To protect Nigerians from the deadly virus, the National Agency for Food and Drug Administration and Control has approved additional Covid-19 vaccines.
Moderna, a vaccine developed by Rovi Pharma Madrid in Spain, and Sputnik V, which was produced by Gamaleya National Centre of Epidemiology and Microbiology in Russia, are the newly approved vaccines.
AstraZeneca AZD1222, a vaccine that was approved earlier by SK Bioscience Company Limited of Korea, is available for emergency use.
According to the News Agency of Nigeria, this was revealed by Prof. Mojisola, Director-General of NAFDAC at a news conference in Abuja on Thursday.
Adeyeye stated that all COVID-19 vaccines had passed the approval process and had been evaluated for safety, efficacy, quality, and quality. This is a prerequisite to acceptance by COVAX.
What the NAFDAC Director General is saying
She pointed out that NAFDAC took 15 days to review the submission package for the vaccines. This was to make sure that the benefits were greater than the risks.
She stated that the EUL would allow Nigeria to get vaccines from the COVAX facility. COVAX is the pillar for the Access to COVID-19 Tools accelerator’s jointly led the Global Alliance for Vaccines and Immunisations (GAVI), the Coalition for Epidemic Preparedness Innovationss (CEPI), and the WHO.
The goal of the program is to develop and manufacture COVID-19 vaccines faster and to ensure fair and equitable access for low-middle income (LMIC), such as Nigeria.
NAFDAC also provides a complete review of vaccines that have not been through the EUL route. This is explained in the COVID-19 Vaccine Committee em> guidance.
Adeyeye stated that Moderna and AstraZeneca had been approved for emergency use by WHO and received accelerated approval. Sputnik V, however, was not yet approved but was subject to six-month review by NAFDAC.
She stated that NAFDAC had been granted access to Moderna’s dossiers and AstraZeneca’s prior assessment reports via the WHO website at various times in the past two months.
She stated that the Moderna vaccine is a ready-to-use dispersion for intramuscular injection. It contains 6.3ml (10 doses) in a multi-dose vial. Each dose also contains (0.5ml) 100 micrograms messenger RNA and is administered as a two-dose vaccine.
The NAFDAC boss stated that Sputnik V vaccine is also known by Gam-COVID Vac COVID-19 vaccination. It is supplied as a 2-component product. Both are 3ml (5 doses), and can be intramuscularly injected in a glass vial.
Adeyeye stated that each vaccine was thoroughly evaluated by the agency and found to be safe, effective, and of high quality. The benefits outweigh the risks.
Here are some things you need to know
NAFDAC approved 2 new vaccines at a time when there are increased fears of a third wave of covid pandemic in Nigeria. Also, it is particularly interesting to note the discovery of the Delta variant in an international passenger from Nigeria. The Nigeria Centre for Disease Control (NCDC), has isolated the Delta strain. It is believed to be more deadly than the other strains.
The Director-General of NAFDAC stated that the agency will be using the recently launched Med Safety App for active pharmaceuticalvigilance of vaccines in collaborations with sister agencies. He urged health workers to download the App to monitor adverse drug reactions (ADR) and to report them.