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.

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.