Fresh Fears, Concerns Over Safety, Efficacy of Astrazeneca Vaccine

In the last few days, complaints over a possible after effect of the COVID-19 vaccines type – Astrazeneca came from no less a place than European Union countries. The alarm raised by some of these countries though largely unsubstantiated has created panic among those who have taken the vaccine and those hoping to do so. Onyebuchi Ezigbo writes on the positions of the WHO, NAFDAC and NPHCDA repudiating claims of adverse side effects

The world was awoken to yet another unsubstantiated safety concern over the use of COVID-19 vaccine. The countries alleged that there were observed serious side effects like blood clotting on some of those administered with the Astrazeneca vaccine. Although such side affects are yet to be proven or backed with official pharmacovigilance report, all the same, the alarm raised by some European countries like Denmark and Netherlands has led to the suspension of the deployment of the vaccine by some countries in Europe. The issue also sent fears and jitters into the spines of most people of the world including those in Africa and Nigeria, who have just started the introducing Astrazeneca vaccine to its people.

WHO’S Response

As expected, the World Health Organisation (WHO) has responded swiftly to the matter. It said it was aware that, as a precautionary measure, a few countries in the European Union have suspended use of a specific batch of the AstraZeneca vaccine distributed in the EU, based on reports of rare blood coagulation disorders in persons who had received vaccine from that particular batch. This was decided as a precaution whilst a full investigation is finalised.

WHO said: “It is important to note that the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee position is that the vaccine’s benefits continue to outweigh its risks, and the vaccine can continue to be administered while investigation of cases of thromboembolic events is ongoing”.

WHO further said that its Global Advisory Committee on Vaccine Safety (GACVS) systematically reviews any vaccine safety signals and concerns related to COVID-19 vaccine safety, and meets every two weeks to advise on any new safety signals or concerns. It said GACVS is carefully assessing the current reports on the AstraZeneca vaccine.

“As soon as WHO has gained a full understanding of these events, the findings and any changes to current recommendations will be immediately communicated to the public”, the world health body said.

As of March 9, WHO said over 268 million doses of COVID-19 vaccines have been administered since the start of the pandemic, based on data reported to it by national governments. In all these, it said no cases of death have been found to have been caused by COVID-19 vaccines to date.

AstraZeneca Plc’s Safety Review

WHO’s reassurance was followed by a clean bill of health from AstraZeneca Plc, the manufacturers of the COVID-19 vaccine. The firm said on Sunday that a review of safety data of people vaccinated with its COVID-19 vaccine has shown no evidence of an increased risk of blood clots.

AstraZeneca’s review, which covered more than 17 million people vaccinated in the United Kingdom and European Union, said: “A careful review of all available safety data of more than 17 million people vaccinated in the European Union and UK with COVID-19 Vaccine AstraZeneca has shown no evidence of an increased risk of pulmonary embolism, deep vein thrombosis”.

NAFDAC Weighs In

Also, the Nigeria’s food and drug approving agency, the National Agency for Food and Drug Administration and Control (NAFDAC) weighed in to give its assessment of the Astrazeneca vaccine.

NAFDAC Director General, Prof. Mojisola Adeyeye while recieving her vaccination in Abuja last week Thursday, explained that agency went through the requisite investigations as soon it got the dossier of the vaccine before it was approved them to be administered on Nigerians for the treatment of COVID-19.

She said: “When we got the dossier or the application package of the vaccine, we went through it line by line. But before we got the application itself, we went through other assessments. I am talking about their assessment report so that we are prepared and guided when we start our own and that was exactly what happened.

“We conclude based on quality, safety and efficacy because we have to depend on the report. This particular AstraZeneca vaccine, over 20,000 people were involved in phase three of the report”.

Adeyeye said from NAFDAC’s assessment and findings, the effectiveness of the AstraZeneca vaccine outweighs the risk”. However, Adeyeye said that COVID-19 vaccine, just like other vaccine types may come with some allergies which can easily be observed and treated.

NPHCDA’s Stance

On its part, the National Primary Health Care Development Agency (NPHCDA) issued a statement signed by its Executive Director, Dr. Faisal Shuaib, saying that since the country commenced its COVID-19 vaccination, no Nigerian has observed any adverse reaction. The agency said that all side effects reported by those who have taken the jab have been mild.

“We are aware of precautionary concerns that have been raised regarding one specific batch of the AstraZeneca vaccine, namely ABV5300. We understand that investigations are being conducted to determine if the batch is in any way linked to an observed side effect. While we await the outcome of the investigations; it is important to clearly state that Nigeria did not receive any doses from the batch of vaccines with issues”.

Shuaib said that the federal government is satisfied that the clinical evidence indicated that the Oxford-AstraZeneca vaccine is safe and effective. “Our assessment is in line with countries such as Spain and the UK; who have indicated that they will continue to administer the vaccine because it remains an important tool to protect against COVID-19.

“The safety of vaccines delivered to Nigeria is paramount to the Presidential Task Force on COVID-19. For this reason, it has enhanced multi-sectoral collaboration among stakeholders and technical entities; such as the Federal Ministry of Health (FMOH), NPHCDA, NAFDAC, the WHO and UNICEF; whose cooperation ensures the highest global standards are met for vaccines delivered to Nigeria before they are distributed to Nigerians. Clear, rigorous protocols are being followed to safeguard the health of Nigerians”.

In as much as the reassurances by these health authorities are very timely and may go a long way to restoring peoples’ confidence in the safety and efficacy of the Astrazeneca vaccine, there is also the need for an intensified sensitisation campaign to inform Nigerians, especially those in the rural areas and are aware of current issues regarding the COVID-19 vaccines.

The fact some people still believe that that there is nothing as COVID-19 virus even with reports of high rate of Infections means that any negative report about the side effects of the vaccine will put a final nail on its acceptability.