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.
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.”