Teachers in Kenya getting vaccinated. Will everyone now need a booster shot?

Shortly after the release of research showing reduced efficacy of the two-jab Pfizer-BioNTech COVID-19 vaccine against Omicron infection, but better protection with boosters, the World Health Organization (WHO) cautioned that more research is still needed to draw definite conclusions about vaccine strategies in the face of the new variant wave. 

A South African study released late Tuesday showed that people double-vaccinated with the Pfizer-BioNTech COVID-19 vaccine had significantly reduced protection against the Omicron variant, now reported in 57 countries.

On Wednesday morning, Pfizer reported that a third booster of its vaccine would provide significant protection against Omicron, according to a laboratory study.

“Sera obtained from vaccinees one month after receiving the booster vaccination neutralized the Omicron variant to levels that are comparable to those observed for the wild-type SARS-CoV-2 spike protein after two doses,” according to a statement from Pfizer.

While double-vaccinated people had a “more than a 25-fold reduction in neutralization titers” against Omicron, they would likely still still be protected against severe disease thanks to their T cells which are not affected by the Omicron mutations, according to Pfizer.

“Although two doses of the vaccine may still offer protection against severe disease caused by the Omicron strain, it’s clear from these preliminary data that protection is improved with a third dose of our vaccine,” added Pfizer CEO Albert Bourla.

Late Wednesday, South Africa’s medicine regulatory authority approved boosters for all adults over 18 who had been vaccinated at least six months ago, and for all immunocompromised people over the age of 12 vaccinated at least 28 days ago. No other southern African countries have authorised boosters yet, although the region was the first to detect Omicron.

WHO says Pfizer results are preliminary & top priority remains jabs for the unvaccinated

Dr Kate O’Brien, WHO Director of Immunization, Vaccines and Biologicals,

In a press briefing later Wednesday afternoon, Dr Kate O’Brien, WHO Director of Immunization, Vaccines and Biologicals, said that the WHO was “very much interested” in the Pfizer findings, but these were preliminary and only concerned one vaccine. 

“We are still very much in a Delta pandemic and so vaccinating all people, especially those at highest risk of disease, with our existing vaccines, continues to be the top priority,” O’Brien told the global body’s COVID-19 briefing on Wednesday.

WHO has spoken out repeatedly against mass administration of booster shots – saying that available vaccine supplies should instead be focused on getting jabs to less-developed countries, mostly in Africa, where less than 40% of  people have yet to get jabs.

Meanwhile, WHO Director-General Dr Tedros Adhanom Ghebreyesus called on all countries to share information about Omicron speedily, as what was happening in South Africa might not be the same as the rest of the world.

“Cases in South Africa are increasing quickly,” Dr Tedros told the media briefing. “However Omicron was detected when transmission of Delta was very low so it had little competition. It will therefore be important to monitor carefully what happens around the world to understand whether Omicron can outcompete Delta.”

WHO Lead on COVID-19, Dr Maria Van Kerkhove, added that the South African population was young and had a high level of exposure to COVID-19 from previous outbreaks, which might lessen Omicron’s impact.

WHO Chief Scientist Dr Soumya Swaninathan also warned that it is too early to come to any conclusions about the efficacy of vaccines against Omicron as the only available studies showed a “wide variation” and samples were small.

New South African findings also show reduced efficacy from two-shot vaccines against Omicron

On Tuesday night, Alex Sigal of the Africa Health Research Institute in South Africa released research on 12 double-vaccinated people, which found a 41-fold reduction in neutralising Omicron. Six of the 12 subjects had also previously been infected by SARS-COV2 and five of these showed a high level of protection against Omicron.

However, the research showed that the variant still used the ACE receptor to bind to the spike protein.

But Swaminathan stressed that “[these studies] are only looking at one element, just the neutralising antibodies”.

“It’s premature to conclude that this reduction in neutralising activity would result in a significant reduction in vaccine effectiveness. The immune system is much more complex, with the T cells and the memory B cells. What we really need now is a coordinated research effort and not jumping to conclusions, study by study,” she added.

The WHO expects information about how infectious Omicron is on Friday, and said that a number of high-level scientific committees were examining Omicron.

WHO Chief Scientist Dr Soumya Swaninathan

WHO expert bodies are examining Omicron

“The technical advisory group for virus evolution is assessing Omicron’s effect on transmission, disease severity, vaccines, therapeutics and diagnostics and the effectiveness of public health and social measures,” said Dr Tedros.

The joint advisory group on COVID-19 therapeutics is analysing the possible effects of Omicron on treatment of hospitalised patients. 

The Research and Development Blueprint for Epidemics is convening researchers to identify knowledge gaps, and the studies needed urgently to answer the most pressing questions. And the technical advisory group for COVID-19 vaccine composition is assessing impacts of Omicron on current vaccines, said Dr Tedros.

Describing the idea that viruses became less virulent as they evolved as “something of an urban myth”, the WHO’s Assistant Director-General for Health Emergencies, Dr Mike Ryan, said that even if this was the case with Omicron, if it generated more cases this would put pressure on health systems and more people die. 

“That’s what we can avoid. We cannot do anything about maybe the inherent qualities of a virus but we can prevent our systems coming under pressure,” stressed Ryan – through vaccination, masks and reducing social contact. 

Lift the travel bans – end ‘travel apartheid’

Dr Tedros thanked Switzerland and France for lifting their travel bans on southern Africa and called on other countries to do the same.

However, on Monday the UK added Nigeria to its red list, while many countries are only likely to reassess the bans after a month – way too late to salvage the Christmas tourist season in southern Africa.

The moves by developed countries to shut out travelers from southern Africa, or all of Africa in some cases, were last week denounced as “travel apartheid” by UN Secretary General Antonio Guterres.

