Fears of AstraZeneca Could Have Dangerous Consequences
Reports that the AstraZeneca vaccine is less effective that the ones from BioNTech and Moderna have fueled widespread reservations. Leading German health experts say they have faith in the company's product and that it is a key tool in the battle against COVID-19.
By Matthias Bartsch, Jan Friedmann, Hubert Gude, Philipp Kollenbroich, Julia Merlot, Andreas Wassermann, Alfred Weinzierl und Steffen Winter
19.02.2021,
A "vaccine vending machine" in Berlin: A major debate has broken out over the differing efficacy of coronavirus vaccines. Foto: Fabrizio Bensch / REUTERS
No, Michael Golke stresses, he’s not an anti-vaxxer. How could he be? He works as a nurse in a Berlin hospital and has been in the profession for more than 20 years, specializing in intensive care. But he finds it offensive what politicians are asking of him.
"How can it be that the very people who have been fighting COVID-19 directly every day for almost a year, and who clearly have a very high risk of infection, are supposed to be protected with a less effective vaccine?” asks Golke, who requested that his name be changed for this story. He says he also wrote and asked the same question of German Health Minister Jens Spahn and Dilek Kalayci, the Berlin state government’s leading health official. Using his real name.
The nurse was to be vaccinated with AstraZeneca’s COVID-19 vaccine. The product performed weaker in studies than the vaccines from BioNTech and Moderna. Golke declined the vaccine. And this week, he says, around 20 to 25 percent of his colleagues also rejected it.
In Germany, the vaccine from AstraZeneca, a British-Swedish company, is only recommended for people under 65 and has been deemed unsuitable for the elderly. It is instead being given to younger members of the group with the highest vaccination priority: Medical professionals and nurses.
"It’s sheer pragmatism,” says Golke. "I don’t expect any preferential treatment, but medical personnel should not be worse off than the general population.” He suspects that later, when more doses are available, the general population will receive a greater proportion of the more effective mRNA vaccines from BioNTech and Moderna.
Whether an injustice is really being done to Golke isn't the main issue. A lot has been asked of doctors and nurses in recent months and many of them are on edge, left with a feeling that politicians and society don't sufficiently value them. They also live with the constant fear of infection. And every patient expects the maximum level of care. Isn’t it only fair that they get the maximum possible protection?
DER SPIEGEL 8/2021
The article you are reading originally appeared in German in issue 8/2021 (February 20, 2021) of DER SPIEGEL.SPIEGEL International
AstraZeneca's vaccine, approved in the European Union at the end of January and thus only in circulation for the last three weeks, doesn't have the best reputation among people in the health-care profession. Not all are skeptical, but enough are that it is causing a serious problem in Germany.
In an interview with the Rheinische Post newspaper, even Frank Ulrich Montgomery, the outspoken chair of the World Medical Association, basically declared that the vaccine is a second choice by default. "You can’t gloss over the fact that it’s less effective,” he said. He added that he believes people with a higher risk of infection like medical staff should be vaccinated with more effective vaccines.
Statements like that, combined with reports of supposedly strong side effects, have a viral effect in the internet. As such, i little surprise that people aren’t showing up for appointments to receive the AstraZeneca vaccine in Germany. In the state of Hesse, officials quietly admitted that they do not have enough under-65-year-olds in the highest priority category who want to take advantage of the offer. The state of Saxony has reported that it has appointments free in almost all of its vaccination centers. The German Red Cross has reported that in almost 50 instances, people didn’t show up for their vaccination appointment – or they attempted to get a different vaccine.
AstraZeneca has thus far delivered 736,800 doses of its vaccine to Germany, but the Robert Koch Institute (RKI), the country’s center for disease control, says that only 106,586 doses of the vaccine have been administered. Some states are building up stockpiles of the medicine. Hesse has received 58,000 doses, but as of Monday, only 851 had been administered.
Frank Ulrich Montgomery, chair of the World Medical Association: Reports of supposedly strong side effects have increased skepticism.
Foto: Benjamin Zibner/laif
For Health Minister Spahn, the chain of bad news doesn’t end there. Approvals for vaccines came late, supplies have been scarce and now health professionals are expressing skepticism about a vaccine – one that was ordered, bought, delivered and given the seal of approval by the highest authorities – and people appear to be rejecting it. As early as next week, the manufacturer will deliver a further 750,000 doses, with that figure expected to reach 5.6 million by the end of March.
Together with Spahn, the health ministers of the German states are now considering modifying the priority lists. In Saxony, for example, officials are pushing to move "educators, teachers and employees of the public health service” up on the priority list.
With all the negative PR coming from medical circles, it is not at all surprising that there is uncertainty among everyday people. But AstraZeneca’s vaccine is the one that is intended to help bring the pandemic to an end as quickly as possible. Chancellor Angela Merkel’s plan to offer every person in Germany a vaccine by September will be jeopardized if not enough people want this one. In contrast to the substances from BioNTech and Modern, the AstraZeneca vaccine doesn’t have to be transported at extremely cold temperatures. It will also be possible to administer it in normal doctors’ offices soon.
