NAFDAC to give emergency approval for N400bn COVID-19 vaccines

The National Agency for Food and Drug Administration and Control is expected to give emergency approval for COVID-19 vaccines once they arrive in Nigeria.

The Director-General of NAFDAC, Prof Moji Adeyeye, said this during an interview.

Adeyeye said NAFDAC would be doing something called, “Emergency Use Authorisation.”

She said the agency had been in contact with Pfizer since May and had already received a preliminary report which would guide NAFDAC’s decision.

Adeyeye explained that vaccines that had been approved by reliable bodies like the United States Food and Drug Administration could easily pass the test in Nigeria but that was not to say that NAFDAC would not be doing its own independent examination.

The NAFDAC boss said, “Any vaccine that will be used in Nigeria must go through NAFDAC. It will be an accelerated approval because we will use what is called reliance. Reliance mechanism means that if a strong regulatory agency like the FDA or European Medicine Agency has approved it (the vaccine), we will go through their approval.

“For example, we are going through the EMA approval of Pfizer now. We are doing this in readiness of when they (Pfizer) will submit their own application. So, we have started doing our own work before they approve the application. We are already in touch with them.

“Pfizer visited us in May and we told them to continue doing what they are doing and when they get to Phase 3, they can submit their own application. But because of this reliance, it will make it very fast for approval. We have asked Pfizer to send it since it has been approved in the US and some other regulatory agencies. It will not take time at all. Reliance means you rely on what another strong agency has done.”

Asked how long it would take for NAFDAC to give final approval, Adeyeye said she would not want to be pre-emptive adding that it would not take long at all.

She said there could be unforeseen problems if, for instance, Pfizer failed to send its complete paperwork, explaining that if there were no hitches, the vaccine would be approved in record time.

“We don’t expect it to be long at all. But again, it depends on what we have. That is if they have the same papers that they submitted to other regulatory agencies. If what is submitted to NAFDAC is different from what was submitted to FDA, it will take longer because we will need to ask questions.

“Hopefully that will not happen. It will be an expedited review. NAFDAC is doing EUA which means Emergency Use Authorisation. So, it is not as if they are coming to register a product but it will still need approval. It is not as if immediately the vaccines are brought, we would tell people to start using it the next day. We will do a desk review,” she said.

Also speaking with our correspondent, the Minister of State for Health, Dr Olorunnimbe Mamora, noted that the government would rely on NAFDAC for approval before the vaccines would be used.

On when the N400bn budget for the procurement and distribution of vaccines would be submitted to the National Assembly, Mamora said it would be next year.

He said the figures were still being collated, adding that it cuts across different ministries. He also said the Presidential Task Force on COVID-19 headed by the Secretary to the Government of the Federation, Boss Mustapha, would be in charge of the vaccines.

The minister said this was the reason the President extended the tenure of the task force.

He said, “We have not yet submitted the budget. We are still putting estimates together and nothing has been finalised. It will be ready early next year. It is not just the Ministry of Health. The President has handed management of the vaccines to the PTF. That was why the President extended the tenure of the PTF till the end of the first quarter next year when we would have started vaccine procurement and administration.”

On whether Nigerians would be forced to take the vaccine, Mamora said there was no such plan. He, however, said there was a need to educate Nigerians on the importance of the vaccines because some people had already started rejecting them.

On when the vaccines would be ready for use, Mamora said, “I think it depends on the assessment report provided by NAFDAC; if favourable and recommended, the Federal Government may approve   emergency use authorisation.”

Meanwhile, it was learnt that the Federal Government’s COVID-19 response may hit N1tn by next year.

The President had in April approved N500bn for the COVID-19 response in the supplementary budget which was approved by the National Assembly.

It was learnt that if the N400bn is approved by the National Assembly next month, this would imply that about N900bn would be spent on the pandemic.

This is apart from the sum that several states have individually spent on prevention and treatment of COVID-19 vaccines as well as intervention programmes.

The Bayelsa State Government has directed all political appointees and other government functionaries as well as civil servants to confirm their COVID-19 status by going for testing.

The state government said the testing had become imperative following the second wave of COVID-19 in Nigeria.

The Commissioner for Health, Dr Pabara Igwele, told journalists that the directive was issued during the State Executive Council meeting at the Government House, Yenagoa.

He said the council further directed the immediate commencement of active case search across the state, especially in Yenagoa, the state capital.

As of Friday, December 25, Bayelsa had recorded 519 confirmed cases of coronavirus with 77 patients on admission, 421 discharged while the number of deaths was 21, according to the Nigeria Centre for Disease Control.

Igwele said the council also reiterated the approved COVID-19 guidelines to safeguard the people during the Yuletide celebrations.

According to him, all informal and formal events, including weddings, conferences, congresses, office parties, concerts, seminars and all end of year events had been restricted to not more than 50 persons in attendance.

He said, “All bars, night clubs, event and recreational centres, restaurants and hotels are to ensure compliance with the COVID-19 protocols by the compulsory wearing of face mask, hand washing and physical distancing.

“All religious gatherings should not be more than 50 per cent capacity of the facility of use, in which physical distancing, mandatory use of the face mask should be strictly enforced.”

Akwa Ibom State Governor, Udom Emmanuel, has solicited the cooperation and commitment to COVID-19 safety and prevention protocols to beat the second wave of the pandemic.

He advised the people to faithfully apply all the prevention protocols including the use of face masks, social distancing and regular hand washing, saying there would be no second lockdown if this was carried out religiously

Emmanuel said these in his Christmas day broadcast on Friday in Uyo, the state capital.

