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Tag: NAFDAC

  • NAFDAC sends important message to Nigerians over COVID-19 vaccine labels

    NAFDAC sends important message to Nigerians over COVID-19 vaccine labels

    The National Agency for Food and Drug Administration and Control (NAFDAC), has advised Nigerians to ensure the Astrazeneca vaccine being administered on them had the original label.

    The agency said the warning was imperative to ensure people did not risk being vaccinated with fake Astrazeneca vaccine.

    The position of NAFDAC is contained in a statement signed by the agency’s Director General, Prof. Mojisola Adeyeye, on Sunday, in Abuja.

    Adeyeye, explained that the original Oxford Astrazeneca University (AZOU) vaccine, had been contracted to India’s world largest vaccine manufacturer, Serum Institute of India (SIIPL), to produce in large quantity.

    “AZOU gave the license of its vaccine to Serum Institute of India PVT Ltd, (SIIPL), to manufacture this vaccine at a commercial scale. SIIPL is the largest vaccine manufacturer in the world and the company got the license by signing the manufacturing agreement.

    “SIIPL gave the vaccine the trade name COVISHIELD, it is the result of a cooperation and a technology transfer from AstraZeneca – University of Oxford to SIIPL.

    “SIIPL is now the world’s largest vaccine manufacturer by number of doses produced and sold globally.

    “More than 1.5 billion doses, which include Polio vaccine, Diphtheria, Tetanus, Pertussis, Hib, BCG, r-Hepatitis B, Measles, Mumps and Rubella,” she said.

    Adeyeye added that the vaccines manufactured by SIIPL were accredited by the World Health Organisation (WHO), and were being used in about 170 countries across the globe in their national immunisation programme.

    She added that both COVISHIELD manufactured by SIIPL and COVID-19 vaccine Astrazeneca, manufactured by Astrazeneca/Oxford University vaccine are the same vaccine.

    According to Adeyeye, ChAdOx1 nCoV- 19 corona virus vaccines (Recombinant), COVISHIELD, was granted Emergency Use Listing (EUL) by the World Health Organisation on Feb.15, and that it was one of the listed vaccines under the COVAX Facility.

  • NAFDAC reveals cause of ‘strange disease, deaths’ in Kano State

    NAFDAC reveals cause of ‘strange disease, deaths’ in Kano State

    The National Agency for Food and Drug Administration and Control (NAFDAC) says the strange disease in Kano State is caused by food poisoning through a flavoured drink.

    The Director-General of the Agency, Mojisola Adeyeye, disclosed this on Wednesday during an interview on a monitored Channels Television programme.

    Adeyeye described the incident as “very serious,” adding that investigations are still in progress.

    “The Kano incident is a case of food poisoning with flavored drinks that has a chemical called Dansami. It is very serious because food poisoning resulted in diarrhoea, vomiting, and hospitalisation.

    “Our zonal director, Pharmacist Gimba, is on top of this and our pharmacovigilance officers are also investigating what actually happened.

    “We’re going to do a lot of testing in the lab to know the nature of this chemical that probably led to the food poisoning,” she said.

    When asked if there is further information on the origin of the flavoured drink, the NAFDAC boss said she does not yet have details on its origin.

    She said although the chances of recurrence are minimal, NAFDAC is yet to find out if it is a drink approved by the agency or an imported drink.

    “But our pharmacovigilance is already there; so once we determine the cause, we’ll know what next to do in terms of arresting the culprit or bringing them to the office to know what is going on,” she said.

    Speaking on chances of recurrence of the incident, Adeyeye said “The chances of recurrence are minimal. But we don’t even know whether the flavored drinks are smuggled. We sometimes find out that manufacturing is not approved by NAFDAC. So, we just have to find out whether this particular flavored drink was approved by NAFDAC.”

    TheNewsGuru.com, TNG reports that the state recently suffered an outbreak of a strange infection with three persons feared dead and many others hospitalised.

