ON January 1, 2020, as the world welcomed a new decade, Chinese authorities in Wuhan shut down a seafood market in the central city of 11 million, suspecting that an outbreak of a new “viral pneumonia” affecting 27 people might be linked to the site.

Early lab tests in China pointed to a new coronavirus. By January 20 it had spread to three countries.

For most people, it was a minor health scare unfolding half a world away.

Nearly a year later it has changed lives fundamentally. Almost everyone has been affected, be it through illness, losing loved ones or jobs, being confined at home and having to get used to a whole new way of working, relaxing and interacting.

Almost 1.5 million people have died globally from the COVID-19 disease related to the coronavirus, and some 63 million people have been infected.

After the initial “wave” of the pandemic was brought under some semblance of control in many countries, nations are now fighting second and third waves even greater than the first, forcing new restrictions on everyday life.

Among the most haunting images to emerge from the pandemic in 2020 are those of medics on the frontlines of the battle against the virus.

In Milan’s San Raffaele hospital, seven intensive care unit staff attended to an 18-year-old patient suffering from COVID-19, pushing the bed into the ward and holding medical equipment and monitors.

Doctors and nurses like them swathed in protective gear – gowns, gloves, masks, and visors, some with their names or initials written on their uniforms – have become a familiar sight.

So, too, have images of medics collapsing from exhaustion or grief at losing one of their own to the disease.

By March and April, many countries began to impose lockdowns and social distancing to slow the spread of the highly contagious virus.

Structures to separate and protect people sprang up – from transparent screens at supermarket checkouts to the plastic sheet which allowed 83-year-old Lily Hendrickx, a resident at a Belgian nursing home, to hug Marie-Christine Desoer, the home’s director.

The effects on the natural world of the shutdown were sometimes astonishing. Birdsong could be heard like never before in towns and wild animals ventured into new empty cities.

At the usually crowded Golden Gate Bridge View Vista Point across from San Francisco, a coyote stood by the roadside.

Even the streets of Manhattan were eerily empty.

Ballet dancer Ashlee Montague donned a gas mask and danced in the middle of Times Square, New York.

In Brazil’s capital, Brasilia, Catholic priest Jonathan Costa prayed alone at the Santuario Dom Bosco church, among photographs of the faithful, attached to the pews.

Wearing masks to combat the spread of the virus became commonplace the world over.

At Tokyo’s Shinagawa train station, crowds of commuters wore face masks, as did prisoners crowded into a cell in El Salvador’s Quezaltepeque jail.

In private homes, families learned to live together 24 hours a day and how to entertain and teach their children.

In San Fiorano in northern Italy, school teacher Marzio Toniolo, 35, took a picture of his two-year-old daughter Bianca painting his toenails bright red.

The pandemic hit some of the world’s poorest people the hardest – exposing the inequalities in access to medical treatment and in government funds to compensate people who lost their livelihoods.

In South Africa in May, at the Itireleng informal settlement near Laudium suburb in Pretoria, people waited in a queue that stretched as far as the eye could see to receive food aid.

As 2020 heads to its close, vaccines are on the horizon. There is hope that some aspects of life as we knew it will return.

Source – Thomson Reuters Foundation.

SCIENTISTS are working around the clock to develop and test vaccines against SARS-CoV-2, the causative agent of COVID-19. Experts agree that widespread use of safe and effective vaccines will rapidly contain the COVID-19 pandemic, preventing transmission and disease.

A key step in the process of any vaccine development is clinical testing, which involves assigning a vaccine or a placebo to human subjects, then evaluating the health effects over a period of time. This testing helps to demonstrate safety in diverse human populations living in different settings, and to determine vaccine efficacy – the ability to prevent infection and disease.

Globally, COVID-19 vaccine trials are being conducted in all continents, representing all diverse human populations in the world. In Africa, Egypt and South Africa are participating in these trials. Many other countries are also preparing to participate.

To date there are 260 COVID-19 vaccine candidates at different stages of development. Sixty of these are undergoing clinical testing (human trials) in different phases. This includes phase III trials – the point at which scientists aim to determine how well a vaccine protects (efficacy) trial participants from infection or severe COVID-19 symptoms.