Guterres said it was “unacceptable to have one of the most vulnerable parts of the world’s economy condemned to a lockout when they were the ones who  revealed the existence of a new variant.”

His comments were echoed this week by Nigeria’s Ambassador to the UK, Sarafa Tunji Isola, who told the BBC that “the reaction in Nigeria is that of travel apartheid.”

“Because Nigeria is actually aligned with the position of the UN secretary general that the travel ban is apartheid, in the sense that we’re not dealing with an endemic situation, we are dealing with a pandemic situation, and what is expected is a global approach, not selective,” Isola said.

Image Credits: Wish FM Radio.

Dr Michel Sidibe, WHO’s Mariangela Simao and representatives from African medicine national regulatory authorities.

The newly constituted African Medicines Agency (AMA) will be key in assisting the African Union (AU) to achieve its aim of producing 60% of vaccines on its own soil by 2040.

This emerged at a two-day meeting of the Partnership for Africa Vaccine Manufacturing (PAVM) hosted by Rwanda this week. The PAVM was set up six months ago by the AU and Africa Centre for Disease Control and Prevention (CDC) to drive vaccine development. 

Major global pharmaceutical companies Pfizer, BioNTech, Moderna and Johnson and Johnson told delegates that vaccine manufacturing required long-term, capital intensive investment.

But they also stressed the need for a harmonised regulatory environment to ensure the smooth and speedy assessment and registration of vaccines and medicines.

That’s something that the AMA, could provide, once the agency is fully operational.  The AMA Treaty formally came into force on 5 November after the AMA treaty was formally signed and ratified by 15 African countries.  Altogether some 28 of Africa’s 55 countries have aligned with the treaty by signing and or ratifying it, as the continent ‘counts down’ to full buy-in from AU nations – with Uganda as the most recent country to ratify the treaty instrument.

But major countries like South Africa, Nigeria and Kenya are among the 27 countries that have yet to sign. 

Differing skills

Michel Sidibe, the AU Special Envoy for the AMA, said that the agency needed to “create a safe environment for investment”.

“You will not attract investors if you have some countries with 40% of fake drugs or substandard drugs,” said Sidibe. “A harmonised regulatory system will help us to create a safe environment for investment from our own continent, and with partners who want to come and invest in our countries.”

He added that “if we produce vaccines and drugs and we don’t have a mechanism on our continent to fast track the authorization process, it will not be helpful for our countries”.

Country medicine regulators appeal for training

While skills at the different country medicine regulators differ considerably, a panel featuring five national regulators, including South Africa, Morocco and Ethiopia, appealed for more support as the continent prepares to manufacture vaccines.

Tumi Semete-Makokotlela, head of the South African Health Products Regulatory Authority (SAHPRA), said that harmonisation of processes across all 55 African states was important “so that we can rely on each other’s decisions”.

She also appealed for investment in the regulators’ capabilities so that they could “do full lifecycle product management” from oversight of the clinical trials to product approval, pharmacovigilance and post-regulatory monitoring of products. 

Professor Bouchra Meddah, Director of Pharmacy and Medicines in Morocco’s Ministry of Health, also appealed to the Africa CDC, AMA and the World Health Organization (WHO) to provide technical assistance and staff training to all the regulators so that they were “all at a sufficient level in order to manufacture the vaccine”. 

Heran Gerba, Director-General of Ethiopia’s  Food and Drug Authority, called for medical products’ approval processes to be expedited and efficient, adding that Ethiopia had an electronic regulatory information system for licencing,  registration, pre-import permits and for imports, which had improved efficiency.

The regulators have some experience in working together at the African Vaccines Regulatory Forum (AVAREF), which was set up in 2006 by the WHO to improve regulatory oversight of clinical trials conducted in Africa. AVAREF has also played an important role in accelerating the review of Ebola vaccines.

AU Special Envoy for the AMA, Michel Sidibe

WHO benchmarks

The WHO benchmarks regulators and currently only two on the African continent – Ghana and Tanzania – have maturity level three, defined as a “stable, well-functioning and integrated regulatory system”.

However, Dr Mariângela Simão, WHO Assistant Director-General or Drug Access, Vaccines and Pharmaceuticals, said 44 African countries had been assessed using the global benchmarking and “a few others are on a fast track to achieve maturity level three”.

“Ideally, I would like to have at least half of the countries in five years times with maturity level three,” said Simao.

Dr Margareth Ndomondo-Sigonda, Head of Health Programmes at the AU Development Agency, NEPAD, said the AU wanted to assist countries to get maturity level three primary through regional centres of excellence.

These regional centres could, amongst other things, create legal frameworks to support harmonisation of vaccine manufacturing regulatory models; develop vaccine manufacturing knowledge; build leadership skills and develop sustainable financing mechanisms, she said.

Sidibe urged that AMA “should become a reality quickly”. 

“We should do whatever we can to quicken the pace of implementation and operationalisation,” he stressed. “It will help us to tap into the African Free Trade Agreement”.

The AMA treaty has been ratified and deposited by 18 African countries at present, with Uganda the most recent to have signed.  See the interactive map here: 

 

 

An AU session early next year is to determine the seat of the new Agency.  Meanwhile, the buy-in from other major AU nations, particularly South Africa and Kenya, as well as Nigeria, will be much-awaited milestones in the full operationalizing of the AMA vision. 

See more resources and details on the developing African Medicines Agency here on our Health Policy Watch ‘countdown’ site.

The ‘African Medicines Agency Countdown’

 

USAID has assisted Sudan with its cold chain storage for COVID-19 vaccines.