The governor said, “Let us press forward by doing all we can to stay alive and beat the ravaging Covid-19 pandemic.

“As you may already know, we are currently experiencing the second wave of the pandemic, but as we had succeeded in stemming the rate of infections when it first hit our shores, I ask you to join hands with us again to beat this second wave.

“The use of face masks, social distancing, regular hand washing and hand sanitisers are protocols that have worked in reducing infections.

“Let us remain committed to applying these protocols. If we adhere to these simple but effective rules, there may be no need for us to impose another lockdown, but if we observe that these rules are flouted, then we may have no other option than to put the state under lockdown.

“We have put in every conceivable tool to manage this pandemic and our gallant medical professionals have been in the frontline, managing and stemming the spread of the virus. We owe them an eternal debt of gratitude.”

He also urged the people to use the birth of Jesus Christ,  which the season represents, to show love and goodwill to all, stressing that in 1914, the German and the English soldiers who had been killing themselves during the World war emerged from their trenches and embraced themselves at Christmas.

According to him, the ‘incident remains the most powerful testament that love knows no boundaries, no ethnicity and no divisions.’

“We pray that this celebration of love will not only bring mortal enemies as friends, but will also cause some of our people who are still in the trenches of tribalism, ethnicism, petty-mindedness, and other vices, to emerge from the foxholes and join us to build a state which would be defined by faith, love and brotherhood,” he added.

The coronavirus pandemic otherwise known as Covid-19 has exposed intrigues of world leaders on pretext of democracy, the President of God’s Kingdom Society, Brother Godwin Ifeacho, has said.

Making the assertion during the 2020 Christian Feast of Tabernacles held at the Church Headquarters Salem City, in Warri, Delta State, the cleric stated that “unfortunately those the masses look up to for help, because of human frailty, greed and sheer confusion, have been found to be part of the problem, rather than the solution.”

He lamented that ‘even with the adoption of democracy as a system of government in many countries of the world, many people have found to their utter disappointment that it does not necessarily promote fairness, equity and justice.’

The cleric said, “Billionaires in the world rose significantly this year while the level and number of poor people increased worldwide as the rich bought up the small companies that could not survive the strains of COVID-19 pandemic and many people lost their jobs.”

“Millions are being thrown out into the streets because they cannot pay their rents. Many are dying every day because of coronavirus, hunger and other diseases, while many are languishing in pain because they cannot afford medical care.”

He noted that ‘even in the technologically advanced countries of the world, there are widening gaps between the rich and the poor.’

In his 2020 message titled, ‘Look up and lift up your heads for your redemption’, the cleric expressed concern that the conditions on earth were worsening in spite of the efforts of a number of leaders in the world to improve public welfare.

The Oluwo of Iwo, Oba Abdulrosheed Akanbi, has warned palace staff to adhere strictly to the COVID-19 protocols, saying any of them seen within or outside the palace without a face mask would be sacked.

Oba Akanbi, in a statement made available to one of our correspondents on Friday by his Press Secretary, Alli Ibraheem, also urged visitors to wear face masks as violators would not be given access to the palace.

The statement read in part, “Saddened with the new recorded death row of COVID-19 in some developed countries, I want to specially task the Federal Government to reintroduce enforcement of precautionary measures.

 “I fear the influx of people into Nigeria. We can’t close the borders. We need to learn to live with COVID-19. As such, a patriotic Nigerian must always wear a face mask, keep social distance, wash hands and avoid gatherings of many people.

“The regular palace visitors such as the princes, chiefs and members of staff are strongly instructed to wear face mask as a condition to accessing the palace. Relationship with the palace are respected but should be maintained with strict observance of COVID-19 precautionary measures. Any member of staff coming to the palace without a face mask is risking his or her job.”

Osun State Government on Friday told residents that the ban on youth carnivals and countdown to the New Year ceremonies still subsisted.

A Public Service Announcement signed by the Secretary to the State Government, Prince Wole Oyebamiji, also said all social clubs, hotels, departmental stores, supermarkets, event centres and allied centres were to henceforth operate at half of their capacities and observe COVID-19 protocols.

The government also appealed to the residents to cut down on social gatherings to reduce the spate of exposure and contact with possible carriers visiting the state during the Yuletide period.

The announcement read in parts, “The State Government of Osun would like to remind all citizens that the new directives aimed at curbing the spread of the coronavirus are still in force.

“By implication, the ban on youth carnivals and countdown to the New Year ceremonies still subsists. Also, all social clubs, hotels, departmental stores, supermarkets, event centres and allied centres are to henceforth operate at half of their capacities and observe Covid-19 protocols.

“Wearing of face masks at public places is equally compulsory. The government further appeals to all residents and citizens to cut down on social gatherings, including weddings, christening, and funeral ceremonies, among others, to reduce the spate of exposure and contact with possible carriers visiting the state during the Yuletide period.

“Furthermore, towns and cities are to put on hold the annual days through physical attendance and change such to virtual version.”

Meanwhile, the Chairman of the Nigeria Medical Association, Federal Capital Territory chapter,  Enema Amodu, said on Friday that at least 20 doctors have died of COVID-19 across the country in the last one week.

At a press briefing in Abuja, Amodu said, “In the last one week alone, we have lost professors, consultants, residents both senior and junior, and other senior medical doctors. This shows that this virus is still much with us.

“For those of us in the health sector, we have lost quite a number of colleagues in the last one week alone. Across the country, we have lost not less than 20 doctors in the last one week.

“We also want to use this opportunity to talk to our patients; as you come to us in the hospitals, in the clinics, please wear your masks and tell us the truth about your past medical condition. Don’t hold any information back.”  (Saturday Punch)