November 2020 has been a celebratory month. Preliminary phase III data of three different COVID-19 vaccine candidates showed impressively high efficacy ranging from 70% to 95%. All three – Pfizer/BioNTech, Moderna mRNA-1273 and Oxford ChAdOx1-S vaccines – are in the late stage of phase III clinical trials. Pfizer/BioNTech and Oxford ChAdOx1-S are being tested in Africa too. After investigations of an initial safety concern in phase III trial, the Oxford ChAdOx1-S vaccine testing has proceeded well.

The groundbreaking developments offer hope and optimism. But there are still major obstacles ahead, particularly for developing countries. Chief among these are the fact that at least one of the vaccines showing promise needs to be kept at extremely low temperatures prior to use. This will be a difficult ask for most African countries.

In addition, there are concerns about access to the vaccines once manufacturing starts. Among the key concerns is the availability of sufficient vaccine doses to meet the high demand. And then there’s the question of affordability. Resources will be urgently needed to procure and distribute COVID-19 vaccines at a rapid pace.

A great deal of focus is being placed on the COVAX Facility, a GAVI co-led global risk sharing plan. This is overseeing the pooling of procurement and equitable distribution of eventual COVID-19 vaccines.

The promise

There are three vaccines at phase III stage with a similar choice of an antigen – the SARS-CoV-2 spike protein. But they work differently in the way they teach the immune system to protect our bodies from COVID-19.

Pfizer/BioNTech is a mRNA vaccine. Such vaccines work by instructing the human cells to make a small part of the virus surface protein and induce the appropriate type of immune response that is thought to confer protection. In this case, it is an immune response to the SARS-CoV-2 spike protein. This protein plays a key role in enabling coronaviruses to infect human cells and replicate.

In some infected people, COVID-19 disease develops, whereas others remain asymptomatic, without any signs or symptoms of the disease. Preliminary data show no major safety concerns are associated with a two-dose administration of the vaccine. This mRNA-based COVID-19 vaccine induces T-cell and strong neutralising antibody immune responses. Both T-cell and antibody immune responses are thought to be critical in protecting against COVID-19. A similar mRNA vaccine, made by Moderna, has shown comparable results.

Efficacy of 95% has been reported for the Pfizer/BioNTech (mRNA) vaccine, far exceeding the expectations. This type of vaccine can be rapidly manufactured and scaled to capacity to meet the high demand for millions of doses. If licensed, it will be the first mRNA vaccine approved for human use by the regulatory authorities.

Oxford ChAdOx1-S is a non-replicating viral vector vaccine. The viral vector, or backbone, used in this vaccine is based on the chimpanzee adenovirus (ChAd). The choice of this type of vector is to circumvent common pre-existing immunity to human adenoviruses (HAdV) that would blunt the ability of such a vaccine to engage the human immune system.

Already, scientists have experience with clinical testing (safety and immunological profiles) of the ChAd viral vectored vaccines.

The Oxford ChAdOx1-S works by using a replication-deficient adenovirus vector to conveniently deliver the spike protein to immune cells or tissues, thereby inducing the desired immune response against SARS-CoV-2. The vaccine-induced immunity comprises of T-cell and strong neutralising (infection-blocking) antibody immune responses.

Novavax NVX-CoV2373 is a protein subunit vaccine. Subunit vaccines work by presenting a specific antigen that stimulates the immune system to mount a response. Importantly, these types of vaccines require combination with adjuvants (a compound that enhances an immune response), as the antigens alone are not enough to induce optimal and long-term immunity.

The antigen (spike protein) in NVX-CoV2373 vaccine is made and purified from cell culture, then formulated – along with Novavax’s saponin-based Matrix-M adjuvant – to a nanoparticle. There is vast clinical experience of this type of vaccine platform in terms of safety and immunogenicity, such as the seasonal influenza vaccine.

Preliminary data shows NVX-CoV2373 vaccine-induced immunity comprises T-cell and strong neutralising antibody immune responses. It is likely this two-dose schedule vaccine candidate will show high efficacy.

The problems

A big challenge for the Pfizer/BioNTec vaccine is the cold chain requirements. It needs to be transported and stored at unusually low temperatures (-70°C, on dry ice) prior to use. Immunisation programmes – particularly those on the continent – don’t have the vaccine supply and cold chain infrastructures that can optimally handle this vaccine. This is especially true at the level-one healthcare facilities where immunisations routinely take place.

This means that significant investments will have to be made prior to rollout to communities in remote areas. This could cause massive delays in the use of the vaccine, especially in low- and middle-income countries. The good news is that innovative approaches, such as the design and development of appropriate transport containers, may address these challenges.