The US Agency for International Development (USAID) has set up a new global initiative to accelerate COVID-19 vaccination efforts, called the Initiative for Global Vaccine Access (Global VAX), the agency announced on Monday

Global Vax’s aim according to USAID, is to “get COVID-19 shots into arms and enhance international coordination to identify and rapidly overcome access barriers to save lives now, with a priority on scaling up support to countries in sub-Saharan Africa”.

Global VAX will coordinate the US government’s COVID-19 vaccination efforts. The US government has already committed more than $1.3 billion for vaccine readiness, and USAID Administrator Samantha Power announced an additional $400 million in American Rescue Plan Act funds, from the  US Congress, to augment this work. 

“Global VAX includes bolstering cold chain supply and logistics, service delivery, vaccine confidence and demand, human resources, data and analytics, local planning, and vaccine safety and effectiveness,” according to the agency.

The announcement was made at a ministerial meeting of key international development partners from around the world, convened by Power.

“The emergence of COVID-19 hotspots and variants including Delta and Omicron further underscore the importance of our global fight. Vaccinating the world is the best way to prevent future variants that could threaten the health of Americans and undermine our economic recovery,” according to USAID.

Global VAX includes:

  • $315 million to support vaccine delivery and get shots in arms in low and middle-income countries.
    This investment will support country-specific needs to ramp up vaccination rates and get more shots in arms. These activities include investing in cold chain and supply logistics to safely store and deliver vaccines; supporting national vaccination campaigns; launching mobile vaccination sites for hard-to-reach and rural populations; assisting countries in vaccine policy-making and planning for strategic health care worker and resource deployment; and supporting the development of health information systems to better evaluate vaccine distribution equity and monitor vaccine safety.
  • $10 million to support in-country vaccine manufacturing.
    This investment will support countries poised to produce vaccines themselves to help them build regulatory capacity, transfer “know-how” to train emerging manufacturers, and provide strategic planning and other assistance. This will enable countries to boost vaccine manufacturing locally, which not only diversifies international production, but also has the potential to drive new investments in local economies and create jobs. This investment strategically complements the U.S. International Development Finance Corporation’s investments to scale regional manufacturing of COVID-19 vaccines.
  • $75 million for additional support for USAID’s Rapid Response Surge Support.
    USAID’s Rapid Response Surge Support delivers life-saving resources to COVID-19 hotspots, or areas experiencing surges in cases. This investment will help strengthen oxygen market systems to improve reliable oxygen production and delivery—often the most critical and in-demand resource needed in communities experiencing COVID-19 surges.

 

Image Credits: USAID.

 

Pharma Panel: Moderator Glaudina Loots (South African government), Sai Prasad (Bharat), Holm Keller (BioNTech), Patrock van der Loo (Pfizer), Adrian Thomas (J&J), John Lepore (Moderna) and Charles Wolf (Sanofi)

The African Union has made steady progress to manufacture vaccines on the continent, but this is a complicated, expensive endeavour that required long-term commitment, Big Pharma companies warned.

Welcoming delegates to the Partnership for African Vaccine Manufacturing (PAVM) reportback six months after it was set up, Rwandan President Paul Kagame said building pharmaceutical manufacturing on the continent had become a matter of life-and-death.

“Africa’s challenges during the COVID pandemic in securing timely access to tests, therapeutics and vaccines have served as a constant reminder that we need to be doing things for ourselves,” said Kagame.

“That does not mean acting alone. Vaccine research and production is fundamentally a global enterprise. We therefore have to work in partnership with each other as Africa and also with key partners around the world,” said Kagame.

He said that the recent ratification of the African Medicines Agency treaty was an important development.

“It is essential to maintain the momentum and fully establish this agency without which Africa cannot independently authorise and register medicines and vaccines,” said Kagame.

He also hailed agreements reached between Rwanda and Senegal and the German company, BioNtech, to start the production of mRNA vaccines as early as next year, as well as the mRNA tech transfer hub set up in South Africa by the World Health Organisation (WHO), which “is working with South African companies to build valuable knowledge best for our continent”.

“These initiatives underway in various countries are evidence of a strong momentum which must be supported and sustained. Because of this terrible pandemic, an opportunity has been created to fundamentally change the pharmaceutical production landscape on our continent,” he concluded.

Africa CDC’s John Nkengasong

Dr John Nkengasong, executive director of the Africa Centres for Disease Control and Prevention (CDC), stressed that partnerships were central to the continental goal of producing 60% of vaccines it needed by 2040. Currently, this figure is 1%.

Nkengasong said one of the meeting’s aims was to get agreement on “an AU-endorsed approach for facilitating regulatory approval processes, which will be packed with what we call potential pathways that we can use because of the speed at which the continent is moving in producing vaccines”.

Options for vaccine authorisation, as presented by Dr Nkengasong.

Complexity of vaccine development

Later in the day, a panel addressed by key Pharma companies stressed the complexity and expense of vaccine development.

Sanofi’s Charles Wolf said that “very long term agreements, and stable negotiations, are vital, vital for vaccine stability”.

Pfizer representative responsive for Africa, Patrick van der Loo, said that for most of his company’s vaccines, tech transfers for formulation and fill finish took around three years.

In July, Pfizer signed a letter of intent with the Biovac Institute in South Africa to manufacture the Pfizer-BioNTech COVID-19 vaccine for distribution within the African Union. 

“To facilitate Biovac’s involvement in the process, the tech transfer, the onsite development, the equipment installation activities, have begun basically immediately,” said Van der Loo.

“We expect that the Cape Town facility will be incorporated into our supply chain by the end of this year,” he added, saying that the company would get the drug substance from facilities in Europe soon and manufacturing of finished doses will commence early in 2022.

“At full operational capacity, the annual production there will exceed 100 million finished doses and all these doses will exclusively be distributed within the 55 member states that make up the African Union,” he added.

