With the many controversies surrounding the administration of the Astrazeneca vaccine to protect citizens from the covid-19 disease, the National Agency for Food and Drug Administration and Control (NAFDAC) has stressed that the benefits of taking the vaccine far outweigh the risks.
This came as the World Health Organisation (WHO) also declared that Astrazeneca Plc’s COVID-19 vaccine should continue to be administered as the benefits outweigh its risks.
Over 20 countries across the globe have suspended the use of the Oxford-astrazeneca vaccine due to random cases of blood-clotting, which has not yet been scientifically linked with vaccination. They have temporarily suspended the vaccination as a precautionary measure while they carry out further investigations and analyses.
Speaking during an interview on Channels Television in Abuja yesterday, the Director-general, Prof. Mojisola Adeyeye, stated that the agency is not nonchalantly approving the emergency use of the vaccine, but predicates its decision on its detailed findings and recommendations from more mature regulatory agencies and the World Health Organisation (WHO).
She noted that out of over 17 million people vaccinated worldwide, sadly, only 37 persons have been reported to have adverse events from taking the vaccine. This, according to her, should not be a basis to suspend the ongoing vaccination of Nigerians.
She said: “We gave the Astrazeneca vaccine emergency use authorisation and this took place after exhaustively going over the data that was contained in the dossier. This was after more mature regulatory agencies have approved. It was after the World Health Organisation (WHO) approved for emergency use listing. So, we did not do this nonchalantly at all because the health of our people is prime to NAFDAC.
“However, when it comes to the development of any product, there are phases in which the product goes through - preclinical, clinical phase that is made up of phases - 1, 2, and 3, and then postmarketing or pharmacovigilance phase.
“These vaccines have been studied up to the phase 3 clinical trials. Where we are right now is post-marketing pharmacovigilance or what we call phase 4. When a product is developed in this emergency approval, it is still being watched and studied because no regulatory agency has given it full assent because it is still under study.
“There will be more information coming out. Part of the information up to phase 3 clinical trial is safety and efficacy. If the side effects or adverse events are very few, in which case the risks are so minimal compared to the benefits, most of the time that product is approved.
“Astrazeneca for example, 17 million people have been injected with it in Europe, UK, and only 37 cases (I don't want to use that only carelessly because it is 37 individuals). But when you look at 37 reaction cases compared to 17 million, you’re talking of 0.000002 per cent. That is very small. If we have to stop the use of a medicine with a risk of 0.000002 per cent, then we will not have medicines at all.”
However, the Chairman of the International Institutes of Advanced Research and Training, Prof Philip Njemanze, has faulted the Federal Government’s ongoing vaccination strategy. He stated that the planned mass vaccination of Nigerians does not make medical sense, as such vaccinations are only carried out when a disease is widespread in a population.
He stated that the current number of infections in the country which is not up to 200,000 is not a basis for deciding to vaccinate nearly 200 million people in order to achieve herd immunity. Furthermore, he believes Nigeria is not experiencing the pandemic compared to other countries in Europe and America.
In her reaction, the NAFDAC boss said: “We are seeing variants of the COVID19 virus developing, and we do not know what will happen tomorrow. COVID-19 may become a seasonal disease. When you have such a disease, you have got to get your vaccination and that cannot be overemphasised because of the seriousness of the disease.
“The approach that he is talking about I will say is logical but not a medically-based approach because we develop drugs every day and we make drugs every day and we see side effects. This is usually when beyond proof the benefits outweigh the risk.
“I could see the perspective of Prof. Njemanze, however, this is not the first drug that will be on the emergency use authorisation, and this is not the first vaccine that is being used for COVID-19.”
Also, a WHO expert group is assessing the latest safety data and will communicate the findings once the review is completed, the organisation said in a statement yesterday.
Reports of blood clots in some people who received Astrazeneca’s shots led to several European Union member states pausing the use of the vaccine, risking another slowdown in the region’s inoculation campaign. The European Medicines Agency is expected to provide a definitive assessment today. Italy and France have indicated they would lift suspensions if the shot is deemed safe by the regulator.
Thromboembolic events are known to occur frequently, and venous thromboembolism is the third-most common cardiovascular disease globally, the WHO said.
On Monday, WHO officials said preliminary data don’t show an association between the vaccine and blood clots.