The other two vaccines can be handled within the current immunisation cold chain infrastructure that keeps the temperature at a range of 2°C to 8°C prior to use.

Another potential challenge is that the use of any of these vaccines by national immunisation programmes will need to be informed by high quality and timely evidence that takes local context into consideration. This means national policymakers must urgently and meticulously consider the merits and demerits of each of the vaccines prior to deciding which one to use.

On cost and access, a great deal of effort is being put into the COVAX Facility. This seems to be Africa’s only insurance policy against being the last in the queue.

Source – The Conversation.

LARGE global trials of several COVID-19 vaccine candidates involving tens of thousands of participants are well underway with some having gathered sufficient data to seek emergency use authorisation.

The following is what we know about the race to deliver vaccines to help end the coronavirus pandemic that has claimed more than 1.45 million lives worldwide:

Who is furthest along?

U.S. drugmaker Pfizer Inc and German partner BioNTech SE released a full late-stage trial data analysis on Nov. 18 that showed their shot was 95% effective at stopping COVID-19, the highest efficacy rate so far.

U.S. pharmaceutical company Moderna released its full analysis on Monday, showing a 94.1% rate in its large, late-stage clinical trial.

Britain’s AstraZeneca this month also announced late-stage trial results showing an average efficacy rate of 70% for its vaccine and as much as 90% for a subgroup of trial participants who got a half dose first, followed by a full dose.

Interim late-stage trial results for Russia’s Sputnik V vaccine published on Nov. 11 showed the shot is 92% effective.

Johnson & Johnson says it is on track to deliver data this year.

What happens in these trials?

The companies are testing their vaccines against a placebo – typically saline solution – in healthy volunteers to see if the rate of COVID-19 infection among those who got the vaccine is significantly lower than in those who received the dummy shot.

How are the trial participants infected?

The trials rely on subjects becoming naturally infected with the coronavirus, so how long it takes to generate results largely depends on how pervasive the virus is where trials are being conducted. Each drugmaker has targeted a specific number of infections to trigger a first analysis of their data.

Early in the trials, infection rates were low. With a surge in infections around the globe in October and November, trial participants became infected more quickly.

Pfizer’s full results were based on 170 cases within its trial while Moderna’s full analysis was conducted after 196 participants developed COVID-19.

AstraZeneca said its interim analysis was based on 131 infections among participants who received the vaccine and those in a control group who were given an established meningitis shot. Russia’s interim examination was conducted after 20 volunteers developed the disease.

How well are the vaccines supposed to work?

The World Health Organization ideally wants to see at least 70% efficacy in trials. The U.S. Food and Drug Administration wants at least 50% – which means there must be at least twice as many infections among volunteers who received a placebo as among those in the vaccine group. The European Medicines Agency has said it may accept a lower efficacy level.

When will regulators rule on safety and efficacy?

U.S., U.K. and European regulators could rule within weeks on the vaccines.

Pfizer and filed for an emergency use authorization from the U.S. Food and Drug Administration on Nov. 20 and has a meeting set with the FDA advisory committee on December 10.

Moderna is filing for FDA emergency use authorization and European Union conditional approval on Monday. It expects to meet with the FDA advisory committee on December 17.

AstraZeneca said on November 23 it will immediately prepare the data to submit to regulatory authorities around the world that offer conditional or early approval.

Could these be the first widely available coronavirus vaccines?

Yes, although China launched an emergency use programme in July aimed at essential workers and others at high risk of infection that has vaccinated about one million people as of mid-November.

At least four Chinese vaccines are far along including those from China National Biotec Group (CNBG), CanSino Biologics and Sinovac Biotech.

Sinovac said on Nov. 18 that mid-stage trial results showed its CoronaVac vaccine triggered a quick immune response but the level of antibodies produced was lower than in people who had recovered from the disease.

Russia has also given the Sputnik V vaccine developed by the Gamaleya Institute to 10,000 members of the general population considered at high risk of contracting the virus.

Source – Thomson Reuters Foundation.

WORLD AIDS Day this year finds us still deep amid another pandemic – COVID-19.

The highly infectious novel coronavirus has swept across the world, devastating health systems and laying waste to economies as governments introduced drastic measures to contain the spread. Not since the HIV/AIDS pandemic of the 1990s have countries faced such a common health threat.