    The State Ministry of Health confirmed that the affected patients presented symptoms of haematuria which causes bloody urine or dark urine, fever, lethargy, and sometimes jaundice.

  • BREAKING: First batch of AstraZeneca vaccines arrives in Nigeria

    BREAKING: First batch of AstraZeneca vaccines arrives in Nigeria

    The first batch of Oxford/AstraZeneca COVID-19 vaccine, which is about 3,924,000 doses, has arrived in Nigeria.

    TheNewsGuru.com (TNG) reports the COVID-19 vaccine arrived in the country via the Nnamdi Azikiwe International Airport, Abuja.

    A small ceremony chaired by Boss Mustapha, the Chairman of the Presidential Task Force (PTF) on COVID-19 is currently being held at the VIP Protocol section of the airport to receive the vaccine.

    ALSO READ || How to register and receive early COVID-19 vaccination in Nigeria

    Meanwhile, the Executive Director of the National Primary Health Care Development Agency (NPHCDA), Dr Faisal Shuaib had said at the end of the ceremony, a few vials of the vaccines would be handed over to the National Agency for Food and Drug Administration and Control (NAFDAC).

    TNG reports NAFDAC is expected to analyze the vaccine over a period of two days, i.e. Wednesday March 3rd and Thursday March 4th.

    Further to the clearance by NAFDAC, the PTF, NPHCDA, the federal ministry of health and strategic leaders will be at the treatment center of the National Hospital on Friday March 5th 2021, where the first vaccination site will be set up to commence the vaccination of the frontline health workers and support staff.

    According to the Executive Director of the NPHCDA, on Monday March 8th 2021, more vaccination sites would have been set up at designated locations such as National Assembly clinic, State House clinic and Federal medical centre, Jabi where strategic leaders such as the SGF, Senate President, Speaker of the House of Representatives, Attorney General of the Federation, Inspector General of Police, the Ministers and Ministers of States, Senators, House of Representatives, traditional leaders and religious leaders would be vaccinated.

    “After this launch and initial roll-out phase, Vaccine distribution to the States for the phase 1 vaccination process will begin. This phase is the vaccination of all frontline health workers, their supporting staff and strategic leaders.

    “Deployment of vaccines to the States would be based on the assessment of their level of preparedness. Some of the parameters that would be used for the assessment include adequate maintenance of their cold chain storage facilities, adequate preparation for logistic transportation to the ward/ health facility, adequate security in place during transportation and at vaccination sites, completion of training of health workers, efficient social mobilization activities in place, adherence to protocol for vaccine deployment.

    “Working with CACOVID, plans are on ground for a cargo plane provided by them to transport the vaccines to the States by air. States without a functional airport will have their vaccines transported by road using vans with fitted Cold Cabins, from the nearest airport. The vaccines will be stored at the State Cold Stores, from where they will be transported by road to LGA Cold Stores

    “Once activities have commenced in the States, there would be strict monitoring by PTF, FMOH, NPHCDA and independent bodies such as EFCC, DSS, ICPC, and Civil Society Organizations.

    “States/health facilities/health workers that are identified as defaulting from the standard protocol and guidelines for this phase of vaccination would be sanctioned.

    “While this is ongoing, the National team would be ready for the arrival of the next batch of vaccines which would be used for the next phase of vaccination.

    “Phase 2 vaccination process involves vaccination of the elderly from 50 years and above. This has been sub grouped into 2, with the vaccination of 60 and above occurring first followed by 50 — 59years. This will occur across all 36 States and the FCT. Those who are eligible for vaccination that have not registered electronically, would be assisted at the designated health facility and would be vaccinated.

    “The phase 3 vaccination process involves vaccination of those between 18 — 49years with co-morbidities (such as hypertension, diabetes, lung disease, other heart disease, liver or renal disease, etc). Individuals at ages 50 and above with co-morbidities would already have been Immunized within their age group.

