EMA Executive Director Emer Cooke

The European Medicines Agency’s safety committee (PRAC) on Thursday gave a resounding endorsement of the Oxford/AstraZeneca vaccine against COVID-19, concluding that the vaccine’s benefits vaccine “far outweigh” any risks  –  despite a possible link between some vaccinations and rare cases of blood clotting associated with low levels of blood platelets. The EMA statement followed two weeks of mounting concerns over reports of such rare events – leading to 17 countries to suspend the vaccine rollout, at least temporarily. 

In a press briefing Thursday evening, an EMA panel stressed that the AstraZeneca vaccine “is not associated” with an increase in the overall risk of blood clots. Nor is there evidence of problems related to specific batches of the vaccine or to particular manufacturing sites. 

However, the EMA safety review did find that the vaccine may be associated with very rare cases of blood clots associated with thrombocytopenia, i.e. low levels of blood platelets (clotting elements in the blood), and also including rare cases of clots in the vessels draining blood from the brain (CVST).

“The EMA Committee has come to a clear scientific conclusion. This is a safe and effective vaccine. Its benefits in protecting people from COVID-19, with the associated risks of death and hospitalisation, outweigh possible risks,” said EMA Executive Director Emer Cooke at the press briefing, adding that overall, “The committee also concluded that the vaccine is not associated with an increase in overall risk of thromboembolic events or blood clots.” 

At the same time, she said, in the Agency’s Pharmacovigilence Risk Assessment Committee (PRAC) investigation and review, a “small number of cases of rare and unusual, but very serious disorders” were detected, that triggered a more focused review.  “And we still cannot rule out definitively a link between these cases and the vaccine,” said Cooke. 

As a result, she said that the agency would be adding a warning about rare events to the vaccine label and patient information – as well as launching more follow up studies. 

“If it were me, I would want to be vaccinated tomorrow,” Cooke stated, when asked by reporters if she would take the AstraZeneca vaccine herself – or wait for another product. ”But I would want to know if anything happens to me after vaccination, what I should do about it, and that’s what we’re saying today.  

“I want to reiterate that our scientific position is that this vaccine is a safe and effective option to protect citizens against COVID-19. It demonstrated that at least 60% efficacy in clinical trials and preventing coronavirus disease, and in fact the real world evidence suggests that the effectiveness could be even higher than that.”

Blood Clots – Still Very Rare Events 
Sabine Straus, chair EMA pharmacovigilence Risk Assessment Committee (PRAC)

Cooke stressed that the instances of thrombocytopenia-associated blood clotting remained very rare events. And rare adverse events are common with almost any vaccine or medication:

“About seven million people have now been vaccinated in the EU with the AstraZeneca vaccine, and 11 million have been vaccines in the UK…When you vaccinate millions of people it’s inevitable that you have rare or serious incidents,” she said.

“But I want to reiterate that our scientific position is that this vaccine is a safe and effective option to protect citizens against COVID-19.” 

According to the latest EMA data, of an estimated 20 million people in the United Kingdom and Europe that have so far received the vaccine as of March 16, the EMA had reviewed only 7 cases of blood clots in multiple blood vessels (disseminated intravascular coagulation, DIC) and 18 cases of CVST (cerebral events).

”A causal link with the vaccine is not proven, but is possible and deserves further analysis,” stated an EMA news release issued simultaneously with the press briefing. 

Greater Proportion of Very Rare Cases Observed in Young Women 
astrazeneca
EMA Panel announces results of its review of the safety of the Oxford/AstraZeneca COVID-19 vaccine.

A greater proportion of these very rare cases, however, have been observed in young women, the committee members acknowledged. This may also explain why more are being seen on the European continent than in the United Kingdom, where the AstraZeneca rollout focused first on older groups. 

The EMA experts did not rule out, either, a possible link between such rare events and contraceptive pill use, which can increase the overall risk of blood clots for young women: 

“Yes, it is always a distinct possibility,’’ said Sabine Straus, EMA Safety Committee head, in referring to those risk factors that might contribute to such a rare event among those being vaccinated. “One of the risk factors that is highlighted for the [thrombosis] disease or the syndrome, as such, is also oral contraceptives. The committee also is investigating if the risk of such events might be higher among recovered COVID patients who are vaccinated.” 

A past COVID infection might also add to the risks of such, she said. “COVID is an important risk factor for thrombosis and also a post-COVID syndrome. So that might have played a role.” 

She added that smoking was also a general risk factor for thrombosis anyway, but cautioned, “I am not sure it’s a risk factor for these specific cases, but it’s something that we are also looking into.” 

United Kingdom versus Europe Differences 

There have also been proportionately fewer reports of the rare events in the United Kingdom – just three cases – as compared to elsewhere on the European continent, including seven cases in Germany, three in Italy, one in Spain and two in India, the panel stated. 

Said Peter Arlett, head of EMA analytics, “we know that the AZ vaccine in the UK, was given predominantly to older patients, compared to the totality of European member states. And therefore, if blood clot cases are more common in younger women, for example, then it would suggest that you get more cases in Europe than you would in the UK.”

In some European countries, health workers, including young women, have been a first priority in vaccine campaigns.

The panel also said that they would be investigating other reports of other rare adverse events seen in any of the vaccines that have so far been EMA approved. Those have also included reports in the United States of sudden decreases in blood platelet clotting elements, called “immune thrombocytopenia” (ITP), shortly after vaccination with the Pfizer and Moderna vaccines.  The syndrome can cause excessive bruising and bleeding. 

Said Straus, “A separate investigation has been started for ITP, and that is a signal that is ongoing for the moment.” 

Image Credits: HPW .

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Smog over Delhi, India

The unexpected – and unexplained – dissolution of India’s brand-new Commission on Air Quality Management (CAQM), established by Prime Minister Narendra Modi at the peak of North India’s air pollution crisis five months ago has taken air pollution scientists and clean air advocates by surprise. Members of the commission were also taken aback, learning of the news through weekend media reports, sources familiar with the issue said.

The Commission, disbanded after the Modi government failed to see through a parliamentary law to back up the executive decree issued in October, prompted immediate protests  by opposition politicians, with Atishi Marlena from Delhi’s ruling Aam Aadmi Party charging the national government with yet another failure in pollution policies.   

“Who will take action on Haryana, Punjab, UP (Uttar Pradesh), Rajasthan due to burning of stubble?,” Marlena asked, referring to the rural regions around Delhi which flood the city with air pollution during the late fall and early winter. “With the CAQM gone, who will now take action against errant polluters,” she asked, speaking to a Hindi language media outlet. 

Government – Rattled by Farm Protests, Doesn’t Want to Penalise Stubble Burning
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Farmers in India protesting new agricultural laws passed by the Modi government.  While the new laws focus on crop price policies – the government may be fearful of any step that could alienate farmers further, some observers believe.

While Modi and his ministers offered no comment, sources told Health Policy Watch that his government was nervous about the powers that had been granted to the new commission – which had been empowered to prosecute polluters, including farmers burning crop stubble, and impose stringent penalties. 

“Farmers protests have become a very sensitive topic,” the source said, noting that the government is rattled by the media attention the protests have gained both domestically and internationally. “It wants no more trouble in this sector in the current scenario.”  

For over 100 days, tens of thousands of farmers have been camped around Delhi’s periphery to protest against a series of agricultural laws passed by the Modi government in September 2020.  Billed as modernization measures, the laws would leave farmers to negotiate produce prices on the open market – something farmers say  will put at the mercy of large agro-businesses, and threaten their livelihoods. Even after multiple rounds of talks between the government and farmers, the protests show no sign of ending. 

