The Presidential Steering Committee (PSC) on COVID-19 has announced the suspension of the second phase of vaccination against the disease earlier scheduled to commence tomorrow in Abuja.
The development comes as some experts raised concerns on the propriety of using the four million doses of Moderna vaccine donated to the country by the United States through the COVAX facility.
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COVAX is a global initiative led by the World Health Organisation (WHO), Gavi, The Vaccine Alliance, and the Coalition for Epidemic Preparedness Innovations (CEPI) aimed at bringing governments and manufacturers together to ensure COVID-19 vaccines reached those in greatest need of it.
Daily Trust gathered that the vaccine consignment that were donated through the COVAX facility and received on August 2, were not accompanied with certificate of analysis and Lot release certificate.
The vaccines were also manufactured from sites not certified by the World Health Organisation (WHO) Emergency Use Listing (EUL) for Moderna mRNA 1273 vaccine.
These shortcomings identified by persons familiar with the processes raised issues about safety, especially with Nigeria being made to sign an indemnity form to take responsibility should something go wrong.
Spokesman in the Office of the Secretary to the Government of the Federation (OSGF), Mr. Willie Bassey, announced the suspension of the vaccines’ roll out in Abuja without giving specific reasons for the sudden change in plans.
Daily Trust gathered that already, Nigerians who have registered to get the vaccine have received appointments through SMS on designated health centres and times for the vaccination.
“This is to announce the postponement of the national flag-off exercise of phase 11 vaccination programme earlier scheduled for Tuesday this week due to unforeseen circumstances. A new date will be communicated, please,” Bassey said.
The notice of the postponement comes a day after announcement of the commencement of the second phase of the vaccination.
Concerns over ‘missing’ documents
Daily Trust learnt that some senior staff and experts are not comfortable using the donated doses over the failure to provide the two important documents.
The documents that usually come with the vaccine shipments consist of certificate of origin, lot release certificate, certificate of analysis, and compliance certificate among others.
Findings revealed that the National Agency for Food and Drug Administration and Control (NAFDAC) became uncomfortable with the batch over the lack of WHO Emergency Use Listing (EUL) for the sites and reluctance of the donor to provide these certificates, particularly the certificate of compliance.
This also raised suspicions from the agency and other health-related organisations in the country, leading to dilly-dallying in the issuance of necessary approvals.
But the Director-General of NAFDAC, Prof Moji Adeyeye, Sunday told Daily Trust that the organisation has no issues with the Moderna vaccines, and has cleared the four million doses supplied for use.
“The US manufacturing sites are fully certified by WHO EUL. We have reviewed the information, tested the batches and have approved the vaccine for immunization,” she wrote in a response to our enquiry.
Daily Trust learnt that even where there is no emergency use listing, NAFDAC requires the certificate of analysis to do reviews of the vaccines since its assessment is majorly based on dossiers, a collection of documents for the vaccines.
But the NAFDAC DG, in her reaction, said the four million doses were brought to the country following earlier approval for the use of Moderna by the agency. She said only shipping documents were delayed but later delivered, in respect of the donated doses.
Executive Director of the National Primary Health Care Development Agency (NPHCDA) Dr. Faisal Shuaib had in preparation to receiving the consignment, said the administration of the vaccines will commence same week and will also flag off the second phase of the COVID administration in the country.
A letter from COVAX facility to the Minister of Health, Dr Osagie Ehanire, dated July 13, 2021 before the shipment of the vaccine and obtained by Daily Trust informed the country of the absence of these documents.
It stated, “These doses were from the United States (US) manufacturing sites that are not yet added to WHO Emergency use listing for Moderna mRNA 1273 vaccine. However, the doses have received approval from the US Food and Drug Administration and in some cases also from the European Medicines Agency.”
While asking beneficiaries to expedite domestic authorisation of use of the vaccine, it stated that only the certificate of Compliance (COC) will be available for the shipment.
Doubts over consignment
According to a source, even though COVAX provided the information before the shipment of the vaccines, questions are being raised on the reluctance to provide these documents after NAFDAC insisted for them.
He said this has raised speculations that the donation may be an avenue to test the vaccines on Nigerians.
“Why is the US not interested in giving the result of analysis? Why are they eager to send it to Nigeria without WHO emergency use listing?” he asked.
He said each vaccine has to go through various phases of clinical trials, and for each phase there is a required number of persons that needed to be tested.
He said, “Even in the US, there is vaccine hesitancy, so now for phase four clinical trials, you need a large number of people.
“Even after vaccination, you need to do some pharmacovigilance and post introduction surveillance to see what will happen to the individuals vaccinated.”
He said he suspected the reluctance to provide the certificate of analysis as a gimmick to make Nigerians guinea pigs for testing the vaccines.
He said the suspicion has heightened among experts and officials of the health agencies after it was discovered that the manufacturers have the certificate of analysis but have blocked all the outcomes of the analysis for the country. He said a hard copy document currently in circulation attests to that.
According to him, pushing out four million doses to a population through donation, vaccinating them and coming back to take data is enough experiment for a clinical trial.