    “The phase 4 vaccination process would involve vaccination of the rest of the eligible population between the ages 18 — 49years. It is worthy to note that at each phase of vaccination, the level of preparedness of the States are assessed before vaccines are deployed and accountability measures have been put in place to ensure strict compliance to the vaccination process. Pregnant women will be evaluated by their health providers to weigh the benefit versus risk, before a decision is taken to vaccinate them,” Dr Shuaib said at a press briefing on Monday.

    The NPHCDA Executive Director urged all eligible Nigerians aged 18 years and above to be patient, saying they will eventually be vaccinated.

    “As the vaccines arrive in batches due to limited supply we will inform Nigerians about who and where to receive the vaccine.

    “A comprehensive and transparent roll-out plan that involves public vaccination of President Muhammadu Buhari and other important dignitaries and stakeholders has been developed,” Dr Shuaib added.

  • How NAFDAC hopes to prevent infiltration of fake COVID-19 vaccines

    How NAFDAC hopes to prevent infiltration of fake COVID-19 vaccines

    The National Agency for Food and Drug Administration and Control (NAFDAC) has said it plans to use Traceability with GS1 technology to monitor Coronavirus disease (COVID-19) vaccine distribution using Global Trade Item Number (GTIN).

    Prof Mojisola Christianah Adeyeye, Director General of NAFDAC made this known on Thursday during a press briefing in Abuja on when the agency approved AstraZeneca/Oxford COVID-19 vaccine for use in the country.

    Prof Adeyeye said it plans to use the technology in order to prevent fake vaccines from infiltrating the supply chain and to ensure there is no diversion of vaccines.

    The NAFDAC boss also stated that the Agency will be using its recently launched Med Safety App for Active Pharmacovigilance of the vaccines in collaboration with sister agencies.

    “The App is free, and millions of healthcare workers can download it free for Adverse Drug Reaction (ADR) reporting. In-country training on the use of the App has begun for the healthcare givers.

    “NAFDAC plans to also use the Traceability with GS1 technology to monitor the vaccine distribution using Global Trade Item Number (GTIN). This is to prevent fake vaccines from infiltrating the supply chain and to ensure there is no diversion. This effort will create a reliable and predictable supply chain,” the NAFDAC DG stated.

  • JUST IN: NAFDAC approves AstraZeneca COVID-19 vaccine

    The National Agency for Food and Drug Administration and Control (NAFDAC) has granted emergency use authorization to the coronavirus vaccine made by AstraZeneca and Oxford University.

    Director general of the agency, Prof Moji Adeyeye, made the disclosure while briefing newsmen in Abuja on Thursday.

    Prof Adeyeye said the agency has been preparing for the COVID-19 vaccines and vaccination since April 2020.

    She said the agency established the COVID-19 Vaccine Committee and has been busy developing guidelines and guidance, adding that NAFDAC is the first national regulatory agency in Africa to have guidance on regulatory preparedness for EUA, licensing or access to COVID-19 vaccines.

    She said, “Finally 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.”

    She said some of the considerations for the recommendation include vaccine quality, safety and efficacy and pharmacovigilance.

    The World Health Organisation (WHO) had on Monday granted approval for emergency use listing of the vaccine.

    WHO’s Emergency Use Listing (EUL) assesses the quality, safety and efficacy of COVID-19 vaccines and is a prerequisite for COVAX Facility vaccine supply.

    It also allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines. The EUL will allow Nigeria to receive the first batch of the vaccine from COVAX Facility within weeks subject to approval by NAFDAC.

    Prof Adeyeye said the agency will be using its recently launched Med Safety App for Active Pharmacovigilance of the vaccines in collaboration with the sister agencies.

    “The App is free, and millions of healthcare workers can download it free for Adverse Drug Reaction (ADR) reporting. In-country training on the use of the App has begun for the healthcare givers,” she said.

    The NAFDAC boss said the agency also plans to use the Traceability with GS1 technology to monitor the vaccine distribution using Global Trade Item Number (GTIN).