Lack of any official communication on the Commission’s sudden dissolution has, however, led to confusion and conjecture. That, after Commision members had reportedly been appointed for a period of three years. 

The confusion continued this week, as some government sources said they still expected the CAQM to be “up and running in a few weeks,” but without saying how that could happen since there is no legal framework for the body to operate – after the time frame for transforming an executive decree into a parliamentary act elapsed. 

One news report even quoted Environment Secretary R.P Gupta saying cryptically “ It’s not that the commission will not come back, but not now. The commission will be coming back slightly late.” 

Commission set up during October Crisis – Initially Offered Hopes Of Change 

The Commission had been hurriedly set up on October 28, 2020 when north India’s air quality was at its worst. The appointed chairman, a retired head of the country’s petroleum and natural gas, took charge on a day in November when official monitors reported PM2.5 levels at almost 100 times more  than WHO’s guidelines for 24-hour average levels of fine particulate matter. 

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Air Quality Index of India – real time air quality data as of 17 March, based on a scale of 0 to 500 (Good to Hazardous). Every city in India observed air quality improvements compared to 2018 and earlier,  However, India continues to feature prominently at the top of the most polluted cities ranking with 22 of the top 30 most polluted cities globally.

It is estimated that 1.7 million people die every year in India from air pollution – with Delhi consistently ranking as one of the most polluted cities in the world. The city was estimated to have seen 54,000 deaths due to PM2.5 air pollution in 2020 – or one death per 500 people, according to the most recent Greenpeace-IQAir study, reported by Health Policy Watch.

When it was established last fall, the Commission was billed as a replacement for a bureaucratically awkward, and largely ineffective, Environment Pollution (Prevention and Control) Authority (EPCA), which had set up 22 years ago by India’s Supreme Court. The Commission, reporting directly to the Modi’s government, was presented as a body that could act more effectively on the thorny air quality issue. 

Although air quality experts and advocates at the time had questioned its mode of creation – by executive decree at a time when India’s parliament was in recess – they also expressed hopes that the Commission could be a step forward – consolidating the functions of the EPCA and multiple other task forces into a single body with more significant powers, and membership including representatives from the central and state governments.  

Defunct Commission Had Innovative Features – Welcomed By Air Quality Campaigners  

The executive decree, or “ordinance”, that established the now-defunct Commission also included some other innovations that were welcomed at the time by air quality campaigners. These included treating the Delhi national capital region as an airshed; involving some well-respected clean air non-profits; and working from the ground up with a fully-funded secretariat. 

And in some ways, the Commission’s creation also represented the most explicit action yet by Prime Minister Modi to address the threat of India’s air pollution to public health – even though the Prime Minister continues to consistently avoid the issue in his public statements.

“While the process of creating the CAQM was problematic, the agency itself represented a significant milestone. The CAQM had an airshed-level mandate, dedicated funds and staff, and would have assumed accountability for air quality outcomes in the region. The lapsing of the ordinance definitely leaves an institutional vacuum, and is a deeply worrying development,” says Santosh Harish, Fellow at the Centre of Policy Research who specialises in energy and environment policy and air quality governance. 

‘Set Up To Fail’ – Clean Air Community Angry and Aghast  
Real time air pollution indicators globally, as of 17 March, from World Air Quality Index – with pollution indicatrors ranging from Good (0 to 50) to Hazardous (301 to 500).

Now, the commission’s dissolution just five months after its formation has left the clean air community wondering if the body was, in fact, created to fail. 

Throughout its five-month tenure, the commission was publicly invisible – with no official or even social media channels of communication, although sources unofficially spoke about data collection that was underway to better identify local emission sources, exposure levels and pollution levels.

“This one was set up to fail – and it did so gloriously. Without periodic reporting on what the CAQM did, it is unclear what they delivered, so what are we lamenting about?,’ says Karthik Ganesan, a fellow with the non-profit Council on Energy, Environment and Water. 

“In theory, these centrally constituted bodies are effectively replicating the Central Pollution Control Board in its coordination role. Strengthening institutions that actually are vested with the task of addressing AQ at various levels – starting with the CPCB and giving it the autonomy to constitute committees to coordinate action in regional air sheds, would make this a more productive effort,” he added. 

In a scathing piece, environmental lawyer Ritwick Dutta echoed the message saying: “It was clear from the beginning that the CAQM was designed to fail. In the five months of its existence, its single major failing was that almost nobody even knew it existed. It had no office, email address, website or even a phone number through which people could contact its offices.” 

Dutta added: “The government gave the CAQM the power to hear grievances of the people affected by air pollution, but the main grievance of the people was finding the commission itself.”

Added Bhavreen Kandhari, a member of activist group WarriorMoms called it a shocking lapse:  “The lapse of the CAQM Ordinance has been very disappointing and shocking. This clearly shows how serious the government is about the critical issue of air pollution.”

Campaigners Call For Intervention of Courts Once More 

Now that the Commission has effectively dissolved, air quality advocates are calling for the courts to intervene once more. Traditionally, India’s Supreme Court has been the leading arbitrator of air quality issues – in the absence of strong government policies. 

In fact, shortly before the CAQM was created, the Supreme Court ordered the creation of a new single-judge committee to lead the charge on the air pollution issue, headed by a retired Supreme Court  judge, Madan Lokur.  

Then, just after that appointment was announced, Modi’s government announced that it was forming the new Commission – making judicial intervention irrelevant at the time. 

Some critics now suspect that the Commission’s creation was merely a ploy to head off intervention by the courts at the peak of India’s annual air quality crisis – a crisis that builds up every winter in the dry season, which coincides with autumn crop burning and household heating, and then ebbs again with springtime weather and monsoon rains.  

“Clearly it wasn’t the honest and genuine political will of the government to set up this commission,” said Vimlendu Jha, founder of environment and sustainability non-profit Swechha.

“The dissolution of the commission is just one more flag up in the air displaying arrogance and ignorance of our political class. This episode is a joke on all of us who felt we had arrived at the regional and airshed approach to clean air,” he added. 

Kandhari said that clean air advocates would now file a new legal appeal to the Supreme Court to reinstate it’s committee.  She  said that  the application will be made on behalf of a 17-year old student Aditya Dubey – who suffers the respiratory effects of air pollution – borrowing on a successful legal strategy used last year in the United Kingdom to get the courts there recognize the health effects of air pollution on children. 

“We need immediate intervention by the honourable court to protect our right to breathe,” she said. 

Aam Aadmi Party criticises the dissolution of CAQM, federal govt

Speaking in the  Hindi language  media outlet, opposition legislator Marlena  urged the city’s government to protest the Commission’s dissolution.  In addition to crop burning, she added, other deliberate development policies are contributing to Delhi’s longtime pollution stew, she stressed.

Those, she added, include the federal government’s allowance of “5,000 polluting  brick kilns, 13 thermal power plants and several polluting industries” to flourish within a 300 km radius of Delhi; some 60%  of Delhi’s pollution comes from outside the city. 

CPR’s Harish sounded a more upbeat note saying: “I hope that a new bill to replace the ordinance may yet get tabled, discussed, and passed in the Parliament, and that the CAQM is only temporarily suspended.” 

Depending on the outrage the dissolution generates, that may yet happen. 

Jyoti Pande Lavakare is a journalist and author whose non-fiction memoir about the human cost of air pollution, ‘Breathing Here is Injurious to Your Health’, was published by Hachette in November 2020.

Image Credits: toiplus/India, Jean-Etienne Minh-Duy Poirrier/Flickr, World Air Quality Index.

Ursula von der Leyen, President of the European Commission, announcing the Digital Green Certificate proposal at a press conference on Wednesday.