However, he warned that challenges experienced in South Africa included unstable power supply and water shortages.

Step-by-step approach

Adrian Thomas of Johnson and Johnson (J&J), which has a partnership with the South African pharmaceutical company, Aspen, said that this relationship was being built in a “thoughtful way, step-by-step building on strength and experience”.

“The overarching message that we have for Africa is that we support, and want to be part of, the long-term strategy for manufacturing internally and across the industry. But it’s it is going to be critical to look at multiple platforms and make sure that we distribute the risk across platforms across diseases and have stepwise progress. It has to be sustainable for the long term,” he stressed.

Moderna’s John Lepore said it was exciting that Africa had a continental strategy for vaccine manufacture – the only region in the world to do so.

“We have committed to spend up to $500 million to produce a factory that can make up to 500 million doses. And it’s really the [PAVM] strategy that gives us the confidence to make that investment,” said Lepore.

“We’re currently doing our own due diligence to make the final site selection, and when we look at the key criteria we need to be successful, they match very well with the strategy that already been developed by the African Union, and the African CDC.”

Production of Sinopharm’s inactivated COVID-19 vaccine candidate.

Not just fill-finish

Unlike the other companies that were mostly involved in fill-finish arrangements with African companies, BioNtech’s Holm Keller said that it wanted its malaria and TB vaccines be manufactured in Africa “end-to-end for drug substance and drug product”

“We have started working on a factory set up that would produce formulated drug bulk,” said Keller. “BioNtech’s focus will be on drug substance and not on fill-finish.”

He added that his company intended to  start building the first factory in a few months in 2022, although he did not disclose where this would be other than to mention meetings in Ghana and South Africa.

Sai Prasad, CEO of Indian manufacturer Bharat, stressed that the “complexity of vaccine  development and manufacturing cannot be overstated”. 

“It takes sometimes decades to develop vaccines. It takes a big amount of investment – usually more than $100 or $200 million, irrespective of whether it is fill-finish or drug substance. 

“And when you make those investments, there has to have stability over a 20 or 30 year period for a vaccine manufacturing company or a product development company to take root and take shape.”

The PAVP meeting continues on Tuesday.

Image Credits: Sinopharm.

Ambassador Grata Endah Werdaningtyas, co-chair of the Working Group on Strengthening WHO Preparedness and Response to Health Emergencies

Now that the World Health Assembly Special Session has overwhelmingly resolved to negotiate a “pandemic accord”, the urgent work of producing a workable plan to tackle future pandemics begins.

This was the view of speakers – most of whom have been integrally involved in “pandemic accord” discussions – addressing an event convened by the Global Health Centre at the Graduate School of International and Development Studies (IHEID) and the United Nations Foundation on Friday.

Colin McIff, co-chair of the Working Group on Strengthening WHO Preparedness and Response to Health Emergencies (WGPR) that brokered the pandemic accord decision, said the two mandates of group were almost “in conflict”.

The first was to assess the International Health Regulations (IHR) that currently govern health emergencies, scanning them for gaps, and the second was to examine the benefits of setting up a WHO instrument on pandemic preparedness and response. 

“These were very challenging mandates,” said McIff, who is Deputy Director of Global Affairs at the US Department of Health and Human Services.

“What we did as a bureau [of the WGPR] very early on was agree that the only way to achieve progress was to keep them as integrated as possible.”

“It was necessary to look at the existing tools and and regulations like the IHR, before looking at a new instrument and to define what those gaps are,” said McIff. 

By the fourth WGPR meeting, the issue of equity was put squarely on the table by the Africa group, added McIff.

The WHASS showed that “there was consensus among Member States, both to take forward a new instrument and to take concrete meaningful steps to strengthen the IHR and to tackle some of these key issues like equity, like sample sharing, like One Health issues”, he added.

Colin McIff, co-chair of the Working Group on Strengthening WHO Preparedness and Response to Health Emergencies (WGPR)

Elusive issue of equity

Indonesia’s Ambassador Grata Endah Werdaningtyas, the other WGPR co-chair, said the pandemic treaty is “a little bit burdened by the hopes of a lot of member states in terms of finding the final solution of our problem”.

“The treaty itself is not a panacea. It has to work in coherent alignment with the existing mechanisms that we have, including the IHR,” she stressed. “The treaty will not stand on its own.”

Werdaningtyas conceded that inequity would not be solved by a new instrument but could be addressed by, for example, “building core capacity in terms of supply compliance and in terms of strengthening our health system”.

WGPR member Dr Malebogo Kebabonye said that WHO member states now had to define how a pandemic accord would work, says, adding that the working group would continue to operate until mid-2022 as it still had to conclude proposals on how to strengthen the IHR.

Pandemic focus, not panacea

Prof Ilona Kickbusch

Despite the WHO now referring to the new instrument as an “accord”, Professor Ilona Kickbusch, said she insisted on it being called a treaty.

She said clarity needed to be reached about its focus – and that it could not be about solving all the problems in global health over the past 75 years, as some seemed to think.

“There is no process of proclaiming a pandemic. If there is to be one, what would this trigger?” asked Kickbusch, chair of the Global Health Center’s International Advisory Board. 

She also said there was an urgent need for increased financing.

“My hair stands on end when I see the expectations on the WHO emergency programme [in comparison to] its budget.

Impatience is giving way to anger

Preeti Sudan, a member of the Independent Panel for Pandemic Preparedness and Response

However, speakers also expressed frustration that the final text of a pandemic accord would only be presented to the 2024 Wold Health Assembly.

“The pandemic is still raging, reinventing itself, throwing up new challenges. Financing is required urgently, the WHO needs to be strengthened. It needs independent financing. How do we do that?” asked Preeti Sudan, a member of the Independent Panel for Pandemic Preparedness and Response.

