COVID-19 vaccines: Delay Imminent Over Failure of Federal Ministry of Health Seeking NAFDAC Approval

COVID-19: We havn't approved any vaccines for clinical trial — NAFDAC

COVID-19: We havn't approved any vaccines for clinical trial — NAFDAC

The delivery of COVID-19 vaccines may suffer delay following the failure of the Federal Ministry of Health to write the National Agency for Food and Drug Administration for approval.


A director at the health ministry confirmed this to one of our correspondents on Saturday.

The Executive Director, Primary Health Care Development Agency, Dr Faisal Shuaib, had said on January 5, 2021, that 100,000 doses of the Pfizer vaccine would arrive in Nigeria by the end of January, which is now two weeks away.


However, a director at the health ministry who wished to remain anonymous said ideally, a letter of approval ought to have been sent to NAFDAC by now in order to get an approval.

He said without the NAFDAC approval, the vaccines would not be cleared at the port of entry.


The director said, “NAFDAC ought to have been notified the moment the vaccines were purchased. This is the standard practice when importing drugs that have never been used in Nigeria. That way, NAFDAC would have set things in motion so that once the drugs arrive, there will be no delay and customs would allow things to move.


“Ideally, NAFDAC will need to review many things before giving approval. They will need to set up an expert committee that will review and advise them. The ministry ought to have written NAFDAC by now.


“The Pfizer vaccines that are being imported ought to be stored at a temperature of -70 degrees. There should not be any form of delay because it would render the vaccine useless.”


“All the ministry needs to do is to write NAFDAC for approvals on time. This is not something that should be difficult. These vaccines are very sensitive and we want to avoid a situation whereby there would be another delay. It happened not too long ago when HIV drugs were stuck at the ports because the health ministry could not get a waiver on time from the Federal Ministry of Finance,” the director said.

A senior customs official who works at an airport told one of our correspondents that the vaccines would not be cleared without a NAFDAC certificate.

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“When such drugs are purchased, you obtain an invoice and a bill of lading. You will present these documents to NAFDAC before they arrive. They must have certified those vaccines before they arrive. Without the NAFDAC approval, customs will not release them,” the officer said.


Meanwhile, the Nigerian Institute of Medical Research says there is not enough space at the moment to store the Pfizer vaccines.

The Director-General of NIMR, Prof Babatunde Salako, said this during an interview on Saturday.


Salako said Nigeria had freezers in different parts of the country to store the Pfizer vaccines at -70 degrees centigrade.


He, however, said most of the freezers were occupied and were storing medical supplies which also needed to be stored at a low temperature.


Responding to a question, Salako said, “Our facilities can hold Pfizer vaccines at -70 degrees but we don’t have enough of such freezers and the ones we have are even full at the moment. We even just got one that we have yet to install but how many samples can it even hold?

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“Even if we rearrange things, I doubt if we can store more than a few hundreds or thousands.”


Asked if other facilities besides NIMR could hold such vaccines, he said, “There are many -80 freezers around in the research institutes and universities but the point is that many of them have samples inside them. So, even if we evacuate, I don’t think we will all be able to do more than a few thousands.”


Salako said storage was the minor problem, adding that the major challenge would be how to transport the vaccines at the temperature of -70 to rural areas.


The NIMR boss argued that in the future, Nigeria might need to buy other brands that did not require such low temperature like Pfizer.


Salako noted that other brands like Oxford/AstraZeneca could be stored at normal freezer temperature while the Russian vaccine could also be stored at a temperature not as low as Pfizer.


He said, “The problem is not just about storing vaccines but moving it to the rural areas and maintaining that same temperature. For example, if you land in Lagos and you store it at -70 and it has to be transported over the creek somewhere, how do you move them? There are other ways but they will be very costly. They can store them with liquid nitrogen or even dry ice but it will cost a lot of money.


“AstraZeneca would have been better because it would stay at normal freeze temperature and I think even Russian vaccines can be stored at the same temperature but I think the government is going with Pfizer because the World Health Organisation has given it an emergency approval.

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“But I think all the vaccines are now being deployed in many countries. So, we can do all of them rather than do just one considering the storage capacity for Pfizer. Even the government knows that we don’t have enough space but we can be taking in batches.”


The NAFDAC Director-General, Prof Moji Adeyeye, refused to comment when contacted on Saturday.

The National Coordinator of the Presidential Task Force on COVID-19, Dr Sani Aliyu, and the Minister of Health, Dr Osagie Ehanire, had yet to respond to an inquiry as of press time.


However, an aide to the minister said NAFDAC was part of the team working on the vaccine acquisition and that things would be sorted out.

“NAFDAC is part of the government team working on vaccine acquisition. All aspects will be taken care of,” he said.

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