Over 8,000 Nigerians Reported Mild Side Effects From AstraZeneca Vaccine, Says FG

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The Federal Government on Friday said 8,439 persons across the country have reported mild side effects after they received the AstraZeneca COVID-19 vaccine.

The government through its healthcare agency, National Primary Health Care Development Agency (NPHCDA), disclosed this in Abuja.

Speaking during a press conference, NPHCDA Executive Director, Faisal Shuaib, said those who reported severe side effects were less than 100, adding that there has been no record of death or blood clots associated with the distribution of the vaccine.

“Out of over a million persons given the Oxford/AstraZeneca COVID-19 vaccine in Nigeria, 8,439 persons have suffered mild adverse events following immunisation (AEFI), and 52 persons moderate to severe adverse events on receiving the jab,” Shuaib said.

“While the mild reactions include body pains and swelling, the moderate to severe adverse events presented were fever, vomiting, diarrhoea, headaches, dizziness and allergic reactions.”

The NPHCDA boss listed the five states with the highest records of side effects as Kaduna (970), Cross River (859), Yobe (541), Kebbi (511), and Lagos (448), noting that investigation is ongoing to verify the nature of the symptoms.

The executive director, who noted that the government has reviewed the timeframe for eligibility for the second dose in line with recommendations by WHO, added that the plan is to ensure that the first phase of vaccination is completed before the expiration date in July.

Speaking further, Shuaib explained that the government has reviewed the timeframe for eligibility for the second dose in line with recommendations by WHO.

According to him, the plan is to ensure that the first phase of vaccination is completed before the expiration date in July.

He added, “Furthermore, as a result of this overall programme review to meet the challenges of global vaccine demand and supply mismatch, and the late commencement of the vaccination in some states, we are expanding the eligibility period between the first and second doses of the vaccine from 12 weeks to between eight to 12 weeks.

“This is still in line with the scientific recommendation provided by the World Health Organisation’s Strategic Advisory Group of Experts (SAGE on immunisation) that the two doses of the vaccine be given at an interval of eight to 12 weeks.”

Nigeria has received close to 4.5 million doses of the vaccine in which 3.94 million have been delivered via the United Nations-led COVAX facility, while others are donations from India and private organisations.

Since the rollout began on March 5, more than one million Nigerians have received the first dose of the vaccine.

Speech by Dr Faisal Shuaib Executive Director/CEO of The National Primary Health Care Development Agency at The Press Conference To Update Nigerians on The Status of Covid-19 Vaccination

PROTOCOLS

Good morning distinguished ladies and gentlemen of the media. I welcome you all to this update on the COVID-19 vaccination in Nigeria.

I am pleased to inform you that the vaccination process across the country is happening according to plan. Even the initial challenges experienced by Kogi state citizens in accessing the vaccines has been resolved by the Presidential Steering Committee (PSC) on COVID-19. As you are aware, about 16,900 doses of the AstraZeneca vaccines were delivered to the State and they have since launched their COVID-19 vaccination programme. We are gratified to say that it is going very well.

As of today, April 16th, 1,071,346 representing 53.2% of the eligible persons targeted with the Astrazeneca vaccine have been administered their first dose in this vaccination phase. It is important to note that these data are based on reports received from states through the Electronic Management of Immunization Data (EMID) system only and do not take into account vaccinations that are not yet captured in the system. What this number means is that these are the people who have their information already uploaded on our database, while others are awaiting upload, potentially due to network problems and the high traffic of those coming in to take their shots at the same time. While we continue to optimize our registration and immunization data system, we also encourage the state teams to deploy the most suitable internet service for their locations in order to speed up the data entry process, so that we can have the actual number of vaccinated people at any given time.

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In many states, we have completed inoculating frontline health workers and are now offering vaccination to the elderly, particularly those that are 65 years and above. We are glad to be able to progress quickly and offer immunization to more members of the community. Our rollout has been marked by safety, efficiency, best practice, and speed. I want to take this opportunity to thank all our health workers for their incredible and tireless commitment to making this work.

The National Primary Health Care Development Agency (NPHCDA) and its development partners have a platform of Senior Supervisors that engage in daily evening review meetings to determine the status of the COVID-19 vaccine implementation in all States and the FCT. These meetings are an opportunity to get reports from the sub-national level on how the campaigns are proceeding, what challenges they face, how we can proactively anticipate and resolve any impending challenges and also troubleshoot to address real-life operational hurdles to our execution plans.

We have been careful to ensure that only those who are eligible to receive the Covid-19 vaccine in the current phase are being vaccinated. These include health workers and their support staff, other frontline workers, strategic leaders and in the last few days, we have also included those who meet the age requirements. We continue to communicate these eligibility criteria to our teams in the states, in order to address earlier misunderstandings around people who are being vaccinated across the country.

There is currently a global shortfall of COVID-19 vaccines largely due to the manufacturers not meeting their projected targets. We are also witnesses to vaccine nationalism that has led Covid-19 vaccine producing countries to restrict exportation and protect vaccines for their citizens. These developments have now necessitated that we reassess our vaccine supply forecasts and take the decision to ensure that everyone who has taken the vaccine in the current phase gets the second dose before the next consignment is delivered to Nigeria.

Furthermore, as a result of this overall program review to meet the challenges of global vaccine demand and supply mismatch, and the late commencement of the vaccination in some States, we are expanding the eligibility period between the first and second doses of the vaccine from 12 weeks to between 8 to 12 weeks. This is still in line with the scientific recommendation provided by the World Health Organization’s Strategic Advisory Group of Experts (SAGE on immunization) that the two doses of the vaccine be given at an interval of 8 to 12 weeks.

