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NAFDAC approves COVID-19 vaccine use without clinical tria

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The National Agency for Food and Drug Administration and Control (NAFDAC) has ruled out the possibility of conducting a local clinical trial on the proposed N400bn vaccines before administering them on Nigerians.

The agency said since the World Health Organisation had approved the vaccines there might not be any need to conduct another clinical trial on the vaccines.

It, however, said it would subject vaccines, which the Federal Government could spend N400bn to procure, to proper revalidation before administering them on Nigerians.

NAFDAC’s Media Consultant, Sayo Akintola, was quoted by Sunday Punch as saying that owing to the exigencies of COVID-19, there might be no reason to conduct a trial before administering the vaccines.

He said, “Once the vaccine arrives, a sample will be taken to the lab for a test. Once its safety and efficacy are certified by NAFDAC, it will be administered on Nigerians. We don’t expect anything to be different though.

“The truth is that once a vaccine is approved by the WHO, it is assumed that it has passed through some preliminary stage of the trial. It is a known fact that for the WHO to sanction a vaccine, it must have gone through a series of trial here and there.” Although he said NAFDAC’s evaluation of the vaccine would not be rigorous mainly because it’s not a new vaccine, Akintola noted that its efficacy and safety needed to be ratified.

He stated, “It is just for ratification. There is nothing on drugs or vaccines you will do without the consent of WHO. It is also expected that the regulatory body in each country would do its work in tandem with the WHO standard.”

The National President, Nigerian Medical Association (NMA), Prof Innocent Ujah, also on Friday made a U-turn on the need for clinical trial.

He said since Nigeria is in an emergency situation, the COVID-19 vaccine will no longer need to pass through clinical trial.

Ujah, who had earlier said the COVID-19 vaccine should be subjected to a clinical trial before being administered on Nigerians, said in a telephone interview with Sunday Punch, that the efficacy of the vaccine had been established by scientific process.

He explained that since Nigeria and Africa as a whole were not involved in the clinical trial, “it is good to revalidate so that we can also report some likely untoward effects – side effects.”

He said, “When we have that, we can tell our people that it (the vaccine) cannot kill our people but we can tell the people the likely reactions some people may likely get. That is revalidation. It is not that we are to go through barrage of clinical trials because to do clinical trial particularly in an emergency situation will take some time.”

Ujah, who is also the Vice Chancellor of Federal University of Health Sciences, Otukpo, Benue State, said even though there was yet to be any vaccine for HIV all along, scientists got vaccine for COVID-19 within nine months and was approved by the Food and Drug Administration in the United States because it required an “emergency authorisation.”

Also, a consultant virologist at the University of Ibadan, Oyo State, Prof Olufemi Olaleye, stated that he did not see the need for another clinical trial of the vaccines.

He explained that there may be little difference in response of people to vaccines/antigens, adding that vaccines were supposed to be universal.

He added, “There is no vaccine for Africans that is different from the one for Caucasians or Chinese or any other race for that matter. Even within the same race, people respond to antigens or vaccines differently. I will be surprised if anyone is calling for clinical trial during a threatening pandemic like COVID-19. It is not when a house is on fire that you want to start testing your fire truck.”

The virologist disclosed that clinical trial was a long process, hence the reason for emergency use authorisation in the United States, United Kingdom and the European Union countries.

He also stated that he was unaware of any institution with trained personnel and facilities for a proper clinical trial in Nigeria currently.

“I think what the Minister of Health requires is full information on the vaccines under considerations such as safety, immunogenicity and the logistics of handling to make an informed decision on which brand to procure. Be that as it may, an important question to ask based on the pattern of the disease in Nigeria thus far is whether we require vaccine now or not?” he said.

He, therefore, recommended that the country should seek ways to ensure adherence to the non-pharmaceutical intervention approaches to more prevention and monitor outcomes of the ongoing vaccination in other countries as may be required.

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COVID-19

NGF: States to reintroduce COVID protocol, fast-track vaccine procurement to prevent third wave

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The Nigeria Governors’ Forum (NGF) says states will reintroduce measures for curbing the spread of the coronavirus to prevent a third wave of infections.

 

This was part of the resolutions reached by the governors after a meeting on Wednesday.

 

The decision was taken following a presentation by Babajide Sanwo-Olu, governor of Lagos, on the concerns about a third wave of infections in the state.

 

On July 11, Sanwo-Olu had warned Lagos residents of a possible outbreak, following a recent increase in COVID-19 cases in the state, which he said may lead to a third wave of infections.

 

In a statement issued after the meeting on Wednesday, Kayode Fayemi, chairman of the forum, said the governors also agreed to liaise with the federal government on ways to speed up the procurement of additional doses of the COVID-19 vaccine.

 

“The Forum received an update from the Governor of Lagos State, H.E Babajide Sanwo-Olu, on the recent rise in confirmed COVID-19 cases and call for consensual action to prevent a third wave in the country,” Fayemi said.

 

“Following the update, the Forum called on all State Governors to revive their COVID protocols and collaborate with the Nigeria Centre for Disease Control (NCDC) to take appropriate and immediate actions to flatten the transmission curve.

