First New HIV Vaccine Efficacy Study Begins
By Dipo Olowookere
The first HIV vaccine efficacy study to launch anywhere in seven years is now testing whether an experimental vaccine regimen safely prevents HIV infection among South African adults.
The study, called HVTN 702, involves a new version of the only HIV vaccine candidate ever shown to provide some protection against the virus.
HVTN 702 aims to enrol 5,400 men and women, making it the largest and most advanced HIV vaccine clinical trial to take place in South Africa, where more than 1,000 people become infected with HIV every day.
“If deployed alongside our current armoury of proven HIV prevention tools, a safe and effective vaccine could be the final nail in the coffin for HIV,” said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health and a co-founder of the trial.
“Even a moderately effective vaccine would significantly decrease the burden of HIV disease over time in countries and populations with high rates of HIV infection, such as South Africa.”
The experimental vaccine regimen being tested in HVTN 702 is based on the one investigated in the RV144 clinical trial in Thailand led by the US Military HIV Research Program and the Thai Ministry of Health.
The Thai trial delivered landmark results in 2009 when it found for the first time that a vaccine could prevent HIV infection, albeit modestly.
The new regimen aims to provide greater and more sustained protection than the RV144 regimen and has been adapted to the HIV subtype that predominates in southern Africa, a region that includes the country of South Africa.
“The people of South Africa are making history by conducting and participating in the first HIV vaccine efficacy study to build on the results of the Thai trial,” said HVTN 702 Protocol Chair Glenda Gray, M.B.B.C.H., F.C.Paed. (SA). “HIV has taken a devastating toll in South Africa, but now we begin a scientific exploration that could hold great promise for our country. If an HIV vaccine were found to work in South Africa, it could dramatically alter the course of the pandemic.” Dr Gray is president and chief executive officer of the South African Medical Research Council; research professor of paediatrics at the University of the Witwatersrand, Johannesburg; and a founding director of the Perinatal HIV Research Unit at Chris Hani Baragwanath Hospital in Soweto, South Africa.
Co-chairing the protocol with Dr. Gray are Linda-Gail Bekker, M.D., Ph.D.; Fatima Laher, M.D.; and Mookho Malahleha, M.B.Ch.B., M.P.H. Dr. Bekker is deputy director of the Desmond Tutu HIV Centre at the University of Cape Town and chief operating officer of the Desmond Tutu HIV Foundation in Cape Town, South Africa. Dr. Laher is a director of the Perinatal HIV Research Unit at Chris Hani Baragwanath Hospital. Dr. Malahleha is deputy director of Setshaba Research Centre in Soshanguve, South Africa.
The experimental vaccine regimen tested in the Thai trial was found to be 31.2 percent effective at preventing HIV infection over the 3.5-year follow-up after vaccination. In the HVTN 702 study, the design, schedule and components of the RV144 vaccine regimen have been modified in an attempt to increase the magnitude and duration of vaccine-elicited protective immune responses.
As the regulatory sponsor of HVTN 702, NIAID is responsible for all operational aspects of this pivotal Phase 2b/3 trial, which is enrolling HIV-uninfected, sexually active men and women aged 18 to 35 years. The NIAID-funded HIV Vaccine Trials Network (HVTN) is conducting the trial at 15 sites across South Africa. Results are expected in late 2020.
HVTN 702 begins just months after interim results were reported for HVTN 100, its predecessor clinical trial, which found that the new vaccine regimen was safe for the 252 study participants and induced comparable immune responses to those reported in RV144.
HVTN 100 and HVTN 702 are part of a larger HIV vaccine research endeavour led by the Pox-Protein Public-Private Partnership, or P5—a diverse group of public and private organizations committed to building on the success of the RV144 trial. The P5 aims to produce an HIV vaccine that could have a significant public health benefit in southern Africa and to advance scientists’ understanding of the immune responses associated with preventing HIV infection. P5 members include NIAID, the Bill & Melinda Gates Foundation, the South African Medical Research Council, HVTN, Sanofi Pasteur, GSK and the U.S. Military HIV Research Program.