“Do we need do we then wait for 2024? How do we address issues of inequity? The situation is dynamic and extremely serious.”

Elhadj As Sy, Co-Chair of the WHO Global Preparedness Monitoring Board, also appealed for urgency.

“What we really have not really taken into account fully is the degree of impatience that is really growing among citizens and communities,” he said.

“That is translating into anger. And that is translating into mistrust and then we should not let that continue. Because then we will not only have a health problem or a pandemic to deal with but a much bigger societal and political issue that will threaten all our efforts.”

Elhadj As Sy, Co-Chair of the WHO Global Preparedness Monitoring Board
PAHO Director Carissa Etienne

Following the detection of the newest WHO COVID-19 variant of concern, Omicron, in Canada and Brazil, and most recently, the US, the Pan American Health Organization (PAHO) has urged countries to “redouble their surveillance efforts in the region, warning that it is likely that the new variant will likely be circulating in other parts of the Americas soon. 

Omicron was first identified in southern Africa late November. Concern has been raised over the fact that the variant has over 30 mutations in the spike protein, the site usually targeted by COVID-19 vaccines.

The first known US case of the variant was announced late Wednesday – a fully vaccinated person in California who returned to the country from South Africa on 22 November and tested positive seven days later. 

In addition, Canada has reported six cases of Omicron while Brazil has reported 2. Delta remains the predominant variant in the region. 

PAHO is currently working with health ministers in the region and will share guidance and updates on Omicron as it becomes available, said PAHO Director Carissa Etienne during a media briefing Wednesday. 

“Speed and transparency is most critical, but above all, we urge people to not be frightened.” 

PAHO officials also discouraged the spread of rumors surrounding the variant, and urged people to continue to get vaccinated. 

“There are many rumors saying, ‘This vaccine doesn’t work, that other vaccine doesn’t work [against Omicron]. But these are just rumors,” said PAHO’s Assistant Director Jarbas Barbosa.

“Within two to three weeks, we will have more valid, accurate information about the ability to neutralize the new variant with the antibodies generated by the vaccine, but until we have more information, we should continue vaccinations.” 

PAHO Assistant Director Jarbas Barbosa

COVID cases predominantly on the rise in the Americas 

Over 753,00 new COVID-19 infections and 13,000 COVID-related deaths were reported in the Americas in the past week, PAHO announced on Wednesday.

Cases in Canada and the United States remain steady but high. Infections and deaths have dropped by over 20% in Mexico.

Central America has seen a reduction in cases and deaths over the last week, with the exception of Panama. 

In South America, cases in the Southern Cone region have increased steadily over the last several weeks, while in the Andean region and Brazil, cases have plateaued. 

Meanwhile, in the Caribbean, cases are on the rise in the Cayman Islands and Anguilla.  

Etienne highlighted the need for countries to sustain public health measures to limit the transmission of the virus.

“This pandemic is dynamic and the decisions we make about upholding preventive measures and expanding access to vaccines will influence how far this virus spreads.”

Vaccine inequity prolongs pandemic 

In light of fears surrounding Omicron, PAHO reiterated how vaccine inequity would continue to prolong the pandemic.

 “The more COVID-19 circulates, the more opportunities the virus has to mutate and change,” said Etienne. 

Only 54% of people in Latin America and the Caribbean have been fully vaccinated against COVID-19. 

Though the WHO had established a target for countries to reach at least 40% of their population vaccinated by the end of 2021, only 20 countries in the Americas have reached the overshot that goal, while 15 countries in the region still have less than 40% vaccinated.

The vaccine inequity is evident in the region – four countries have more than 70% of their populations vaccinated, but two countries still have not reached even 20% in the Americas – Jamaica and Haiti .

Haiti has less than 1% of its people fully vaccinated against COVID-19, while Nicaragua has 17%. Both countries had failed to reach the original goal of vaccinating at least 10% of their people back in September. 

“While progress is being made, there is still a persistence of a situation of inequality and inequity in access,” Barbosa noted. 

Increased access to antiretroviral therapy still needed 

To commemorate World AIDS Day, 1 December, PAHO officials called for increased access to vital treatments such as antiretroviral therapy (ARV), by combating the still-existing discrimination and stigma in health care, as well as the disruptions in services due to COVID-19. 

“Expanding access [to HIV treatment] is only possible if we combat the persistent stigma and discrimination that keep health services out of reach from too many men who have sex with men, transgender women, and sex workers across our region,” said Etienne. 

For people living with HIV, proper ARVs can help keep their disease in check and avoid infection. However, this requires consistent access to these life-saving drugs.

Even before the pandemic, just 65% of people living with HIV were receiving antiretroviral therapy. But the pandemic has caused more countries to report partial disruptions in services.

But while the region is falling behind on the 2030 target to reduce new HIV infections and eliminate AIDS-related deaths, significant progress  has been made with new treatments for people living with AIDS. 

In order to reach the 2030 target, Etienne emphasized the need for a human-rights approach to addressing the AIDS pandemic.

“Our AIDS-elimination responses must reflect the cultural and sexual diversity, gender equality, and human rights, with active participation from communities most affected.” 

Image Credits: PAHO.

SA launches a COVID-19 vaccination drive in schools on Thursday as the country enters a fourth wave of infection amid the highly infectious Omicron.

CAPE TOWN – While much is still unknown about Omicron, the new COVID-19 variant, South African health officials are “optimistic” that the current vaccines will continue to offer protection against severe illness and death.

Speaking from Gauteng province, South Africa’s economic hub and the place where Omicron was first sequenced, Dr Mary Kawonga told a media briefing on Thursday that “analysis is continuing but we are optimistic”.