“No drug or vaccine could ever be 100 per cent safe,” Soumya Swaminathan, the WHO’S chief scientist, said on Monday.
“You could have something that happens one in a million. But then you need to look at what’s the benefit of protecting people against a disease that’s killing millions against the potential risks.”
It was also learnt that pregnant women vaccinated against COVID-19 could pass along protection to their babies in the womb, according to a new study in Israel.
But, European Commission President Ursula von der Leyen yesterday upped the ante in an escalating global fight over coronavirus vaccine shipments.
Speaking at a midday news conference, von der Leyen threatened to cut off vaccine exports to countries that refuse to share their own vaccines a thinly veiled shot at the U.K. The EU may also restrict vaccine exports to countries with higher vaccination rates than Europe, she added, a threat that could affect countries like Israel and Chile.
FIVE persons were reportedly injured yesterday in a clash between some Muslim and Christian groups in Ilorin, the Kwara State capital, over the use of hijab by Muslim pupils.
The clash followed the state government’s reopening of some grant-aided schools where the authorities opposed the use of hijab among the pupils.
It was gathered that both groups initially engaged in verbal attacks and eventually resorted to throwing stones at each other.
It was in the melee the five persons were injured with blood oozing from their heads.
The chaotic situation happened at Baptist Secondary School at Surulere, and ECWA School, Oja Iya, both in Ilorin.
The law enforcement agents who were drafted to the scenes to restore normalcy were said to have fired tear gas canisters to disperse the rampaging crowd.
The state government announced the reopening of the schools on Tuesday night, saying the peace talk on the matter would continue.
It argued that its policy of allowing female Muslim pupils to wear hijab in the grantaided schools was aimed at entrenching peace and harmony.
Some Muslims groups who had laid siege to the main gate of Baptist Secondary School, chanting Laillah Illaha Lahu, Laillaha Illah lahu (There is no other god but Allah).
Efforts by the Muslims groups to have their children enter the affected schools were rebuffed by the Christians who were also at the main gate to enforce their “no hijab” policy.
The tense situation propelled the government to deploy security operatives in the affected schools.
The pupils and teachers who were willing to resume fled the area while the schools gate remain shut.
At Cherubim and Seraphim Grammar School, Sabo Oke, Christian leaders in their white robes staged a protest at the main entrance of the school and prevented pupils and their teachers from resumption.
The protesters wielded placards with inscriptions, such as: “O Toge, give us our schools back”; “No to hijab in Kwara”; “Kwara is not an Islamic state, Kwara is for all”; “Our schools is our heritage” and “We oppose hijab in our schools.”
The same scenario played out at Bishop Smith Grammar School on Agba Dam, GRA, Ilorin and St. Anthony’s College.
Reacting to the development, the Permanent Secretary in the state Ministry of Education and Human Capital Development, Mrs. Mary K. Adeosun said: “The government is convinced that its policy to allow willing Muslim schoolgirls to wear their hijab in public schools will lead to sustainable peace and communal harmony anchored on mutual respect and understanding.
“This path to mutual respect, understanding, and peace with regards to hijab had long been adopted in all of the northern Nigeria and many states in the Southwest, such as Lagos, Osun, Ekiti, and Oyo states…”
Also, the Christian Association of Nigeria (CAN) has urged the Federal Government and the Inspector General of Police (IGP) to intervene in the ongoing violence over the hijab policy that has led to violence and bloodletting in Kwara State.
CAN said Governor Abdulrahman Abdulrazaq should be held responsible for the ugly development the controversy had generated.
In a statement yesterday in Abuja by its General Secretary, Joseph Daramola, CAN said: “We learnt that the state government has ordered the reopening of the closed schools without resolving the crisis and, consequently, churches and mission schools are being vandalised with impunity by the hoodlums banking on the state government’s support in the pretext of enforcing the policy.
“Some innocent Christians are being violently abused and attacked under the watch of the governor who is playing the ostrich.
“The governor should be held responsible if the matter degenerates because it was his pronouncement on the issue of hijab wearing in violation of the court directive on the matter to maintain the status quo until the matter is finally resolved by the court that led to this trouble.”
CAN said wisdom should be applied in handling the matter.
The umbrella Christian body added: “If any damage is done to any church or anyone is injured on this matter, the governor of Kwara State will be held responsible…”
source: Medicalworldnigeria
