The National Agency for Food and Drug Administration and Control (NAFDAC) has granted emergency-use-authorisation for three COVID-19 vaccines in Nigeria.
The three additional vaccines approved are Moderna, AstraZeneca and the Sputnik V vaccine yet to receive approval from the World Health Organisation.
The NAFDAC director-general, Mojisola Adeyeye, announced this at a briefing in Abuja on Thursday.
Mrs Adeyeye said the approved AstraZeneca vaccines are from Korea “due to the stall in procurement of those manufactured under licence by Serum Institute of India, and were initially administered in the country.”
“NAFDAC is announcing the approval of Moderna, AstraZeneca vaccines and conditional approval of Sputnik V vaccine.
“The NAFDAC Vaccine Committee has been carefully assessing several vaccines despite the fact the vaccines have been approved by stringent regulatory countries or have received WHO’s Emergency Use Listing (EUL),” she said.
She said Moderna and AstraZeneca AZD1222 vaccines have received WHO EUL listing and were given expedited approvals.
NAFDAC had previously approved AstraZeneca (India), Pfizer BioNTech and Johnson & Johnson COVID-19 vaccines.
Controversial Sputnik V
Although the Sputnik V was the first COVID-19 vaccine to be registered for use in any nation, it
is yet to receive approval for emergency use from the European Medicines Agency (EMA) and the WHO.
Approval by the WHO is crucial for widespread distribution through the COVID-19 Vaccines Global Access (COVAX) initiative, which is providing vaccine doses for lower-income nations.
Mrs Adeyeye said despite the vaccine not getting approval from the health regulatory bodies, the agency had done a thorough assessment of the vaccine and found that the benefits outweigh the risks.
“Sputnik V is yet to receive the EUL approval and therefore was subjected to full six-months review by NAFDAC. The agency did a thorough assessment of each vaccine and were found to have the quality, safety and efficacy attributes, with the benefits far outweighing the risks,” she said.
Despite the absence of approval from the EMA or the WHO, several countries, including South Korea, Argentina and India, are already manufacturing Sputnik V. India also plans to pump out at least 850 million doses, to help speed up the vaccination of its embattled population.
Many other countries, such as Hungary and Iran, are importing Sputnik V, and it has become a key plank of their vaccination campaigns.
Expected Vaccines
Having exhausted the initial four million doses of the Oxford-AstraZeneca vaccines delivered in March 2021 through COVAX, Nigeria is expecting additional 41,282,770 doses by the end of September.
The expected dose is a combination of the AstraZeneca vaccines, Pfizer-Bio-N Tech/Moderna and Johnson & Johnson (J&J) COVID-19 vaccines.
The Executive Director of Nigeria’s Immunisation agency, Faisal Shuaib, at a briefing on Tuesday said the vaccines are expected from COVAX while the Jassen vaccines are expected from the African Union Commission.
He said: “We have received communication for the delivery of the following vaccine shipments in the coming months. 3,924,000 doses of Oxford/AstraZeneca/Moderna by end of July or early August 2021 from the COVAX facility.
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“3,930,910 doses of Pfizer-Bio-N Tech/Moderna COVID-19 vaccine in August from the COVAX facility donated by the United States Government, 3,577,860 doses of Pfizer-Bio-N Tech/Moderna COVID-19 vaccine in Q3 from the COVAX facility.
“29,850,000 doses of Johnson & Johnson (Jassen) COVID-19 vaccine by the end of September will arrive in batches from the African Union Commission.”
He also said 3,938,945 eligible persons across 36 states and FCT have so far been vaccinated.
The AstraZeneca COVID-19 vaccine is given in double doses. A person is required to come back for a second shot, some weeks after taking the first jab.
“2,534,205 people have been vaccinated for the first dose and 1,404,205 have received their second dose of the vaccine,” he said.
