The National Agency for Food and Drug Administration and Control (NAFDAC) has approved more vaccines for the treatment of the Coronavirus (COVID-19) pandemic.
The Director-General of the agency, Prof. Mojisola Adeyeye, disclosed this at a news conference in Abuja on Thursday.
She said approval had been given to Moderna, a vaccine from the Rovi Pharma Madrid, Spain.
Other vaccines also approved are: AstraZeneca AZD1222 produced by SK Bioscience Company Limited from Korea and Sputnik V, produced by Gamaleya National Centre of Epidemiology and Microbiology, Russia.
Adeyeye said that the NAFDAC Vaccine Committee had been carefully assessing the vaccines and several others in spite of
the approval by stringent regulatory countries and the World Health Organisation (WHO) Emergency Use Listing (EUL).
She added 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.
According to her, most regulatory agencies across the world use this mechanism to expedite their own regulatory approval to import and administer the vaccines.
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.
“NAFDAC also gives a 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.”
On Moderna and AstraZeneca AZD1222 vaccines, the director-general said that the 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.
She said that NAFDAC was granted access to the dossiers and prior assessment reports of Moderna and AstraZeneca AZD1222 from the WHO website at different times over the past two months.
According to her, the Moderna vaccine is presented as a white to off-white, ready-to-use dispersion for intramuscular injection in a
the 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 a two-dose vaccine.
She said that unopened vaccine vials could be stored or transported frozen at -25 degrees centigrade to -15 degrees centigrade for up to seven months and 30 days when stored at 2 to 8 degrees centigrade, protected from light.
She added that the AstraZeneca AZD1222 is a recombinant ChAdOx adenoviral vector encoding the structural surface glycoprotein (Spike protein) antigen of the SARS-CoV-2.
Adeyeye said that the AstraZeneca AZD1222 vaccine solution is colorless 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 degrees centigrade, and is given as two dose injection.
On Sputnik V vaccine which is also known as Gam-COVID-Vac COVID-19 vaccine, NAFDAC DG said “it is supplied as a two-component product, both of which are 3ml (5 doses) solution for intramuscular injection in a glass vial.
“It is a two-dose injection. Each 0.5 ml dose of 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,” adding that 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.
She said that the pharmacovigilance unit would conduct safety and monitoring studies on the vaccines to record the side and adverse effects following immunization.
She further said that other studies like immunological responses, incidences of reactogenicity, and possible dose optimization would be done in a cohort of vaccines.
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 the same App to monitor Adverse Drug Reaction (ADR) and report.
She said NAFDAC had begun in-country training on the use of the App for healthcare workers.
She noted that the agency planned to also use the traceability with GS1 technology to monitor vaccines distribution using Global Trade Item (GTIN), adding that “all these were to prevent fake vaccines from infiltrating the supply chain and to ensure there was no diversion.”
CAN Opposes Christian-Christian, Muslim-Muslim Presidential Ticket In 2023
The Christian Association of Nigeria (CAN) has warned political parties not to buy the idea of Christian/Christian tickets or Muslim/Muslim presidential tickets in 2023.
CAN President, Samson Ayokunle gave the warning on Thursday after a brief meeting with Deputy Senate President, Ovie Omo-Agege at the National Assembly.
Ayokunle told politicians not to heat up the polity with utterances as campaigns commence.
Ayokunle advised them to always remember there is already tension across Nigeria due to insecurity
“We urge that a balance of both religious practitioners be considered. We don’t want Christian/Christian ticket nor Muslim/Muslim ticket”, he said.
Ayokunle expressed disappointment with the economic downturn and its consequences on the people.
The CAN President called for quick actions and policies that will cushion the effect.
“Unemployment is at an unimaginable level. While we appreciate the efforts of the legislature in calling the attention of the executive, more robust and daring efforts are required
“Enabling environment should be created for investments and incentives or tax exceptions given to local manufacturers on some goods”, Ayokunle added.
NSCDC Deploys 20,000 Personnel For Anambra Election
Nigeria Security and Civil Defence Corps (NSCDC) has deployed 20,000 personnel to provide security for the November. 6 governorship election in Anambra.