Hospitalisations are lower than at a similar point in the province’s previous COVID-19 wave, which was driven by the Delta variant, said Kawonga, a public medicine specialist who made a presentation on behalf of the Gauteng Premier’s COVID-19 advisory group. 

Gauteng is currently the epicentre of South Africa’s fourth COVID-19 wave and scientists have shown that the current infections are being driven by Omicron, not Delta as in the previous wave.

During the Delta third wave, vaccinations were not widely available whereas currently 42% of South Africa’s adult population is now vaccinated.

Based on current figures, statisticians predict that Gauteng will record less than half the hospitalizations of the previous wave when this (fourth) wave peaks, likely in two weeks’ time –  an estimated 4000 hospitalisations in comparison to 9,500 previously.

Currently, most of those hospitalised are people under the age of 39, a group that has lower vaccination rates than older people. 

In addition, deaths were “significantly lower”, reported Kawonga.

Highly infectious

However, the rate of infection appears significantly faster than Delta, with Gauteng cases increasing by over 20% per day. By 22 November, the Reproduction number (R) had increased to 2.33 with 12,5% of tests being positive for the week ending 27 November – a whopping 261% increase compared to the previous week.

Johannesburg – the biggest city in the province – recorded 155 COVID-19 cases in the first week of November but this had shot up to 3,595 cases two weeks later.

Cases are starting to rise rapidly in the rest of the country too, and late Thursday South Africa reported 11,535 new COVID-19 cases, an increase of 368% from last week, and a case positivity rate of 22,4%.

Reinfection does not offer protection

Aside from the rapid transmission rate, scientists are also concerned that previous infection from COVID-19 does not appear to offer protection from Omicron infection.

“Many [South Africans] have had previous COVID infection and we believe that previous infection does not provide them protection from infection due to Omicron,” Professor Anne von Gottberg, told a media briefing on Thursday called by the World Health Organization’s (WHO) Africa region.

Von Gottberg, a microbiologist from South Africa’s National Institute for Communicable Diseases, said that this was in contrast to during the Delta-driven third wave when those previously infected had been protected from reinfection.

‘“We believe that vaccines will still, however, protect against severe disease. Vaccines have always held out to protect against serious disease, hospitalisations and death,” she added.

Ghana and Nigeria identify Omicron

Dr John Nkengasong, Director of the Africa CDC

In the past few days, Omicron has been identified in Ghana and Nigeria, aside from Botswana and South Africa, according to Dr John Nkengasong, Executive Director of the Africa Centre for Disease Control (CDC). Over 23 countries worldwide have also found the variant, the WHO reported on Wednesday.

But WHO Africa virologist Dr Nicksy Gumede-Moeletsi reports that only half of African States have the capacity to do their own genome sequencing which would enable them to identify the variant. 

However, only southern Africa and to a lesser extent, the north of the continent, are experiencing significant case increases.

“In the past week (22 – 28 November 2021), a total of 52,300 new cases were reported in Africa. This is a 105% increase from the previous week,” said Nkengasong. “The highest proportion of new cases is from the Southern region, which accounts for 63% of new cases.”

The Northern region had reported a 25% increase in cases, while there were small upticks in the Eastern (8%), Western (3%) and Central (1%) regions.

Dr Richard Mihigo, WHO Africa’s co-ordinator of immunisation, said that the global body was ready to help member states and was currently helping Botswana to increase its oxygen capacity.

WHO officials reiterated that the travel bans imposed on a number of African countries in the wake of Omicron’s identification were “unfair” and would deter other countries from reporting variants as required by the International Health Regulations. South Africa reports losing $63-million in tourist bookings since the variant was announced.

Image Credits: Gauteng Department of Health.

Standing ovation at special World Health Assembly session that decides to negotiate a new pandemic accord

The World Health Assembly Special Session (WHASS) closed on Wednesday with a standing ovation as virtually all 194 Member States committed to negotiating a new global accord to guide the response to future global pandemics.

The World Health Organization’s (WHO) Director-General, Dr Tedros Adhanom Ghebreyesus, described the decision as “cause for celebration, and cause for hope, which we will need”.

While Dr Tedros warned that “there are still differences of opinion about what a new accord could or should contain”, delegates had “proven to each other and the world that differences can be overcome, and common ground can be found”.

“A convention, agreement or any other international instrument will not solve every problem, but it will provide the overarching framework to foster greater international cooperation and provide a platform for strengthening global health security,” Dr Tedros told a later press briefing.

WHO Assistant-Director-General for Health Emergencies and International Health Regulations (IHR), Dr Jaouad Mahjour, said what had emerged from over 300 recommendations was that the new pandemic would rest on four major pillars.

He identified these as governance and leadership; financing of preparedness; global mechanisms that can be activated during the crisis, and finally, equity, including equitable and timely access to goods.

WHO legal advisor Steven Solomon added that negotiating any global agreement was “complicated”. 

“What is important is that there be a transparent, inclusive and consensus-driven process among Member States to work it out,” added Solomon.

Driven by ‘almost complete consensus’

WHA Vice-Presidents Professor Benjamin Hounkpatin (Benin) and Dr Hanan Al Kuwari (Qatar)

WHASS vice-president, Qatar’s Dr Hanan Al Kuwari, praised the “near complete consensus on the path we must take”.

This path involves:

  • The WHO convening the first meeting of the intergovernmental negotiating body (INB) by 1 March 2022
  • A draft global agreement by July 2022
  • The second INB meeting by August 2022
  • Discussion of the draft agreement at the WHA in May 2023
  • Adoption of the agreement at the 2024 WHA.

However, other issues will also impact on the negotiation process. These include the working group on sustainable finance for the WHO, a proposal for a pandemic standing committee of the WHO executive board, and the call to strengthen both the WHO and the International Health Regulations (IHR) before the next World Health Assembly.

