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.
BREAKING: COVID-19: Ngeria announces first case of Omicron variant
The Nigeria Centre for Disease Control, NCDC, has confirmed two cases of COVID-19 Omicron variant in the country.
A statement signed by the NCDC Director-General, Dr Ifedayo Adetifa said the two cases were discovered through genomic sequencing.
Adetifa said the cases were detected in two passengers who came into the country from South Africa, adding the patients were asymptomatic and contact tracing had begun.
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”Genomic sequencing of positive cases from routine day two testing for travellers to Nigeria identified two cases of Omicron variant among travellers from South Africa who arrived in Nigeria last week.
“Retrospective sequencing of previously confirmed cases among travelers to Nigeria also identified the omicron variant among samples collected in October 2021”, he added.
COVID-19: FG deadline for unvaccinated workers ends tomorrow
The deadline for all federal civil servants to get vaccinated against coronavirus (COVID-19) is tomorrow as only those who have taken the jabs will be allowed into government’s offices and facilities.
All many workers especially in Abuja are rushing to hospitals and designated centres to take the COVID-19 vaccine ahead of the deadline, according to a Daily Trust’s report.
This is in the wake of the ravaging effect of another COVID-19 variant named Omicron, which puts the world on red alert as many countries contemplate closing their borders and restricting movements.
The Federal Government had months ago announced that workers who were yet to receive the COVID-19 vaccine will be denied access into government offices from tomorrow, December 1, 2021.
Daily Trust’s correspondents who went round Abuja saw hundreds of civil servants rushing to get the jab as many centres recorded a high influx of civil servants.
An anonymous source at the Federal Secretariat vaccination centre said many people were rushing to be vaccinated.
“So far, we have been able to vaccinate dozens of civil servants and their family members with the Astrazeneca and Modena today. Also, we have been able to administer the second round of the COVID-19 vaccine to many people today. The second jab is administered eight weeks after the first jab,” the health worker said.
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Long way to go
Daily Trust could not get the verifiable data of workers under the employ of the federal government with a credible source saying while some workers were being retired, others are dead and the speed at which replacements were being carried out was slow.
“It will be difficult to tell you the exact number of civil servants…It will not be easy because of ongoing replacements, new recruitments, deaths and all that. So, I don’t think if you will get the exact number of civil servants that have been vaccinated against COVID-19,” he said.
Also, the Director Communication, Office of the Head of the Civil Service of the Federation (OHoCSF), Malam Abdulganiyu Aminu, said they could not be specific on the actual number of civil servants vaccinated, especially for the fact that the exercise was ongoing.
In an interview with one of our correspondents, he said, “But reports reaching us from the various vaccination centres are encouraging. Many civil servants are responding to the call to get vaccinated.”
The Executive Director of the National Primary Healthcare Development Agency (NPHCDA), Dr Faisal Shuaibu, had said that as of November 26, a total of 6,242,224 Nigerians had received the first dose of COVID-19.
He also said 3,487,298 Nigerians had received their second dose and therefore fully vaccinated.
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This meant only 1.7 per cent of the total population target of 111,776,503 has been vaccinated.
The federal government had last Friday ordered federal workers from Grade Level 12 and below to resume normal duty effective from Wednesday, December 1.
The Head of the Civil Service of the Federation (HoCSF), Dr Folasade Yemi-Esan, gave the order in a circular with ref. no: HCSF/3065/Vol.1/107 dated November 26, 2021.
She recalled that as part of the measures to curtail the spread of the COVID-19 Pandemic, officers on GL 12 and below were directed to work from home.
She, however, said President Muhammadu Buhari had approved the Vaccine Mandate Policy, which would require all federal government employees to show proof of COVID-19 vaccination.
Also, the Secretary to the Government of the Federation (SGF) and Chairman, Presidential Steering Committee (PSC) on COVID-19, Mr Boss Mustapha, had announced that all federal workers would be barred from office from December 1, unless they showed proofs of their vaccination against the coronavirus.
Speaking with Daily Trust on Monday in Abuja, some of the federal workers expressed mixed feelings about the development.
While some of them said it was good that the government made the COVID-19 vaccination mandatory in the interest of the nation, few others said it violated their fundamental rights.
“I am happy that the government has made it mandatory for workers to get vaccinated against COVID-19,” a worker with the ministry of power, said.
“It is sad that we don’t trust our government because from the look of things, millions of Nigerians are not willing to take the jab and this is dangerous.
“Look at how the variant is mutating! Look at the Omicron that is ravaging the world. Government must deploy all the resources it has to ensure that all Nigerians are vaccinated not only civil servants. The civil servants are a fraction of the over 200m people in the country. It is saddening that up till now less than 2 per cent have been vaccinated. We are sitting on a time bomb,” he said.
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“I hope the government is not using style to embark on workers retrenchment”, another worker with the ministry of education, said.
