European AstraZeneca suspensions threaten global COVID response
European countries are pausing the use of the Oxford-AstraZeneca coronavirus vaccine over concerns of blood clots, colliding with expert opinion and creating a crisis of faith in the shot that could hamper progress to stop the COVID-19 pandemic.
Sweden and Latvia on Tuesday joined more than a dozen other European countries, including Portugal, Germany and Italy, that have publicly announced they are temporarily suspending use of the vaccine following reports of blood clots.
Europe’s top medical regulator is insisting the vaccine is safe and that the benefits of preventing hospitalization and death from COVID-19 outweigh any possible side effects.
“At present, there is no indication that vaccination has caused these conditions,” Emer Cooke, executive director of the European Medicines Agency, said during a Tuesday press conference. “They have not come up in clinical trials, and they’re not listed as known or expected side events.”
The agency has convened a safety committee of experts from across the European Union (EU) and beyond for an emergency meeting on Thursday to discuss and release the findings of its investigation into reports of rare but dangerous blood clots in the brain and abnormal bleeding.
The overall number of events “seemed not to be higher” in vaccinated people than in the general population, Cooke said. People are going to get blood clots, and just because they occurred shortly after vaccination does not mean there’s a link.
Asked about countries’ decisions to suspend the vaccine, Cooke said they were taken “in the context of the information that is available at the national level, and it is the country’s prerogative to do so.”
The World Health Organization (WHO) has also been quick to back the vaccine’s safety and has encouraged countries to continue using the shot.
Mariângela Simão, a WHO assistant director-general, last week said she thinks people have confused causation with correlation.
“People die every day,” she said. “There will be people who have been immunized who will die of other causes. So far the preliminary data we have seen does not lead to a causal relationship.”
AstraZeneca has also said there is no evidence linking its vaccine to blood clots.
The British pharmaceutical company released a statement after it reviewed 17 million vaccines administered in Europe, saying it found only 15 events of deep vein thrombosis and 22 events of pulmonary embolisms.
But the flurry of suspensions is concerning health experts, who say the decisions do not seem to be supported by medical data. Not only could the pauses set back vaccination efforts across Europe, but they could have ripple effects across the world.
“I think that many of these countries will have done damage to what is a good vaccine” said Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security.
Even if the countries resume vaccinating people in a few days, the damage might have been done.
“What people are going to remember is not the fact that this is … not a causal effect. What they’re going to remember is hearing something vaguely about blood clots, and that’s going to undermine confidence in the vaccine, which I think is especially dangerous,” Adalja said.
Hundreds of millions of Europeans are facing the prospect of another strict lockdown as the continent struggles with a new wave of COVID-19 infections and a flawed vaccine rollout. Suspending AstraZeneca’s shots could slow it down even more.
Only about 9 percent of the eligible population across all EU countries has received at least one dose, according to the European Centre for Disease Prevention and Control.
By contrast in the U.S., nearly 22 percent of the population has received at least one shot, with nearly 2.2 million doses getting administered a day.
Many European countries are relying heavily on the Oxford-AstraZeneca vaccine, as it is being sold using a nonprofit model and is far cheaper to make than other COVID-19 vaccines.
It is also the main shot being used by Covax, the global program to deliver vaccines to low- and middle-income countries.
But AstraZeneca has also been plagued with production issues. Last week, the company said it would try to deliver 30 million doses to the EU by the end of March, much less than its contractual obligation of 90 million and down from a previous promise made last month to deliver 40 million doses.
AstraZeneca has not yet filed for authorization with the Food and Drug Administration (FDA) because the FDA wants to wait for U.S. clinical trial results, which could come shortly.
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Why home-produced Covid vaccine hasn’t helped India, Russia and China rollouts
Challenge of reaching vast, far-flung populations is combined with a lack of public interest
Guardian (UK) The day India started coronavirus vaccinations, Amit Mehra’s name was on the priority list. But he never made an appointment. “I’m not inclined to get vaccinated just because it’s available,” says the 47-year-old Delhi hospital worker.
Two and a half thousand miles away, strolling past a popup inoculation centre near Red Square in Moscow, Magomed Zurabov is similarly reluctant. Suspicious that the pandemic was deliberately engineered, he has no intention of being vaccinated, he says. Instead, he is “taking the necessary precautions”: wearing a mask and using disinfectant.
As vaccinations rates soar in Israel, the UK, the United Arab Emirates and other countries that have monopolised supply, and poorer nations make do with a trickle of doses, a third category are beginning long climbs. Supply is less of an issue in Russia, China or India, all of which produce their own vaccines. But their respective government programmes have had slow starts, and there has been little public clamour to speed things up.
“People have not shown that eagerness and urgency to be vaccinated,” says Ajeet Jain, a doctor at the Rajiv Gandhi Super Speciality hospital in Delhi. “India is going through that phase where the disease is no longer prevalent except in a few states. People are relaxed that the disease is over from their point of view.”
