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NAFDAC approves COVID-19 vaccine use without clinical tria



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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US to halt J&J COVID vaccine after blood clotting cases



The United States federal health agencies on Tuesday recommended suspending the use of the Johnson & Johnson COVID-19 vaccine.

The development comes after six recipients of the vaccine — all women– developed a “severe type of blood clot”.

The Food and Drug Administration (FDA) and the Center for Disease Control and Prevention (CDC) said they would stop using the vaccine at federal sites and asked states to do so as well while they investigate safety issues.

The agencies, in a joint statement, said they were “reviewing data involving six reported US cases of a rare and severe type of blood clot in individuals after receiving the vaccine. Right now, these adverse events appear to be extremely rare”.

“Treatment of this specific type of blood clot is different from the treatment that might typically be administered,” they said.

“CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance. FDA will review that analysis as it also investigates these cases.

“Until that process is complete, we are recommending this pause. This is important to ensure that the health care provider community is aware of the potential for these adverse events and can plan due to the unique treatment required with this type of blood clot.”

It is the third COVID-19 vaccine that has received FDA’s authorisation, and also the first single-dose COVID-19 vaccine available in the US.

About seven million people in the US have received the vaccine.

Similar reports of blood clot development in recipients of the AstraZeneca vaccine made several European countries to suspend use of the product in March.

They have, however, resumed using the vaccine after European Union and British regulators said there was no link between the vaccine and the reported side effects.

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COVID-19: PTF transforms into presidential steering committee, completes task December



COVID-19: PTF transforms into presidential steering committee, complete task December

President Muhammadu Buhari has approved the transition of the Presidential Task Force (PTF) on COVID-19 to the presidential steering committee.
Secretary to the Government of the Federation, Boss Mustapha, said President Muhamadu Buhari, stated this at a media briefing on Tuesday, adding that the mandate of the PSC would end on December 31.
According to him, the PSC will focus on ensuring effectiveness in the roll-out of the vaccine, and promote policies that will result in the development of the country’s health sector.
“Mr president has considered the report and has approved the following: That the PTF will transition to a presidential steering committee on COVID-19, effective from 1st April, 2021, with a modified mandate to reflect the non-emergent status of COVID-19 as a potentially long-term pandemic,” he said.
“That the structure of the PSC shall reflect the new focus of the response with a targeted approach on vaccine oversight, risk communication, international travel quarantine processes and sub-national engagement; that the tenure of the presidential steering committee shall last till 31st December, 2021.
“The presidential steering committee would maintain the present constitution, functions and strategies of the PTF; be supported by a slim technical and administrative structure.”

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Lagos shuts 430 event centres, night clubs



The Lagos State Safety Commission says it has shut 430 event centres and night clubs for violating COVID-19 protocols.
Director General at the commission, Lanre Mojola, said at a news conference in Alausa, Ikeja that the commission was saddled with developing safety guidelines for the state’s reopening of economic activities in post COVID-19 lockdown.
“The commission was involved in the enforcement of COVID-19 protocols and this led to the shutting of 30 event centres and 400 clubs across the state,” he added.
On construction safety, the DG said the commission carried out risk assessment and unscheduled safety inspection of construction sites to ensure safety compliance, as well as adherence to COVID-19 protocols, to prevent accidents, incidents, illnesses and loss of lives.
He said the commission issued provisional safety compliance certificates for 90 days and safety compliance certificates thereafter if compliance status was maintained.
Mojola said the enforcement was carried out in 609 construction sites for repeated failure to comply with safety regulations.
He said the annual World Safety Day would hold across the world on April 28 to create awareness, sensitise and educate people on the importance of keeping the workplace safe and free from occupational hazards, accidents, incidents and preventable illnesses.

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