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COVID-19 vaccine: Uncertainty over new supplies delays second jab

By Chukwuma Muanya (Lagos), Nkechi Onyedika-Ugoeze and Sodiq Omolaoye (Abuja)
17 April 2021   |   4:25 am
More reasons have emerged why Nigeria cannot have enough COVID-19 vaccines to reach the proposed 70 per cent of its population by the end of next year.

(Photo by STR / AFP) / China OUT

• Nigeria Records Zero Death One Month After Rollout
• Behind Target, Schedule, Says Tomori
• 8,439 Nigerians Exhibit Mild Side Effects
• WHO To Scale Up Pressure On Countries Hoarding Vaccine
• NPHCDA Reviews Eligibility Period
• Nothing Inappropriate With Two Months Gap, Says Guild Of Medical Directors 

More reasons have emerged why Nigeria cannot have enough COVID-19 vaccines to reach the proposed 70 per cent of its population by the end of next year.

Until now, The Guardian investigation revealed that the country has taken delivery of only 3.92 million doses of Oxford AstraZeneca vaccine and expended just over one million as first doses, while nobody has received the second booster dose, which is supposed to be administered within four weeks of the first.

The situation has raised so many questions, including the health implications of not taking a second jab within the stipulated period, even as Nigeria continues to administer the AstraZeneca vaccine despite growing global resentment.

However, one month after Nigeria officially began COVID-19 vaccination, the country has not recorded any death from the immunisation process, the National Primary Health Care Development Agency (NPHCDA) has said.

This is even as the agency announced that over a million Nigerians have been administered the first dose of the AstraZeneca vaccine.

Meanwhile, Nigeria has reviewed the eligibility period between the first and second doses of the vaccine from 12 weeks to between eight and 12 weeks. This is still in line with the scientific recommendation provided by the World Health Organisation’s (WHO) Strategic Advisory Group of Experts (SAGE on immunisation) that the two doses of the vaccine be given at an interval of 8 to 12 weeks.

Executive Director of NPHCDA, Dr. Faisal Shuaibu, who made these disclosure at a briefing yesterday in Abuja, explained that there is currently a global shortfall of COVID-19 vaccines largely due to the manufacturers not meeting their projected targets and vaccine nationalism that has led producing countries to restrict exportation and protect vaccines for their citizens.

Shuaibu observed that these developments have now necessitated that the country reassess its 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.

The NPHCDA boss, however, disclosed that about 8,439 Nigerians experienced mild adverse effects after taking the vaccine, while 52 cases of moderate to severe incidents of Adverse Events Following Immunization (AEFI) were reported.

According to Shuaibu, the mild side effects reported ranges from pain, swelling at the site of the inoculation, to body pains and nausea, while moderate to severe incidents were presented as fever, vomiting, diarrhea, headaches, dizziness and allergic reactions.

He observed that five states have the highest records of the AEFI- Kaduna, 970; Cross River 859; Yobe 541; Kebbi 511 and Lagos, 448.

He informed that unlike what was reported in some countries, Nigeria was yet to diagnose any case of blood clots related to the administration of the vaccines, insisting that AstraZeneca vaccine administered to Nigerians is safe and effective against COVID-19.

He explained that the agency was working with National Agency for Food and Drug Administration and Control (NAFDAC) and Nigeria Centre for Disease Control (NCDC) to set up a more active surveillance system built on its experience with polio surveillance.

WHO Country Representative in Nigeria, Dr. Walter Kazadi Molumbo, assured Nigerians of the vaccine safety, saying the world body would intensify pressure on countries hoarding vaccines to ensure equitable distribution.

Africa’s top public health official on Thursday warned that many Africans who have received their first COVID-19 vaccine do not know when they will get a second shot because of delayed deliveries.

Head of the Africa Centres for Disease Control and Prevention (Africa CDC), John Nkengasong, told reporters: “We cannot predict when the second doses will come, and that is not good for our vaccination programme.

“Africa lags behind most other regions in COVID-19 vaccinations, with just less than 14 million doses having been administered on the continent of 1.3 billion.