Those to be deployed include personnel in the NSCDC Arms Squad Unit, Counter-Terrorism Unit and Chemical, Biological, Radiological and Explosives Unit.
NSCDC Commandant-General, Dr Ahmed Audi, said this on Thursday in Abuja while delivering a keynote address at a three-day Train-the-Trainers Capacity Building and Electoral Workshop, ahead of the Anambra poll.
Audi said that the special forces would be drafted to key areas in the state where they would be saddled with the responsibility of protecting lives and property.
“They will also see to the protection of sensitive and non-sensitive election materials, INEC officials and all critical assets against vandalism, damage or arsonist attacks,” he said.
He said that NSCDC, in collaboration with other security agencies, had developed strategies to checkmate any act of electoral violence and other nefarious activities capable of undermining the electoral process.
The commandant-general further said that the deployed personnel would ensure effective monitoring before, during and after the election.
Audi also said that the personnel would be drafted from the NSCDC commands in all the states in the South-South and South-East zones.
“In addition, personnel from Kogi, Ekiti, Ondo, and Benue have been placed on standby, in case there is the need for reinforcement,” he said.
The NSCDC boss warned the officers to strictly adhere to the ethics of the corps and comply with the law in the discharge of their duties.
“Let me warn, and I mean it, that any conduct of an officer of NSCDC that undermines the rule of law will be seriously dealt with, in accordance with the public service rule,” he added.
Stakeholders Call On NERC, EEDC To Scale Up Performance In S’East
Stakeholders in the electricity industry in the South-East have charged the Nigerian Electricity Regulatory Commission (NERC) and Enugu Electricity Distribution Company (EEDC) to scale up their performances.
The people gave the charge on Thursday in Enugu at a NERC Stakeholders’ Engagement on Consultation on the Review of Customer Protection Regulations.
They described the periodic review of the regulations after five years as worthwhile.
They, however, said the practical implementation of the regulations, especially concerning the treatment of customers’ complaints, was of greater importance than the proposed review.
An electricity consumer, Mr Joshua Itumo, said the period between the supply of bills and disconnection of defaulting customers “must be reviewed to meet present realities and hardship customers face to get the money to pay their bills.
“The review also has to include that those enforcing disconnection must do it with human face and listen when superior argument or evidence of payment is presented,” Itumo said.A landlord in Trans Ekulu, Enugu, Mr Ifeanyichukwu Okorie, urged NERC and EEDC to clearly state the amount, which when accumulated by a tenant, must be paid before he or she parks out.
Okorie said: “It is not palatable that someone will park into a new apartment and inherit over N500,000 as electricity liability.
“Where does he start as a new tenant to off-set such a huge bill?”
Mr David Emeson, who lives at Agui Road, Enugu, said it was better to ensure the existing regulations were implemented to the latter than have a review that could not be implemented.
“We are not lacking good regulations. The problem is that NERC and EEDC most times fail to carry out what the regulations say and leave customers to their fate,’’ Emeson said.
Earlier, Prof. Frank Okafor, the Commissioner in charge of Engineering and Performance Monitoring in NERC, said the review had become necessary after five years in order to accommodate new ways of doing things, technology and other innovations.
Okafor said the review was not to witch-hunt any stakeholder but ensure more efficient and robust regulations to the benefit of electricity consumers.
“We are looking for ways to ensure more proactive and fast-result oriented ways of attending to customers’ complaints and using technological devices to do this, since NERC cannot be everywhere,” he said.
He said it was difficult for NERC to be proactive due to limited manpower, pointing out that the commission had only 150 staff members nationwide.
Responding, the Managing Director of EEDC, Mr Chorghade Praveen, assured the customers that the company was eager to resolve their complaints in good time, “just as we have recorded noticeable improvement in power supply across our network”.
Praveen also said the company was designing some technological innovations for complaints to be reported and solved within few hours of the report, where possible.
“We are working to improve our customers’ experience just as we have improved in the rate and quality of power supply throughout our franchise area.
“EEDC is moving from customers’ satisfaction to customers’ affection in order to allow our esteemed customers the best quality of service and care so far.
“All the complaints raised here and others to come, I assure you will be treated with dispatch,” he said.
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