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At this juncture, I would like to provide an update on the vaccine accountability issues that erupted in Falomo clinic, Lagos State. There has been a rich engagement with the Governor of the Lagos State and his Health team led by the Hon. Commissioner for Health. A rapid fact-finding team was established to investigate the veracity of these reports not only in the said Falomo Clinic but in designated health facilities all over the State. The information reaching us is that these reports of widespread mismanagement of the vaccination process were inaccurate and do not represent what transpired in these locations. One thing that the PSC and the Lagos State Government are aligned behind, is zero tolerance to diversion of Covid-19 vaccines. The vaccine is free to all Nigerians irrespective of social standing. The current batch of vaccines was made available courtesy of the COVAX facility, to ensure equal access to the Covid-19 vaccines by all countries. Equity, fairness and social justice is at the core of why COVAX was established. For us at the PSC and the Federal Ministry of Health, these are our guiding principles, our North Star, as we distribute and administer the vaccines to our beloved citizens.

Let me seize this opportunity to acknowledge that we are not unaware of attempts by individuals who are not eligible to access the vaccines. With willing accomplices, it will not be surprising that some may succeed. When people skip the eligibility lines we have established to access the C-19 Vaccines ahead of frontline health and other workers, then they should ask themselves if it is ethically and morally right to jump the queue ahead of those who need the vaccines the most. In anticipation of this, we have deployed structures and personnel to ensure these acts are minimized to the barest minimum. On this note, I wish to commend the Chairmen of the ICPC, the EFCC and their personnel for the enthusiasm and dedication with which they have joined our quest for vaccine utilization transparency and accountability.

Permit me to once again draw your attention to the fact that the Federal Government of Nigeria through the PSC has only one channel of distributing the COVID-19 vaccines to all Nigerians. It is very important for the general public to be mindful that the ongoing vaccination is only available in designated health centres as structured by the NPHCDA, which is the primary agency under the Federal Ministry of Health (FMoH), charged with the responsibility of all vaccine-related matters. The safety of Nigerians is paramount, we hold this responsibility as a sacred trust. Therefore, Nigerians should rest assured that working with NAFDAC, NCDC and other related agencies, we have a well-guarded and strictly compliant system to ensure that no unauthorized or counterfeit process is introduced from foreign countries.

There are also developments in the international community, which some of you may be following, but even if you are not, I want you to be informed.

Europe’s medical regulator, the EMA, recommends that Oxford/AstraZeneca – the vaccine being administered here in Nigeria – is administered to all populations and age groups and it is currently being administered in Europe following a temporary pause last month to allow the EMA to examine the potential, rare side effects of blood clotting. The EMA completed its review and Oxford/AstraZeneca is now being used again.

The EU has had a challenging time getting its vaccination program off the ground and we wish them well. As you can imagine, it is incredibly complicated to organize collective policy among many nations.

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The UK has decided to pause the administration of AstraZeneca to the population of 18-29 following an investigation into rare incidents of blood clotting. Europe, however, is administering AstraZeneca to all age groups following its own investigation into the blood clotting incidents.

The World Health Organization strongly recommends the continued use of AstraZeneca for all age groups, and its top scientists advocate for its safety. The calculated benefits far outweigh the risks.

When incidents, no matter how rare, appear in populations receiving the vaccine, relevant authorities must investigate to determine whether there may be a connection between the medical incident and the vaccine. At this stage, different countries are taking different approaches. In Nigeria, since the vaccination program was officially rolled out on the 15th of April 2021, a total of 8,439 mild Adverse events following immunization (AEFI) have been reported. These range from pain, swelling at the site of the inoculation, to body pains and nausea. Similarly, 52 cases of moderate to severe incidents of AEFI have been reported. These presented as fever, vomiting, diarrhoea headaches, dizziness and allergic reactions. Five states have the highest records of the AEFI namely: Kaduna (970) Cross River (859), Yobe (541), Kebbi (511), and Lagos (448).

There has been no death from the administration of the vaccine. We have also not diagnosed any case of blood clots related to the administration of the vaccines. Nevertheless, we are working with NAFDAC, NCDC and other relevant agencies to set up a more active surveillance system built on our experience with polio surveillance.

We have said from the start and I’ll say it again: we will only administer vaccines to Nigerians that are both safe and effective against COVID-19. We will continue to follow international best practice and the advice of the World Health Organization and other leading international regulatory bodies throughout this process.

In the coming few weeks, in collaboration with the States, we plan to engage more at the community levels across the country, by organizing Zonal town hall meetings to facilitate the discussions around COVID-19 vaccination in Nigeria. The proposed dates and venues for these Zonal Town Hall meetings are as follows:

North Central: Lafia, Nasarawa State on 20th April 2021

North East: Yola, Adamawa State TBC

South South: Asaba, Delta State TBC

North West: Kano, Kano State TBC

South East: Owerri, Imo State TBC

South West: Lagos, Lagos State TBC

We invite you to PLEASE JOIN US

Thus far, credible and respected Nigerians from the traditional, religious and academic sector have continued to lend their voices and support to the vaccination effort by receiving their first dose of the COVID-19 vaccine and testifying its benefits. This will go a long way in encouraging their adherents to also take the vaccine, promote herd immunity and protect our communities.

Let me end by appreciating you all once again for your commitment to our collective determination to protect Nigerians against COVID-19. You have not relented in educating Nigerians and keeping the world abreast of Government’s efforts to protect its people against COVID-19. Please keep it up.

Thank you indeed for your time and attention. God bless.

Dr. Faisal Shuaib

ED/CEO NPHCDA

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