The European Commission has released a proposal establishing a framework for a “Digital Green Certificate”, clearing the way for a vaccine certificate system to be set up by the summer. 

The proposal comes as many European countries are witnessing a third wave of infections and as the region’s vaccination campaign is lagging from vaccine shortages and the suspension of the AstraZeneca vaccine, a key vaccine in the inoculation effort – with only 10% of EU residents vaccinated. 

European Commission and WHO Encourage Trust in AstraZeneca Vaccine

President of the European Commission, von der Leyen, announced the moves  in a press conference – whrere she also stressed her confidence in the safety of the AstraZeneca vaccine, echoing the same message sent by the European Medicines Agency and the World Health Organization. 

“I trust AstraZeneca, I trust the vaccines,” said Von der Leyen. 

WHO’s expert safety team called the investigation into the thromboembolic events “good practice,” but stressed that there is currently no causal link to the vaccine. 

“At this time, WHO considers that the benefits of the AstraZeneca vaccine outweigh its risks and recommends that vaccinations continue,” said WHO in a statement released on Wednesday.   

The EMA is expected to publish its assessment of the vaccine on Thursday in a statement that Von der Leyen said would “clarify the situation.” 

Certificate System to Support Free Movement and Revitalize Economy

The Digital Green Certificate is designed to facilitate the safe and free movement of citizens in the EU during the COVID-19 pandemic. It will provide proof that an individual has been vaccinated against COVID-19, has received a negative test, or has recovered from COVID-19. 

Mock-ups of a paper and digital vaccination certificate, proposed by the European Commission on Tuesday.

“The Digital Green Certificate offers an EU-wide solution to ensure that EU citizens benefit from a harmonised digital tool to support free movement in the EU,” said Vera Jourová, Vice President for Values and Transparency at the European Commission, in a press release. 

“Our key objectives are to offer an easy to use, non-discriminatory and secure tool that fully respects data protection,” Jourová added. 

Several EU member states that rely heavily on tourism, including Greece, Spain, and Italy, were strong proponents of a common approach to such a system to revitalize air travel and ease the pressure on economies. Airlines and the travel industry also put pressure on EU politicians to implement a standardised travel solution. 

“We aim to help member states reinstate the freedom of movement in a safe, responsible and trusted manner,” said Ursula von der Leyen, President of the European Commission, at a press conference on Wednesday. 

Certificate System Won’t Be Discriminatory, Say Commission Officials

The proposed system will benefit everyone travelling within the EU and won’t discriminate against those who have not been vaccinated, emphasised the Commission in a statement. This comes after several countries and experts raised concerns about the ethics of such a system. 

National authorities in EU member states will be responsible for issuing the certificate, meaning it could be issued by hospitals, test centres, or health authorities. The certificate will include the individuals’ name, date of birth, date of issuance, information about the vaccine, test or recovery status, and a unique identifier. 

A QR code will be used to authenticate the certificate, ensure the security of data, and protect against falsification. According to the Commission, no personal data will be retained by the visited countries. 

The stages of the Digital Green Certificate System in practice.

The rights of individuals falling within the three categories on the Digital Green Certificate will be equal and member states will be required to waive the same public health restrictions, such as testing or quarantine, for all travellers with a certificate. 

“The Digital Green Certificate will not be a pre-condition to free movement and it will not discriminate in any way,” said Didier Reynders, Commissioner for Justice. “A common EU-approach will not only help us gradually restore free movement within the EU and avoid fragmentation. It is also a chance to influence global standards and lead by example based on our European values like data protection.”

Free movement is a fundamental right for EU citizens and the certificate system will “make it easier to exercise that right,” said the Commission. Those without a certificate will be able to travel, but may be subject to testing or quarantine. 

Commission officials have made a point to avoid the term “passport,” instead describing the Digital Green Certificate as a common system to help EU member states coordinate travel measures.

The certificate will be available to EU citizens and their family members, non-EU nationals who reside in the EU, and visitors who have the right to travel to other member states. It will be valid in all EU member states and Iceland, Liechtenstein, Norway, and Switzerland will be able to decide whether or not to introduce it. 

There will be no difference in the treatment of citizens and eligible non-EU citizens, said the Commission. 

The European Commission will develop a gateway for all certificates to be verified across the EU, assist member states in the technical implementation of the certificates, and support member states to develop software to scan and check the QR codes.

Vaccines Included Under Certificate System

The COVID-19 vaccines that have received EU marketing authorization will automatically be recognised on the certificate, but member states will be able to accept vaccine certificates issued for other vaccines, specifically ones that have been granted authorization by a member state’s regulatory agency or ones that have received WHO Emergency Use Listing. 

This is particularly an issue for the countries – Hungary, Slovakia, and Czech Republic – that have rolled out the Russian Sputnik V and Chinese Sinovac and Sinopharm vaccines before they have been approved by the European Medicines Agency (EMA). 

It is unclear if the proposed system will automatically be updated with the vaccines currently under rolling review by the EMA, including the Sputnik V vaccine, once they receive authorization.

The proposed system leaves the door open for updates based on new scientific evidence on the efficacy of vaccines in halting the transmission of SARS-CoV2 and the duration of protective immunity from prior infection. 

Currently the framework sets the maximum validity period of the certificate of recovery from a previous COVID-19 infection at 180 days. 

Next Step for Approval of Proposal

The Commission’s proposal is subject to approval by the majority of member states and the European Parliament before it can be implemented across the region. The proposal will be discussed at the next European summit, which is set to take place in late March. 

Member states will have to implement the trust framework, which defines the rules, protocols, and standards to ensure that the certificates are interoperable, verifiable, and trusted, in order to take a common approach to the certificates. 

The system could be implemented within three months EU officials said in February during the virtual summit of the European Council.

The Digital Green Certificate system will be temporary, “it will be suspended once the World Health Organization (WHO) declares the end of the COVID-19 international health emergency,” said the Commission. 

EU Threatens to Halt Vaccine Exports to UK, If Vaccine Exports to the Continent Aren’t Reciprocated

Meanwhile, in vaccine rollout news, the EC President threatened to curb the export of COVID-19 vaccines produced in the EU to countries that have higher vaccination rates, referring to the United Kingdom and the United States, both of which have been restrictive in their export of vaccines manufactured locally. 

“We want reliable deliveries of vaccines, we want to see increases in the contracts, we want to see reciprocity and proportionality in exports,” said Von der Leyen at a press conference. “We are ready to use whatever tool we need to deliver on that.”

“This is about making sure that Europe gets its fair share,” she added. 

The EU has exported 41 million doses of vaccines manufactured in the region to some 33 countries over the past six weeks – including 9.1 million Pfizer/BioNTech vaccines to Britain and one million to the US – and is the largest funder of the WHO co-sponsored COVAX global vacccine facility, which aims to share vaccines more equitably with low- and middle-income countries too.

But the bloc of 27 member states has not received its “fair share” of vaccines in return, particularly from the UK, Von der Leyen stressed, referring to the AstraZenec/Oxford vaccine produced there. 

“It is hard to explain to our citizens why vaccines produced in the EU are going to other countries that are also producing vaccines, but hardly anything is coming back,” said Von der Leyen. 

The EU is “still waiting for doses to come from the UK,” produced by AstraZeneca, said Von der Leyen. 

According to the Commission, two factories manufacturing the AstraZeneca vaccine in the UK are mentioned in the EU’s contract with the pharma company as sites for the production of vaccines designated for the EU.

The irony is that at the same time that the EU is clamouring for the UK to permit more AstraZeneca exports, some 17 countries have suspended its use due to about 30 reports of blood clots and abnormal bleeding in recipients of the jab. 