“Ghana, for example, has administered around 742,000 doses of the 815,000 shots it has so far received and would run out by the end of next week.

“Even if Ghana had the money, they will not know where to go get the vaccine. That’s the challenge.”

So far, the majority of the vaccines available in African countries have been delivered via the World Health Organisation (WHO)-backed COVAX facility, which aims to deliver 600 million shots to some 40 African countries this year, enough to vaccinate 20 per cent of their populations. The majority of those doses are AstraZeneca shots produced by the Serum Insitute of India.

However, as at last month, India suspended its exports to meet rising domestic demand amid a surge in COVID-19 cases. That caused great uncertainty for Africa’s vaccination rollout.

Nkengasong added: “We are in a bind as a continent. Access to vaccines has been limited for us,” hoping that India, where new infections have topped 200,000 a day, would lift its restriction as soon as possible.

On December 30, last year, the United Kingdom (UK) announced a deviation from the recommended protocol for the Pfizer-BioNTech vaccine, prolonging the interval between doses from three to 12 weeks.

Twelve similar decisions were made for the Oxford-AstraZeneca vaccine, for which a longer gap between doses had been shown to improve efficacy in some age groups. The stated intention was to maximise benefit with limited supplies and to minimise hospital admissions and deaths.

For the Pfizer-BioNTech vaccine, the decision to delay the second dose was based on extrapolations from Phase III trial data, showing an efficacy of 89 per cent 15-21 days after the first dose. At the time, Pfizer did not support the decision, stating that high efficacy could not be guaranteed.

The efficacy of some COVID-19 vaccines relies on having two doses within a certain amount of time. The UK government decided to leave a 12-week interval between doses of the Oxford-AstraZeneca vaccine, as new analysis of trial data suggests that a 12-week gap “might” be more effective than shorter intervals.

Those who have received their first jab are already benefiting from some protection from the virus, Nkengasong said, urging nations to use their doses before they expire.

Chairman, Expert Review Committee on COVID-19, Prof. Oyewale Tomori, told The Guardian: “Information on the OurWorldInData says we have vaccinated 964,000 as of Monday April 12.

“Remember, the National Primary Health Care Development Agency (NPHCDA) has decided to fully vaccinate about two million people with the 3.9 million doses they got. The exercise is complicated by the expiry date of three months for the vaccines. So, all doses must be used up early June.”

On how many Nigerians who had taken the first dose have taken the second jab after two weeks, Tomori, who is also a virologist and pioneer Vice Chancellor of Redeemer’s University, Ede in Osun State, said: “Officially, nobody, because the initial plan was to give the two doses 12 weeks apart. I understand that those receiving the first doses now will only wait for eight weeks because of the expiry date of the vaccine.

“Originally, time interval between doses was 21 to 28 days, but Britain opted for 12 weeks for consideration of spreading the vaccines to more people while awaiting more consignments. It does not really matter when you get your booster, so long as you have at least three to four weeks between doses.”

Asked the health implications of not taking a second jab within the stipulated period, if any, Tomori stated: “The major health implication is that you may not be fully immunised or protected. So, for full protection, ensure you get the booster dose.”

On whether Nigeria is continuing with the AstraZeneca vaccines despite worldwide discontent due to confirmed adverse reaction of rare blood clotting, he said: “Countries that have alternatives can afford to ditch one vaccine or the other, but beggar nations like us do not have the luxury of a choice.

“However, the WHO, National Agency for Food and Drug Administration and Control (NAFDAC) and other regulatory authorities say the benefits of Oxford AstraZeneca vaccine far outweigh its risks. So, I say we continue to use it until we have an alternative.

“I am aware that government is working hard through the African Union (AU) and bilaterally with other manufacturers to procure more doses of alternative vaccine types.”

Regarding whether Nigeria is vaccinating its target number for the period, the virologist said: “Certainly not. With the donation of only 3.9 million doses for a target of 70 per cent of our population and with the time scale of our national tardy and poorly coordinated roll out, we are miles off our target both in time schedule and population target.”