    According to her, this will prevent fake vaccines from infiltrating the supply chain and to ensure there is no diversion.

    “At the continental level, NAFDAC is on the Regulators Steering Committee of African Union -3S (Smart, Safety Surveillance) with Ghana, South Africa and Ethiopia. The committee was formed as a preparatory caucus for safety monitoring of medicines but using COVID-19 vaccine as a pilot,” she added.

  • NAFDAC receives directive to control sale of beauty creams in Nigeria

    NAFDAC receives directive to control sale of beauty creams in Nigeria

    The Nigerian Senate has directed the National Agency for Food and Drug Administration and Control (NAFDAC) to rise up to its duty of regulating importation, formulation and sale of beauty creams and other cosmetics within Nigeria.

    TheNewsGuru.com (TNG) reports the Senate gave NAFDAC the directive on Tuesday, following a motion moved by Senator Oluremi Tinubu on the need for the Agency to move swiftly to regulate formulation and distribution of cosmetics in the country.

    The Senate also directed NAFDAC to maintain a products database, showing name and address of manufacturers and ingredients list; while also mandating the Agency to embark on sensitization and awareness campaigns on the ills of these harmful substances.

    The legislative chamber also directed NAFDAC and the Federal Competition and Consumer Protection Council (FCCPC) to collaborate towards ensuring the tracking of Consumer injury; while also mandating the Senate committee on Health to investigate the procedures in place for certification on quality and safety of Cosmetics, and propose a way forward for accountability.

  • NAFDAC cautions clearing agents, importers

    NAFDAC cautions clearing agents, importers

    The National Agency for Food and Drug Administration and Control (NAFDAC) has cautioned clearing agents and importers against illegal activities, saying sanctions await culprits of any shady deals.

    The caution is in a statement signed by NAFDAC’s Resident Media Consultant, Mr Olusayo Akintola in Abuja on Sunday.

    Akintola stated that the warning was given by the agency’s Director General, Prof. Mojisola Adeyeye, during a recent virtual stakeholders meeting.

    He quoted Adeyeye as saying “NAFDAC will not tolerate any unprofessional act from its stakeholders; the disturbing development where agents, with the connivance of importers, engage in falsification of documents will not be tolerated nor treated with kid gloves any longer.

    “We shall take all legal means as an agency set up by the Law of Nigeria to prosecute any erring stakeholders, importers.”

    The NAFDAC boss, who advised importers to desist from entrusting the entire process of clearance their consignments to agents, said “you

    are urged to initiate the clearance of your goods.

    “I am happy to state that from wherever in the world, you can process the clearance of your products with NAFDAC without visiting any formation of NAFDAC or port offices.”

    She also advised importers and clearing agents to ensure that they completed every clearing transaction with NAFDAC “up to the point of generation of NAFDAC electronic Release Notices.”

    She reiterated commitment to modernise NAFDACs processes and institutionalisation of international best practices in the way activities were conducted in the agency.

    She added that NAFDAC had deployed various processes to ensure auto verification of documents presented to the agency during clearance.

    She said “the agency had placed in the hands of stakeholders, the ability to verify the true status of clearance of regulated products and ensure that it rewarded clients with low risk profile.

    “I wish to appeal that you comply with the fast-changing updates currently ongoing in NAFDAC, these include the current issuance of electronic NAFDAC Invoices, NAFDAC Receipts, First Endorsement Notices and Release Notices.

    “We are conscientiously working toward assisting stakeholders to achieve regulatory compliance by ensuring that these requirements are made transparent and accessible to stakeholders through the availability of regulations, guidelines, tariff, and process requirements on the NAFDAC website.

    “I have also ensured that we maintain transparency and continue the implementation of the Quality Management Systems in our ports processes, this has led to a review and update of existing Standards Operating Procedures (SOP).

    “We also maintain the implementation of strategic QMS activities for ISO 9001-2015 certification, and entrenchment of World Health Organisation (WHO) global benchmarking (ISO 9004) across all the Airports, Seaports, and land borders.”