He said the problem there is that the experiment is being done at the expense of other people who are Nigerians.
“So you have four million people (that is Nigerians) vaccinated through donation, and after six months or one year you come and do sero-prevalence survey. You get the titre serum, you can say your vaccine is good or not good, and you can use the result to really readjust your manufacturing procedure among others,” he added.
Approval for Moderna COVID-19 vaccine
The Moderna COVID-19 vaccine (mRNA-1273) is an mRNA–based vaccine and the World Health Organisation (WHO) has already granted approval for emergency use listing of the vaccine.
NAFDAC has also granted emergency use authorization for the vaccine. However, this particular four million consignments are from sites in the US not yet granted WHO’s Emergency Use Listing (EUL).
WHO’s Emergency Use Listing (EUL) assesses the quality, safety and efficacy of COVID-19 vaccines and is a prerequisite for COVAX Facility vaccine supply.
Speaking during the approval for the vaccines, NAFDAC said the NAFDAC Vaccine Committee has been carefully assessing several vaccines though the vaccines have been approved by stringent regulatory countries or have received WHO’s Emergency Use Listing (EUL).
Significance of the two documents not provided
The certificate of analysis shows the contents of the vaccines such as the concentration, purity, and PH level – in other words gives an idea of the safety of the vaccines, while the lot certificate is a certificate from the country of origin or its national regulatory agency certifying the batch or consignment.
Explaining the significance of the documents, an expert who craves anonymity said, “Whenever the country is going to receive any vaccine, there are some documents that need to come with the vaccine as part of the regulatory processes.
“So prior to the arrival of the vaccines, the National Primary Healthcare Development Agency (NPHCDA) will inform NAFDAC that they are importing so and so vaccines.
“NAFDAC will then give NPHCDA a kind of import permit. That has been granted for several other vaccines including the Moderna vaccines in question.
“When the vaccines arrive, NAFDAC will take samples and do their analysis, and to do so, they have to go with some documents that the vaccine came with it.”
He said though the US stated clearly from the outset of the donation through a letter to the Minister of Health that these documents will not come with the shipment, he said there are concerns because the documents are critical to public safety and the regulatory processes in Nigeria.
“So there is no reason why this one has to be an exception,” he added.
He said, “You know when COVID-19 issues started when WHO said all vaccines must be given emergency use listing (EUL) before use on human beings; all along all other vaccines have been complying with these.
“Of course there are countries that don’t care about WHO emergency listing. But as it is in Nigeria all our vaccines must be WHO prequalified. So there is no reason why this one has to be an exception.
“They wrote to the country and the country accepted through the minister. But when the vaccines came, NAFDAC was not aware that the country said they are accepting without certificate of analysis. NAFDAC asked for it and the certificate could not be provided.
“So NAFDAC has not given the emergency use authoritisation because there is no emergency use authorisation by WHO for the US manufacturing sites of the vaccine and because NAFDAC needs to see the certificate analysis. It has to see all the components in the vaccine.
“The certificate of compliance that came with it only states that this vaccine has been manufactured under good manufacturing practices, that is not enough. So this is why NAFDAC is insisting on the certificate of analysis to know what the real contents are.
“For every batch of vaccines, the country of origin needs to certify each batch, through issuing the lot certificate. But this is not provided for the four million Moderna vaccine doses too,” he said.
Experts’ view
A public health expert, Dr Casmir Ifeanyi said while the two documents are important, the whole problem is caused by the federal government’s cap-in-hand approach and depending on donors for the vaccines instead of manufacturing or procuring it.
He said another cause of the challenges is NAFDAC’s approval for vaccines based on review of dossiers and literature, or manufacturer’s analysis rather than real in-country analysis or testing of the vaccines.
Prof Oyewole Tomori, a renowned virologist, said the fact that the manufacturing sides of the vaccine is not under WHO listing is not a major problem because NAFDAC also gave conditional approval to SPUTNIK V (Russian) vaccines without WHO listing.
He said while the Certificate of Analysis is important, the fact that the US Food and Drug Administration (FDA) has given approval may suffice.
He said for FDA to approve it, it must have gotten the Certificate of Analysis. He however added that he does not know why the FDA is not sharing it.
Prof Tomori called on government all levels to enlighten Nigerians on the vaccines so that those who have taken only the first dose of Astrazeneca will not take Moderna or John and Johnson vaccine, which is a single dose.
Federal Ministry of Health, NPHCDA silent on concerns
When the spokesman of the Federal Ministry of Health was contacted, he directed the reporter to the Director, Hospital Services, Mrs Adebiyi Adebimpe. She however did not pick calls or respond to queries on the issue, repeatedly over several days.
Spokesman of the National Primary Healthcare Development Agency, Mohammad Ohitoto, also did not respond to messages and calls to confirm if the documentation processes were followed at press time.
However, sources within NAFDAC and NPHCDA said many directors in both agencies are concerned about the safety of the vaccines but are afraid to speak out for fear for their jobs, and have rather being expressing concern via whispers and circulating documents within themselves including the one blocking the certificate of analysis to NAFDAC.
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