…AstraZeneca vaccine has no side effects – NAFDAC,…We‘ll investigates side effects – NPHCDA,…Govt must develop tracking system to check fakes – Pharmacist,…We won’t suspend vaccination because some countries have – FG
One week after Nigeria began vaccination for coronavirus, there have been concerns about its safety, misinformation, hoarding and fake vaccines. SAMSOM BENJAMIN and ABDULRAHMAN ZAKARIYAU in this report examine the unfolding scenario.
Nigeria on Friday last week began the vaccination of its citizens against Covid-19, beginning with health care workers. Health care workers are often at the risk of exposure to infections, including Covid-19, as they are the first responders to patients.
Chairman of the Presidential Tasks Force on Covid-19, Boss Mustapha, at the national flag-off of the vaccination at the National Hospital, said, “In keeping with our promise, the PTF is prioritising the frontline health care workers in the first batch of vaccines received.”
Cyprian Ngong, a medical doctor, was the first person to receive a jab of the Oxford-AstraZeneca vaccines in Nigeria. Three other health workers also received jabs during the flag-off event.
Quantity
About four million doses of the Oxford-AstraZeneca Covid-19 vaccines were delivered to Nigeria through the Covid-19 Vaccines Global Assess Facility (COVAX)
The four million doses are part of the 16 million doses of AstraZeneca vaccines planned to be delivered to Nigeria in batches over the next weeks. The vaccines arrived in Nigeria one year after the country’s index case was reported in an Italian who arrived in Lagos. Over 155,000 cases have since been reported in the country and over 1,900 deaths recorded.
Roll-out plans
Explaining the roll plans for the vaccine, the executive director of the National Primary Health Care Development Agency (NPHCDA), Faisal Shuaib, said an online portal has been open for Nigerians to register, adding that the vaccine roll-out will be in four phases, starting with health workers, frontline workers, Covid-19 rapid response team, laboratory network, policemen, petrol station workers and strategic leaders.
“Phase two: Older adults aged 50 years and above. Those with co-morbidities aged 18 – 49 years of age. Phase three – Those in states/LGAs with high disease burden and who missed phases one and two. Phase 4: Other eligible population as vaccines become available,” he said.
While the Nigeria Centre for Disease Control (NCDC) has been in charge of the country’s coronavirus response in the areas of testing, communication, and surveillance, the task of coordinating vaccination rests squarely on the National Primary Health Care Development Agency (NPHCDA).
Confusion over roll-out
Public health experts and citizens in the country are worried that conflicting, and sometimes confusing information, on the vaccine deployment will hinder the process. Despite the outlined phases, Blueprint Weekend found out that the registration process also does not provide any means for the government to verify those claiming to be front-line workers.
Speaking with this reporter, Victor Bassey, a 46-year-old university lecturer at the National Open University of Nigeria (NOUN), who has used the platform, described the open registration process as “potentially disenfranchising those who should be prioritised and ensuring the phased approach fails.” He noted that young people are more likely to register online than older adults, who have been identified as a priority population.
“By registering online, the federal government will distribute the few vaccines to the less vulnerable group, and the problem will just begin from there. When other countries would say bye to Covid-19, Nigeria will be looking for help. The registration process also does not provide any means for the government to verify those claiming to be front-line workers,” he said.
Fears, anxiety
An international news channel, France24, reported that seven European countries – Denmark, Norway, Austria, Estonia, Latvia, Lithuania and Luxembourg – suspended all or part of its roll-out as a precaution while they investigated concerns relating to blood clots and other side effects caused by the vaccine. The BBC reported that Iceland had suspended the vaccine, bringing the total number of countries to eight.
The Danish health authorities suspended all AstraZeneca vaccinations for two weeks after a 60-year-old woman who had been vaccinated formed a blood clot and died, according to France24.