Supplies of the BioNTech and Moderna vaccines may not be sufficient for vaccinating more than 50 million people in Germany by autumn. More education is thus needed about the different types of vaccines, because the cacophony of the past few weeks has been partly the result of a communications disaster in which almost everyone involved has some blame: the pharmaceuticals industry, politicians, the medical profession and the media.
Viewed objectively, AstraZeneca’s vaccine is quite capable of slowing down the pandemic, regardless whether it is administered to bus drivers, cashiers or nurses. The summary results of the studies conducted as part of the approval process showed 60 percent efficacy for the vaccine after the administration of two doses. That may sound low, especially when compared to BioNTech and Moderna, which came in at around 95 percent. However, the percentage does not indicate in how many people the vaccine works and in how many it does not. It describes the percentage by which vaccinated people’s risk of contracting COVID-19 decreases compared to unvaccinated people.
A little bit of math can contribute to a better understanding. It’s a subject that many doctors usually aren’t very well versed in, as Gerd Gigerenzer of the Max Planck Institute for Human Development has discovered: "Many doctors don’t even understand basic statistics because they aren’t taught enough. There is a widespread and totally unnecessary collective blindness to numbers.”
In the coronavirus pandemic, and this is the basic consideration of any risk calculation, the risk of getting sick isn’t 100 percent, even without the vaccine. Not every infected person falls ill; in many cases, the virus remains undetected.
So, to find out how well a vaccine works, manufacturers divide up to tens of thousands of test subjects into two comparable groups in large studies. One group receives the vaccine and the other gets the placebo. Then it is a matter of waiting until a statistical meaningful number of illnesses have occurred.
A comparison of the two groups reveals how many cases of disease the vaccine prevented. If it is ineffective, then you see about the same number of sufferers in both groups. If it provides protection, then the number of people who get infected is lower in the vaccinated group than it is in the placebo group.
The AstraZeneca vaccine: In Berlin, people are no longer given a choice as to the vaccine they receive. Foto: Jens Schlueter / AFP
AstraZeneca supplied around 10,500 people with the active ingredient or a placebo during the pre-authorization trials. Some 218 subjects developed COVID-19, with 154 in the placebo group and 64 in the vaccine group. So, during the study period, the vaccination prevented 90 cases of the disease and reduced the risk of contracting the disease by around 60 percent.
There is no question: The results from BioNTech and Moderna are better, but the AstraZeneca vaccine still significantly reduces the risk. Even more important is the rate of severe illness prevented by vaccination. And it is becoming apparent that all vaccines that have been approved in the European Union to date provide almost 100 percent protection against severe courses of the disease. This is particularly true for AstraZeneca: According to a recent review, after the second dose, not a single study participant became so severely ill with COVID-19 that they had to be hospitalized or died.
This week, the three leading voices in Germany on health policy right now – Health Minister Jens Spahn, Christian Drosten and Karl Lauterbach – all hastened to confirm the reliability of a vaccine of which the German government has purchased millions of doses. Spahn assured that he would get vaccinated immediately with AstraZeneca once it was his turn. Drosten, who has gained fame in Germany not only for his science, but also for his highly regarded explanatory podcast about developments in the pandemic, said that many things had been misunderstood in the public discussion in Germany and that AstraZeneca’s vaccine was very good and not "second rate.” Lauterbach, a member of parliament and health policy expert with the center-left Social Democrats (SPD), said he would return to work starting next week as a doctor administering vaccinations in the city of Leverkusen, his electoral district. "The whole team, including myself, will be vaccinated using the Astra vaccine,” he said. "We trust it.”
The pleas in support of the product seemed urgently necessary after medical staff at German hospitals and ambulance services started refusing to take the AstraZeneca vaccine. Within days, reports of severe side effects popped up around the country.
Herzogin Elisabeth Hospital in the city of Braunschweig was hit especially hard. The hospital had set up a special vaccination station for employees, with a staff member receiving an injection every five minutes. At shortly before 10 a.m., Hristina Markova freed her upper arm. She thought it would be a small prick and nothing more. "Then, about 12 hours later, I suddenly got chills and a fever, and at night it went up to 40.3 degrees," the resident reports. The next morning, she had dragged herself to the hospital on fever-reducing medication, before calling in sick at noon. "I just couldn’t do it.”
Many have had experiences similar to Markova’s. Of 88 employees who were vaccinated, 37 called in sick. "I felt like someone had put me through a meat grinder,” says intensive care nurse Kati Schmidt. She spent two days in bed. As word of the side effects spread through the hospital and the number of people calling in sick grew, no one wanted to be vaccinated anymore. Senior physician Nikolas Bollenbach, a passionate cyclist, was one of the last to get his shot – and he, too, suffered the usual symptoms the following night. "On Saturday, I was exhausted, like I'd done a 200-kilometer bike race,” he says.