The HVTN 702 vaccine regimen consists of two experimental vaccines: a canarypox vector-based vaccine called ALVAC-HIV and a two-component gp120 protein subunit vaccine with an adjuvant to enhance the body’s immune response to the vaccine. The vaccines do not contain HIV and therefore do not pose any danger of HIV infection to study participants. Both ALVAC-HIV (supplied by Sanofi Pasteur) and the protein vaccine (supplied by GSK) have been modified from the versions used in RV144 to be specific to HIV subtype C, the predominant HIV subtype in southern Africa. Additionally, the protein subunit vaccine in HVTN 702 is combined with MF59 (also supplied by GSK), a different adjuvant than the one used in RV144, in the hope of generating a more robust immune response. Finally, the HVTN 702 vaccine regimen includes booster shots at the one-year mark in an effort to prolong the early protective effect observed in RV144.
The study volunteers are being randomly assigned to receive either the investigational vaccine regimen or a placebo. All study participants will receive a total of five injections over one year.
The safety of HVTN 702 study participants will be closely monitored throughout the trial, and participants will be offered the standard of care for preventing HIV infection. Study participants who become infected with HIV in the community will be referred to local medical providers for care and treatment and will be counselled on how to reduce their risk of transmitting the virus.
HVTN 702 is one of many NIAID-supported HIV prevention trials in progress in southern Africa. These include the AMP Studies, which are testing infusions of the VRC01 antibody; the open-label HOPE study, which is examining a dapivirine vaginal ring; and HPTN 076 and 077, which are studying long-acting injectable rilpivirine and cabotegravir, respectively.
Ramadan: Ogun Community Gets Free Medical, Household Items
By Modupe Gbadeyanka
Ahead of the annual Islamic fast known as Ramadan starting in the coming days, a group known as the Zenith Pathfinders has organised a free medical screening for a community in Ogun State.
The group also shared free healthcare packages to residents of the Adiyan Muslim Community in Agbodo Oja, Ogun State, to enable them to be medically for the annual Islamic ritual.
According to a statement, the event was held on Sunday at 296 Orodu Road at Ilese Bus Stop, Adiyan in Agbado Oja, and more than 200 persons benefited from this.
The screening involved blood pressure, sugar level tests, as well as specialist consultation, with the required prescriptions and drugs given to the inhabitants of the community.
In a bid to also alleviate the suffering of the less privileged, Zenith Pathfinders also donated household items like shoes and clothes, among other items.
Addressing newsmen, the founder of Zenith Pathfinders, Hajiah Aminah Yahya, expressed joy at seeing the smiles on the faces of people who benefited from the gesture.
She explained that the purpose of the programme was to encourage Muslims to know their medical status before fasting so that can be able to have a hitch-free Ramadan.
“We are at the Adiyan Muslim community for the second edition of Pre-Ramadan Medical Screening. We started last year with over 300 participants, but this year, we have over 200 participants.
“The essence of having this programme before Ramadan is to encourage our people to know their medical status before Ramadan comes in.
“They have to know their health status so that they can take care of themselves before Ramadan so that they can have a hitch-free Ramadan. We also gave free household items like cloth materials, fans, freezers and others to over 150 Muslims,” she added.
On his part, Dr Alabi Olarenwaju Usman of the Nigerian Navy Reference Hospital, Ojo, Lagos, said the majority of the Muslims who participated in the medical services were medically fit to fast in the month of Ramadan.
“We are here for humanitarian services for Adiyan Muslim Community. We attended to over 200 Muslims in the community. A few of the cases here involved hypertension, diabetes and malaria. We have given them the necessary assistance, and most of them are eligible for Ramadan,” the medical practitioner, who was the consultant on the ground, said.
Some of the beneficiaries commended Zenith Pathfinders for the gesture, urging the government to do more to make health services affordable.
“This is good, and we sincerely thank the organisers. They conducted medical screening for us without collecting a dime. We are so grateful,” the Imam of Ajumoni Central Mosque, Mutta Three, Ustadh Usman AbdulRaheem, said.
