WHO’s Franceso Zambon has resigned after he spoke out against the Organization’s censorship of a crucial report on Italy’s botched COVID-19 response

The WHO scientist who spoke out against the suppression of a damning report exposing key flaws in Italy’s COVID-19 response has resigned, Health Policy Watch has learned.

Franscesco Zambon, a senior figure at WHO’s Venice Office who led the preparation of the controversial report, told Health Policy Watch that he resigned over the WHO’s censorship of an “independent” report that was intended to “critically examine” both the strengths and weaknesses of Italy’s COVID-19 pandemic response. That report, said critics, contained valuable evidence that could have helped other countries in their COVID-19 response when it first hit.

But the report was removed on 14 May, just a day after it was published online on the WHO European Regional Office website – at the request of Ranieri Guerra, WHO’s assistant director-general for strategic initiatives, and former chief of preventive health at the Italian Ministry of Health from  2014 to 2017.

Strikingly, the report revealed that Italy’s national pandemic preparedness plan had not been updated for 14 years – a task that Guerra was meant to have undertaken while he was working with the Ministry between 2014 and 2017. The report also said that Italy’s initial response to the pandemic was “improvised, chaotic and creative” – which is likely to have contributed to a devastating death toll in the country in the early days of the pandemic.

The WHO’s suppression of the report adds to a growing body of evidence that has compromised the international organisation’s credibility, neutrality and transparency at a time when it is most needed, critics have said.

Read more about the report in our three-part series here.

EU Ambassador to the African Union, Birgitte Markussen.

Although the European Union (EU) is opposed to the proposal by South Africa and India urging the World Trade Organisation (WTO) to waive intellectual property (IP) rights on COVID-19 products for the duration of the pandemic, the EU will support the expansion of vaccine access in Africa.

This is according to the EU Ambassador to the African Union, Birgitte Markussen, who told a recent AU media briefing that the EU is putting its full weight behind the COVAX Facility to ensure that African countries are able to vaccines, rather than supporting the waiver proposal. 

“The universal and equitable access to safe and effective diagnosis, treatments and vaccines, is the crucial issue for us. The whole issue of intellectual property rights does not really stand in the way for the efforts. It’s rather part of the solution,” Markussen said.

WTO ‘Flexible Enough’ Without Waiver

“I know that there are many issues related to the transfer of technology and so on, and the WTO rules are already flexible enough to address the problems. So it’s not that we are against it, we just think that the solution is already there,” she said.

Markussen said there were provisions in the licensing of vaccine technology and know-how, including the granting of compulsory licenses without the patent owner’s consent, that can be fast-tracked in emergencies, such as the pandemic.

Together with the Africa Centers for Disease Control (CDC), the EU has been involved in multilateral responses to control the spread of COVID-19 in Africa, but acknowledged that there needed to be more fostering of solidarity and cooperation to tackle the threats that both Europe and Africa are facing.

Markussen also told Health Policy Watch that the EU supports calls by France and Germany for  European countries to donate substantial doses of their COVID-19 vaccines to African countries.

However, she said there is no date yet for when the donation exercise will begin although  measures are already in place to coordinate it.

“We have a mechanism whereby our member states can redistribute these types of vaccines and that’s an additional instrument to the COVAX Facility,” she told Health Policy Watch. 

Africa CDC Wants Continent to Produce COVID Vaccine

Meanwhile, Africa CDC Director John Nkengasong, Director of the Africa CDC, said the center  is keen on ensuring that African institutions including the Institut Pasteur de Dakar in Senegal are capable of producing COVID-19 vaccines to ensure that African countries are able to have quick access to the vaccines especially when additional doses are needed.

“It is so important for us as a continent to have that because we truly don’t know how these vaccines will perform in terms of the longevity of immunity,” said Nkengasong. “So if it happens that immunity wanes after two years or so, then it means you need regular additional vaccination or boosting, and that will require that we have a continental capacity so I’m really really hoping there will be the right partnerships, and then see how we can roll that across the continent,” he said.

Novavax’s COVID-19 candidate vaccine NVX-CoV2373 is administered to a health volunteer during the clinical trial.

Novavax’s COVID-19 vaccine candidate has an efficacy rate of 96.4% against the original strain of SARS-CoV2. However, the efficacy rate drops up to 55.4% against the new B.1351 variant first identified in South Africa, and also spreading globally. 

The pharma company, which has never brought a vaccine to market before, published the data from two late-stage trials conducted in the United Kingdom and South Africa on Thursday.

The Phase 3 clinical trial conducted in the UK had over 15,000 participants, including 27% over the age of 65. The efficacy rate against the original SARS-CoV2 strain is on par with results from the Pfizer/BioNTech and Moderna vaccines. 

The efficacy rate reduced to 86.3% against the B.1.1.7 variant, first identified in the UK, and declined even further against the B.1.351 variant, initially detected in South Africa. 

The South African trial included two cohorts, one of 2,665 HIV-negative adults and the other of 240 HIV-positive adults. An analysis of both groups found an overall efficacy of 48.6%, but among HIV-negative participants, the efficacy rose to 55.4%. The majority of SARS-CoV2 cases in the trial were linked to the B.1.351 variant.

Although the efficacy was lower against both widespread variants, the vaccine candidate still demonstrated  “100%  protection against severe disease, including all hospitalisation and death,” across all arms of the trial, the company stressed.   

“We are very encouraged by the data showing that NVX-CoV2373 not only provided complete protection against the most severe forms of disease, but also dramatically reduced mild and moderate disease across both trials,” said Stanley C. Erck, CEO of Novavax, in a press release. 

“Importantly, both studies confirmed efficacy against the variant strains,” he added.

Leading COVID-19 Vaccines Have Reduced Efficacy Against New Variants

Novavax announced in January, after the release of the interim trial results, that it started developing a new version of the vaccine to target the more contagious and potentially more deadly variants. Clinical testing on the new vaccine will begin between April and June of this year.