  • COVID-19: NAFDAC evaluating Sputnik V, Covax vaccines – Health Minister

    COVID-19: NAFDAC evaluating Sputnik V, Covax vaccines – Health Minister

    The National Agency for Food and Drugs Administration and Control (NAFDAC), is presently studying the Russian Sputnik V and India’s Covax vaccines against COVID-19, the Minister of Health, Dr Osagie Ehanire, says.

    Ehanire made the disclosure at the Presidential Task Force (PTF) on COVID-19 national briefing on Monday in Abuja.

    According to him, Nigeria has kept abreast of global development of the COVID-19 vaccines and supports the call from the World Health Organisation (WHO) for a fair and equitable distribution of vaccines, since COVID-19 has become a threat to mankind.

    “We subscribed to two multilateral vaccine access platforms; the first being the Covax facility that will supply vaccines free of charge to members, including Nigeria, to cover 20 per cent of our population.

    “The expected first wave of 100,000 vaccines was to be derived from this facility. There has since been a change that now offers Nigeria 16 million vaccine doses in the first half of the year.

    “The other multilateral platform is the African Union AVATT platform, the African Vaccine Acquisition Task Team, chaired by the President of South Africa, Mr Ramaphosa.’’

    According to him, AVATT has acquired 300 million doses of three types of vaccines which have been offered to African countries, based on population, such that no country is left behind.

    “Nigeria subscribes to this `whole-of-Africa’ approach that strives to ensure that we are safe and our neighbours are safe.

    “We shall be offered over 42 million doses by AVATT. If all the projected vaccines are supplied, we estimate we should have covered over 45 per cent of the population.

    “Nigeria has had bilateral negotiations with Gamaleya of Russia over their Sputnik V vaccine, which they are willing to supply to Nigeria.

    “This vaccine has an efficacy of 91 per cent. We are also in talks with the High Commissioner of India over the Covax vaccine of Barhat Institute. Both vaccines dossiers are under evaluation with NAFDAC,’’ he said.

    According to the minister, the increase in oxygen availability began with the repair of two Oxygen plants at the National Hospital Abuja, through the Federal Government intervention and the commendable intervention of the Private Sector.

    “This has ensured that large quantities of oxygen cylinders are delivered to treatment centres as needed.

    “This has improved availability of oxygen for the management of critical COVID-19 cases, as well as treatment of other illnesses that depend on oxygen supplementation such as asthma and pneumonia,;; he said.

    While debunking the news that Nigeria was disqualified from vaccine allocation, Ehanire said: “ I must request viewers and readers here, to disregard the news over the weekend that Nigeria was ‘disqualified’ from a vaccine allocation.

    “This is false. Nigeria has ultracold (minus 80oC) freezers in strategic stores in Lagos, Abuja and Bauchi, with space to hold over 400,000 doses of vaccines, more than the 320,000 doses WHO Afro had offered.

    “Those vaccines had been reserved for countries with extremely high burdens, to which Nigeria did not belong.

    “​Nigeria has made elaborate plans and micro plans to roll out COVID-19 vaccination and address any gaps in financing an early rollout activity.

    “The National Primary Health Care Development Agency is on top of this programme to deliver the vaccines in collaboration with state governments,’’ the health minister said.

  • How we will monitor COVID-19 vaccine distribution – NAFDAC

    How we will monitor COVID-19 vaccine distribution – NAFDAC

    The National Agency for Food and Drug Administration and Control (NAFDAC) has revealed the technology to be used in monitoring the distribution of Coronavirus disease (COVID-19) vaccines when finally available in Nigeria.

    TheNewsGuru.com (TNG) reports Prof Mojisola Adeyeye, Director General of the agency made the revelation in a statement on Friday, stressing that NAFDAC was yet to approve any COVID-19 vaccines for use in the country.