Chile’s Frank Tressler and Australia’s Sally Mansfield, the countries that chaired the informal member state negotiations that thrashed out the decision, were also upbeat about the outcome.

“Today was have taken the first step in the process that calls upon all of us to work together,” Tressler told the assembly. “Pandemics recognise no borders. It is therefore very important that we have a consensus among Member States and equity must be at the centre of our new international instrument.”

“The text before us is the product of extensive discussions, of frank exchanges and of compromises, but above all, it represents a shared commitment to an ambitious, coordinated whole-of-government and whole-of-society effort to strengthen pandemic prevention, preparedness and response,” said Mansfield. 

Australia’s Sally Mansfield

Mansfield also credited the hard work of the “Bureau” of six countries that guided a months-long review by a Working Group of member states examining the International Health Regulations (IHR) needs and gaps, headed by the US and Indonesia, for having “laid the groundwork” for the decision.

As reported earlier by Health Policy Watch, Colin McIff,  deputy director of the office of global affairs in the US Department of Health and Human Services, had been positive about the potential advantages a new treaty could offer in  light of the failings of the existing IHR legal framework.  

Speaking on behalf of the 43 Member Countries that made up the Group of Friends of the Pandemic Treaty, Costa Rica described the WHASS decision as a “turning point”.

“The challenge of distributing vaccines throughout the world, and the slow reaction to the crisis, must be dealt with at the highest level and lead to a timely, coherent and coordinated response from all member states,” said Costa Rica. 

The Group of Friends facilitated informal negotiations on the pandemic “treaty” – now being referred to as a convention, instrument and agreement – that led to speedier agreement on the current decision, and could play a similar role in the new discussions outside of the formal INB.

Why the speed, ask civil society groups

However, a group of civil society organisations have questioned the speed of the negotiations.

“The mechanics of the current treaty proposal have been enacted at full speed without a serious assessment of the reasons why the implementation of the current binding arrangement on health emergencies – the 2005 International Health Regulations – have been so broadly neglected and disregarded by all countries in the world.

“What’s the real advantage of starting a negotiation on the same topic again?” asked Nicoletta Dentico, Head of Global Health Justice Program, Society for International Development (SID) and G2H2 co-chair in a press release.

Alexandra in Johannesburg during a COVID-related lockdown. Millions of South Africans have lost their jobs during the pandemic.

CAPE TOWN – The Omicron-related travel bans imposed on southern Africa are costing the economically fragile region millions of dollars every day – and countries that introduced them did not follow the process laid out in the International Health Regulations (IHR) adopted by the World Health (WHO) Organization in 2005.

A snap survey of over 600 tourism and hospitality operators in South Africa found that they have lost over $63-million in cancelled bookings since last Thursday when the new COVID-19 variant was announced.

“If the travel bans remain in place, based on the cancellations to date, respondents would lose 78% of their previously expected business levels for the period December to March. This would support in order of 205 000 jobs annually,” according to a statement issued this week by the Federated Hospitality Association of Southern Africa and tourism body SATSA.

Enver Duminy, CEO of Cape Town Tourism, said that the city alone was losing an estimated $15million every day in cancelled bookings since the announcement of Omicron.

Over two million South Africans have already lost their jobs during the COVID-19 pandemic, and 34.4% of all adults were now officially unemployed – the highest recorded level ever, Statistics South Africa announced on Tuesday.

Last month, the UK – South Africa’s biggest tourism partner – finally removed South Africa from its red list, while the US did so on 8 November.  International bookings followed and the tourism sector expected to make a modest recovery over the Christmas period – until the identification of Omicron.

Internal Health Regulations require scientific reasons

Botswana’s Ambassador to the UN in Geneva, Dr Athaliah Molokomme

Botswana’s Ambassador to the UN in Geneva, Dr Athaliah Lesiba Molokomme, told Wednesday’s closing session of the World Health Assembly special session that the travel bans were a violation of the very International Health Regulations (IHR) that many member states had urged the assembly to strengthen this week.

Speaking on behalf of the 47 African WHO Member States, Molokomme called for the immediate lifting of the travel restrictions imposed on southern African countries.

“We remain deeply concerned and disappointed by the lack of upholding of collective action, shared responsibility and solidarity. In a globalised and highly interconnected world, locking out a whole sub-region is dangerous and is neither effective nor sustainable,” said Molokomme.

Furthermore, she said that the countries that had jumped to restrict travel – 56 of them, according to the WHO – had not followed the process laid down in the IHR, the only global legally binding rules relating to health emergencies. 

“Member states are required to implement the recommendations in line with the International Health Regulations of 2005 and are supposed to inform the WHO of the travel measures and further provide the scientific and public health rationale when informing the WHO,” Molokomme pointed out. 

According to Article 43 of the IHR, any member state that implements health measures which “significantly interfere with international traffic shall provide to WHO the public health rationale and relevant scientific information for it”. 

WHO needs to be given public health and scientific rationale

The WHO has to be informed “within 48 hours of implementation, of such measures and their health rationale unless these are covered by a temporary or standing recommendation”. 

Significant interference is defined as “refusal of entry or departure of international travellers, baggage, cargo, containers, conveyances, goods, and the like, or their delay, for more than 24 hours”. 

Once a Member State has informed the WHO of its action, the global body “may request that the State Party concerned to reconsider the application of the measures”.

Ironically, this week’s World Health Assembly special session was dedicated solely to the need for negotiations for a new “convention, agreement or other international instrument on pandemic prevention, preparedness and response” – as most Member States deem the IHR to be inadequate.