Novavax joins Pfizer, Moderna, and AstraZeneca with results showing lower efficacy against the COVID-19 variants, specifically the B.1.351 variant. Moderna found a six fold reduction in neutralizing antibodies against B.1.351, Pfizer reported lower neutralization of the variant, AstraZeneca’s vaccine was minimally protective against mild to moderate infection from the variant, and Johnson & Johnson’s vaccine efficacy rate fell from 72% in the US to 57% in South Africa. 

The B.1.1.7 variant has been detected in over 90 countries by early March and the B.1.351 variant has spread to at least 48 countries. With the increased ability for the variants to evade the immune response triggered by the vaccines, new or updated vaccines will likely be necessary for sustained protection.

Sputnik V Vaccine Developers Question EMA’s Neutrality
Healthcare worker prepares Sputnik V COVID-19 vials.

Meanwhile, the developers of Russia’s Sputnik V COVID-19 vaccine accused the European Medicines Agency (EMA) of politicizing the vaccine approval process after a senior EMA official urged EU member states to postpone national rollouts of the vaccine until the EMA had completed its regulatory review.

In an interview last week, Christa Wirthumer-Hoche, chair of the EMA managing board, likened the use of the Sputnik V vaccine without a sufficient evaluation of the safety data to “playing Russian roulette.”

In response, the vaccine developers wrote on the Sputnik V Twitter account, “demand[ing] a public apology from EMA’s Christa Wirthumer-Hoche for her negative comments…, (which) raise serious questions about possible political interference in the ongoing EMA review.”  The EMA had not made any other such comments about other vaccines that it had reviewed, Sputnik’s developers noted. 

The Sputnik V vaccine is currently under rolling review by the EMA.

The issue was quickly resolved by Thursday, but tensions are still present between the EMA, the Russian Direct Investment Fund (RDIF), the company responsible for marketing the Sputnik V vaccine abroad, and EU countries that are welcoming of the new vaccine.

Italy Becomes Latest EU Member State To Embrace Sputnik V

Italy, meanwhile, became the first country in the EU to sign a deal to produce the Sputnik V vaccine, with plans to produce 10 million doses of the vaccine in Italy by the end of the year. The deal was signed between Adienne, an Italian-Swiss pharma company, and Kirill Dmitriev, CEO of the RDIF, on Tuesday.

The production could start as early as July, if the vaccine is authorised by the EMA and Italy’s national medicines regulatory agency, AIFA. 

“The innovative production process will help create new jobs and allow Italy to control the entire production of the compound,” said the Italian-Russian Chamber of Commerce, which facilitated the negotiations. “This step will help solve the problem of the shortage of vaccine doses in Italy.”

Italy has significant business ties with China – and there has been longtime speculation that the heavy travel patterns back and forth between northern Italy and China may be one of the reasons why the Italy became the first European epicentre for the virus a year ago.

As for the Russian vaccine, a couple of EU countries have already moved forward with national approval and rollout, including Hungary, Slovakia, and Czech Republic. 

A RDIF spokesperson said on Tuesday that discussions also were underway with production facilities in Spain, France and Germany to manufacture the Sputnik V vaccine. A conversation on vaccine production cooperation was held between German Chancellor Angela Merkel and Russian President Vladimir Putin in January. 

Germany is reportedly “open to the idea of bilateral cooperation for the purpose of tapping European production capacities,” said Ulrike Demmer, deputy spokesperson for the German government. 

“Sputnik V is a very clever construct,” Thomas Mertens, head of Germany’s standing commission on vaccination, told Rheinische Post in an interview. “[It is a] good vaccine that will presumably also be approved in the EU at some point.” 

Proposed EU Vaccine Certificate Will Include Sputnik V and Chinese Vaccines

According to reports on the EU vaccine passport, the preliminary plans for which will be announced next week, the Sputnik V, Sinovac and Sinopharm vaccines will likely all be accepted as part of the certificate system, along with the EMA-approved vaccines. 

This system is designed to ease certain restrictions for individuals who have been inoculated, specifically for travelling between particular countries or within regions, in an effort to revitalize air travel and ease the pressure on economies.

Including the Chinese and Russian vaccines is being seen as a pragmatic move insofar as some EU countries have also authorised the Sputnik V, Sinovac, or Sinopharm vaccines for use, or are preparing to do so. 

Image Credits: Novavax, RDIF.

The daily new COVID-19 cases in Kenya, reaching over 550 on 11 March.

Kenya has officially announced a third wave of the COVID-19 outbreak this week, while the World Health Organization’s (WHO) Africa region reported a “slight uptick in cases and an upward trend in 12 countries, including in Cote d’Ivoire, Ethiopia and Cameroon.”

Dr Matshidiso Moeti, WHO Regional Director for Africa, during the weekly press conference said there was an upward trend in some countries. 

On Friday, Kenyan President Uhuru Kenyatta tightened up the country’s COVID-19 measures, extending the 9pm curfew and decreeing that bars and restaurants close by 9pm.

Kenya recorded 713 new cases and 12 deaths on Wednesday, a record number since the start of this year. The positivity rate is up to 14% since November last year and the country’s total official death toll is 1,898. The Africa CDC reported a 13% average increase in deaths for Kenya for this week’s COVID-19 epidemiology update.  

Mutahi Kagwe, Kenya’s Cabinet Secretary for Health, said there had been an increase in the number of patients on ventilators and in need of oxygen and warned that the situation could worsen. 

“We are about to start another difficult period, but we can also overcome this period. It has taken a toll on us over the past year, and it is at this time that we can’t let our guard down,“ Kagwe stressed.

Meanwhile Raila Odinga, the leader of opposition in Kenya is being treated with COVID-19 in Nairobi Hospital, according to a statement from his doctor.  

Kenya’s health ministry established a National COVID-19 Vaccine Deployment Task Force this week to guide the rollout of COVID-19 vaccines, including regulation and safety monitoring, financing, procurement and logistics.