The experience of India, Russia and China may prove, in time, to be typical. Even once vaccine shortages are alleviated, much of the world could still take years to achieve widespread Covid-19 vaccination, encumbered by the challenges of reaching vast and far-flung populations, lack of interest from the public and other, more pressing health priorities.
Some countries may shake off growing pains: India’s rollout has accelerated in the past fortnight, with private clinics enlisted to help administer shots and new groups, including anyone over 60, invited to make appointments. The programme hit 3m doses a day this week which, if maintained, would put it within reach of its target of vaccinating 20% of the population by August.
Uptake was slower than expected among the 30 million healthcare and frontline workers who were prioritised for the first round of doses, with some hesitant about receiving Covaxin, a locally developed vaccine that was pressed into use before the release of phase 3 trial results. (Interim data has since shown that it is 81% effective.)
“That caused quite a bit of confusion, as a result of which healthcare workers who were supposed to be vaccinated in the first round, and who understood this process a little better than other people, didn’t come forward as much as they should have,” says Dr Shahid Jameel, a virologist and director of the Trivedi school of biosciences at Ashoka University.
India has also held off from deploying its entire workforce of vaccine deliverers to fight Covid-19, keeping about half at work administering jabs for other deadly diseases, Jameel says. “There is a childhood immunisation programme, there is one for pregnant mothers, and they have to go on unhindered despite Covid.”
The most significant impediment may be that, since September, virus rates in India have dropped steeply. And in a country with a median age of about 28, Covid-19 has not proved especially deadly, implicated in about 160,000 recorded deaths, a third of the number of Indians who die from tuberculosis each year. Signs of a second wave taking off in the past week may change the calculation for some.
“Look at death rates in South Asia and you’ll know why people are not dying to get vaccinated,” says Oommen C Kurian, a senior fellow at Delhi’s Observer Research Foundation thinktank. “Their sense of risk is considerably lower than, say, a Londoner.”
The same is true for the average resident of Beijing, though not for demographic reasons. China has employed blunt but effective quarantine measures to contain Sars-CoV-2 successfully, and life in the country has largely returned to normal. Though it authorised its first vaccines for emergency use in July, just 4% of the country has been vaccinated so far.
“One of the most important contributors is this perception that China has a low risk of infection,” said Yanzhong Huan, director of the Center for Global Health Studies at Seton Hall University in New Jersey. “So people think, why bother to get vaccinated? We’re already safe.”
The country aims to inoculate 40% of its population by July, a target that will require administering about 4m shots a day, up from about 640,000 a day on the latest public figures.
But Beijing must also balance commitments to supply at least 463m doses to countries overseas, many of them donations to strategic partners. So far, it is under little pressure to hoard those vaccines for use at home. “People view this as an example of China being a global leader, something that showcases China being a responsible and reliable great power,” Huang says.
Russia has been hit harder by the virus, losing 90,000 lives on official figures thought to be a significant underestimate. But there, too, uptake of the vaccine is tracking well short of government targets of inoculating 60% of the population by mid-year.
A poll of Russians this month found that two-thirds were unwilling to receive the locally developed Sputnik-V shot, in spite of peer-reviewed research suggesting that it is safe and effective. Their scepticism extended to the origins of the coronavirus, with 64% believing that it was a biological weapon, the independent poll said. (Most virologists disagree and say there is no evidence that the virus was engineered.)
Lack of trust in the Russian government is a key hurdle, says Sergei Rybakov, a representative of the Doctors’ alliance, an opposition-linked medical union that has criticised the official response to the pandemic. Though the state has marketed Sputnik-V overseas, including with its own Twitter account, it has done less to promote the vaccine among Russians, he says.
“The task of the state is to show that the vaccine is necessary, the vaccine is safe. In Russia this hasn’t been done to the extent it needs to be,” Rybakov said. “You need to show people that not getting the vaccine is more dangerous than getting it.”
Similar hurdles are likely to slow rollouts elsewhere, too, as countries assemble one of the largest logistical operations most have ever undertaken. Even once supplies are secured, some may struggle for years to reach the 70% of the population thought to be required for herd immunity, says Babak Javid, an infectious diseases scientist at the University of California, San Francisco.
They might focus their efforts instead on reaching healthcare workers and the most vulnerable, he says. “You’re not going to eliminate Covid deaths, but you’ll eliminate the likelihood of healthcare infrastructure being overwhelmed.”
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Pressure mounts on Boris Johnson to launch coronavirus inquiry
Exclusive: scientific advisers and ex-Whitehall chief join bereaved families, medics and ethnic minority leaders in calling for inquiry
Guardian (UK) Senior doctors, government scientific advisers and a former head of the civil service have spoken out in favour of a public inquiry into the UK’s handling of Covid-19, raising pressure on Boris Johnson to finally launch the process as the UK’s coronavirus fatalities rose to almost 126,000.
Thousands of bereaved families, nurses and ethnic minority leaders also backed calls for an inquiry into everything from lockdown tactics to test and trace after the UK’s handling of the pandemic resulted in the worst death toll per capita of any of the world’s large economies.