 

“The Forum will interface with the Presidential Steering Committee on COVID-19 to accelerate processes required to fast track the delivery of additional vaccines for the country.”

 

During the first wave of infections, guidelines such as restriction of movement, compulsory use of face masks, and strict adherence to physical distancing were in force, but with the drop in infection numbers, such measures have been relaxed across the country.

 

However, with concerns raised over a possible increase in infections, following the confirmation of the “highly infectious” Delta variant in Abuja and Oyo, it isn’t yet clear what exact measures the governors will reintroduce.

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COVID-19

Delta COVID variant, linked to high infection rate, detected in Nigeria

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The Nigeria Centre for Disease Control (NCDC) has confirmed the index case of the delta variant of the coronavirus in Nigeria.

The NCDC disclosed this in a statement on Thursday.

According to the NCDC, the variant was detected during routine tests for in-bound travellers in Abuja.

“The Nigeria Centre for Disease Control (NCDC) has detected a confirmed case with the SARS-CoV-2 Delta variant, also known as lineage B.1.617.2. The variant was detected in a traveler to Nigeria, following the routine travel test required of all international travelers and genomic sequencing at the NCDC National Reference Laboratory, Abuja,” the statement reads.

“The Delta variant is recognised by the World Health Organisation (WHO) as a variant of concern, given its increased transmissibility. The variant has been detected in over 90 countries and is expected to spread to more countries.

“The variant has also been linked to a surge in cases in countries where it is the dominant strain in circulation. There are ongoing studies to understand the impact of the variant on existing vaccines and therapeutics.”

The development comes days after the World Health Organisation (WHO) expressed concern over the “speedy” spread in infection rates in Africa as countries battle a third wave of COVID-19.

In a statement issued on July 1, the WHO had raised concern over variants of concern, especially the delta variant, adding that infection rates are doubling every week, and the virus is spreading faster than previous records.

However, according to the NCDC, the federal government is stepping up efforts through collaboration with the “Nigerian Institute of Medical Research (NIMR), African Centre for Genomics of Infectious Diseases (ACEGID), and other laboratories within the national network, to carry out genomic sequencing”, in order “to enable the detection of variants of concern, and initiate response activities”.

“Given the high transmissibility of the Delta variant and following its detection in Nigeria, NCDC urges all Nigerians to ensure strict adherence to public health and social measures in place. Proven public health and social measures such as physical distancing, frequent handwashing, and proper use of face masks, prevent infections and save lives. The COVID-19 vaccine is safe and effective and offers protection against the disease,” the agency said.

“Additionally, states are urged to ensure sample collection and testing for COVID-19 is accessible to the public. Public settings such as schools with accommodation facilities, workplaces and camps should utilise the approved Antigen-based Rapid Diagnostic Test (RDT) for rapid testing of their population.

“The recommended control measures to limit the spread of the Delta variant continue to be testing, following the existing public health guidance and abiding by the current travel and public restrictions.”

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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COVID-19

FG declares 132 violators of COVID-19 travel advisory wanted

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The Federal Government through the Presidential Steering Committee on COVID-19 has declared another 132 travellers wanted for violating a recently issued travel advisory.

The PSC, on May 1, 2021, issued a travel advisory, instructing travellers arriving from India, Brazil and Turkey, or who had visited the countries within 14 days of their trip to Nigeria, to observe certain protocols, including compulsory quarantine and testing in designated facilities on arrival.

However, the committee observed that many travellers had been violating the advisory, leading to earlier announcement of 90 violators as wanted persons on May 9.

A statement on Thursday by the Chairman of the PSC and Secretary to the Government of the Federation (SGF), Mr Boss Mustapha, the Committee announced the 132 additional violators of the advisory, who entered through Nnamdi Azikiwe International Airport in Abuja, advising members of the public to be on the lookout, describing the persons as immediate health hazard.

It stated, “The Presidential Steering Committee (PSC) on COVID-19 on 1st May, 2021 issued a Travel Advisory for Passengers arriving in Nigeria from Brazil, India and Turkey.

“These precautionary measures are a necessary step to mitigate the risk of importation of variants of concern and break the chain of transmission to the population.

“Under the new measures, passengers arriving from/or that have visited any of these three countries within fourteen (14) days prior to the visit to Nigeria, are required to follow mandatory arrival quarantine and testing protocols in designated facilities.

“The Presidential Steering Committee (PSC) has however observed that while most of the arriving passengers dutifully observed the guidelines, some (Nigerians and Foreigners) have violated them in contravention of the provisions of the Coronavirus (Covid-19) Health Regulations Protection, 2021.

“Accordingly, the underlisted persons who arrived in Nigeria through the Nnamdi Azikiwe International Airport, Abuja and whose names and passport numbers are displayed, have been declared Persons of Interest (POI) on account of posing considerable danger to overall public health and for the violation of Nigeria COVID-19 travel protocol by evading the mandatory seven-day quarantine for persons arriving from restricted countries.

“Members of the public are by this notice advised that these persons of interest constitute an immediate health hazard to the society.

“They must therefore transport themselves safely, to the nearest state public health departments within 48 hours of this notice for immediate evaluation and call the Port Health Services, Federal Ministry of Health.”

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