This week the Kenyan Conference of Catholic Bishops (KCCB) condemned the statement by the Kenyan Catholic Doctors’ Association that COVID-19 vaccines were “totally unnecessary.” The KCCB said in a statement on Tuesday that the association did not speak for the Catholic Church, and encouraged all Kenyans to accept the vaccine.

Africa Centres for Disease Control (CDC) director John Nkengasong told last week’s WHO Africa briefing that “we are beginning to see the beginning of a third wave in East Africa.”

The WHO warned that Africa is poised to surpass 4 million COVID-19 infections this week since the continent’s first confirmed case in February 2020, but described the arrival of vaccines in the continent over the past two weeks via COVAX as a “crucial boost.”

More than 14.6 million vaccine doses have been delivered to 22 African countries since 24 February through COVAX, a global vaccine effort co-led by the Coalition for Epidemic Preparedness Innovations (CEPI), Gavi, the Vaccine Alliance and the WHO.

“While deaths reported have dropped by more than 50% over the past 28 days compared with the previous 28 days, the case fatality ratio or the proportion of deaths among confirmed cases is at 3.6% for the past 28 days. This is higher than the global average,” warned the WHO Africa.

Image Credits: Twitter: @WHOKenya, Our World in Data.

Rumours about the whereabouts of Tanzanian president John Magufuli, are intensifying as the leader who questioned the existence of the SARS-CoV2 virus was reportedly in intensive care with COVID-19 – somewhere in Nairobi or possibly now even in India.

Magufuli has not been seen for almost two weeks, sparking widespread speculation about his health. His absence is unusual as he is known for making frequent public speeches and appearing on state television several times a week.

Tanzanian opposition leader, Tundu Lissu, who lost last year’s election to Magufuli, tweeted on Thursday that the president had been transferred from a hospital in Kenya to India – although he did did not provide evidence:  “His COVID denialism in tatters, his prayers-over-science folly has turned a deadly boomerang!” Said Lissu in a tweet. 

But Tanzania’s Prime Minister, Kassim Majaliwa, urged citizens to ignore “fraudsters”, claiming that  the president was strong and at work, as usual. Majaliwa also said he had talked to him on the phone and that he was grateful to the voters.

“The president is very busy. Where do they want him to go? Have you ever found him wandering around Kariakoo or Magomeni?” he asked while at a function in Tanzania’s Njombe region. The information was sent in tweets on social media in Swahili.

Rumours and Conspiracies

However, the government is under increasing pressure to reveal Magufuli’s whereabouts – as an online publication speculated that the rumours about him also were being fed by the Tanzania Intelligence and Security Service (TISS) as part of a power struggle withn in the ruling party.

Government sources in Tanzania told Health Policy Watch that they did not know the whereabouts of the President: “

We are just following what is happening on social media and other news outlets but we do not know what is happening to him,” one source said. 

Some source salso  are reporting ‘unusual activity’ at the Tanzania High Commission in Nairobi, Kenya. 

Opposition leader Lissu told the BBC that the 61-year-old president had suffered a cardiac arrest before being flown to a hospital in Nairobi for urgent treatment.  Lissu later said that the president was in a coma and had been transferred to a hospital in India. 

Scientist and Devout Catholic – But COVID-Skeptic

Magfuli, a scientist and a devout Catholic, has frequently played down the threat of COVID-19, saying that God would protect his nation from the disease.  In late-February, following a rebuke by the WHO and the death from COVID of his own vice-president, Magfuli finally signaled that he was willing to take the disease more seriously.   

At that point, the Tanzania Medical Association unleashed a new camapign on prevention of COVIVD-19.  But some worry that the shift may have been too little too late. 

For months, Tanzania has refrained from reporting to the WHO on new COVID cases – and doctors in the country privately admitted that they were under tremendous pressure to write anything but COVID on death certificates. 

Meanwhile, officials such as the chief government chemist, Fidelice Mafumiko, promoted the use of herbal medicine to cure COVID-19. Tanzania’s Health Ministry announced in a press conference last month that it had no plans to accept COVID-19 vaccines, insisting that the country is safe. 

Now social media is awash with news of the Tanzania president allegedly being admitted in a high care hospital because of the virus. 

Many people posting on social media with the hashtag #prayforMagufuli have also criticized irresponsible the way Tanzania handled the pandemic.  

“If it’s true Covid denier Magufuli is in Nairobi Hospital with related complications, the inequity of it would be endless. He gets to fly to a Nairobi hospital, while those who listened to him stay home inhaling eucalyptus steam & hanging on to prayers. Still, wish him recovery,” said Charles Onyango- Obbo, a Ugandan author, journalist and editor. 

 

The Brazilian government needs to enforce “serious social measures” to contain the virus before it overwhelms its health facilities, World Health Organization (WHO)  Director-General Dr Tedros Adhanom Ghebreyesus told the body’s weekly COVID-19 briefing.

Brazil’s President Jair Bolsanaro continues to downplay the pandemic despite the country reaching its highest death rate in the past week and having the second-highest death rate in the world after the US.

“Starting from the government, all the stakeholders should really take it seriously,” added Tedros, warning that pandemic threatened neighbouring countries, most of which had the pandemic under control.

“There should be clear messages from the authorities on what the situation is, and what measures people should take and enforce those measures with full participation of the health system,” said Tedros.

Mike Ryan, WHO’s executive director of health emergencies, reported that ICU bed occupancy had reached over 96% in the midwest and south of the country, and there was very little “resilience” left in the health system.

Despite Deaths, Bolsanaro Tells Citizens to Stop Whining

Despite the grim situation, complicated by a fast-spreading variant named P.1,  Bolsonaro told citizens in the midwestern state of Goiás last week to “stop all this fussing and whining” about the pandemic.

In a veiled reference to the Brazilian president’s poor handling of the pandemic, Tedros said that the rapid spread of COVID-19 was “contrary to our expectations” given the country’s relatively strong health system based on primary healthcare.

Meanwhile, the P.1 variant circulating in Brazil “has a number of mutations that confer increased transmissibility” and it appeared to be more easily transmitted and possibly more severe, added WHO’s COVID-19 response lead Maria Van Kerkhove.

