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.