines to be approved for use in the country.

“I think it’s important we stick with the guideline and what we do hereby covid-19 should be what dictated by WHO, and countries in EU. It is important that government spare no resource in acquiring vaccines for Nigerians.”

Ifeanyi who also appealed to the federal government to use appropriated funds in the 2021 budget for the procurement of the COVID-19 vaccine, said that the country cannot afford to rely on donor agency in the face of rising cases of the delta variant.

Kamila/Vanguard