On Tuesday, Brazil registered a record daily number of deaths due to COVID-19 and hospitals are buckling under the strain of widespread infections from the coronavirus. The country’s Health Ministry reported 1,972 fatalities and more than 70,000 new COVID-19 cases. 

The strain on Brazil’s health system is immense. One Brazilian health care provider dies of the coronavirus every 19 hours, according to the latest Brazilian government statistics. 

Dr. Miguel Nicolelis, in São Paulo, told The World’s Marco Werman (🎧) that his colleagues are under such immense stress that many feel as though they’ve spent the past year in a war zone.

“If I can be totally frank … I got a shivering to my body,” Nicolelis said. “You know, it is probably the worst loss of health professionals in the world. It probably is the worst in the world.”

WHO Gives J&J Emergency Use Listing

The WHO gave emergency use listing (EUL) to Johnson & Johnson’s COVID-19 vaccine on Friday making it the first single-dose vaccine to qualify, Tedros told the weekly COVID-19 briefing.

EUL is a prerequisite for a vaccine to be procured by the global distribution platform, COVAX, which has already pre-ordered 500 million J&J doses in anticipation of its approval.

“We hope that this new vaccine will help to narrow vaccine inequalities and not deepen them,” said Tedros, adding that COVAX looks forward to receiving these doses “as soon possible”.

However, the WHO’s approval of J&J came a day after its approval by the European Union Medicines Agency (EMA), which also has a significant order with the company and it is unclear which orders will get precedent, according to Health Policy Watch.

 

WHO Chief Scientist Dr Soumya Swaminathan

WHO special advisor Bruce Aylward and the body’s COVAX representative said that COVAX “is trying to work with the company” to get the vaccine by July.

While COVAX has delivered almost 30 million doses to 38 low- and middle income in the past two weeks, it represents barely over 10% of the 335 million doses administered globally, three-quarters of which have taken place in only 10 countries, said Tedros.

“The inequitable distribution of vaccines remains the biggest threat to ending the pandemic and driving a global recovery,” he added.

Meanwhile, a shortage of supplies such as glass vials is limiting the production of COVID-19 vaccines and could also “put the supply of routine childhood vaccines at risk’, said Tedros

WHO Chief Scientist Soumya Swaminathan said that the WHO was ready to help J&J and any other vaccine manufacturers to expand their capacity, adding that COVAX partner the Coalition for Epidemic Preparedness Innovation (CEPI), had identified “fill and finish capacity that is immediately available to any company to expand supplies”. 

The AstraZeneca vaccine being administered in Catalonia, Spain in mid-February.

Both the European Medicines Agency and the World Health Organization have urged that immunizations with the Oxford/AstraZeneca COVID-19 vaccine continue – despite a decision by several European countries to suspend its use – after reports of serious blood clots among 30 of the 5 million people vaccinated – leading to at least five deaths. 

An EMA statement said that the inoculations can continue while the investigation is underway.

“There is currently no indication that vaccination has caused these conditions,” said the EMA in a press release. “The position of EMA’s safety committee PRAC is that the vaccine’s benefits continue to outweigh its risks and the vaccine can continue to be administered.”

In addition, the number of cases of blood clots doesn’t exceed the cases in the general population, the EMA said. 

This message was echoed by a WHO spokesperson, Margaret Harris, who called the pause of the vaccine a “precautionary measure,” saying that no causal relationship has been established yet. 

“It is very important we are hearing safety signals because if we were not hearing about safety signals that would suggest there is not enough review and vigilance,” said Harris at a media briefing on Friday. “Any safety signal must be investigated.”

Some 30 cases of blood clots have been reported among the 5 million people vaccinated in the European Economic Area with the AstraZeneca vaccine, as of Thursday. This includes one death in Austria, one in Denmark, one in Bulgaria, and two in Italy.

Ten EU Countries Temporarily Pause Vaccinations, While Others Push Ahead

Denmark, Norway, Iceland and Bulgaria are pausing all AstraZeneca vaccinations, while Austria, Italy, Estonia, Latvia, Luxembourg and Lithuania are blocking further use of doses from the most recent batch of vaccines.

The batch of one million doses was delivered to 17 EU countries. A full investigation conducted by the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) is ongoing and it will evaluate the batch quality, along with all reported cases of post-vaccination blood clots with the AstraZeneca vaccine.

A WHO advisory committee on vaccine safety is also currently reviewing the reports.

“It’s very important to understand that…we should continue to be using the AstraZeneca vaccine,” said Harris, calling it an “excellent vaccine.”

Germany, France and the United Kingdom have decided to continue with their rollout of the vaccine, reaffirming the safety and efficacy of the jab. Germany and France are facing a scarcity of vaccines and a rise in infection rates. Suspending the AstraZeneca vaccine could undermine their already struggling vaccination efforts. 

“Everything we know so far suggests that the benefits of the vaccine, even after every individual case reported, are greater than the risks, and that continues to be the case,” said Jens Spahn, Germany’s health minister, at a news briefing on Friday. 

“Available evidence does not confirm that the vaccine is the cause,” said Phil Bryan, vaccine safety lead of the UK Medicines and Healthcare Products Regulatory Agency (MHRA). 

Investigation Into Blood Clots As Possible Vaccine Side Effect
A package of 10 multidose vials of the Oxford/AstraZeneca COVID-19 vaccine.

National health agencies in the EU countries that have paused the use of some or all AstraZeneca vaccines have emphasized their need to examine and clarify the possible serious side effects before resuming with vaccinations. 

“It is currently not possible to conclude whether there is a link,” said Magnus Heunicke, the Danish health minister, on Twitter. “We are acting early, it needs to be thoroughly investigated.” 

Five deaths have been reported among individuals who were inoculated from the same batch of AstraZeneca vaccine doses. A 49 year old nurse in Austria died of blood coagulation problems, a 60 year old woman in Denmark formed a fatal blood clot, a 57 year old woman in Bulgaria died of heart failure, and two police officers in Italy, aged 43 and 50, died of severe coagulation disorders. 

