COVID-19

NAFDAC approves COVID-19 vaccine use without clinical tria

Published

4 years ago

January 3, 2021

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.

COVID-19

China records nearly 13,000 COVID deaths in a week

Published

2 years ago

January 22, 2023

Trends Admin

China reported nearly 13,000 Covid-related deaths in hospitals between January 13 and 19, after a top health official said the vast majority of the population had already been infected.

The death toll came a week after China said nearly 60,000 people had died with Covid in hospitals in just over a month – but there has been widespread scepticism over official data since Beijing abruptly axed anti-virus controls last month.

China’s Center for Disease Control and Prevention (CDC) said in a statement on Saturday that 681 hospitalised patients had died of respiratory failure caused by coronavirus infection, and 11,977 had died of other diseases combined with infection over the period.

The figures do not include anyone who died at home.

Airfinity, an independent forecasting firm, has estimated daily Covid deaths in China will peak at about 36,000 over the Lunar New Year holiday.

COVID-19

Nigeria records 42 fresh cases of COVID-19 in 14 days

Published

2 years ago

January 15, 2023

Trends Admin

Fresh 42 COVID-19 cases have been recorded in Nigeria in two weeks, with Lagos State topping with 27 cases, the Nigeria Centre for Disease Control and Prevention (NCDC) has said.

The NCDC made this known via its official website on Sunday, adding that Edo, Kano, Nasarawa, Kaduna, Plateau and the Federal Capital Territory contributed the remaining cases.

This is coming amid resurgence of the new variant of the disease from China where the authorities said nearly 60,000 people with COVID-19 had died in hospitals in about a month.

The NCDC said that the new cases brought Nigeria’s total of COVID-19 infections to 266,492 and that the fresh cases were recorded between December 31, 2022 and January 13, 2023.

”From December 31 to January 6, 13 new confirmed cases have been recorded in Nigeria. The 13 new cases are reported from two states – Lagos (12) and Edo (one),” it said.

It confirmed that the country recorded 29 new cases from January 7 to 13; and the new cases are reported from, Lagos (15), FCT (five), Kano (four), Nasarawa (three), Kaduna (one) and Plateau (one).

It also said that a multi-sectoral national Emergency Operations Centre activated at Level 2, had continued to cordinate the national response activities.

Meanwhile, the country registered 266,492 COVID-19 confirmed cases, 3,155 deaths, and 259,858 cases had been discharged across 36 states including the FCT.

The National Primary Health Care Development Agency (NPHCDA) said, “If you are yet to be vaccinated, visit the nearest vaccination site to receive your Johnson and Johnson single-dose vaccine. All COVID-19 vaccines are free, safe and effective.”

COVID-19

Panic spreads as China records 60,000 fresh COVID deaths in 34 days

Published

2 years ago

January 14, 2023

Trends Admin

China says almost 60,000 deaths linked to COVID-19 were recorded between December 08, 2022 and January 12, 2023 in the country.

A major wave of the virus surfaced in China after President Xi Jinping abruptly lifted zero-Covid policy restrictions last month, UK Guardian reports on Saturday.

A report from Peking University said 900 million Chinese people are already infected with the virus.

It also said some major cities had experienced infection rates of between 70% and 90% of their populations since then.

The surge in infections has been attributed to the Chinese government’s emphasis on shielding the 1.4 billion people that make up its population rather than inoculating them effectively against the Covid-19 virus.

However, authorities have announced the fatalities resulting from the wave was 59,938.

The head of the Bureau of Medical Administration, Jiao Yahui, on Saturday announced there had in fact been 59,938 Covid deaths between December 8 and January 12.

This figure included about 5,500 individuals who died of respiratory failure, while the rest also had underlying health conditions. The average age of those who died was 80, Jiao said, with 90.1% aged 65 and above.

The holidays in China officially start January 21 and involve the world’s largest annual migration of people.

Some two billion trips are expected to be made and tens of millions of people have started to travel – although they have been urged not to visit their elderly relatives, in order to prevent them from becoming infected.

Jiao claimed case rates were declining and the peak had passed in most areas. She said the daily number of people going to fever clinics peaked at 2.9 million on 23 December and had fallen by 83% to 477,000 on Thursday.

“These data show the national emergency peak has passed,” she said.