“Some of us have not been vaccinated and I need to be convinced that I would be fine after taking it. We need serious sensitisation because some people alleged that they took ill after taking the jab,” he said.
Daily Trust reports that as of Monday, November 29, Nigeria’s COVID-19 infection toll stood at 214,092; active cases at 3,862; total discharged cases at 207, 254; and the death toll at 2,976.
FG to review travels, other protocols over Omicron variant
As the world’s attention shifts to the new COVID-19 variant Omicron, the federal government said that it will review Nigeria’s travel and other protocols to curtail the entry or spread of the disease.
SGF Boss Mustapha said this on Monday in Abuja at the national briefing of the committee.
Mustapha said, “The world has been hit with a new COVID-19 Variant of Concern called Omicron as announced by the World Health Organisation (WHO). This variant is potentially dangerous and Nigerians and residents are required to exercise extra caution and vigilance in practice and enforcement of preventive measures.
“As the DG WHO stated today, the emergence of the highly-mutated Omicron variant underlines just how perilous and precarious our situation is. South Africa and Botswana should be thanked for detecting, sequencing and reporting this variant, not penalised,” he said.
He said that the PSC was reviewing the situation around the world and putting in place measures to curtail the impact of the variant on the country and that the new travel protocols would cover travels, testing, enforcement, surveillance and risk communication.
The SGF also said that the impasse on the Nigeria-UAE flights had been resolved in the interest of both parties.
“A date for the commencement of flights between the two countries will be announced in due course,” he said.
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We should resist unscientific travel restrictions -Ramaphosa
Speaking elsewhere on the debate on restricting movement, South Africa’s President, Cyril Ramaphosa has said that the world needed to resist unjustified and unscientific COVID-19 travel restrictions that mostly hurt developing nations.
Ramaphosa said his country was being punished for its advanced ability to detect new variants early, as bans and restrictions threaten to harm tourism and other sectors.
“We need to resist unjustified and unscientific travel restrictions that are damaging the economies and sectors of the economies that rely on travel,” Ramaphosa said during a speech at the opening of the China-Africa Summit in Dakar.
“There is a world order where a country’s wealth is the difference between sickness and health,” he added. Senegal’s President, Macky Sall, who was hosting the summit, replied that Africa was in solidarity with South Africa and Africa “Will not close its doors to South Africa.”
Lagos airport, others on high alert
Our correspondent in Lagos reports that the Federal Airports Authority of Nigeria (FAAN) had alerted relevant agencies in charge of health screening of inbound passengers at all international airports in the country.
Daily Trust learnt that officials had ramped up medical checks of passengers at the Murtala Muhammed International Airport (MMIA), Lagos, which is the busiest entry point into the country.
Sources told our correspondent that the Airport Manager at Lagos Airport was directed to summon an emergency meeting of all relevant agencies in charge of health checks at the airport.
The intent, it was learnt, was to impress on every stakeholder to be on high alert to detect any passenger.
It was learnt that authorities at other international airports like the Nnamdi Azikiwe International Airport, Abuja; Malam Aminu Kano International Airport, Kano; Port Harcourt International Airport, Rivers and Enugu International Airports have been put on high alert to prevent the importation of the new variant into the country.
General Manager, Corporate Communications of FAAN, Mrs Henrietta Yakubu, in a chat with our correspondent confirmed the development.
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AfDB Investment Forum postponed
Also, following consultations with the Government of Côte d’Ivoire and the Board of Directors of the African Development Bank Group (AfDB), the 2021 Africa Investment Forum, which was scheduled for December 1-3, 2021, in Abidjan, has been postponed until further notice.
The President of AfDB, Dr Akinwunmi Adesina said: “The Africa Investment Forum is the premier investment marketplace for Africa. Several billion dollars of investment projects were scheduled for investment board rooms with project sponsors and investors at this edition of the Africa Investment Forum. Unfortunately, with rising global travel restrictions due to the COVID-19 Omicron variant and heightened concerns for health and safety, it is necessary, regrettably, to postpone the event. The health and safety of everyone come first.”
Similarly, the German Biotechnology Company, BioNTech, which manufactures vaccines, has started the development of a new COVID-19 vaccine that aims to combat the Omicron variant.
This was made known by the BioNTech spokesperson yesterday saying that to avoid wasting time, the company was developing an updated vaccine as well as testing its existence shot pending when the data is available.
The vaccine manufacturer, which partners with US giant, Pfizer on COVID-19 vaccines, is reported to have said that it had initiated the development of an adapted vaccine for Omicron to allow it to move forward quickly.
No case of Omicron COVID variant in Nigeria – NCDC
- Variant detected in more countries
The Nigeria Centre for Disease Control (NCDC) has said no case of the Omicron COVID-19 variant has been detected in Nigeria.
The new variant said to be more deadly that the Delta variant has reportedly been detected in more countries after news broke out that the UK recorded the first case last week.