Following the news of the suspension of vaccination programs, Thailand announced its decision to delay the rollout of the AstraZeneca vaccine, which was set to begin on Friday. 

“We are delaying to let others prove [the side effects] of whether or not it is because of the vaccine or if it is only on that specific batch,” Yong Poovarawan, a Thai virologist, told the Guardian. “We are waiting for Denmark and Austria to make a conclusion.”

Blood clots were not listed as possible side effects from the vaccine and no pattern of serious adverse events provided a safety signal, according to clinical trial results. 

“An analysis of our safety data of more than 10 million records has shown no evidence of an increased risk of pulmonary embolism or deep vein thrombosis in any defined age group, gender, batch or in any particular country,” Gonzalo Viña, a spokesperson for AstraZeneca, told the New York Times. 

EMA To Review Bleeding and Bruising Issues Associated With Three Vaccines  

In sharp contrast, to the reports of clotting, there also have been reported side effects of bleeding and bruising from both the AstraZeneca vaccine as well as Pfizer’s and Moderna’s. 

The EMA announced on Friday that the PRAC started a review of reports of immune thrombocytopenia – a disorder of low levels of blood platelets that can lead to bruising and bleeding – for those three EMA authorized COVID-19 vaccines. 

Following reports of several cases of immune thrombocytopenia, case reports and clinical trial data from Pfizer/BioNTech, AstraZeneca, and Moderna will be gathered to determine if there is a causal relationship.

“At this stage, it is not yet clear whether there is a causal association between vaccination and the reports of immune thrombocytopenia,” said the EMA in a press release. “These reports point to a ‘safety signal’ – information on new or changed adverse events that may potentially be associated with a medicine and that warrants further investigation.” 

In a separate investigation, the EMA concluded that a link between severe allergic reactions and the AstraZeneca vaccine was “likely in at least some of [the 41 cases of anaphylaxis].” 

This finding comes after the Agency reviewed the 41 reports that emerged among five million vaccinations in the UK. The EMA is recommending an update to AstraZeneca’s vaccine product information to add to the existing warning of anaphylaxis and hypersensitivity as side effects. According to the EMA, any individual that develops a severe allergic reaction to the first dose of the vaccine shouldn’t be given a second dose.

AstraZeneca to Delay Vaccine Deliveries to EU Again, Risking Restarting Feud with EU

Meanwhile, AstraZeneca is reportedly facing difficulties with its international supply chains and expects to deliver 30 million doses to the EU by the end of March – 10 million less than it pledged in February and a third of its contractual obligation, according to a document seen by Reuters.

The pharma company risks angering EU officials once again by scaling back vaccine deliveries, adding to the EU’s problem of vaccine scarcity. AstraZeneca’s manufacturing and delivery efforts were described as “not good enough” by Thierry Breton, EU Commissioner on internal market.

AstraZeneca said it expects to ship doses produced in the US – where some 30 millions of doses are in manufacturing facilities, waiting for the US Food and Drug Administration’s (FDA) authorization – to the EU. The FDA won’t make a decision on the vaccine until the US late-stage clinical trial is complete, which may take another month.

“We understand other governments may have reached out to the US government about donation of AstraZeneca doses, and we’ve asked the US government to give thoughtful consideration to these requests,” said Viña to the New York Times.

The Biden Administration, however, has denied these requests for the near future.

“If we have a surplus, we’re going to share it with the rest of the world,” said President Joe Biden to reporters on Wednesday. “We’re going to start off making sure Americans are taken care of first.”

The US’ hesitancy to export vaccines was criticized by Charles Michel, President of the European Council, who said in a statement that the US and UK have “imposed an outright ban on the export of vaccines or vaccine components produced on their territory…[while] the EU has never stopped exporting.”

Image Credits: Flickr, Flickr, Flickr.

WHO Headquarters in Geneva, Switzerland.

One year after the World Health Organization (WHO) declared the coronavirus outbreak a pandemic on 11 March 2020, a new report by the Foundation for Geneva has traced the success and the failures of the WHO and other international Geneva organisations in their response – as well as the implications for the future of multilateralism.

“This deep-dive into 2020, seen from international Geneva, reveals in a crude way the underlying planetary crises: multilateralism at half-mast, states turning in on themselves, the race for drugs and vaccines, and vaccines disrupted by private financial issues and national sovereignty, increasingly noisy alternative truths, etc. But what COVID reveals is also the capacity of the international community to unite to defeat the same common enemy, with a cockpit located mainly in Geneva,” states the report, released this week.

At the time the epidemic was declared to be a “pandemic, the virus had already swept across 110 countries or territories, infected over 110,000 people, and claimed 4,000 lives. A year on, and 117 million confirmed cases later, health experts and researchers have been trying to dissect how the global health body could have reacted differently in the face of the unfolding crisis and how to overhaul it.

With the 70-plus NGOs and international organisations that gravitate around the WHO and make up its global health hub,  international Geneva has been at the front lines of the global efforts to fight the disease.

An Already ‘Weakened’ WHO

WHO has been heavily criticised over its handling of the pandemic. However, before the onset of the pandemic, the WHO was already facing one of the deepest crises of its 73 years of existence. An earlier edition of the Foundation for Geneva (Fondation pour Genève) study conducted before the emergence of COVID-19 revealed that alread by the end of 2019, WHO was financially and politically fragile.

Its limited budget was funded less and less by member states, whose regular, assessed contributions had dropped from 46% of the total budget in 1999 to just 17% last year. Meanwhile, voluntary donations by members and private donors like The Bill and Melinda Gates Foundation now contribute to around 80% of WHO’s overall budget. “This poses an obvious governance problem: who makes the decisions in Geneva? Civil society made up of Member States and WHO or private donors?,” ask the report’s authors, led by Heidi News health journalist Annick Chevillot.