    She said the goal of monitoring COVID-19 vaccines is to prevent fake vaccines from infiltrating the supply chain and to ensure there is no diversion, and that the effort will create a reliable and predictable supply chain.

    She stated that the agency had not received any application from vaccine manufacturers “and therefore, no vaccine had been approved by NAFDAC.

    “There are reports of fake vaccines in Nigeria; NAFDAC is pleading with the public to beware. COVID-19 vaccines are new, and the side effects must be monitored.

    “No COVID-19 vaccines have been approved by NAFDAC. Fake vaccines can cause COVID-like illnesses or other serious diseases that can kill.’’

    The director general, who restated the commitment of the agency toward guaranteeing drugs security, warned companies and corporate bodies against unapproved ordering of vaccines, noting that genuine manufacturing companies had to submit applications to NAFDAC first.

    “No government establishment or agencies should order for COVID-19 vaccines without confirming from NAFDAC.

    “However, NAFDAC is discussing with manufacturers of candidate COVID-19 vaccines concerning potential Emergency Use Authourisation (EUA), registration or licencing of their products as the case may be.”

    Adeyeye, however, assured applicants of NAFDAC’s determination to approve vaccines for emergency use if phase three clinical data were convincing and robust with regards to safety and efficacy, and the vaccine had been submitted for World Health Organisation (WHO) emergency use listing.

    She emphasised the commitment of NAFDAC in using “Reliance” or “Recognition” to expedite Emergency Use Authourisation (EUA) for vaccines already approved by mature regulatory authorities.

    “The full dossiers submitted by manufacturer or Market Authourisation Holder (MAH) will be thoroughly reviewed by the Vaccine Committee that is made up of multiple directorates in the agency.”

    The NAFDAC boss, who said that the agency would welcome the application for Emergency Use Authorisation in Nigeria, however, reiterated readiness to examine the safety of any vaccine.

    She affirmed the collaboration of NAFDAC with sister agencies as National Primary Health Care Development Agency (NPHCDA), Nigeria Centre for Disease Control (NCDC), UNICEF, WHO and Ministry of Health, aimed at achieving holistic approach for effective immunisation and delivery.

    “NAFDAC plans to also use Traceability with GS1 Technology to monitor vaccine distribution, using Global Trade Item Number (GTIN).

    “The goal is to prevent fake vaccines from infiltrating the supply chain and to ensure there is no diversion.

    “This effort will create a reliable and predictable supply chain. The multi-stakeholder technical working group has been meeting to address different issues from access to distribution to traceability to monitoring of adverse events following immunisation.

    “NAFDAC is also a member of Regulators Steering Committee of African Union -3S (Smart, Safety, Surveillance) with Ghana, South Africa and Ethiopia, collaborating with UK Medicines Healthcare Products Regulatory Agency (MHRA) with funding from Bill and Melinda gates Foundation.

    Adeyeye explained that the aim of the continental collaboration was to use COVID-19 vaccines distribution and immunisation as pilot to actively monitor the distribution, delivery and monitoring of Adverse Effects Following Immunisation at the continental level, aimed at creating an African-based vigilance system for safety of medicines.

  • NAFDAC raises alarm to fake COVID-19 vaccine circulating in Nigeria

    NAFDAC raises alarm to fake COVID-19 vaccine circulating in Nigeria

    The National Agency for Food and Drug Administration and Control (NAFDAC) has raised an alarm to a fake Coronavirus disease (COVID-19) vaccine circulating in Nigeria.

    TheNewsGuru.com (TNG) reports the agency warned Nigerians against the use of fake COVID-19 vaccines.

    The Director-General of the Agency, Prof Mojisola Christianah Adeyeye gave the warning during a virtual press conference on Friday.

    Prof Adeyeye warned said the agency was yet to approve any vaccines or received any application from COVID-19 vaccine manufacturers.

    “COVID-19 vaccines are new, and the side effects or adverse events must be well monitored, therefore, if NAFDAC does not approve, the public should not use,” Adeyeye said.