In a statement on Sunday, the NCDC Director-General, Ifedayo Adetifa, said the Federal Ministry of Health (FMOH) and the NCDC were aware of reports of a new COVID-19 variant and monitoring emerging evidence on this new variant and its implication, to inform Nigeria’s response to the COVID-19 pandemic.
“While this variant has so far not been detected in Nigeria, a number of cases have now been reported in the UK, Israel, Botswana, Hong-Kong, Germany, Belgium, Italy and counting. However, no deaths have been attributed to this new variant yet,“ the statement reads.
“Given the high number of mutations present in the Omicron variant and the exponential rise in COVID-19 cases observed in South Africa, this virus is considered highly transmissible and may also present an increased risk of reinfection compared to other VOCs.”
He, however, said the fears about the variant’s ability to evade protective immune responses and/or its being vaccine resistant are only theoretical so far.
“This virus can still be detected with existing Polymerase Chain Reaction (PCR) tests. The WHO and researchers across the world are working at speed to gain understanding of the likely impact of this variant on the severity of COVID-19 and on the potency of existing vaccines and therapeutics,” he said.
Adetifa said the agency will continue to ensure daily review of surveillance data for public health decision making, and he appealed to all states to ensure that sample collection and testing are accessible.
He said the NCDC, through the National Reference Laboratory (NRL), will continue to coordinate genomic surveillance and other activities required for the detection of variants.
“In collaboration with Port Health Services of the FMOH, enhanced surveillance is ongoing at the airports and points of entry, and to ensure compliance with current travel guidance, especially for the day 2 COVID-19 PCR testing,” he said.
“Should there be any changes to travel guidance, this will be communicated in due course. Considering the highly likely increased transmissibility of the Omicron variant and its emergence that is linked to unmitigated community transmission of the virus, the NCDC urges Nigerians to ensure strict adherence to the proven public health and social measures in place, which are enforceable by the Presidential Steering Committee on COVID-19 (PSC-COVID-19), through the COVID-19 Health Protection Regulations 2021.”
The index case of Omicron was detected in South Africa on Tuesday, and the World Health Organisation (WHO) subsequently designated Omicron as a “variant of concern”, calling on global leaders to take action to contain its spread.
More countries record new variant
Meanwhile, the Omicron coronavirus variant spread around the world on Sunday, with new cases found in the Netherlands, Denmark and Australia even as more countries imposed travel restriction to try to seal themselves off.
The World Health Organization (WHO) said it was not yet clear whether Omicron, first detected in Southern Africa, is more transmissible than other variants, or if it causes more severe disease.
“Preliminary data suggests that there are increasing rates of hospitalization in South Africa, but this may be due to increasing overall numbers of people becoming infected, rather than a result of specific infection,” WHO said.
It said understanding the level of severity of Omicron “will take days to several weeks”.
The detection of Omicron triggered global alarm as governments around the world scrambled to impose new travel curbs and financial markets sold-off, fearing the variant could resist vaccinations and upend a nascent economic reopening after a two-year global pandemic.
In its statement, the WHO said it was working with technical experts to understand the potential impact of the variant on existing countermeasures against COVID-19, including vaccines.
Britain said it would convene an urgent meeting of G7 health ministers on Monday to discuss the developments.
Dutch health authorities said 13 cases of the variant were found among people on two flights that arrived in Amsterdam from South Africa on Friday. Authorities had tested all of the more than 600 passengers on the flights and found 61 coronavirus cases, going on to test those for Omicron.
“This could possibly be the tip of the iceberg,” Health Minister Hugo de Jonge told reporters.
Omicron, dubbed a “variant of concern” last week by the WHO that is potentially more contagious than previous variants, has now been detected in Australia, Belgium, Botswana, Britain, Denmark, Germany, Hong Kong, Israel, Italy, the Netherlands, France, Canada and South Africa.
Many countries have imposed travel bans or curbs on Southern Africa to try to stem the spread. Financial markets dived on Friday, and oil prices tumbled.
A South African doctor who was one of the first to suspect a different coronavirus strain said on Sunday that symptoms of Omicron were so far mild and could be treated at home.
Dr. Angelique Coetzee, chair of South African Medical Association, told Reuters that unlike with Delta, so far patients have not reported loss of smell or taste and there has been no major drop in oxygen levels with the new variant. read more
In the most far-reaching effort to keep the variant at bay, Israel announced late on Saturday it would ban the entry of all foreigners and reintroduce counter-terrorism phone-tracking technology to contain the spread of the variant.
Prime Minister Naftali Bennett said the ban, pending government approval, would last 14 days. Officials hope that within that period there will be more information on how effective vaccines are against Omicron.
The top U.S. infectious disease official, Dr. Anthony Fauci, told President Joe Biden on Sunday it would take about two weeks to have more definitive information about the transmissibility and other characteristics of Omicron, the White House said in a statement, adding that Fauci believes existing vaccines “are likely to provide a degree of protection against severe cases of COVID”.
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