Even before the new pandemic emerged, the organization had yet to fully restore its reputation following the Ebola epidemic in 2014, when it was widely blamed for failing to take leadership and for being too slow in declaring it an international public health emergency: “The WHO is facing a crisis of confidence and mistrust at the dawn of 2020,” explains the report. The organisation “begins 2020 with a new enemy to face: the coronavirus.”

International Geneva’s COVID-19 Response

The international community’s response, at least initially, “overwhelmingly followed the tempo set by the WHO.” More than 20 core organisations based in Geneva or with a direct link to Geneva, like the International Committee of the Red Cross (ICRC), the Global Fund or the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), have played a key role in tackling the crisis, making it “possible to appreciate the extent of the number of actors that have made Geneva an international centre of influence in the fight against the pandemic,” the report finds.

The International Committee of the Red Cross headquarters in Geneva, Switzerland.

However, the pandemic grew into more than a health crisis and organizations working across the fields of human rights, humanitarian aid, trade and the economy were soon implicated, with various calls for funding support.

Despite its clear need for reform, the pandemic also underscored the crucial role of the WHO, the authors say: “The global crisis generated by the pandemic has also shown the importance of multilateralism, of which the WHO is a tool that is as fragile as it is indispensable.”

It was only with the support of the international global health institutions, including Geneva-based “heavyweights” such as the Global Fund and Gavi, that WHO was able to respond to the emergency, and launch one of the greater successes last year: the ACT Accelerator to speed up access to vaccines, treatments and diagnostics against COVID-19.

The Global Health Campus, home to the Global Fund, Gavi, Unitaid, Roll Back Malaria and Stop TB.

Within the ACT Accelerator, its vaccine pillar, the COVAX initiative, has beeen designed to ensure that vaccines reach poor and middle income countries – with the vaccine  rollout having reached the first countries in Africa, including Ghana, Cote d’Ivoire and Ghana, just last week.

“The COVAX initiative is a good illustration of the raison d’être of International Geneva and its ability to find solutions. It offers the prospect of a world that is both interdependent and united,” says Olivier Coutau, delegate for International Geneva at the directorate of international affairs of the canton of Geneva.

Key Achievements

Among some of the other key successes of International Geneva’s health cluster, the report lists:

  • The international randomised clinical Solidarity trials, which “made it possible to evaluate the effectiveness of already existing treatments against Covid-19”, such as dexamethasone.
  • Fundraising that allowed the WHO to raise US$ 241 million (as of January 25, 2021).

“Experts believe that the WHO has risen to the challenge by providing technical and normative guidance, taking the lead in coordinating the scientific response to the pandemic and shaping logistical operations with a number of other international organisations,” says Priti Patnaik, a global health journalist, who is cited in the report.

Read also: Covid-19 vs WHO and the world: successes, failures and hopes a year on

The Road to Reform

The report concludes with a series of recommendations for the “International Geneva” health and development community, but in particular, for the World Health Organization, with respect to its need for reforms.

Observed Antoine Flahault, director of the Institute for Global Health: “The Member States of the WHO, which ensure its governance through the World Health Assembly and its Executive Board, will first have to ask themselves what prerogatives they wish to entrust to the WHO in the event of a health emergency…As long as the WHO General Secretariat has no independent investigative powers in member states, it cannot be expected to play the role of conductor that it is sometimes criticised for not playing.”

WHO’s funding also needs to be reviewed, as explained by Gian Luca Burci, former WHO legal adviser and associate professor of international law at the Graduate Institute of International and Development Studies (IHEID) in Geneva, “because it is dysfunctional. Voluntary contributions, which represent about 80% of the budget, are too volatile. The WHO must have sustainable and predictable funding in the future.”

Partly as a result of such imbalances, Patnaik observes: “the decisions that shaped the international response to the pandemic quickly and decisively shifted from WHO to some donor governments, other actors, including private philanthropists, public-private partnerships, outside the global health field.”

Republished from Geneva Solutions. Health Policy Watch Watch is collaborating with Geneva Solutions, a non-profit Geneva platform for constructive journalism covering International Geneva.

Image Credits: Flickr – Guilhem Vellut, Flickr – US Mission Geneva, Flickr – US Mission Geneva, Global Fund/Vincent Becker.

The Johnson & Johnson COVID-19 vaccine.

With the European Union Medicines Agency (EMA) approval Thursday of Johnson and Johnson’s one-shot COVID-19 vaccine, it now remains to be seen which countries and regions will be the first in line for distribution of the one-jab vaccine. Along with its comparatively low-cost, and ease of storage, the one-shot vaccine could be particularly important to Africa in light of its demonstrated its efficacy against the wily virus variant B.1351, first identified in South Africa.

“With this latest positive opinion, authorities across the European Union will have another option to combat the pandemic and protect the lives and health of their citizens,” said Emer Cooke, EMA’s Executive Director, adding, “this is the first vaccine which can be used as a single dose”.

The challenge now, for the pharma company is how to share the bounty.  Johnson and Johnson had last year reached an agreement in principle with Gavi, The Vaccine Alliance, to supply the new COVAX vaccine facility with up to 500 million doses through 2022 – which would go to low- and middle-income countries. It also has pledged to charge a ‘non-profit’ US$ 10 price during the pandemic, making it particularly attractive to lower-income countries. But it also now has major supply commitments to Europe, the United Kingdom and the United States. 

Following the EMA approval, the WHO can be expected to rapidly issue its own “emergency use listing”, clearing the way for the vaccine’s rollout by COVAX.  

Known Vaccine Manufacturing Capacity – J&J

However, the United States this week doubled its own order of the J&J vaccine to 200 million doses. The European Union has also ordered 200 million doses of the shot, with an option for 200 million more. The UK has options for 55 million doses. And, meanwhile, the J&J agreement with COVAX would only supply 100 million doses to the global facility this year. 