Russian COVID-19 Vaccines Disappear from Africa’s Radar
By Kestér Kenn Klomegâh
Until recently, Africa has not been high on Russia’s policy agenda. African leaders have to understand that Russia, for the past three decades, Africa was at the bottom of its policy agenda. After the end of the Soviet era, Russia has focused broadly on the United States and Europe, dreaming of becoming part of Europe, part of the configuration of the Global North. The low economic presence of Russia from 1991 until 2019 was a testament to the fact that Africa was at the bottom of its priority list. Of course, the October 2019 summit was symbolic, but after that, Russia has left most of the bilateral agreements undelivered across Africa.
With its “special military operation” on Ukraine that necessitated the imposition of stringent sanctions from the United States, European Union and their allies, the United Nations Security Council, mounting pressure on Russia since February 24 2022, pushes Russia to begin soliciting aggressively for support in Africa. Last July, in an article posted to its official website, Foreign Minister Sergey Lavrov wrote: “The development of a comprehensive partnership with African countries remains among top priorities of Russia’s foreign policy; Moscow is open to its further build-up multifaceted relations with Africa.”
In his Op-Ed article, Lavrov argues: “We have been rebuilding our positions for many years now. The Africans are reciprocating. They are interested in having us. It is good to see that our African friends have a similar understanding with Russia.” Lavrov, however, informed about broadening African issues “in the new version of Russia’s Foreign Policy Concept against the background of the waning of the Western direction” and this will objectively increase the share of the African direction in the work of the Foreign Ministry.
Lavrov consistently displays his passion for historical references. Soviet support for struggles for political independence and against colonialism should be laid to rest in the archives. The best way to fight neo-colonialism is to demonstrate by investing in those competitive sectors and depart away from hyperbolic rhetoric on an endless list of sectors. In practical terms, we rather face today’s development challenges and what is in store for the future generation. Africa today does not need anti-Western slogans; Africa simply needs external players who would passionately and genuinely invest in the critical economic sectors. The fundamental fact is that Africa is making efforts to transform its economy to create employment, modern agriculture, and industrialize the continent, especially with the introduction of the African Continental Free Trade Area (AfCFTA).
Despite criticisms, China has built an exemplary distinctive economic power in Africa. Besides China, Africa is largely benefiting from the European Union and Western aid flows and economic and trade ties. Compared, Russia plays very little role in Africa’s infrastructure, agriculture and industry and makes little effort to leverage the African Continental Free Trade Area (AfCFTA). Our monitoring shows that the Russian business community hardly pays attention to the significance of the African Continental Free Trade Area (AfCFTA), which provides a unique and valuable platform for businesses to access an integrated African market of over 1.3 billion people.
Lavrov’s efforts toward building non-Western ties in these crucial times are highly commendable, especially with Africa. But, the highly respected Minister easily and most times forgot the fact that during these two-three years of a global pandemic, the coronavirus that engulfed the planet, in every corner of the world, Africa was desperately looking for vaccines. Health authorities are still warning that Covid-19 has not been completely faced throughout the world.
Quartz, a reputable global media, reported early this year that “as of the end of 2022, about a quarter of the population of African countries has been fully vaccinated against Covid-19, according to the latest figures shared by Africa CDC. The coverage varies drastically depending on the country. In Liberia, for instance, nearly 80% of the population is fully vaccinated, while only 34% is in neighbouring Sierra Leone. Congo, Sudan, Senegal, and Madagascar all have vaccination rates below 10%.
In his briefing, Ouma said the target for Africa remains to vaccinate 70% of the population. That goal, however, was set by the World Health Organization (WHO) for the overall population. These numbers are about to change – and not because of an increase in vaccinations. Africa CDC acting director Ahmed Ogwell Ouma announced in a video briefing on December 22 that it will modify the way it reports vaccination rates. Rather than reporting coverage of the overall population, it will only report vaccinations of the eligible populations aged 12 or more.
Due to delays in international vaccine deliveries, Africa lags behind the rest of the world in Covid vaccination rates and is the only continent where less than 50% of the population is fully vaccinated. Currently, just more than 800 million doses of vaccines have been administered in Africa, or 80% of the total received. About a third of the vaccinations have been made with Johnson & Johnson’s vaccine, followed by Pfizer (22%), AstraZeneca (17%), China’s Sinopharm (15%) and Sinovac (7%).