EU is “Not Ruling Out Anything” to Secure Vaccines

“We need to ensure that there is ‘reciprocity’ and ‘proportionality,’” said Von der Leyen. “If the situation does not change, we will have to reflect on how to make export to vaccine-producing countries dependent on their level of openness.”

When asked about potentially seizing production or waiving intellectual property rights to secure vaccine supplies for member states, von der Leyen said that “all options are on the table.”

“We are in the crisis of the century and I’m not ruling out anything for now because we have to make sure that Europeans are vaccinated as soon as possible,” Von der Leyen said.

Her comments contrasted sharply with the EU’s longstanding opposition to an IP waiver on COVID-19 tools and technologies at the World Trade Organization (WTO). The EU has joined several high income countries in blocking the proposal, arguing that WTO rules are flexible enough to address the vaccine access issues faced by low- and middle-income countries.

The export restrictions could also extend to countries “who have higher vaccination rates” than the EU, which could apply to Israel, Chile, the United Arab Emirates, Bahrain, Serbia, Qatar, Turkey, and Morocco.

UK Defends its Use of the “UK-Funded” Vaccine

In a rebuke to Von der Leyen’s comments, Matt Hancock, the British Health Minister, said that the UK had the legal right to prioritize doses of the AstraZeneca vaccine, developed with government support, to its citizens. The government has repeatedly prioritised UK citizens but continues to say it has not imposed an export ban on doses. 

“We legally signed a contract for delivery of the first 100 million doses here for people in the UK, as you would expect, both to ensure that people in the UK can get their jab and also because this is a UK-funded, UK-delivered vaccine,” Hancock said at a press conference on Wednesday. 

Matt Hancock, the UK’s Health Minister, at a news briefing on Wednesday.

“It remains the case that we expect the EU to stand by its commitment,” said a spokesperson for the UK government. “Putting in place restrictions endangers global efforts to fight the virus.”

“We’ve, all of us, including with our European friends, been saying throughout the pandemic that you’d be wrong to curtail or interfere with lawfully-contracted supply,” Dominic Raab, the UK’s Foreign Secretary, said on Wednesday. “I’m surprised we’re having this conversation. It is normally what the UK and EU team up with to reject when other countries with less democratic regimes than our own engage in that kind of brinkmanship.”

The decision to fulfill the UK’s vaccine needs before exporting to the EU coincides with an announcement on Wednesday that there will be a significant reduction in the amount of vaccines available in the UK from 29 March. 

This is due to “reductions in national inbound vaccines supply,” said a letter from the National Health Service, conveying information it received from the government’s vaccines task force. 

The EU has faced vaccine supply issues for several months now. AstraZeneca has underproduced and underdelivered doses to the EU, which has slowed the speed of the regional vaccination campaign. Initially the pharma company was expecting to deliver 90 million doses in the first quarter, but this has dropped to 30 million doses.

Despite the struggles the EU has faced with their rollout of vaccines, Von der Leyen said that she remains optimistic that the target of having 70% of the adult population fully vaccinated by the end of the summer could still be reached. 

Image Credits: Twitter – Ursula von der Leyen, European Commission, European Commission, Sky News.

A new WHO brief calls for strengthening of tobacco control measures around the world, to protect the health of infants and young children.

Tobacco use and second-hand smoking during pregnancy doubles the risk of sudden infant death and birth defects – issues highlighted in a new policy brief on the linkages between tobacco control and children’s health, published by the World Health Organisation(WHO).

The brief,  Tobacco Control To Improve Child Health and Development, notes that exposure to second-hand smoke during pregnancy is linked to a 23% increased risk to stillbirths and 13% increased risk of congenital malformation. And of  the 1.2 million deaths every year caused by second-hand tobacco smoke exhaled by smokers, the study found that up to 65,000 occurs among children under 15 years.

Emerging evidence suggests that smoking during pregnancy can have an impact across generations, the brief notes: “For example, grandchildren of women who smoked during pregnancy are at a higher risk of asthma,” it states.  The brief, released on Tuesday, is part of a new “Nurturing Care” initiative by WHO, which aims to highlight ways in which healthcare practices and policy choices and improve children’s prospects of health and development.

Calling for the strengthening of the tobacco control measures around the world, to protect the health of children, the brief advocates for tobacco control through what it calls the MPOWER measure -an acronym describing a raft of tobacco control actions including tax increases and, advertising bans on tobacco products in addition to assisting smokers to quit the habit. 

It further calls for the promotion of smoke-free environments to promote infant health and prevent needless deaths caused by second-hand tobacco smoke. 

Exposure to second-hand smoke during pregnancy was linked to 23% increased risk of stillbirths and 13% increased risk of congenital malformation. However, the risk of stillbirths is not limited to second-hand tobacco smoke alone. As a matter of fact, “even the use of smokeless tobacco during pregnancy increases the risk of stillbirth, preterm birth or having a low-birth-weight baby.” 

Brought Up In Homes With Smokers

Children living with smokers are at a greater risk of developing bronchitis, pneumonia and other respiratory infections and are likely to die before their fifth birthday. Children brought up in homes with caregivers who smoke are almost 70% more likely to try smoking by the age of 15; and children who experiment with smoking earlier in life are likely to take up the habit in their adulthood.

But it is not just the smoking environment at home that predisposes children to take up smoking. The study states that marketing tactics of the tobacco industry are also to blame as these promote  false images and messages that hide and distort the true impact of tobacco on health, interfering with tobacco control efforts. “

The industry also regularly uses children in the tobacco supply chain, particularly for growing tobacco,” notes the report. This puts children at risk of multiple conditions and diseases including green tobacco sickness, a kind of nicotine poisoning, due to farm-level exposures.

Call For Comprehensive Policies 

“Creating 100% comprehensive smoke-free policies result in greater benefits, especially when those policies are adequately enforced, without exceptions,” says Dr. Vinayak M Prasad, Unit Head, No Tobacco (TFI) at the WHO Department of Health Promotion, speaking at the launch of the brief. Legislation to make public places smoke-free for example, is associated with important reductions in preterm births, asthma hospitalizations and hospital visits for severe respiratory tract infections.

The study cites the example of Brazil, where comprehensive legislation banning smoking in all indoor public places substantially reduced infant deaths.  Even earlier implementation of comprehensive laws could have avoided 10 000 additional infant deaths.

In terms of policies, up to 5 billion people around the world are now covered by at least one national MPOWER measure, but only 293 million people live in countries or regions that have adopted all MPOWER measures. For instance, only 62 countries, home to just 22% of the global population, have implemented legislation on smoke-free work and public places. “Governments should be resolute in imposing and enforcing strict measures,” the study recommends.

More broadly, the brief argues that incorporating child health and development measures into national tobacco control policies – might help countries, and their citizens to take tobacco control more seriously, overall.  For instance, many women still don’t realize that kicking the habit even during pregnancy will improve the health of their fetus, and overall prospects for survival.  

 

Image Credits: WHO .

 

Dr John Nkenkasong, Director of the Africa CDC says negotiations to secure COVID-19 vaccines are out of their hands.

Africa’s goal of achieving herd immunity against COVID-19 hangs in the balance as 270 million doses of vaccines are yet to arrive in the continent despite being secured three months ago by the African Union (AU) and African Centres for Diseae Control (ACDC).

Mid-January 2021, Health Policy Watch reported that the Africa CDC had pre-ordered millions of much-needed vaccines from various suppliers. But to date not even the centre’s leadership knows when the first set of shipment is due to arrive – or which country will be the first to receive the doses.