The move “follows reports of serious cases of blood clots among people vaccinated with AstraZeneca’s Covid-19 vaccine,” the Danish health authorities said in a statement. However, the country cautiously added that “it has not been determined, at the time being, that there is a link between the vaccine and the blood clots.”
Norway followed suit, suspending all AstraZeneca vaccinations. Austria earlier announced it had suspended the use of a batch of AstraZeneca vaccines after a 49-year-old nurse died of “severe blood coagulation problems” days after receiving an anti-Covid-19 shot.” Four other European countries – Estonia, Latvia, Lithuania and Luxembourg – have also suspended the use of the vaccine from the batch, which was sent to 17 European countries and consisted of one million jabs.
The BBC further reported that Iceland stated that it was suspending use of the vaccine because it wanted, “to err on the side of caution.”
In an interview with Blueprint Weekend, James Omale expressed doubts about the safety of the AstraZeneca Covid-19 vaccine.
He said, “There are so many issues surrounding this Covid-19 pandemic vaccination. The reported side effects of almost all the vaccines are adverse. We have read how people who take some of them died; some still got Covid-19. So for me I doubt the effectiveness of these vaccines.
When told that it had been approved by NAFDAC, Omale said, “NAFDAC? My brother anything can happen. Those that want to take it can. But as for me and my family, we are not ready for any vaccination. We are still monitoring the situation.
Also, expressing his view on frontline workers taking the AstraZeneca vaccine, Bagudu Joseph said the decision was not properly thought out.
He expressed fears that if health care workers, especially those in the frontline, take the vaccine and it fails, Nigeria will find it difficult to fight and win the Covid -19 battle.
“I think it’s not a good idea for the government to try this Covid-19 vaccine on medical workers first. Because it fails, we are going to be deep in trouble. My honest advice is try, it on politicians, head or tail,” he said.
NAFDAC’s take
In her reaction, the director-general of the National Agency for Food and Drugs Administration and Control (NAFDAC), Prof. Mojisola Adeyeye, said the AstraZeneca vaccine “has no side effects.” Adeyeye, who stated this Thursday in Abuja, shortly after she was vaccinated, noted that NAFDAC went through the application dossier of the vaccine before it was approved to be administered on Nigerians.
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 further that the effectiveness of AstraZeneca vaccine outweigh the risk, as it has already been scrutinised. She noted that there was no medicine without its side effects, especially when still going through the developmental stage.
The director-general said from all indications of quality and efficacy, the benefits of AstraZeneca vaccine outweigh the risks and the side effects. She said the agency also believed in herbal medicine, but it must be backed with research before such could be approved.
Adeyeye said the agency had accommodated 14 of such herbal medicine for listing to ascertain whether it was safe to use it and that the agency must also do its own clinical trials before any herbal medicine would be approved.
She disclosed that the federal government had arranged for a research and development scheme for the health sector, adding that a lot of herbal medicines were going to be used for the testing.
FG speaks
Speaking to The Punch on Thursday, the Minister of State for Health, Mamora, said Nigeria would continue to administer the vaccine. He said since Nigeria rolled out the vaccine last week, there had been no recorded severe side effects.
Mamora said apart from being approved by the World Health Organisation (WHO), the vaccine had also been endorsed by the NAFDAC for emergency use.
The minister argued that persons who died of the vaccine use in Europe might have had other co-morbidities or complications that led to their death, adding that it was best for regulatory agencies to complete their probe before any conclusions were made.
“We have not had any unusual reaction from any of the doses administered. I have taken it and I have not felt unusual and no one has been established to have had it so far. So, we cannot just suspend right now. That would amount to a fire- brigade approach.
“We will continue to administer doses and monitor reactions of all those who have taken the vaccines. We are not going to suspend vaccination just because some countries have done so.”
NPHCDA’s assurances
Meanwhile, NPHCDA has doused apprehensions about side effects and safety of the vaccine. The Agency’s head, public relations unit, Mohammed Ohitoto, in a statement Thursday, said it was awaiting the outcome of the investigations.