Vulnerable are advised to postpone travel

Late Tuesday, the WHO issued an “advice on international traffic” in light of Omicron, advising people who are unwell, not fully vaccinated or recovered from previous SARS-CoV-2 infection and are “at increased risk of developing severe disease and dying” to postpone travel to areas with community transmission.

This includes “people aged 60 years or older or those with comorbidities that present increased risk of severe COVID-19 (eg heart disease, cancer and diabetes)”

However, the WHO stressed that “blanket travel bans will not prevent the international spread, and they place a heavy burden on lives and livelihoods”.

The WHO commended South Africa and Botswana for their surveillance and the speed and transparency with which they notified and shared information with the WHO Secretariat on the Omicron variant in accordance with IHR. 

“WHO calls on all countries to follow the IHR and to show global solidarity in rapid and transparent information sharing and in a joint response to Omicron (as with all other variants), leveraging collective efforts to advance scientific understanding and sharing the benefits of applying newly acquired scientific knowledge and tools”.

It appealed to countries to “apply an evidence-informed and risk-based approach when implementing travel measures in accordance with the IHR, including the latest Temporary Recommendations issued by the WHO Director-General on 26 October”.

 

Image Credits: Flickr: IMF Photo/James Oatway.

South African protestors call for universal access to antiretroviral treatment.

Pandemics exacerbate and thrive on inequity. They find the fissures in our societies and deepen them. As a result, the poorest and most marginalized always suffer the most.  

We have seen this with HIV and we are seeing it again with COVID-19. Rich countries are starting booster vaccination campaigns while most people in poor countries are without even a first dose. But as we mark World AIDS Day, we must also acknowledge that inequities exist within countries as much as between countries.  

Since the first cases of AIDS were reported 40 years ago, the world has made huge progress in the fight against HIV. In countries where the Global Fund invests, AIDS-related deaths have dropped by 65% since we were founded 20 years ago. Globally, more than 27.5 million HIV-positive people are on lifesaving antiretroviral therapy (ARVs).

Yet in many countries, persistent inequities have proved a formidable barrier to accelerating progress against the virus. In such countries, new HIV infections are concentrated amongst those made vulnerable by human rights or gender-related inequities. 

People in communities that are stigmatized or criminalized, and thus cannot access essential services to protect them from HIV, can be up to 25 to 35 times more likely to acquire HIV infection than the general population. In sub-Saharan Africa, adolescent girls and young women face an array of gender-related barriers that predispose them to HIV: six in seven new HIV infections among adolescents aged 15 to 19 years in the region occur among girls.

Most vulnerable are most exposed

COVID-19 has exposed the most vulnerable and marginalized communities to even greater risks, as lockdowns and restrictions to curb the new pandemic hindered access to lifesaving HIV treatment, tests, care and prevention services.

In the fight against HIV, we now face a new reality: we were off track even before the pandemic, and COVID-19 has pushed us further off track. What got us this far will take us no further.

To accelerate progress – and reach the even more ambitious global HIV targets for 2025 – we will need to invest more and invest more smartly. We must be even more precise and differentiated in devising and delivering prevention and treatment approaches for communities most at risk. Achieving this entails empowering communities themselves to play an even greater role in designing and implementing interventions.

For prevention, we are advancing the concept of “Precision HIV Prevention” to ensure we get maximum impact from the scarce resources that are available. 

That means we’re supporting countries to focus efforts on locations where HIV is most prevalent and on people with the greatest HIV prevention needs so they have the tools, knowledge and power to protect themselves. 

For treatment, we are supporting innovative and cost-effective models of drug and care delivery that make services more accessible, which is critical for getting people on ARVs early and improving retention and viral suppression. Such practices include multi-month dispensing of ARVs – now recognized as a best practice for increasing adherence to treatment. 

A variety of antiretroviral drugs used to treat HIV infection.

Human rights and gender barriers

We also need to be even more determined in tackling the human rights and gender-related barriers that prevent the people most at risk from accessing the services they need. 

Key and vulnerable populations, including adolescent girls and young women, gay men and other men who have sex with men, people who use drugs and transgender people, face a daunting array of barriers arising from stigma, discrimination and criminalization. Unless we address these through a rights-based approach, we will not defeat HIV.

These imperatives are central to the Global Fund’s new strategy, approved by our Board last month. Putting people and communities at the center, this strategy puts even greater emphasis on equity, human rights and gender equality, and on reinforcing the role and voice for communities living with and affected by HIV.

The strategy also commits the Global Fund to investing in people-centered, integrated systems for health, including community systems. 

Without diluting our focus on saving lives and reducing infections, we will be more deliberate in leveraging the synergies between the fight against HIV and interventions to combat other pathogens, so as to serve people better and improve the resilience and sustainability of our interventions.

For example, in many countries we already invest in integrated programs for HIV and tuberculosis, but now there is a need to manage the interaction with COVID-19 as well. High throughput molecular diagnostic instruments installed for viral load testing are now being utilized for COVID-19 testing; testing people for both HIV and COVID-19 fights both pandemics at once. 

People living with HIV who are not virally suppressed are more likely to be severely affected by COVID-19, so it is all the more important to provide them with ARVs and protect them from the new virus.

Again and again, we have seen the poorest and most marginalized suffer the most from the most dangerous infectious diseases. We must take an approach that recognizes this cruel reality. 

HIV was the last big pandemic to strike humanity, and while we have made great progress, we have not yet defeated it. COVID-19 poses another huge challenge, particularly to communities most at risk from HIV. We must fight both pandemics, and beat both, and do so in a way that tackles the inequities they exploit and deepen.

Peter Sands is the Executive Director of the Global Fund to Fight AIDS, Tuberculosis and Malaria. 

 

 

 

 

 

 

 

Image Credits: Louis George 2011 , Louis George 2011 , NIAID.