With two weeks to the anticipated April roll-out of the vaccine, Dr John Nkenkasong, Director of the Africa CDC, told Health Policy Watch that the finalisation of the process, by which Member States of the African Union (AU) can confirm and obtain their doses, is yet to occur. This includes the negotiations with the Afreximbank which is providing African countries with credit facilities, with which they can procure doses of the vaccines from the manufacturers.

“Most of the processes and negotiations are work in progress,”  said Dr Nkenkasong.

In the statement in January announcing the acquisition of the 270 million doses, the African Vaccine Acquisition Task Team (AVATT) established by African Union Chair President Cyril Ramaphosa, said the doses will be supplied by Pfizer, Johnson & Johnson and AstraZeneca (through an independent licensee, Serum Institute of India).

“From the onset of this pandemic, our focus as a continent has been on collaboration and collective effort. We have held steadfastly to the principle that no country should be left behind,” Ramaphosa said at the time.

AVATT officials said at the time that all 270 million vaccine doses will be made available this year with at least 50 million being available for the crucial period of April to June 2021.

Africa CDC then asked African countries to order doses through the African Medical Supplies Platform and when the deadline for the expression of interest expired in mid-February, Nkenkasong revealed that only about 26 countries (less than half of the countries in Africa) had expressed interest in securing doses through the platform.

But less than two weeks to April, there is no clear indication of whether the doses will be available by April or not.  And any delays would threaten the goal of achieving herd immunity for COVID-19 in Africa within one year, as AU and Africa CDC officials aim to do.  

 

Africa’s Long Road to Herd Immunity
Vaccinations in Kenya: about a dozen African countries have now launched vaccine drives in priority groups like health workers, older people and teachers, with the support of the WHO co-sponsored COVAX global facility. But supplies available through COVAX fall far short of demand. 

Last week, the president of the African Development Bank, Dr. Akinwumi Adesina called for vaccine justice for Africa. Speaking at the launch of the Bank’s African Economic Outlook 2021 report on Friday, Adesina decried the lack of Covid-19 vaccines reaching Africa.

“So far, 14.6 million vaccines have been delivered in Africa, but many people still cannot get shots in their arms. That is only 1% of what we need. We are way off the mark in terms of getting to 60% of herd immunity, and sadly, I do not see that happening for another year or two at this rate— not unless things change,” Adesina said.

According to him, there is a need to improve Africa’s access to vaccines. But so far, the COVAX Facility has been the major source of vaccine doses available to African countries, beginning with Ghana in late February.   However, the COVAX supplies would cover only about 20% of the population, at most, by the end of 2021. 

“COVAX is doing a great job but still, we need more. We need them in adequate quantity. We need them quickly and we need them at an affordable price,” Adesina said.

Negotiations to Secure Vaccine Doses “are really out of our hands”

Nkenkasong is a major proponent of African countries accessing vaccine doses through multiple means considering COVAX will only provide doses for one in five of those needing jabs. But he told Health Policy Watch that several aspects of the processes involved in securing the doses of the various COVID-19 vaccines are beyond the control of the public health agency.

“Our own role is to say to the continent — this is the kind of vaccines we should get, this is exactly why we should get this vaccine and these are the targets that we are trying to achieve. The rest of the back end negotiations are really out of our hands. So be patient with us,” Nkenkasong told Health Policy Watch.

But the non-arrival of the doses of COVID-19 vaccines, which have been expected through AVATT,  has not stopped Africa CDC from getting involved in the roll-out of COVID-19 vaccines in the tens of African countries where COVAX-supplied doses are available. 

“What we are doing is to collect all those vaccines that are coming in, in a dashboard, project them and show where each country is with respect to getting to 60%. That is our role and we will use that to catalyse the process and advocate for more partners,” Nkenkasong said.

 

Image Credits: Wish FM Radio.

Vaccinated: Sister Amanda Swartz believes the vaccinations will give South Africa a fighting chance against COVID.

South Africa’s vaccination programme for health workers is inching forward, fuelled by small deliveries of the Johnson & Johnson vaccine every two weeks.  However, overall supplies remain far short of the needs – even for the health sector. 

The country has an estimated 1.25 million health workers in public and private health to serve its population of 60 million – but by 15 March, slightly fewer than 148,000 had been vaccinated due to a dearth of vaccines.

A looming third wave of COVID infections, predicted in June when the country’s winter forces people indoors, and the more infectious B.1.351 variant now dominant in the country, are two big anxieties facing health workers.  There is also hesitancy with some health workers believing that there is insufficient safety and efficacy data for most vaccines so far approved.

But Sister Amanda Swartz did not hesitate when offered a vaccine in late February. At the very front of the ‘frontline’ against the pandemic, Swartz works at Brackengate Intermediate Care Facility,  a 300-bed facility set up specifically for COVID-19 patients in Cape Town. A nurse for 30 years who has worked with HIV and tuberculosis patients, Swartz says she has never experienced anything like the second wave of the pandemic, which hit the country in December and January. 

At its zenith, South Africa was recording 22,000 new cases per day, and Swartz says the Brackengate facility was overwhelmed with patients: “We lost 20 patients in one day. Young people with no comorbidities were coming in scared because they have never been sick in their lives but they couldn’t breathe,” says Swartz. 

Swartz felt sickly on Christmas eve and spent the next 10 days in isolation. Sick with COVID-19, she had to self-isolate from her three children.

Covid is a Lonely Disease
Health workers in the Western Cape province of South Africa getting their Covid vaccination.

Describing COVID-19 as a “lonely disease”, Swartz said the nights she spent alone and struggling to breathe were the worst – but hearing her family in the house kept her going.

“It made me think about my patients differently. How they were all alone in the hospital and scared, and we are the only people that can motivate them and keep them in touch with their families.”

Returning to work was “scary”, admitted Swartz. She was still tired, suffered shortness of breath and feared being reinfected. 

When she was offered the vaccine, she grabbed the opportunity and was one of the first to be vaccinated at her facility on 24 February.

“I couldn’t actually wait for us to start with vaccinations in the country because this gives us a fighting chance against the disease,” said Swartz. “I didn’t only do it for myself. As I’m working with COVID patients, I also put the people that I love at risk. So by protecting myself, I’m also protecting my family.”

While there is still “negativity” about the vaccine on Facebook and other social media platforms, most of Swartz’s colleagues who were afraid to be vaccinated have come around:

“They see that those who have taken the vaccine didn’t have side-effects or, if we did, they were very mild like a headache or fatigue – just like if you have Hepatitis B vaccine. So most of them say they are prepared to take the vaccine now.”

Swartz believes that a third wave is inevitable in the country as people have become lax about wearing masks and physically distancing.

The Western Cape government on Thursday said that to date 27 570 healthcare workers in the province had been vaccinated,  urging others to register and get the jab to “shield each other”.

“The vaccine is currently being rolled out to healthcare workers, but not enough of us have been vaccinated at this stage to stop the spread of the virus,” the province said in a statement.

Relaxed Lockdown Regulation Could See Spike in New Cases 
On 1 March, most pandemic-related restrictions were relaxed in South Africa in the face of falling caseloads and the devastating economic impact of lock-downs. 

But with the curfew eased, alcohol on sale again over weekends, bars and restaurants open and people allowed to mingle, health experts warn that new cases are soon going to rise again –  although, for now, new infections remain under the bar of 700 a day in a country of 60 million people.

In the face of another wave of infections, Swartz said: “What I would really like to see is that each and everyone in our country takes the vaccine if the world will give it to us. We had too many losses in the second wave. If we can prevent that by taking the vaccine, I think that will help a lot.”

South Africa’s vaccine procurement, like that of other African countries, is slow and uncertain. 