The bigger dilemma is that the COVAX rollout is right now almost exclusively dependent on the Astra Zeneca vaccine. And that vaccine yielded poor results in a South African trial of healthy adults, where it failed to demonstrate efficacy in preventing mild and moderate forms of COVID disease. That left South Africa to rapidly pivot to the Johnson & Joshnson vaccine several weeks ago, for the first stage of its vaccine rollout to health workers. Insofar as South Africa was participating with J&J in clinical trials, it had access to at least some initial vaccine supplies.  But other African countries don’t have that luxury.

So in more ways than one, the J&J vaccine’s distribution is likely to be watched as a bellweather of equity – or not. 

Advocacy Groups Call For More J&J Vaccines to be Shifted to Low-Middle Income Countries
johnson
COVID -19 Secured Doses 2021, aggregate and per capita, by countries’ income level

Advocacy groups have recently issued calls for the first cuts of the J&J vaccine to go to low- and middle-income countries through COVAX.

They point out that even South Africa, whose Aspen Pharmacare is set to produce some 300 million doses of the vaccine, will only keep a fraction ( 9 million doses)  for itself.

Meanwhile, the country is on the front lines of the battle with the B.1351 variant, which is slowly creeping northward across eastern Africa – as well well as appearing in Ghana on the west African coast. All of those countries remain almost exclusively dependent on the COVAX supply of AstraZeneca vaccines – complemented by some donations from China, whose vaccines have never undergone a regulatory review.

“MSF is worried that if J&J continues with business-as-usual tactics, countries most affected by this variant will once again be left waiting at the back of the queue,” stated an appeal two weeks ago, issued just ahead of the very first, US Food and Drug Administration, approval.

“For example, South Africa has the highest prevalence of this variant in the world and has been a critical partner in J&J’s clinical trials, yet the country is due to receive a mere nine million of the 300 million doses that will be filled in vials and packaged by a local manufacturer. J&J should right away ensure that South Africa receives, at minimum, enough doses to vaccinate its healthcare workers and high-risk groups, as well as prioritize shipments to other low- and middle-income countries.

While WHO has sought to reassure African nations the the AstraZeneca vaccine can still be effective against serious disease from the variant – that hasn’t yet been demonstrated in a clinical trial – in the same way that the J&J vaccine has been tested.  And as MSF stated, the vaccine’s one-jab regimen and modest refrigerator storage requirements make it particularly attractive in lower-income settings:

“The vaccine could be an important tool in the world’s response to this pandemic – particularly in low-resource settings where MSF works – since unlike the other COVID-19 vaccines being used today… it could require only one dose and could be stored at normal refrigerator temperatures.”

US and Other Rich Countries Keep Piling Up Vaccine Surpluses

On the other side of the Atlantic, meanwhile, noting that some 850 million vaccine doses have been purchased by the United States for an adult population of only 260 million – enough to vaccine all eligible adults three times over. “Prospects of a vaccine shortage giving way to a surplus seem nearer than ever this week,” noted the Washington Post, wryly.  However, with the largest J&J manufacturing base in the United States, the US also can impose export barriers on the vaccine – should it choose to do so.   

And even without an outright export ban, nearly 1.5 billion doses of J&J’s vaccine are already tied up in advance purchase agreements, most (801 million out of 1.439 billion doses) committed to high-income countries.

Dr Paul Stoffels, vice chairman and chief scientific officer at Johnson & Johnson.Pharma sources say that J&J’s Vice Chairman and Chief Scientific Officer Paul Stoffels, the Belgian-born physician who has spearheaded the vaccine’s R&D through its European affiliate, Janssen, is deeply committed to a rapid rollout of the new product in low- and middle-income countries – and possesses a track record on equity issues, with J&J’s prior development of an Ebola vaccine, as just one example.

At the same time, J&J has also received US $1.5 billion from the US government for its COVID-19 vaccine R&D, and the United Kingdom is co-funding a global clinical trial testing a two-dose regimen of the vaccine.

In light of those hefty research investments, the pre-purchase agreements, and the J&J manufacturing hubs clustered in the United States and Europe, it remains to be seen if the US, the EU or other high income countries that have snapped up more vaccines than there are people to jab, might offer to release some of those excess supplies to COVAX, the African Union or even directly in bilateral deals.

If those countries act, it might enable a more rapid rollout of the single-jab vaccine in parts of the world that not only need it the most – but where the vaccine could also have the most impact in halting the global spread of dangerous variants.

Image Credits: Johnson & Johnson, Johnson & Johnson, IFPMA, IFPMA , World Economic Forum.

Proponents to the African Medicines Agency say that it will improve access to safe, affordable medicines – and also ensure a better COVID-19 response.

NAIROBI – Kenya is one of the leading African countries yet to ratify the African Medicines Agency Treaty (AMA) – but a senior official in the Ministry of Health has said that the move  should come soon. 

According to Susan Mochache, the country’s Principal Secretary in the Ministries of Health (MoH), Kenya has already undergone the induction process, and is now waiting for details on operational modalities, which need to be worked out, before ratifying the treaty.

 “The country is now waiting for clarity on whether payments will be made directly to the suppliers and on information on the tax exemption modalities,” Mochache told Health Policy Watch in an interview.

She was referring to questions arising among some African countries about whether the AMA would take on bulk procurement functions – alongside its regulatory role. 

Proponents of the continent-wide approach to medicines regulation say that it will help streamline medicines and vaccines reviews and approvals – also ensuring a better COVID-19 response. 

A unified regulatory mechanism could also pave the way for more efficient bulk procurement of medicines and vaccines, through the African Union or regional blocs of countries – and more local production, its advocates say. 

However, the functions assigned to the AMA through the pending treaty, requiring ratification, are strictly regulatory in nature, the treaty’s architects and proponents underline. 

Dr Margaret Agama-Anyetei, of Head of the Health, Nutrition and Population Division, Africa Union – speaking at the AMA session Wednesday.

“It’s important to focus on Article 6 and what the African Medicines Agency’s specific role would be,” said Dr Margaret Agama-Anyetei, of Head of the Health, Nutrition and Population Division Africa Union, in a panel session on the AMA Wednesday at the African Health Agenda International Conference 2021. She underlined the need for caution in assuming that the AMA could do everything that is needed on the continent – in terms of procurement and production – even though it can set the stage.

