COVID: 19: More huddles to cross as NAFDAC approves Astrazeneca vaccine

By Hassan Zaggi

The announcement by the National Agency for Food and Drug Administration and Control (NAFDAC) on Thursday morning, that it has given an emergency approval for AstraZeneca/Oxford COVID-19 vaccine to be used in Nigeria triggered reactions from experts and stakeholders in the health sector across the country.

While others see it as a step the in the right direction in the fight against COVID-19 in the country, others, however, are of the opinion that much harder huddles are ahead for Nigeria.

Speaking at a media briefing on Thursday morning, on why it approved the vaccine for emergency use in Nigeria, the Director General of NAFDAC, said: “NAFDAC received the AstraZeneca/Oxford COVID-19 vaccine dossier from Serum Institute of India on February 10, 2021.

“The NAFDAC Vaccine Committee commenced the expedited review immediately and the members of the committee have worked assiduously to ensure that review was done as planned.

“The recommendation for Emergency Use Authorization was based on rigorous scientific considerations which include vaccine quality, vaccine safety and efficacy and pharmacovigilance of Covid-19 vaccines.”

According to her, the active substance of the vaccine is manufactured and controlled by Serum Institute of India Private Limited (SIIPL).

“A GMP certificate and manufacturing license issued by the India National Regulatory Authority (NRA) has been presented and found to be authentic and valid.

“The multidose (2 dose or 10 dose) vial is stored at 2-8OC, one dose (0.5ml) contains 5 x 1010 virus particle. On available stability data, the applicant has proposed a drug product shelf life of 6 months.”

On safety and efficacy, she said: “From the Phases 2/3 conducted, COVISHIELD was found safe and well-tolerated in adults above 18 years of age.

“The incidence of solicited, unsolicited AEs and SAEs was comparable in the study control. groups. No causally related SAE was caused by the study vaccine.”

However, a renowned medical expert in Nigeria, Dr. Ejike Orji, while responding to questions from our Correspondent said that it was not yet uhuru as there are still many huddles to cross for Nigerians to get the vaccine.

While explaining what the approval by NAFDAC means in the fight against COVID-19 in Nigeria, Orji said: “Nigeria has a regulatory body, even though the vaccine has been approved the World Health Organisation (WHO), it has to go through our regulatory process. What they are saying now is that the vaccine has passed through them and they have approved it to be used in Nigeria.”

He, however, said: “Until we see the vaccine that is when we will heave a sigh of relief. This is because the problem we have now is that it will be difficult for Nigeria to get the vaccine until the bigger countries vaccinate a considerate per centage of their population.

“America has vaccinated over 60 million of its population, it has a population of over 300 million people. President Bidden recently said that in his 100 days, he will vaccinate 100 million Americans. Do you think they will allow any vaccine leave their country when they have not achieved their target?

“Just recently, the European Union had a fight with Astrazeneca, there was a number of vaccine they wanted to be supplied so they felt that they were not getting that supply and they threatened court action.

“You can see that vaccine is being struggled all over the world. The only countries that are receiving vaccine in Africa now are Tunisia and South Africa and that is the Modena and Cuvey vaccines. This is because the temperatures in which these vaccines operate is below 80 degrees Celsius and they are afraid that Nigeria has not met the logistics support and it will be difficult to give to Nigeria and that is why Nigeria is now going to Astrazeneca which has around 2-3 degrees Celsius like the other polio vaccine and all that.”

Identifying another challenge Nigeria may face in the administration of the vaccine, Dr. Orji said: “But the problem we have here, because of national interest we feel that the distribution of vaccine will not be equitable even under the COVAX initiative where 2 million dosses of the vaccines will be made available to low and medium income countries across the world for the free. This is donated by different international agencies.

“We don’t know how that will happen because they said that Nigeria will start receiving in April the over 16 million dosses of Astrazeneca that is due for Nigeria.”

He explained that: “Now that NAFDAC has approved, it means that there is a regulatory approval legally for the vaccine to be given in Nigeria. At least that huddle has been passed. It is now the logistics of reeling it out will be required. You know there is a structure that you have to think of the elderly first, the frontline workers who have co-morbidities and all that.”

A cross section of Nigerians interviewed by our Correspondent expressed mixed feelings, insisting that until they get vaccinated that is when they will take the government serious.

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