Shortly after securing 1.5 million doses of the AstraZeneca/ Oxford vaccine in a bilateral deal with the Serum Institute of India for health workers in early February, a small study, just now published in the New England Journal of Medicine, showed that the AstraZeneca vaccine was not effective in preventing mild and moderate infection against the B.1.351 variant prevalent in the country.

The government decided instead to offer the Johnson & Johnson vaccine to health workers. Although the vaccine is not yet registered for use in the country, a clinical trial on efficacy had just been completed – so scientists expanded the terms of the trial to encompass an implementation study for health workers.  Since then, the J&J vaccine has been approved both by the US Food and Drug Administration and the European Medicines Agency. 

South Africa Sells AstraZeneca Vaccine Doses Despite Calls for Roll-Out


The government, however, generated a controversy when it resolved to sell its 1.5 million AstraZeneca doses to the African Union. A number of leading scientists condemned this decision, particularly Professor Schabir Madhi, dean of the Faculty of Health Sciences at the University of the Witwatersrand and Director of the SA Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit.

Madhi was the principal investigator on an AstraZeneca efficacy trial being run in South Africa.

Writing in Business Day earlier this month, Madhi argued that “there remains a strong biologically plausible reason to expect the AstraZeneca vaccine will protect against severe disease due to the B.1351 variant, likely to a similar magnitude as the J&J vaccine”.

The World Health Organization also recommended in mid-February that the AstraZeneca vaccine should still be rolled out, even in countries where the B.1.351 variant was circulating, said Madhi.

He and other health professionals, including infectious diseases expert Professor Francois Venter, believe that the AstraZeneca vaccine should have been rolled out to high-risk South Africans who have no other protection against severe illness and death.

“Every additional day of procrastination lends itself to much of the R75m [75 million Rand/$US 4.87 million] used to procure the vaccine going to waste, while the elderly and other high-risk individuals would certainly remain unprotected as opposed to being offered a fighting chance of being protected against Covid-19 severe disease and death,” wrote Madhi.

The AstraZeneca vaccine is the backbone of the global COVAX vaccine platform’s vaccination programme and it also makes up a large portion of the African Union’s vaccine procurement.

Unlike many other African countries, South Africa has yet to receive a COVAX vaccine delivery. According to the COVAX allocation plans published on 2 March,  South Africa is still due to get over 2.4 million doses of the AstraZeneca vaccine and 117 000 Pfizer doses.

However, given the government’s decision to return its own AstraZeneca purchases and a global shortage of vaccines, it is going to take a while before the country’s citizens get the jab.

Image Credits: Western Cape government, Kerry Cullinan , Western Cape Provincial Government, South Africa .

AstraZeneca vaccine

Major European nations remain divided over the use of Oxford/AstraZeneca’s COVID-19 vaccine, while the pharma company said there was no evidence of increased risk of blood clotting and abnormal bleeding among people who get the vaccine.    

AstraZeneca’s review of all the safety data of more than 17 million people vaccinated in the European Union (EU) and the United Kingdom (UK) has shown no increased risk of pulmonary embolism, deep vein thrombosis (DVT) or thrombocytopenia in any particular age group, gender, or country, the company said on Sunday. 

Across the EU and the UK, there have been 15 cases of DVT and 22 cases of pulmonary embolism reported among those given the AstraZeneca vaccine. Five deaths have also been reported – two dying from brain hemorrhages.

The reports have prompted more than a dozen countries to either partially or fully suspend the vaccine’s use while cases are being investigated. Some 17 countries, including Spain and Sweden have joined France, Germany, and Italy in suspending use of the vaccine. 

“The nature of the pandemic has led to increased attention in individual cases and we are going beyond the standard practices for safety monitoring of licensed medicines in reporting vaccine events, to ensure public safety,”  AstraZeneca said in its statement on Sunday. Ann Taylor, Chief Medical Officer, added:

 “number of cases of blood clots reported in this group is lower than the hundreds of cases that would be expected among the general population,” but she said that the company will continue to closely monitor the vaccine rollout.   

UK’s Boris Johnson Issues Strong Defense – Australia, and Thailand Also Remain Confident in AstraZeneca 

Outside of Europe, however, the AstraZeneca vaccine rollout through the WHO co-sponsored COVAX initiative was continuing in most countries – although the Democratic Republic of Congo said they had postponed an immunization launch that had been planned for this week. 

And Australia, India and Thailand were moving ahead with the vaccine as well as the UK. 

UK Prime Minister Boris Johnson issued a series of strong statements in defense of the vaccine – whose R&D the UK also supported. “The vaccine is safe and works extremely well,” Johnson wrote in an article published on Tuesday in The Times.

Prime Minister Boris Johnson says UK ‘very confident’ about AstraZeneca vaccine

“People should still go and get their COVID-19 vaccines when asked to do so,” said Dr Phil Bryan, UK Medicines and Healthcare products Regulatory Agency (MHRA) Vaccines Safety Lead, in a statement. 

Bryan added: “We are working closely with international counterparts in understanding the global safety experience of COVID-19 vaccines and on the rapid sharing of safety data and reports.” 

On Monday, Johnson told reporters that Britain’s MHRA is “one of the toughests and most experienced regulators in the world,” saying it’s approval signalled that the vaccine was safe. He went on to praise the UK’s vaccine rollout, one of the largest so far, which is helping to bring down COVID-19 rates. . 

More than 24 million people in the UK have received at least one dose of a coronavirus vaccine, with the UK government aiming to offer a first vaccine dose to about 32 million people in nine priority groups by 15 April.  

But Johnson reiterated, “Successful as the UK vaccination programme may be, there is little point in achieving some isolated national immunity. We need the whole world to be protected.” 

Australia will also not pause their AstraZeneca COVID-19 vaccine rollout with Chief Medical Officer Paul Kelly remaining “confident that [the vaccine] is safe.”  

“The Therapeutic Goods Administration is aware of the issue and also does not’ see any link between the AstraZeneca vaccine and blood clots,” Kelly said in a press conference on Tuesday.  

Australia’s CMO (right) Paul Kelly addresses blood clot concerns over AstraZeneca vaccine

Kelly also stated that there have been no increased incidence of blood clots among Australians who have already received the AstraZeneca vaccine. 

Thailand’s prime minister, Prayuth Chan-ocha, who received a dose of the AstraZeneca vaccine on Tuesday, urged people to “believe doctors” as other countries suspended the vaccine’s use. 

“There are people who have concerns,” Chan-ocha said after receiving the vaccine. “But we must believe doctors, believe in our medical professionals.”

Most Asian countries have continued to administer the AstraZeneca vaccine, with India the largest user. 

Thailand has ordered enough doses from AstraZeneca and China to cover around half of its population. The country has so far vaccinated around 50,000 people in high-risk groups. 

Suspensions of Vaccine is ‘Political’, Says Italy 

As many national vaccination strategies remain reliant on the vaccine made by AstraZeneca, the decision to suspend its use may slow down rollout even more, as efforts are marred by political infighting, mixed messaging, and supply shortages. 

Despite delays of the vaccine in several countries, Spain remains confident that the Spanish government’s two-week suspension will not alter the country’s vaccination calendar, government spokeswoman Maria Jesus Montero said on Tuesday. 

Spain aims to vaccinate 70% of its 47 million population by the end of the summer. 

Italy’s medicines authority director-general called the decision to delay the vaccines largely “political”.

“We got to the point of a suspension because several European countries, including Germany and France, preferred to interrupt vaccinations… to put them on hold in order to carry out checks. The choice is a political one,” Nicola Magrini told the la Repubblica daily in an interview, Reuters reported. Prior to taking on his new role,  Magrini was a former top WHO official specializing in medicines approvals and access.   

Italy has recently blocked a shipment of AstraZeneca vaccines from leaving the country, arguing that it had failed to meet its contractual obligations to provide the vaccine to the European Union. 