Article 6 lays out the primary functions of the African Medicines Agency, which include: coordinating and strengthening initiatives to harmonize medical product regulation; providing guidance on regulation of traditional medical products, and evaluating and deciding on medical products for treatment of priority diseases and conditions, as determined by the African Union and WHO.

African Union Agreed To Create AMA Two Years Ago – But 7 More Countries Need To Ratify Treaty.  

A resolution to create the AMA was adopted at the 32nd African Union Assembly two years ago. However, among Africa’s 54 countries, only 19 countries have so far signed the treaty and only eight countries, mostly in West Africa, have ratified it. 

While that is still three more ratifications since October, the treaty needs to be signed by at least 15 countries to become operational. And meanwhile,  the continent’s biggest countries like South Africa, Nigeria,… and Kenya  remain outliers. 

 In terms of its regulatory function, the agency would function much the same way as the European Medicines Agency (EMA) operates – offering a region-wide umbrella for countries to use in review and approval of drugs and vaccines. 

It may however, also play a role in managing bulk medicines and vaccines procurement – ensuring that the process is cheaper, simpler and faster for the countries that have joined, while also guaranteeing safety in a region where fakes often proliferate.

Kenya Medical Association – AMA Ratification Will Help Expand Vaccines Access 
Teachers aged 50 years and above, are to be the among first to get COVID-19 vaccines in Kenya.

 In a separate interview, Dr. Elizabeth Gitau, CEO of the Kenya Medical Association (KMA), also expressed hopes that the national government will soon ratify the AMA Treaty, saying it would also help improve COVID-19 vaccines access. 

“So, we are waiting and actually do hope that at the end of the day the government will ratify the treaty so that we have more access to vaccines,” she said in a separate interview. 

But, she added, “The Ministry is still going through the decision making process.” 

The KMA has been a key partner in the government’s COVID response, providing technical support to the Ministry of Health, including on prioritization of people who should receive vaccines, advocacy and rollout.  

Its members are participating in the COVID-19 vaccine administration training programmes currently under way in the country – as part of the rollout of the first AstraZeneca vaccines, which were received through the WHO co-sponsored COVAX global distribution facility last week .

AMA would help Kenya Fight Fakes & ‘Grow’ Its Pharma Industry 
kenya
Kenya receiving the first suppplies of Oxford-AstraZeneca COVID-19 vaccines from the WHO co-sponosored global COVAX facility.

Whereas cross-boundary harmonization of the regulatory standards and guidelines in accordance with global standards, and specifically those mandated by the WHO, will be the core function of the AMA, Kenya also stands to benefit in other ways, should it join the agency.

Notably, AMA membership could also help link up Kenya’s pharma producers to a much larger purchasing block, should the AMA’s functions also extend to the supervision of pooled medicines procurement. 

Said Dr. Fred Siyoi, CEO of the country’s Pharmacy and Poisons Board (PPB): “It will help Kenya nurture its growing pharmaceutical industry leading to the realization of the provision in the constitution of the right to health by guaranteeing safe, quality and efficacious locally manufactured medicines.”

For instance, “pooled procurement will enable countries to receive medicines from WHO prequalified, or from AMA prequalified manufacturers,” explained Dr. Siyoi. The PBB Board regulates the pharmaceutical practices in the country in addition to the manufacture and trade of drugs and poisons.

Dr. Gitau concurs, adding:  “Negotiating as a block as opposed to going it alone as individual countries, we are bound to benefit in terms of economies of scale, but also we are more likely to get better access to vaccines with the initiative and possibly better pricing.”

Pooled AMA Procurement Also Would Help “Fight the Fakes” 
The African Medicines Agency’s framework would help combat falsified products

Even though the PPB has its own mechanisms in place for detection and prevention of substandard and falsified products (SF), pooling resources together within the AMA framework will serve to strengthen its programmes further, Siyoi said.

For instance, the national board would benefit from “information sharing from regional blocks on substandard and falsified products,” he says, something which will ensure timely response to risk alerts on medicines of substandard quality and safety.

Dealing with fake medicines has been one of the biggest challenges facing many African countries.

Up to a quarter of the continent’s medicines are substandard or falsified, according to the African Union Development Agency New Partnership for Africa’s Development (AUDA-NEPAD).

One reason why this continues to be a problem for Kenya – just like other countries on the continent – is the lack of adequate personnel.

Understaffing is a big challenge facing the PPB, according to Dr. Siyoi. The limited number of inspectors manning the border points, leaves the agency ill-equipped to cope with vast areas laced with informal border crossings between neighbouring countries through which smuggled drugs find their way.

“This is in addition to modified transport vehicles for concealment of [counterfeit] medicines,” says Dr. Siyoi.

Should the AMA come into being, the PPB hopes to benefit greatly from the technical assistance drawn from the pool of experts at the continental level.

In addition, the Agency will also enhance PPB’s capacity for dossier evaluations and the undertaking of joint Good Manufacturing Practices inspection of drugs being manufactured in Kenya itself. 

Some of these challenges, other pharma sources admit, would indeed be “better be addressed” through the AMA mechanism. 

Oksana Pyzik, Senior Teaching Fellow, Global Engagement Lead and Founder of UCL Fight the Fakes

At no time has the existence of AMA been so critical as today, observed Oksana Pyzik, Global Engagement Lead and founder of the University College London Fight the Fakes initiative, during a Wednesday panel session on ‘Why AMA’ – held under the auspices of the African Health Agenda, International Conference 2021 (AHAIC).     

“AMA is critical now more than ever and ties into the WHO’s patient safety plan directly,” she said. This, she explained further, is a concept which Dr. Tedros Adhanom, WHO’s director general, has been pushing, that without quality medicines, there is no universal health coverage for patients.

Image Credits: MOH_Kenya, AHAIC, Wish FM Radio, Inquirer, Marco Verch/Flickr.