NAFDAC approves more Covid-19 vaccines, Moderna and Sputnik for use

NAFDAC approves more Covid-19 vaccines, Moderna and Sputnik for use

Covid-19: AstraZeneca vaccine gets huge boost, produces immune response in elderly

The National Agency for Food and Drug Administration and Control (NAFDAC) has approved more Covid-19 vaccines to protect Nigerians against the dreaded virus.

The newly approved vaccines include Moderna, a vaccine from the Rovi Pharma Madrid, Spain and Sputnik V, produced by Gamaleya National Centre of Epidemiology and Microbiology, Russia.

The other vaccine which had been earlier approved is AstraZeneca AZD1222 produced by SK Bioscience Company Limited from Korea for emergency use.

This was disclosed by the Director-General of NAFDAC, Prof. Mojisola Adeyeye, at a news conference on Thursday in Abuja, according to the News Agency of Nigeria.

Adeyeye said that all the COVID-19 vaccines that had gone through the process of approval had been certified for quality, safety and efficacy evaluation, a prerequisite for acceptance by the COVAX facility.

What the NAFDAC Director-General is saying

She noted 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 effects for proper monitoring.

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.

that have not gone through the EUL route. This mechanism is explained in our guidance developed by the COVID-19 Vaccine Committee.”

On Moderna and AstraZeneca vaccines, Adeyeye said that the vaccines had received WHO emergency use listing and were given accelerated approval, while Sputnik V was yet to receive the emergency use listing approval but was subjected to six months review by NAFDAC.

She said that NAFDAC was granted access to the dossiers and prior assessment reports of Moderna and AstraZeneca from the WHO website at different times over the past 2 months.

According to her, 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 has (0.5ml) contains 100 micrograms of messenger RNA, and is given as two-dose vaccine.

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

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.

What you should know

The approval of 2 new vaccines by NAFDAC is coming at a time of heightened fears about a possible third wave of the covid pandemic in Nigeria and of particular interest, the detection of the Delta variant of the virus in an international passenger in Nigeria. The Delta strain isolated by the Nigeria Centre for Disease Control (NCDC) is believed to be deadlier than the previous strains.

Meanwhile, the NAFDAC Director-General said that the agency would be using its recently launched Med Safety App for active pharmacovigilance of the vaccines in collaboration with respective sister agencies, urging health workers to download the same App to monitor and report Adverse Drug Reactions (ADR).

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