Several reports monitored by this author show that Russia has played a minimal role in the entire health sector in Africa. With the Covid-19 vaccination, Russia randomly sprinkled a few thousand as humanitarian assistance among its “Soviet friends”, including Egypt, Ethiopia, Guinea, Angola, Mozambique, Zimbabwe and South Africa. Nevertheless, the worse was Russia’s sudden failure to supply the 300 million vaccines through the African Union (AU), especially during the times of health crisis.
An authoritative policy report presented in November 2021 titled ‘Situation Analytical Report’ and prepared by 25 Russian policy experts headed by Sergei A. Karaganov noted explicitly the failure to supply Sputnik vaccines to the African Union. The report criticized Russia’s current policy and lukewarm approach towards Africa.
“In several ways, Russia’s possibilities are overestimated both publicly and in closed negotiations. The supply of Russian-made vaccines to Africa is an example. Having concluded contracts for the supply of Sputnik V to a number of African states, Russian suppliers failed to meet contractual obligations on time,” says the report in part.
The coronavirus outbreak a pandemic on March 11, 2020. Worth noting that Russia claims that it was the first to find a coronavirus cure. The World Health Organization (WHO), until today, has not certified Russia’s vaccines, though. On the other hand, all the vaccines that have been registered in Russia – Sputnik V, Sputnik Light, CoviVac and EpiVacCorona – are produced in large quantities by Russian pharmaceutical companies and are currently used for vaccination.
Director of the Gamaleya National Research Centre for Epidemiology and Microbiology Alexander Gintsburg has several times highlighted aspects of vaccine production and marketing. He noted to raise the attractiveness of the vaccines on foreign markets, including countries in the Middle East, Africa and Latin America.
The Russian Direct Investment Fund, tasked to engage in marketing the vaccines abroad, got messed up, especially in Africa. Of course, it took steps and speedily registered the vaccines in more than 20 African countries but terribly failed on delivery deadlines. Worse was the Russian Direct Investment Fund supplied, at exorbitant prices, through middlemen in the Arab Emirates to a number of African countries. Russia’s Foreign Ministry has, however, held a series of African Foreign Ministers during this Covid-19 period and desperate moment reiterated to assist with direct supplies to Africa. That is Russia, considered a reliable partner for Africa.
The above thoughts on the part of the Covid-19 business offered the reasons why Russia absolutely refused to join and be part of the Covax facility, which acts as a global collective bargaining initiative to secure vaccine doses for countries who signed up, including those are self-financing their purchases, as well as assistance from donors for poorer developing countries. The first vaccines purchased through Covax were indeed destined to reach Africa. That was, monitored by this author, some 88.7 million doses of the AstraZeneca and Pfizer vaccines distributed to 47 countries, including Africa, during the first half of 2021. This same year, during the virtual meeting of G7 leaders, the European Union announced it had donated a further 500 million euros to the COVAX program. The World Bank also committed $12 billion as concessional loans to assist African countries in accessing foreign vaccines.
That is not all from several reports monitored. In April 2022, writing under the headline: “How Russia’s Hollow Humanitarian Hurt Its Vaccine Diplomacy in Africa,” – the co-authors, Matthew T. Page and Paul Stronski, both noted in 2020 that Russia touted deliveries of medical and protective supplies to several African countries, while the Russian-developed Sputnik V vaccine offered hopes that African countries would soon be able to launch large-scale immunization drives. Russian efforts to promote Sputnik V in Africa have floundered for a variety of reasons, including regulatory worries, production and logistical shortfalls, bureaucratic inertia, and even sticker shock. There is, however, another key factor behind Moscow’s failed vaccine diplomacy: its traditionally diminutive post-Soviet development presence on the continent.
Compared to Australia, Canada, the European Union, Japan, the United Kingdom, the United States, and even many foundations, Russia has provided a tiny share of international development assistance to African countries since the end of the Cold War. Unlike India and Cuba, it has provided scanty medical assistance to – or investment in – African countries.