The statement read in part, “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 that was issued.
“Vaccinations in Nigeria started earlier this month and we have not observed any similar adverse reactions. All side effects reported by those who have been administered the vaccine have been mild.
“We are satisfied that the clinical evidence indicates the Oxford-AstraZeneca vaccine to be 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.”
Fake vaccines
Also, anxiety was heightened last week when the global police organisation, Interpol Police, in China and South Africa reportedly seized thousands of fake doses of the Covid-19 vaccine, warning that it represented only a “tip of the iceberg” in vaccine-related crimes.
Interpol said 400 vials – equivalent to around 2,400 doses – containing the fake vaccines were found at a warehouse in Germiston outside of Johannesburg in South Africa, where officers also recovered fake masks and arrested three Chinese and Zambian nationals.
The situation has raised questions about the readiness of Nigeria to prevent fake vaccines from getting into the country, a situation that could increase concerns about efficacy and apathy.
Blueprint’s investigations revealed that the real challenge for the government is that there aren’t enough vaccines. Some travellers may become so desperate to be tempted to take from the black market, which might encourage its smuggling.
While relying on the fact that the only remedy, perhaps, is the vaccine certificate, which only the government issues, some fear that Covid-19 vaccine certificates could be faked too, just as Covid-19 test results are faked for travelling.
Reacting, the Minister of Health, Dr. Osagie Ehanire, told journalists that the “Nigerian government issues vaccination certificates with QR code you can scan for authenticity; the president and vice-president were issued QR coded certificates, valid after they get the second dose.”
“All questions can be directed to the Ministry of Health and NPHCDA, but this is not a time to work at cross purposes; it is not a time to be making private arrangements for vaccine procurement and administration. Vaccines that are not approved by the National Agency for Food and Drug Administration and Control (NAFDAC) will be determined as dangerous, and will be seized by Customs Services and NAFDAC, who are on high alert for illegal vaccine importation.
“Manufacturers of vaccines require an official indemnification to be able to use their product, which Nigeria has provided for the COVAX facility, adding that vaccines from other sources must first have NAFDAC’s Emergency Use Authorisation, and are not covered under the indemnification arrangement warning that such vaccines will be illegal and therefore subject to be impounded by NAFDAC and Customs.”
Similarly, in a chat with Blueprint Weekend, a virologist and vaccinologist, Prof. Chukkwuebuka Iguebe, said: “It is unfortunate that some miscreants are already faking vaccines. This is a crime that should carry the death penalty.
“Ultimately, the private sector will need to come in to supplement government efforts in the vaccine distribution. Government has said that there will be no private sector importation of vaccines for now, the government said the same thing about Covid-19 isolation facilities and tests. Now both are mostly being done in the private sector.”
“The government has warned that there are already fake vaccines around and that people should take vaccines only from government facilities. People should also be patient, as more vaccines will come into the country, just as the government is still negotiating with other vaccine-manufacturers to provide adequate vaccines for at least 70-80 per cent of Nigerians.
“No country is requesting Covid-19 vaccine certificate as far as I know; so, there should be no reason for anyone to seek fake vaccines.”
Way out
Speaking with this reporter, Dr. Isa Yakub, a pharmacist at the National Hospital Abuja, advised authorities to develop a tracking system to check fake vaccines.
He said, “Tracking transactions will be a good strategy the regulators can employ to disrupt chains of counterfeit Covid-19 vaccines. My understanding is that the NPHCDA has developed a portal, which will enable citizens to be registered and the portal should be made available in addition to vaccine certificates. This should be similar to our international passports.
“From the available information, NAFDAC is using a tracking system to monitor Covid-19 distribution nationwide, which is one of the safeguards put in place to prevent counterfeit vaccines from coming into the country.
“Furthermore, people should be educated to know that there is serious vaccine shortage globally and no organisation has access to Covid-19 vaccines outside the well-established channels. This will certainly change after the pandemic is over and when more vaccines become available.
