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COVID-19

European countries face slower vaccination as Johnson & Johnson delays rollout

Pharmaceutical company Johnson & Johnson is to delay the rollout of its Covid-19 vaccine in Europe due to concerns over rare potential side effects detected in the United States.

Published: 13 April 2021 17:43 CEST

European countries face slower vaccination as Johnson & Johnson delays rollout

Photo: Kamil Krzaczynski/AFP/Ritzau Scanpix

The company confirmed the decision in a statement on Tuesday afternoon.

Rare cases of blood clots combined with low platelet numbers in persons who have received the vaccine are the background for the decision, the company said.

“We have made the decision to proactively delay the rollout of our vaccine in Europe,” Johnson & Johnson said in the statement.

“We have been working closely with medical experts and health authorities, and we strongly support the open communication of this information to healthcare professionals and the public,” it added.

According to the company, the United States Centers for Disease Control (CDC) and Food and Drug Administration (FDA) are reviewing data “involving six reported US cases out of more than 6.8 million doses administered”.

“Out of an abundance of caution, the CDC and FDA have recommended a pause in the use of our vaccine” in the United States, it said.

Vaccination programmes in several European countries could be impacted by the decision to delay rollout of the vaccine, which is also known as the Janssen vaccine after the Johnson & Johnson subsidiary which developed it.

France was scheduled to receive its first 200,000 doses of the Janssen vaccine this week. The vaccine has already been authorised for use on all age groups by French medical regulator Haute autorité de santé.

France’s rollout had been planned primarily through family doctors and pharmacies, while mass vaccination centres continue to rely more heavily on Pfizer and Moderna.

Nordic countries Sweden, Denmark and Norway were also due to receive their first doses of the Johnson & Johnson vaccine later this week, while the first delivery was received in Austria on Tuesday morning.

Sweden will decide how to use the vaccine within the coming days, the country’s health agency Folkhälsomyndigheten said earlier on Tuesday.

“We are looking at the issue and the data available from the European Medicines Agency and our American colleagues,” Sweden’s state epidemiologist Anders Tegnell said at a briefing, adding a decision would be announced “within one or a few days.”

Each of the Nordic countries has factored large-scale deliveries of the Johnson & Johnson vaccine into their vaccination calendars.

Sweden expected to receive 67,000 doses of the Janssen vaccine in April, a reduction on the 229,000 doses previously expected. Another 295,000 doses were set to arrive in May, and another 888,000 by the end of June.

Denmark has ordered more vaccine doses from Johnson & Johnson than from any other supplier, having earmarked 8.2 million doses. Those doses were scheduled to begin arriving from Wednesday.

“It is very important for us… before we initiate use in Denmark, to ascertain whether we, for example, need further documentation and scientific research, whether there should be certain provisions for use, whether it should be used (only) for certain target groups,” the director of the Danish Health Authority (Sundhedsstyrelsen) Søren Brostrøm told news wire Ritzau in a written comment.

Norway’s programme for vaccinating its population faces a setback of delays of up to 8-12 weeks if the country does not use the Janssen vaccine and also chooses not to reimplement the AstraZeneca vaccine, which remains suspended in the country, also due to concerns over side effects.

The estimate was given by department director Line Vold of the Norwegian Institute for Public Health (Folkehelseinstituttet) at a briefing on Tuesday afternoon.

“If both AstraZeneca and Johnson & Johnson are excluded, vaccination can be completed 8-12 weeks later provided other vaccines are delivered as promised,” Vold said.

Austria, which ordered 2.5 million doses of the vaccine for a population of 8.5 million, plans a heavy reliance on the Johnson & Johnson vaccine.

On Tuesday morning, the first delivery of around 16,800 doses of the vaccine arrived in Austria.

Austrian health authorities indicated that a plan to start administering the doses immediately would be temporarily suspended.

“Until there is clarity about any side effects, these doses will not be delivered to the vaccination centres and will not be administered,” said a spokesperson for the Ministry of Health on Tuesday.