Suppose Russia wants to be influential on the continent. In that case, African political and economic leaders should demand more of Moscow, not simply settle for the symbolic diplomatic engagements or agreements at which the Russian leadership excels. Indeed, Africa has not ranked high on the Russian foreign policy agenda for much of the past three decades, getting barely a mention in the country’s key security documents except as either a partner in an emerging multipolar world or a source of instability.
Indeed the time has come for African leaders to rally together to ensure that no effort is spared in facilitating and supporting the building of large-scale vaccine manufacturing capacity on the continent. The African Vaccine Manufacturing Summit held in April 2021 was an encouraging start. Focus needs to be on developing real vaccine R&D capacity, which must necessarily lead to health products. This requires substantial investment and a long-term commitment. In a similar vein, under the aegis of the African Union, leaders have to begin looking for inside solutions rather than base hopes on these geopolitical games, great external powers seeking only support for their peculiar or parochial interests.
Understandably, while making efforts to maintain and expand its presence in Africa, Russia simply lacks the capability to deliver on its various promises in Africa. Surely, African countries have to begin to re-evaluate their relationship with Russia. African leaders should not expect anything tangible from meetings, conferences and summits. Since the first Russia-Africa summit held in 2019, very little has been achieved. Given the stringent sanctions imposed following Putin’s invasion of neighbouring Ukraine, it is even more improbable that Moscow would commit adequate financial resources to invest in economic sectors.
In stark contrast to key global players, for instance, the United States, China and the European Union and many others, Russia obviously has limitations. Notwithstanding that, for Russia to regain a part of its Soviet-era influence, it has to address its policy approach, this time trying to shift towards new paradigms – implementing some of the decade-old pledges and promises, and those bilateral agreements; secondly to promote development-oriented policies and how to make these strategic efforts more practical, more consistent, more effective and most admirably result-oriented with African countries.
Fidson Shops For N3.5bn from Series 4 Commercial Paper Issuance
By Dipo Olowookere
A leading manufacturer of pharmaceutical and nutraceutical products, Fidson Healthcare Plc, is planning to get about N3.5 billion from the capital market.
The firm, which operates a World Health Organisation (WHO) compliant state-of-the-art manufacturing facility, is issuing series 4 commercial paper under its N10 billion commercial paper issuance programme.
Subscription for the exercise started on Friday, March 10, 2023, and will close on Thursday, March 16, 2023.
According to details of the sales, the least of the commercial paper of Fidson investors can purchase is N5 million.
Business Post reports that the tranche of this exercise is 268 days, with a yield of 14.50 per cent.
Funds from this series 4 commercial paper sales would be used to support the company’s short-term working capital and funding requirement.
Fidson is one of the top players in the Nigerian health sector and has maintained an organic growth strategy by investing in research, extensive distribution channels, and product innovation.
The organisation also associates with global partners to deliver high-quality products to its customers and insists on these same values across its entire value chain.
Fidson commenced operations on March 1, 1995, as a local distributor of pharmaceutical products and barely a year after, it began importing its brand of finished medicines, introducing Ciprotab and Peflotab brands of quinolones to the market.
By July 2002, the firm set up its first local manufacturing facility and later became the first company in sub-Saharan Africa to manufacture Antiretroviral (ARVs) drugs in March 2005.
In February 2007, Fidson set up a second manufacturing facility and ceded the former manufacturing facility to an international joint venture project, which led to the setting up of Ecomed Pharma Limited. In November of the same year, the company received the NIS ISO 9001:2000 certification for its Quality Management System from the Standard Organization of Nigeria (SON).
Expanding its business further, the company was listed on the floor of the Nigerian Exchange (NGX) Limited to become a publicly quoted company in 2008 and completed its 3rd factory (FPL) in the same year.
Further positioning itself as a leading pharmaceutical manufacturer in Nigeria, Fidson completed its 4th factory, an ultra-modern WHO-compliant plant in Ota, Ogun State, in 2016 and increased its capacity to manufacture more products across various therapeutic categories.
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