Lord Kerslake, the head of the civil service under David Cameron, and Prof John Edmunds, a leading scientific adviser to the government on Covid, are among a dozen influential figures who have told the Guardian they support a public inquiry. Kerslake said it could save lives and it would be “criminal not to learn the lessons”.
“We can’t rule out the possibility that we will hit this problem again,” he said, adding the inquiry should begin by summer.
Edmunds said: “An event of this magnitude needs to be looked at in detail, including – if necessary – compelling witnesses to attend.”
With infections now at their lowest rate since September and close to 25 million people vaccinated with a first dose, others calling for the inquiry to be triggered include Prof Dame Donna Kinnair, the general secretary of the Royal College of Nursing, Zara Mohammed, the secretary general of the Muslim Council of Britain, Chaand Nagpaul, the chair of the British Medical Association council and Diane Mayhew, a co-founder of the Rights for Residents group, which campaigns on behalf of care home residents, about 40,000 of whom died with Covid.
But despite a promise last July by the prime minister to set up an “independent inquiry”, Downing Street is refusing to start the process many consider essential to learn lessons for future pandemics.
“We are focused on protecting the NHS and saving lives and now is not the right time to devote huge amounts of official time to an inquiry,” a government spokesperson said. “There will be an appropriate time in the future to look back, analyse and reflect on all aspects of this global pandemic.”
Other leading scientists calling for an inquiry include Prof Sir Paul Nurse, the director of the Francis Crick Institute and a Nobel Laureate.
Prof Andrew Hayward, an expert in infectious disease epidemiology who also sits on the Scientific Advisory Group for Emergencies (Sage), said in a personal capacity: “Many would argue that much of this could have been avoided if different [or] earlier decisions had been made at various points in the pandemic. These decision-making processes therefore need to be scrutinised and I think they are only likely to become completely clear if people are compelled to give evidence.”
The rising pressure on Johnson comes amid calls from more than 2,800 families bereaved by Covid for an “urgent” statutory inquiry with the power to demand witnesses give evidence and to uncover documents.
The Covid-19 Bereaved Families for Justice group is threatening legal action to force ministers to launch an inquiry, arguing an unprepared government “serially failed to take reasonable steps to minimise the effects of the pandemic, leading to massive, unnecessary loss of life”.
“It’s not just us bereaved families – there are millions of people around the country who want answers,” said Jo Goodman, a co-founder of the group. “Did the prime minister do everything he could to prevent it? Could his government have been better prepared or did it ignore warnings? Were decisions made which cost lives rather than saving them? An urgent statutory public inquiry is essential if we are to learn lessons and save lives now and in the future.”
Some senior Conservatives have already indicated they want a public inquiry and the former prime minister David Cameron said earlier this month he expected an inquiry and that “more should have been learned from the experience with Sars and respiratory disease in terms of our own preparedness”. The Commons constitutional affairs select committee, chaired by the Tory backbencher William Wragg, called for an inquiry last summer.
Christinea McAnea, the general secretary of Unison, which represents 1.3 million health staff including porters, cleaners, care workers and nurses, said an independent, judge-led public inquiry should launch as soon as society opens up again – currently scheduled for 21 June.
“If the UK is to heal, people need to understand why things went so disastrously wrong,” she said. “There are key questions to answer about why care homes were left so vulnerable, frontline staff were without safety kit and testing was abandoned in the early stages.”
The two largest doctors’ and nurses’ membership groups – the British Medical Association (BMA) and the Royal College of Nursing – also backed the calls.
“We have seen suffering at levels people have not experienced,” said the BMA’s Nagpaul. “We have seen livelihoods lost and inequalities exacerbated to levels that have devastated communities. Putting all that together, of course it demands an inquiry.”
Kinnair said nurses were still experiencing a lack of PPE and that “a full inquiry into the preparation and management of Covid-19 is the only way the government, its agencies and advisers will … truly reflect and learn”.
Prof Andrew Goddard, the president of the Royal College of Physicians, said he expected an inquiry and it should “identify and recommend changes so we can improve preparedness for and management of future crises … [It should] look at how prepared we were and the decisions we took in terms of very practical things, such as stocks of PPE, the size of the NHS workforce and how many critical care beds we have … [as well as] the greater impact of Covid-19 in the UK because of the state of public health.”
Lord Simon Woolley, who until last summer was the chair of the advisory group to the government’s race disparity unit, said he wanted a public inquiry to reach beyond scientific and medical factors to include housing, health, education and employment.
“For black, Asian and minority ethnic communities [Covid] has been utterly devastating,” he said, adding that if an inquiry followed the disease it would expose societal fault lines.
“This inquiry is a once-in-a-generation opportunity to dramatically change the infrastructure,” he said. “Are we going to put a plaster on a gaping wound or are we going to have an infrastructure change that builds to a fairer society?”
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WORLD STATS
The post Astra Zeneca Global Threat, Push for UK Virus Probe, Problem for Homegrown Vaccines, World Stats appeared first on The St Kitts Nevis Observer.
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