Member comments

Johanna - 14 April 2021 at 12:14 CEST

I haven’t heard anything bad about Sputnik V! LOL Why do they do difficult now? We still use astrazeneca after learning a few wil die but those people will save the lives of many others, so well worth. If it’s you? well….. so sorry, you’re a great person and will be remembered forever.
When are international flights allowed? That’s the only question keeping me occupied.
1. David - 15 April 2021 at 20:55 CEST
  
  Very utilitarian thinking. You ask “if it’s you?” but I’m curious if you’ve asked “if it’s me?”? Would your response still be “So sorry, I’m a great person and will be remembered forever”?
  
  The people who die from side effects will not save others. The people who safely take vaccines will save others. In essence, people who die from vaccines are lives lost for no good reason, that could have been avoided. I’m not advocating rejecting astrazeneca/johnson but I also wouldn’t be so dismissive of the concerns of people regarding serious side effects either. We only have one life.
Johanna - 15 April 2021 at 22:35 CEST

David I agree with you, I personally think it is unacceptable that very young people die who would survive covid anyway. I find it very strange those people who died are barely noticed, while the first few dying from covid got covered in the news endlessly. Ofcourse if you see photo’s of the women and see their children or families hear what they did in life it becomes ‘personal’ and especially younger people will refuse the vaccins. If the news covers their stories, one a week, they have now nearly 2 years material!
The goverments want us to believe it’s ‘nothing’, every medicine has side effects. Well that’s true and you choose those when you’re sick, here we are injecting healthy people, that’s the difference.
Danark is testing aspitation (so you can see if you’ve hit a vein) before injecting, let hope this will be the answer. To be clear I only wrote what was told, I personally do not want anyone to die from a vaccine,

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FACT CHECK: Did Sweden have lower pandemic mortality than Denmark and Norway?

At one point in May 2020, Sweden had the highest Covid-19 death rate in the world, spurring newspapers like the New York Times and Time Magazine to present the country as a cautionary tale, a warning of how much more Covid-19 could ravage populations if strict enough measures were not applied.

“Per million people, Sweden has suffered 40 percent more deaths than the United States, 12 times more than Norway, seven times more than Finland and six times more than Denmark,” the New York Times reported in July 2020.

An article in Time in October 2020 declared Sweden’s Covid response “a disaster”, citing figures from Johns Hopkins University ranking Sweden’s per capita death rate as the 12th highest in the world.

So there was undisguised glee among lockdown sceptics when Svenska Dagbladet published its data last week showing that in the pandemic years 2020, 2021 and 2022 Sweden’s excess mortality was the lowest, not only in the European Union, but of all the Nordic countries, beating even global Covid-19 success stories, such as Norway, Denmark and Finland.

Versions of the graph or links to the story were tweeted out by international anti-lockdown figures such as Bjørn Lomborg, a Danish sceptic of climate action, and Fraser Nelson, editor of Britain’s Spectator Magazine, while in Sweden columnists like Dagens Nyheter’s Alex Schulman and Svenska Dagbladet’s opinion editor Peter Wennblad showed that Anders Tegnell, the state epidemiologist who led Sweden’s strategy had been “right all along”.

Excess mortality — the number of people who die in a year compared to the number expected to die based on previous years — is seen by some statisticians as a better measure for comparing countries’ Covid-19 responses, as it is less vulnerable to differences in how Covid-19 deaths are reported.

But are these figures legitimate, where do they come from, and do they show what they purport to show?

Here are the numbers used by SvD in its chart:

Where do the numbers come from?

Örjan Hemström, a statistician specialising in births and deaths at Sweden’s state statistics agency Statistics Sweden (SCB), put together the figures at the request of Svenska Dagbladet.

He told The Local that the numbers published in the newspaper came from him and had not been doctored in any way by the journalists.

He did, however, point out that he had produced an alternative set of figures for the Nordic countries, which the newspaper chose not to use, in which Sweden had exactly the same excess mortality as Denmark and Norway.

“I think they also could have published the computation I did for the Nordic countries of what was expected from the population predictions,” he said of the way SvD had used his numbers. “It takes into consideration trends in mortality by age and sex. The excess deaths were more similar for Denmark, Sweden, and Norway. Almost the same.”

Here are Hemström’s alternative numbers:

Another issue with the analysis is that the SvD graph compares deaths in the pandemic years to deaths over just three years, a mean of 2017-2019, and does not properly take into account Sweden’s longstanding declining mortality trend, or the gently rising mortality trend in some other countries where mortality is creeping upwards due to an ageing population, such as Finland.

