NAFDAC Approves Moderna, Sputnik, Korean Astrazeneca for COVID-19 Vaccination

Onyebuchi Ezigbo in Abuja

The National Agency for Food and Drug Administration and Control (NAFDAC) has approved three additional COVID-19 vaccines for use in Nigeria.

Ahead of the arrival of more vaccines doses in Nigeria, the agency said that its vaccine committee had recommended Moderna (Rovi Pharma Madrid, Spain); AstraZeneca AZD1222 (South Korea Bioscience Co Limited); Sputnik V (Gamaleya National Centre of Epidemiology and Microbiology, Russia) for emergency use.

The agency added that following observations of some avoidable effects during vaccination, it has recommended that health officials carry out preliminary checks on individual’s health status before administering the vaccine on anyone.
NAFDAC had earlier granted emergency use authorisation approval for Astrazeneca from India, Pfizer Bio-N-Tech and Johnson and Johnson (Jassen) vaccines to be deployed in the country against COVID-19.

NAFDAC Director-General, Prof. Mojisola Adeyeye, told reporters yesterday in Abuja that the agency was the first national regulatory body in Africa to have guidance on regulatory preparedness for Emergency Use Authorisations (EUA), licensing or access to COVID-19 vaccines.
She said: “NAFDAC is announcing the approval of Moderna and 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). A COVID-19 vaccine that has gone through the prior approval from either of these two sources had gone through quality, safety and efficacy evaluation, which is a prerequisite for acceptance by COVAX Facility.”
She added that most regulatory agencies across the world use this mechanism to expedite their own regulatory approval to import and administer COVID-19 vaccines.

“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 stated.

According to her, the agency spends at least 15 days to examine the dossier or submission package of the vaccine to ensure that the benefits of the vaccine far outweigh the risks and that any side effects are well noted for monitoring after vaccination by the respective NAFDAC and primary health officers.

She added that the EUL will allow Nigeria to receive supplies of the vaccines from the COVAX facility.
Adeyeye explained the processes involved in the vaccine approval mechanism to include: submission of dossiers by manufacturers and market authorisation holders, assessment of dossier through different mechanisms and using the common technical document for the rolling submission.

Other stages in the process are emergency use authorisation, expedited approval, full review, post-marketing, pharmacovigilance and Surveillance.
Adeyeye explained that Moderna and AstraZeneca AZD1222 vaccines have received WHO EUL listing and were given expedited approvals.

She, however, said the Russian Sputnik V was yet to receive the EUL approval and therefore was subjected to full six-month review by NAFDAC.

She said the agency was granted access to the dossiers and prior assessment reports of Moderna and AstraZeneca from the WHO website at different times over the past two months.

She said Pharmacovigilance/Post-marketing Directorate would conduct safety and monitoring studies on the vaccines to record the side effects and adverse effects following immunisation.

In addition, Adeyeye said the agency would be using its recently-launched Med Safety App for active pharmacovigilance of the vaccines in collaboration with other agencies.

While giving NAFDAC’s assessment of the outcome of the first phase COVID-19 vaccination rollout, Adeyeye said about 4,500 adverse effects were recorded out of the four million doses of Astrazeneca vaccines administered nationwide.

According to her, as part of measures to further reduce the incident of adverse effects of the vaccine, the agency has recommended that health officials will hold pre-vaccination interaction with individuals to understand their health conditions before administering the vaccine on anyone.