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How NAFDAC approves 3 COVID-19 Vaccines: Prof. Adeyeye

*Nigeria’s National Agency for Food and Drug Administration and Control says the approved Moderna, AstraZeneca and Sputnik V COVID-19 Vaccines have gone through certification for quality, safety and efficacy evaluation as a prerequisite for acceptance by COVAX facility

Isola Moses | ConsumerConnect

Sequel to their certification for quality, safety and efficacy evaluation as a prerequisite for acceptance by COVAX facility, the National Agency for Food and Drug Administration and Control (NAFDAC) said it had approved more vaccines for the treatment of the Coronavirus (COVID-19) pandemic in Nigeria.

ConsumerConnect reports Prof. Mojisola Adeyeye, Director-General of the country’s health regulatory agency, disclosed this development at a news conference Thursday, July 15, 2021, in Abuja, FCT.

Prof. Mojisola Adeyeye, Director-General of NAFDAC

The NAFDAC Chief said approval had been given to Moderna, a vaccine from the Rovi Pharma Madrid, Spain.

Prof. Adeyeye also stated that the agency approved other vaccines as AstraZeneca, AZD1222 produced by SK Bioscience Company Limited from Korea; and Sputnik V, produced by Gamaleya National Centre of Epidemiology and Microbiology, Russia.

The NAFDAC Vaccine Committee, she noted, has been carefully assessing the virus vaccines and several others in spite of the approval by stringent regulatory countries and the World Health Organisation (WHO) Emergency Use Listing (EUL).

The Director-General of NAFDAC informed Nigerians that all the three approved COVID-19 Vaccines have gone through the process of approval and certified for quality, safety and efficacy evaluation, a prerequisite for acceptance by COVAX facility.

Most regulatory agencies across the world use this mechanism to expedite their own regulatory approval to import and administer the vaccines, she said.

On how the agency arrived at the approval of Moderna, AstraZeneca and Sputnik V COVID-19 Vaccines, Adeyeye stated that NAFDAC spent 15 days to thoroughly examine the dossier or submission package of the vaccines to ensure that the benefits outweighed the risks and any other side effect for proper monitoring.

The Director-General said:

She said “the EUL will allow Nigeria to receive supplies of the vaccines from the COVAX facility. COVAX is the pillar of the Access to COVID-19 Tools (ACT) accelerator’s jointly led by the Global Alliance for Vaccines and Immunisation (GAVI) and the Coalition for Epidemic Preparedness Innovations (CEPI) and the WHO.

“Its aim is to accelerate the development and manufacture of COVID-19 Vaccines, and to guarantee fair and equitable access to low-middle income countries (LMIC) of which Nigeria is one.

“NAFDAC also gives full review for vaccines that have not gone through EUL route. This mechanism is explained in our guidance developed by the COVID-19 Vaccine Committee.”

Regulatory approvals for Moderna, AstraZeneca and Sputnik V Vaccines

As regards Moderna and AstraZeneca AZD1222 vaccines, Adeyeye said that the Coronavirus vaccines had received WHO EUL and were given accelerated approval, while Sputnik V was yet to receive the EUL approval, subjected to six months review by NAFDAC.

The health agency, she noted, was granted access to the dossiers and prior assessment reports of Moderna and AstraZeneca AZD1222 from the WHO Web site at different times over the past two months.

The NAFDAC Director-General also stated the Moderna Vaccine is presented as a white to off-white, ready-to-use dispersion for intramuscular injection in a

multi-dose vial containing 6.3ml (10 doses in a 10-vial pack, adding that, each dose have (0.5ml) contains 100 micrograms of messenger RNA, and is given as two dose vaccine.

According to her, unopened vaccine vials could be stored or transported frozen at -25 degree centigrade to -15 degree centigrade for up to seven months and 30 days when stored at 2 to 8 degree centigrade, protected from light.

The AstraZeneca AZD1222 is a recombinant ChAdOx adenoviral vector encoding the structural surface glycoprotein (Spike protein) antigen of the SARS-CoV-2, she said.

Adeyeye also explained that the AstraZeneca AZD1222 vaccine solution is colourless to slightly brown, clear to slightly opaque packed as a 5ml solution that contains 5 x 10 virus particles for injection in a 5ml clear glass multidose vial that could be stored at 2 to 8 degree centigrade, and is given as two dose injection.

On Sputnik V vaccine which is also known as Gam-COVID-Vac COVID-19 vaccine, the NAFDAC Director-General disclosed that “it is supplied as a two-component product, both of which are 3ml (5 doses) solution for intramuscular injection in glass vial.

“It is a two-dose injection. Each 0.5 ml dose of the component I is formulated to contain virus particles (1.0+0.5) x 10 of Ad26 vector encoding the S glycoprotein of SARS-CoV-2.”

She noted the product has a shelf life of six months when stored at -18 degree centigrade or three months when stored at 2-8 zero degree centigrade.

Adeyeye said 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.

Meanwhile, Adeyeye noted that the Pharmacovigilance Unit of NAFDAC would conduct safety and monitoring studies on the vaccines to record the side and adverse effects following immunisation.

Other studies like immunological responses, incidence of reactogenicity and possible dose optimisation would be done in a cohort of vaccines, she said.

The Director-General added that the agency would be using its recently launched Med Safety App for active pharmacovigilance of the vaccines in collaboration with respective sister agencies, and urged healthcare workers to download same App to monitor Adverse Drug Reaction (ADR) and report.

According to her, NAFDAC has begun in-country training on the use of the App for healthcare workers.

Adeyeye said that the agency planned to also use the traceability with GS1 technology to monitor vaccines distribution using Global Trade Item (GTIN).

“All these were to prevent fake vaccines from infiltrating the supply chain and to ensure there was no diversion,” she added.

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