“It’s very difficult to compare countries and the longer the pandemic goes on for the harder it is, because you need a proper baseline, and that baseline depends on what happened before,” Karin Modig, an epidemiologist at Sweden’s Karolinska Institute whose research focuses on ageing populations, told The Local.

“As soon as you compare between countries, it’s more difficult because countries have different trends of mortality, they have different age structures, and in the pandemic they might have had different seasonal variations.”

She described analyses such as Hemström’s as “quite crude”.

In an interview with SvD to accompany the graph, Tegnell also pushed back against giving the numbers too much weight.

“Mortality doesn’t tell the whole story about what effect a pandemic has had on different countries,” he said. “The excess mortality measure has its weaknesses and depends a lot on the demographic structures of countries, but anyway, when it comes to that measure, it looks like Sweden managed to do quite well.”

Do the numbers match those provided by other international experts and media?

Sweden’s excess mortality over the three years of the pandemic is certainly below average worldwide, but it is only in the SvD/SCB figures that it beats Norway and Denmark.

A ranking of excess mortality put together by Our World in Data for the same period as the SvD/SCB table estimates Sweden’s excess mortality between the start of 2020 and the end of 2022 at 5.62 percent, considerably more than the 4.4 percent SvD claims and above that of Norway on 5.08 percent and Denmark on 2.52 percent.

The Economist newspaper also put together an estimate, using their own method based on projected deaths.

Our World in Data uses the estimate produced by Ariel Karlinsky and Dmitry Kobak, who manage the World Mortality Dataset (WMD). To produce the estimate, they fit a regression model for each region using historical deaths data from 2015–2019, so a time period of five years rather than the three used by SCB.

What’s clear, is that, whatever method you use, Sweden is, along with the other Nordic countries, among the countries with the lowest excess mortality over the pandemic.

“Most methods seem to put Sweden and the other Nordic countries among the countries in Europe with the lowest cumulative excess deaths for 2020-2022,” said Preben Aavitsland, the Director for Surveillance and the Norwegian Institute of Public Health.

So if Sweden had similar excess mortality as the other Nordics over the period, does that mean it had a similar Covid-19 death rate?

Not at all. Sweden’s per capita death rate from Covid-19 over the period covered by the SvD/SCB figures, at 2,249 per million people, is more than double Norway’s 959 per million, 60 percent more than the 1,409 per million who died in Denmark, and more than 50 percent more than the 1,612 per million who died in Finland.

While Sweden’s death rate is still far ahead of those of its Nordic neighbours, it is now much closer to theirs than it was at the end of 2020.

“The most striking difference between Sweden and the other Nordic countries is that only Sweden had large excess mortality in 2020 and the winter of 2020-21,” Aavitsland explained. “In 2022, the field levelled out as the other countries also had excess mortality when most of the population was infected by the omicron variant after all measures had been lifted.”

So why, if the Covid-19 death rates are still so different, are the excess mortality rates so similar?

This largely reflects the fact that many of those who died in Sweden in the first year of the pandemic were elderly people in care homes who would have died anyway by the end of 2022.

About 90 percent of Covid-19 deaths were in people above 70, Aavitsland pointed out, adding that this is the same age group where you find around 80 percent of all deaths, regardless of cause, in a Scandinavian country.

“My interpretation is that in the first year of the pandemic, say March 2020 – February 2021, Sweden had several thousand excess deaths among the elderly, including nursing home residents,” he said. “Most of this was caused by Covid-19. In the other [Nordic] countries, more people like these survived, but they died in 2022. The other countries managed to delay some deaths, but now, three years after, we end up at around the same place.”

So does that mean Sweden’s state epidemiologist Anders Tegnell was right all along?

It depends on how you view the shortened lives of the close to ten thousand elderly people who caught Covid-19 and died in Sweden in the first wave because Sweden did not follow the example of Denmark, Norway, and Finland and bring in a short three-week lockdown in March and April 2020.

Tegnell himself probably said it best in the SvD interview.

“You’ve got to remember that a lot of people died in the pandemic, which is of course terrible in many ways, not least for their many loved ones who were affected, so you need to be a bit humble when presented with these kinds of figures.”

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