Health experts call for caution over approval of malaria vaccine

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Express optimism innovation will change Nigeria’s health sector narrative

 

By Cosmas Omegoh

The newly approved  malaria vaccine will change the health sector narrative in Nigeria. This is the considered belief of a cross section of Nigerian health professionals who spoke on the matter.

The National Agency for Food and Drug Administration and Control (NAFDAC) recently gave provisional approval for the anticipated R21 Vaccine to fight Malaria scourge.

NAFDAC’s Director General, Mojisola Adeyeye, on April 17 said that her agency has approved of the vaccine which is believed to be 75 per cent effective in preventing malaria in infants from  five to 36 months.

The vaccine which was developed by Oxford University in England, was manufactured by the Serum Institute of India.

Nigeria became the second country after Ghana to grant such approval.

In Phase 2B trial involving young West African children, the vaccine was believed to have a 77 per cent protective efficacy over 12 months after an initial three doses.

Why Nigeria needs malaria vaccine

Health professionals were unanimous in saying that Nigeria needs to use the vaccine to protect her own against malaria attacks. However, this should be done with cautious optimism.

According to Prof Cyril Osifoh, president, Pharmaceutical Society of Nigeria, (PSN), “malaria is a severe health issue in Nigeria with a lot of mobility and mortality rate because of our population.”

He is unhappy that “malaria has remained a formidable foe in the country,” and worse still, “yearly over 100 million malaria cases are estimated to occur, with over 300,000 deaths. That is a very high number,” saying that “we must look for all means to combat this.”

He regretted that “some of those deaths involve children under 5. And this is recorded yearly; it is a terrible thing.”

Malaria vaccine long over due

Although there is jubilation following the provisional approval given by NAFDAC, a community pharmacist, Mr Damian Izuka, is insistent that the vaccine was long overdue.

Izuka, a fellow of PSN recalled that “over the years, Nigeria has been talking about health for all. Based on that, I don’t fancy it that up till now, we are still talking about malaria. We ought to have gone past that.

“As for the vaccine, what it would do now is to place us at a good position. When that happens, we will definitely be happy for it.”

The vaccine too late or too early?

To those who believe the malaria vaccine was late in arriving, here is an answer from Dr Chris Ewuru, medical microbiologist at Centre for Infectious Disease Research, Nigerian Medical Research (NIMR), Yaba, Lagos.

He said: “Getting this vaccine has been very difficult because of the nature of the plasmodium that causes malaria.”

He is, however, happy that it has shown prospect of changing the malaria story in Nigeria.

“The vaccine is undergoing clinic trial, but it is giving a positive indication that it has the potential of preventive action against the plasmodium.”

He recalled that “vaccines go with the stimulation of the immune system to produce anti-bodies that will prevent organisms from thriving in the body.

“But as for malaria parasite, the causative agent is the parasite plasmodium. So, the lifecycle is not necessarily the same thing  with the bacteria that we have established a vaccine for. That is why many trials that had been made failed. But this time round, the present vaccine found some positive tendency towards preventing the plasmodium that causes malaria.”

He took a swipe at the leadership, which he said “are skeptical about the issues of vaccine,” while applauding the positive indications that the vaccine was producing the required results “even at the level of clinical study.”

The world did not abandon African

Going further, Dr Ewuru dismissed insinuations that the world was playing poker with Africa by delaying to come up with malaria vaccine.

He said: “It might not be safe to say that for failing to produce this vaccine for long, the world abandoned Africa.

“It was not necessarily so because even if people in the developed world are able to produce a vaccine against plasmodium, it is still a big market for them because the entire Africa and other parts of the world are prone to malaria.

“What I can see is that African leadership keeps playing lip service to the issues of the endemicity of the plasmodium.

“Because of the nature of our terrain, it is very difficult to eradicate malaria parasite since the way it is transmitted by mosquito is supported by our environment.

“That is why eradicating the anopheles mosquito that propagates the transmission of the plasmodium is very difficult to eradicate.”

Expected benefits of the vaccine

 According to Izuka, “the vaccine will definitely minimise the challenges we have in the healthcare sector,” contending that “this is not arguable. We can, therefore, adopt the vaccine and then follow it up. That is my imprecision.”

Recalling the effectiveness of vaccines in combating diseases, Prof Osifoh noted that “vaccines like we saw it during the COVID-19 years is an effective strategy in combating and eliminating any infectious diseases such as malaria and so we welcome this development; we welcome what NAFDAC has done.”

Similar sentiment was shared by Dr Innocent Orji, president, National Association of Resident Doctors (NARD), who said:

“What vaccines do is to help in preventing some diseases from happening or from taking root in individuals.

“Therefore, a vaccine is usually deployed when there is a high prevalence of a disease in a community and the purpose is to prevent a large number of people from coming in contact with a particular disease.

“So, knowing that malaria is endemic in Nigeria and indeed other African countries, and it is a major cause of child mortality, what the vaccine will do is to prevent the disease from taking root or to prevent its endemicity. By doing so, child mortality consequent upon malaria infection will be reduced.

“The news of the coming of the vaccine, therefore, is a happy one.

“But we must note that the vaccine is an innovation about to take off. Based on that, as Nigerians and healthcare professionals, we should be hopeful with some cautious optimism to see how it pans out.