This explains why UNAIDS has selected the theme “Global Solidarity, Shared Responsibility” for this year’s World AIDS Day.

Infectious diseases such as these remain a major threat to human health and prosperity. Around 32.7 million people have died from AIDS-related illnesses in the last 40 years. At the time of writing, 1.4 million people had already died from COVID-19 in just one year.

These diseases take incredible expertise, collaboration and dedication from all levels of society to track, understand, treat and prevent.

The HIV/AIDS response played out over a much longer trajectory than COVID-19. But it is, in some respects, a shining example of what can be achieved when countries and people work together. The work of organisations such as the World Health Organisation, UNAIDS and the International AIDS Society help to coordinate rapid sharing of information and resources between healthcare providers and communities.

The Global Fund and PEPFAR have mobilised resources that have helped to reduce morbidity and mortality in low- and middle-income regions. AIDS-related deaths have declined worldwide by 39% since 2010.

These and other groups have also fought against high drug prices that would render medication inaccessible to many in the developing world. In South Africa, the epicentre of the HIV epidemic, a day’s supply of the simplest antiretrovirals cost about R250 in 2002. Today easier, more palatable treatment taken once per day costs a few rands.

Collaboration and co-ordination has also meant that medications have been developed and tested in populations across the world. And once available, global guidelines and training opportunities ensure that healthcare provision and quality is standardised.

Many of these achievements did not come without a fight. Dedicated and sustained activism, at a political and community level were required to drive down drug pricing for the global South and is constantly required to ensure inclusive distribution of resources.

The corollary is also true – areas where the world continues to struggle arise predominantly where there’s a lack of solidarity and agreement. These include a lack of political support to implement evidence-based protection mechanisms for vulnerable or stigmatised populations. For example the legalisation of homosexuality. This results in continued but avoidable HIV infection and related mortality.

These lessons need to be taken on board as the world prepares for the next phase of managing COVID-19. All the interventions that helped contain and manage HIV and AIDS are critical in ensuring that no country, regardless of developmental status, and no population, especially those that face stigma and battle to access healthcare services, are left behind.

Building on existing systems

The lessons learnt from HIV and AIDS can be used to inform the COVID-19 response as the challenges are similar.

Many of the ongoing COVID-19 vaccine trials are taking place in multiple countries, including South Africa. The capacity to conduct these studies, including the clinical staff and trial sites, are well established as a result of decades of HIV/AIDS research. There are fears that developing nations might be excluded from accessing an effective COVID-19 vaccine. But global mechanisms are now in place to avoid this and to, instead, encourage and enable global solidarity, some of which were championed by the HIV/AIDS response.

The Access to COVID-9 Tools (ACT)-Accelerator, established by the World Health Organisation in April 2020 in collaboration with many other global organisations, governments, civil society and industry, have committed through the pillar known as Covax, to equitable distribution of a COVID-19 vaccine as well as diagnostic tests and treatments. These global institutions and mechanisms require continued support.

With the deployment of an effective vaccine, an end to COVID-19 might soon be in sight. For HIV, vaccine development has been more complex and disappointing. The global community needs to remain committed to promoting access and support for the many incredible prevention and treatment options that are available. The unprecedented effort on the part of private industry in the COVID-19 vaccine response shines a light on what can be achieved when all interested parties engage. The HIV and TB vaccine endeavours need a similar effort.

These are not the only pandemics the world will face. In fact, there are strong predictions that the emergence of new pandemics will increase in the future. This is due to the effects of globalisation, climate change and proximity to wildlife.

The best hope for humanity is to not lose sight of what these pandemics cost us in terms of loved ones, in terms of freedom and economically. We must prepare now collectively across countries and across all levels of society. These preparations need to be grounded in the lessons learnt from HIV/AIDS and re-learnt from COVID-19.

Social solidarity

The success of the global response to current and emerging pandemics will rely on the ability of the less vulnerable to acknowledge their shared responsibility and respond to those calls.

An important truth of the HIV epidemic is that it doesn’t discriminate. No infectious disease acknowledges political borders and everybody is at risk of being infected or affected. If nothing else, because of this we need to continue to work together on a global scale knowing that “no one is safe, until everyone is safe”.

Carey Pike, Executive Research Assistant at the Desmond Tutu Health Foundation contributed to this article. 

Source – The Conversation.