EMA and WHO Urge Continued Use  – WHO Data Review to be Completed on Thursday 

The European Medicines Agency and the World Health Organization have been quick to defend the Oxford/AstraZeneca vaccine – and urge its continued use. 

“I’m not here to give you the outcome of any scientific review”, said EMA director Emer Cooke at the start of a press conference on AstraZeneca vaccine safety on Tuesday. 

“I’m here to explain the steps in the process, what we’re doing, and when you can expect us to come to a conclusion.”

Experts will meet on Thursday “to come to a conclusion on the full information that has been gathered and to advise us as to whether there are further actions that need to be taken,” said Cooke. “We will inform the public of the outcome immediately after this meeting.” 

The EMA currently concludes that while the investigation is still ongoing, “We are firmly convinced that the benefits of the AstraZeneca vaccine in preventing COVID-19 with its associated risk of hospitalization and death outweigh the risk of the side effects.” 

The WHO has also issued similar messages, with the WHO’s Global Advisory Committee on Vaccine Safety saying that at the moment, “benefits of the vaccine outweigh the risks”.  The  EMA is to issue reports about the safety of the vaccine on Thursday, after examining all data. 

WHO Director General Dr Tedros Adhanom Ghebreyesus

WHO Director General Dr Tedros Adhanom Ghebreyesus said the events are not necessarily linked to vaccination, “but it’s routine practice to investigate them, and it shows that the surveillance system works and that effective controls are in place.”

–Updated 18 March, 2021

Image Credits: Flickr, gencat cat/Flickr, The Guardian, Sophie Scott/ABC.

ISLAMABAD – Pakistan authorities are threatening to fire healthcare workers who refuse to be vaccinated with the Chinese-donated SinoPharm COVID-19 vaccine. 

In a harshly worded letter, , the Directorate of Health Services in Sindh warns frontline health care workers that reluctance to get the jab will result in “strict disciplinary action” including suspension or dismissal from government services.

The letter dated 24 February and signed by Dr Nazir Ahmed Rind states that: “If any frontline health care worker refuses to vaccinate, he/ she may be terminated/ suspended from the Government Services”.

Warning letter to health workers.

The objection to being vaccinated with the SinoPharm vaccine stem from concerns raised about its efficacy and safety, particularly as a division of Pakistan’s health ministry initially declared that the vaccine was unsafe for people older than 60, pregnant women and lactating mothers. 

Although the government has since reversed its position on this, it has done little to address  health workers’ concerns. 

So far, only half of the 500,000 HCWs registered to be vaccinated have received the vaccine and the country’s health authorities are not taking kindly to their unwillingness to be vaccinated.  

The Sindh health ministry confirmed that the notice was issued by the secretary’s office, but the provincial health minister’s PR officer failed to respond to requests for comment.

Similarly, in another letter dated 27 February, the management of the Pakistan Institute of Medical Sciences (PIMS) in Islamabad, one of the largest hospitals in the country, has issued a stern warning to employees that “all registered PIMS staff must get vaccinated as soon as possible. Otherwise, strict disciplinary action will be taken against the defaulter, as per rules”.

Flip-flopping decisions and ‘trials’  

Pakistan started vaccinating its frontline health care workers (HCWs) – including doctors, nurses and paramedics – in its federal capital and all of its federating units simultaneously in early February. 

Dr Rana Mohammad Safdar, Director General of the Health Ministry’s National Health Services Regulations and Coordination (NHSR&C), said that about 250,000 people have been vaccinated out of the 500,000 HCWs that had registered.

“The vaccine has side effects,” said Dr Yasmin Rashid, Health Minister of Pakistan’s most populous province, Punjab, in a press briefing after receiving the SinoPharm vaccines. She added that anyone getting the vaccination should do so at their own risk. 

At the time, the minister also said that it would be “premature to say how long [the vaccine] will be effective”.

 

https://twitter.com/Nadeemchisd/status/1368582866175721472

Initially, the Ministry of NHSR&C had recommended that people over the age 60, lactating mothers and pregnant women should not get this vaccine, but a month later, the Drug Regulatory Authority of Pakistan approved the vaccine for these groups.

The contradictory advice raised concerns among HCWs. Dr Tanvir-ullah, serving in the federal capital Islamabad’s Federal Government Services Polyclinic Hospital, said that he tested COVID-19 positive after getting the vaccine.

“I received the vaccine on 18 February and after that I felt body aches and later on, mild flu symptoms also developed,” he said.

On 4 March he tested positive for COVID-19.

Tanvir-ullah said that HCWs feared that the vaccine may be being tested on them. 

“Generally, HCWs are reluctant of the vaccine [and] believe they are being involved in the vaccine’s trial,” said Tanvir-ullah. “Safety and efficacy are indeed a concern of HCWs not going for vaccination.” 

Mixed Messages

Dr Qaiser Sajjad, secretary general of the Pakistan Medical Association (PMA) – a body working for doctors’ rights – said the vaccination of HCW was “slow” as doctors are ‘reluctant’ to get the Chinese vaccine.

Sajjad said that PMA has registered 189 doctors’ deaths in the fight against COVID-19 and the “unclear” message by the government regarding the efficacy of the vaccine was creating problems.

“Doctors [are] reaching out to the PMA platform and ask[ing] about efficacy, data availability, research standards, expiry and status of the donated SinoPharm vaccine,” said Sajjad. “Unfortunately, instead of convincing the HCWs, the government is trying to force them to vaccinate, which is unethical.” 

“Government must inform HCWs on how a vaccine that was not effective for people above the age of 60 years, suddenly became effective,” said Sajjad.

Public health expert Dr Zafar Mirza, who served as health minister for Pakistan and director of the Health System of World Health Organization (WHO), said that the government should have communicated to the HCWs about the safety of the vaccine in a well thought-out way.

“There is a need to correct the perception of safety and efficacy of the SinoPharm vaccine in HCWs and the public as well,” he said.

Mirza pointed out that, although no adverse case had been recorded after administering the SinoPharm vaccination, the vaccine’s safety had not been appropriately conveyed.

“Out of 500,000 HCWs the number of registered and vaccinated is very low and should have been completed so far,” said the doctor.

No Adverse Events Recorded

Akhtar Abbas, spokesperson for the Drug Regulatory Authority of Pakistan said the authority had approved the vaccine after analyzing the submitted data. He said no adverse case about safety of the SinoPharm vaccine had been reported from anywhere in the world.

Abbas said the vaccine had also been approved for people older than 60 after the expert committee reviewed the data that no adverse effect was recorded from any other country.  

According to the data released by Pakistan’s National Command and Operations Center (NCOC), a strategic forum established by the government to deal with the COVID-19 pandemic, 504,000 doses of the SinoPharm vaccine had been distributed in all federating units of the country for the frontline HCWs.

Punjab had received 118,000 doses, Sindh 102,100, Khyber Pakthunkhwa 28,000, Baluchistan 16,000, Islamabad 15 000, Azad Jammu & Kashmir 11,000 and in Gilgit Baltistan, 5 000 doses of the vaccine have been provided so far.

In the southern region, only 12,194 HCWs had been vaccinated and in north-western province, Khyber Pakthunkhwa, 26,697 HCWs had been vaccinated so far.

Rizwan Malik, Public Relations officer for the health minister of Khyber Pakthunkhwa, said that health authorities had observed an upward trend in vaccinations in the last two weeks of February, but this dropped off recently.

“Provincial government is encouraging HCWs to come for the vaccination,” he said.

Federal Minister Asad Umer, who heads the NCOC, said that around 50 percent of the HCWs had been vaccinated and “not a single case” regarding safety of the vaccine had been reported.