President of the Guild of Medical Directors (GMD), Prof. Olufemi Dokun-Babalola, said there is nothing untoward with government’s decision to peg the intervals for receiving the first and second jabs of the vaccine at two months, considering that the second jab is valid for up to three months apart.

Dokun-Babalola, who said research is ongoing on the issue, argued that the interval between dosing is not cast in stone, adding that the UK, where the vaccine was developed, has a three-month gap, as the important thing is to give the booster at an appropriate time.

He stated that because of vaccine nationalism, the Europeans and Americans want to ensure they take care of their own people first before ‘releasing’ the vaccine to the rest of the world, noting: “This is the price we pay for not developing our own vaccine. We are at the mercy of other countries.

“Also, we are getting this vaccine under the COVAX facility at a 20 per cent discount. But then, we have to borrow the money to make up the rest. This is increasing our indebtedness to the Western lending institutions. The larger question is: Should we spend so much money on the vaccine alone, rather than spread such money over our moribund health infrastructure?”

On the directive by the National Primary Healthcare Development Agency (NPHCDA) to states that have reached 50 per cent vaccination mark to stop further vaccination in order to meet up with the second dose for those that have already had their first jab, Dokun-Babalola said: “I think government took the right decision to halt the vaccination rollout to make allowance for the second dose for people who have had the first.

“We are at the mercy of the Western countries, as I said earlier. There is a statistically small risk of blood clot for both the AstraZeneca and the J$J vaccine, but the advantages still outweigh the risks. Research should focus on the risk factors for developing a clot and preemptive measures worked out.”

Also speaking, Head, Department of Otorhinolaryngology, University of Abuja and Faculty Secretary, ORLHNS National Postgraduate Medical College of Nigeria, Prof. Titus Ibekwe, corroborated that the vaccine is effective up to three months after the first jab, adding that none of these vaccines have a manufacturing plant in Nigeria or any African country, therefore supply is sourced and well planned.

Ibekwe observed that the Federal Ministry of Health and the NPHCDA, under which the vaccine is domiciled to distribution chain, know that anyone who had first dose must be given second dose, adding: “You plan second dose based on when you think you would have completed second round (considering available manpower and logistics).

“Vaccine apathy is still very high in Nigeria and therefore, my fear is that we may not be able to exhaust the ones here at the present rate.”

A public health physician and Executive Secretary, Enugu State Agency for the Control of AIDS (ENSACA), Dr. Chinedu Arthur Idoko, stated: “The coming days and weeks would determine the path the country finally takes.

“As it stands, I believe more investigations is ongoing and increased information/ data gathering in process regarding these stated/suspected untoward effects of the vaccines. Isolatedly, there have been concerns, but these are obviously being investigated.

“The implications are the heightened consciousness of the concerns of the conspiracy theories. Invariably, this would lead to people staying away from the vaccines and increasingly less people/population accessing the vaccines with its rebound effects.

“You are aware that the original target is to possibly have up to about 70 per cent of the population vaccinated to achieve herd immunity. With this kind of situation, this target would be indeed, a mirage.”

Virologist and vaccinologist, Dr. Simon Agwale, added: “It is important to be fully vaccinated in order to maximise all the benefits of the vaccines. For example, Pfizer-BioNTech vaccine is only about 52 per cent effective after the first dose. With both shots, research suggests the vaccine is 95 per cent effective.

“Also, Moderna says its vaccine is about 80 per cent effective after the first shot and over 95 per cent effective in people ages 18 to 65 if both doses are administered.

“On the other hand, AstraZeneca vaccine efficacy with a single dose was 76 per cent for up to three months. With three months between the two doses, efficacy was 82.4 per cent. It is, therefore, important to stick to manufacturers specifications, because they were based on clinical trials data that led to Emergency Use Authorisations of the vaccines.

“There is COVID-19 vaccine shortage globally and the options are reducing by the day because of repeated safety concerns with AstraZeneca and J & J vaccines. However, whatever decision the country wants to take should be based on local data.

“We should review safety of the vaccine in the over 1 million people that have been vaccinated and take decision based on that.”