“In all, the vaccine idea is to end the endemicity of malaria especially among children, having known that they are highly susceptible to malaria infection. We just have to observe and monitor the efforts to see how it will help to reduce malaria infections and its complications.”

Will vaccine disrupt existing bussinesses?

However, part of the fears being expressed was that with the arrival of the vaccine, malaria drug manufacturers and vendors might lose businesses. But this fear has been allayed by Izuka who runs pharmaceutical outlets.

He said: “It will be wrong to reason that importers and manufacturers of malaria drugs will lose their businesses.

“It needs to be said that there are a thousand and one drugs out there to deal in. There are a thousand and one things one can do with medicinal products. They are uncountable. If we have 1,000 drugs and one is off the list, I don’t think its economic implication will be anything.

“But even at that, which one should be our major concern – to be healthy or for us to be smiling while others are suffering malaria?

“I disagree that with malaria drugs off the market, that will be huge impact on pharmacy practice in Nigeria, after all, malaria drugs are not the sole providers of profit to those who are in the pharmaceutical industry.

“For all I know, there are so many things we can do in the area of medicine. I don’t think that when malaria drugs are removed from the list, the pharmaceutical industries will collapse; I don’t think so.

“There are so many countries that don’t have anything to do with malaria, yet pharmacy practice there is doing well.

“There are so many things that will make one close to drugs. It is not only malaria. And so, if the suppliers now find out that there is no more market for their products, they will adjust.

“There is a time a particular molecule could be found in a drug, and the authorities would say for one reason or the other, such drugs should not be used again. That puts paid to that particular medication.

“When there is a need to say a particular drug is now history, let it be history.”

On the other hand, Prof Osifoh reasoned that “if you sign a contract to buy drugs from a company for 10 years, I don’t know what Nigeria might have signed, even though the vaccines are effective, one might still need to purchase the said drugs.

“But the good news is that if the vaccine is effective, it will drastically reduce the quantity of drugs purchased which is still good for us. But we have to watch what comes before us.

“I don’t know what comes up on the other side of the river, but we still need to be hopeful.”

Vaccine will take little long to arrive

Although there is optimism in the air regarding the malaria vaccine, Prof Osifoh disclosed that beneficiaries still needed to wait for a little longer before assessing it.

“It might not come until 2024 even though it has been announced,” he said, adding that “but until then, we will have to put the necessary things in place since the vaccine is undergoing clinical trials.”

On arrival, he said: “It will not be as if the drug will be available to everybody. It might be restricted until we get good fellers to enable us do what we should do.

“Remember very well that during the COVID-19 era because of the urgency and the endemic nature of the scourge, approvals were given to the vaccine even when enough studies had not been done.”

Worries over the vaccine

It is natural to entertain fears over the said vaccine as it comes into the country.

But Dr Ewuru said there should be none of such.

“I have no fears over the product since it is one against mere plasmodium. It will not have any damaging effect on man.

“We need to find time, say a period of six months, one, or two years to evaluate its efficacy and make informed decisions and statements.”

He, however, stated that “as it is being administered, it needs to be monitored by the agents and stakeholders.”

Similarly, Prof Osifoh, agreed that “NAFDAC and officials of the Ministry of Health need to work with concerned stakeholders like the PSN and WHO, so that a lot of things can be monitored while the implementation strategies are going on.”

He said that it was important to do that without sounding alarmist.

“We don’t need to be alarmist for now. But I will say when these issues are put closely together, we will reap their benefits.”

Although Dr Orji said there was no specific worries over the vaccine for now, he still believes that “we must note that when you have something new to us – something we have not used for the first time, we should not go to sleep.

“There has to be adequate monitoring to ensure that the vaccine is effective, and to ensure that there is no untoward side effect that will arise from it given that we are just starting to use it for the first time.

“Therefore, we should not relax. We should monitor the individuals that will be given the vaccine and make sure they don’t come down with some side effects.”

Efficient ways to sustain vaccine

For Prof Osifoh, it’s thumbs up for the innovation. He believes with strategic partnership, the novelty will be sustained for the good of the teeming populace.

“We welcome the development,” he noted, adding, “but we also have to watch out for other possible issues that might crop up which might not be ascertained as of now.

“We must work closely with WHO so that issues are monitored; NAFDAC too must monitor what is going on.

“We as a society, have to monitor it also because this is very important so that our population will not run into a big problem.

“I must say that implementation and compliance must be sustainably controlled; implementation strategies put in place.”

Then turning to NAFDAC, he said: “I’m confident that God helping us, Madam NAFDAC will put strategies in place to ensure that the right things are done at the right time.”

He called for more enlightenment so as to boost the status of the vaccine.

“The media have to be very helpful here to educate the members of the public. If you don’t educate the public, they will not have the right knowledge. When the people have enough knowledge about diseases, they can actually be combated.

“Actually, the hygiene conditions around us create problems. People can learn how to remove still water around their homes, and stay away from waterlogged places. That alone will save quite a lot of things.

“But we won’t say because a vaccine is coming and begin to shout Eureka. We still need to use drugs, mosquito-treated nets, education and enlightenment to ensure that this bonding and endemicity of malaria in Nigeria is reduced to the barest minimum.”

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