He agreed that there was a reluctance from HCWs to get vaccinated but that this was happening in other parts of the world as well. “Maybe HCWs are reluctant because it is something new for them,” he said.

Meanwhile, Dr Imran Sikandar of PIMS hospital, who received the first vaccine in the countrywide vaccination drive, said that he feels “perfect” after getting both doses of the SinoPharm vaccine.

“I received the first dose on 2 February and the second jab on 23 February and I am feeling healthy,” said Sikandar.

He said concerns about the vaccine were only misconceptions and needed to be eradicated. He added that vaccinations of HCWs should be made mandatory for the safety of the public.

 

Inactivated COVID-19 vaccine candidate produced by Beijing Institute of Biological Products and Sinopharm Group.

No Peer Review Study Yet

Neither of China’s two leading vaccine candidates, SinoPharm and Sinovac, have been approved by an external regulatory agency and discussions are still continuing with the WHO, according to WHO officials.

Chinese vaccine developers have also not published peer-reviewed studies on their vaccines. Company reports show SinoPharm’s multi-country trials yielded efficacy results of 79 percent, while Sinovac trials from four different countries showed results ranging from 91.3 percent in a Turkish trial to 50.3 percent in an independently managed Brazilian trial among health care workers.

Although China has been accused of donating its COVID-19 vaccines for political power, Chinese President Xi Jinping stressed at recent meetings of the World Health Assembly that it viewed its COVID vaccines as a global “public good”.

China has also joined the global vaccine access platform, COVAX, and promised it 10 million doses. China reports that it has also offered vaccine assistance to 53 developing countries, and that it has exported or is exporting vaccines to 22 nations, according to Foreign Minister Wang Yi.

A recent preprint paper, which has not undergone peer review, suggests that SinoPharm’s vaccine held up well against a South African SARS-CoV2 variant (501Y.V2). In the analysis of blood samples from a dozen vaccinated participants, the vaccine’s neutralizing power was only reduced by a factor of 1.6 when it was exposed to the variant.   

Countries Have Autonomy to Authorise Health Products, says WHO

When asked for comment about countries using vaccines that did not yet have WHO emergency using listing, the WHO stressed that “countries have the autonomy to issue emergency use authorizations for any health product. Domestic emergency use authorizations are issued at the discretion of countries and not subject to WHO approval”.

“There are and will likely continue to be manufacturers of some vaccine candidates who may be delayed in seeking or choose not to seek emergency use listing by WHO or authorisation by a stringent regulatory authority,” the WHO told Health Policy Watch.

“The use of some of these products has proceeded in a number of countries with the agreement of national authorities. It is possible that the data required for a WHO emergency use listing assessment may not have been available at the time of national decisions to use such vaccines.”

In cases where a country’s vaccines were not requalified by the WHO but approved by a country’s national regulatory authority, it was common for the global body and UNICEF to provide technical assistance, added WHO.

“WHO’s support is provided to the immunization programme of the country, not to a specific vaccine. This support includes capacity assessments, planning, advising on delivery strategies, ensuring adequate cold chain, data monitoring, communication including raising public awareness and promoting demand for vaccination, and risk communication,” stressed the WHO.

Image Credits: Sinopharm.

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.

Elizabeth Cousens, CEO of the UN Foundation

Over 662,000 people, hundreds of corporations and organisations from 190 countries have donated $242 million to the COVID-19 Solidarity Response Fund in the past year, according to Elizabeth Cousens, CEO of the UN Foundation.

Addressing the World Health Organization (WHO) biweekly media briefing on Monday, the first anniversary of the fund, Cousens said the fund had been a demonstration of global solidarity.

“In just six weeks, we raised more than $200 million, and to date the fund has dispersed more than $226 million, making it one of the top donors to WHO’s COVID-19 response,” said Cousens.

Donors included “online gamers (who) ran livestream marathons generating hundreds of thousands of dollars, celebrities, fitness gurus, musicians, artists, athletes, children, even the Minions”, said Cousens, who was assisted to set up the fund by the Swiss Philanthropy Foundation.

Fund Covers Millions of Items of PPE, COVID Tests and ICU Beds

Thanking all those who had donated, WHO Director General Dr Tedros Adhanom Ghebreyesus said that the fund had enabled the WHO to ship “more than 250 million items of personal protective equipment, provide technical support to hundreds of labs, supply more than 250 million COVID-19 tests, coordinate the deployment of more than 180 teams and missions, deliver oxygen and support over 12,000 intensive care beds to prevent health systems from being overwhelmed”.

Expressing his heartfelt thanks, Mike Ryan, WHO’s Executive Director of Health Emergencies Programme, admitted that funds for the pandemic had been extremely tight a year ago.

“This time last year was a very, very difficult time. Funding was very sparse. Everyone was reacting in different ways. The creation of the fund, and the fact that companies and institutions and individuals people out there just reached into their pockets and put money into this response, provided a vital lifeline for many organisations,” said Ryan.

However, Cousens and Tedros appealed for more donations as many countries were struggling to finance their COVID-19 vaccine programmes.

Countries Should Continue to Vaccinate With AstraZeneca 

WHO Chief Scientist Soumya Swaminathan

The WHO repeated its advice to countries to continue to vaccinate people with the AstraZeneca vaccine, despite safety concerns.

This follows the suspension of vaccinations with AstraZeneca in Denmark, Norway, Iceland and Bulgaria and Austria, Italy, Estonia, Latvia, Luxembourg and Lithuania stopping the use of vaccines from the most recent batches after reports of serious blood clots among 30 of the 5 million people vaccinated. 

During the course of this week, the WHO’s Global Advisory Committee on Vaccine Safety and the European Medicine Agency would issue reports about the safety of the AstraZeneca vaccine after examining all the data, said WHO Chief Scientist Soumya Swaminathan.

“In European and the UK, more than 17 million doses of AstraZeneca vaccines were administered so far,” said Swaminathan. “The recommendation is that the risk benefit of not vaccinating using AstraZeneca vaccines is outweighed by the risk of the COVID-19 infection.”

‘No Association’ Found Between Vaccine and Adverse Events

“If you remember, there was an initial scare about excess deaths amongst the elderly that was reported from Norway and then it was clarified that it was not really excess deaths. It was just a normal, expected rate of deaths.”

She added that “people do get thrombo-embolic events, pulmonary embolisms, and people die every day”.

“So the question really is the linkage with the vaccine and this is why we need to look at all of the data, and the experts are looking at the data. So far, we do not find an association between these events, and the vaccine, because the rates at which these events have occurred in the vaccinated group are in fact less than what you would expect in the general population at the same time,” stressed Swaminathan.

Although at least 300 million vaccine doses had been administered worldwide, not one documented death has been linked to a COVID-19 vaccine, she concluded.

Vaccine Passports Must Not ‘Create Inequity’

Mike Ryan, Executive Director of WHO Health Emergencies Programme.

While the European Union is expected to issue guidelines this week on a digital “green passport” allowing people who have been vaccinated against COVID-19 to move freely in the EU, Ryan warned of the human rights consequences of such a move.

While the concept of digital registration of health information, including vaccination records, was “a very positive thing within national health systems”, said Ryan, such a policy should not create inequity particularly given the unequal access to vaccines at present.

“We need to be very, very careful that the process of certifying vaccination does not result in personal freedoms, or human rights being impeded in any way that is not justified,” said Ryan.

There has to be a “very strong justification” for any health measure to be mandatory “and then whether or not someone has the right to do certain things after vaccination again requires deep thought on the ethical and human rights issues at the centre of this,” he added.

 

Image Credits: WHO.