Strictly speaking, neither Bollenbach nor his colleagues had any side effects. They aren’t really side effects – they are reactions to the vaccine that were observed and published in all studies that, as in Braunschweig, went away after a few days.
As early as last year, New York researcher Florian Krammer noted that both the mRNA vaccines from BioNTech and Moderna and DNA vector vaccines like the one from AstraZeneca cause stronger reactions than classical vaccines made from attenuated viruses. "This has to be communicated very clearly,” says Krammer, otherwise people who get vaccinated will think, "the vaccination has made me sick.”
To prevent hospital departments or ambulance services from suddenly being understaffed for a day or two, government ministries are now recommending that vaccinations be spread out to a greater degree. Microbiologist Christian Bogdan, a member of the Standing Committee on Vaccination, an independent scientific advisory group that is part of RKI, says that because AstraZeneca’s drug is being administered mainly to younger people, there are more reactions among them. "Their immune systems are more active than those of older people, which is why they have stronger reactions to vaccinations.”
“Germany needs to make every effort to vaccinate widely as quickly as possible.”
But will scientific explanations like that suffice when large numbers of people already have it in their heads that AstraZeneca is second-rate compared to BioNTech or Moderna?
At the beginning of the week, a union representing police officers in Bavaria demanded that only "the best vaccine” be used for police employees. "The constant operational readiness of the police must not be endangered by a possibly unreliable vaccine under any circumstances," the organization stated. And a dentist in Saarland addressed his health minister directly: "I have the most dangerous job in the world, you can't give me the worst vaccine." In the forum of the Ärztezeitung, a publication for doctors, a physician from Dortmund complained that the AstraZeneca vaccine shouldn’t have been approved because of the "extremely poor quality of the data.”
Is it any wonder then, that the German Red Cross in Saxony says that in some vaccination centers, the consultations with doctors administering the vaccines "take longer” if the vaccine being administered is from AstraZeneca? Or that, according to a survey taken by online pollster Civey, only 2.8 percent of Germans willing to get vaccinated would be most likely to choose the AstraZeneca vaccine?
Related Articles
The Third Wave: Coronavirus Mutants Are Spreading Fast By Rafaela von Bredow und Veronika Hackenbroch
BioNTech Executive on New Vaccine Plant: "It Will Take a Few Months before We Reach Full Capacity" Interview Conducted by Martin U. Müller und Thomas Schulz
In Berlin, there was so little demand for appointments to get the AstraZeneca vaccine that the city’s health minister, Kalayci, felt compelled to abolish any right to what vaccine people choose. Effective immediately, residents of Berlin must accept the vaccine that is offered to them. Virologist Drosten just shakes his head at such news. "Germany needs to make every effort to vaccinate as widely and as quickly as possible.”
Experts like Drosten believe the real risks like in the virus mutants. More the one from South Africa than the British mutant, but also other variants that are to be expected.
It is still unclear how the vaccines approved so far will work against the mutations. South Africa has temporarily halted vaccinations with AstraZeneca after laboratory tests indicated the vaccine was only moderately effective against the variant first discovered there. BioNTech and Moderna were still exuding optimism after the first mutations were announced, but skepticism is now spreading. BioNTech CEO Uğur Şahin has assured that his company’s vaccine will be further developed to address the mutations, but that could take up to six weeks.
However, just adding a third, modified version on top of the first two doses may not easily lead to the desired result. In the case of the mRNA vaccines, for example, vaccination reactions could be so severe that the risk-benefit assessment becomes negative. Experts like Michael Hoelscher, an infectious diseases doctor in Munich, are therefore recommending a third way apart from mRNA or vector vaccines: protein vaccines.
The great advantage they offer, says Hoelscher, who is a professor at the city’s university hospital, is that they can be administered several times, probably without loss of efficacy or tolerability, and adapted to the new mutants. "This will prove to be an important feature as the epidemic progresses,” Hoelscher says.
Two pharmaceutical companies, Novavax and Sanofi/GlaxoSmithKline, have been developing these protein vaccines for months. None has been authorized for use in the European Union yet. But the date doesn’t seem too far off when the rankings of vaccines will be reordered with the potential for new claims and myths about them.
For Health Minister Spahn, the chain of bad news doesn’t end there. Approvals for vaccines came late, supplies have been scarce and now health professionals are expressing skepticism about a vaccine – one that was ordered, bought, delivered and given the seal of approval by the highest authorities – and people appear to be rejecting it. As early as next week, the manufacturer will deliver a further 750,000 doses, with that figure expected to reach 5.6 million by the end of March.
Together with Spahn, the health ministers of the German states are now considering modifying the priority lists. In Saxony, for example, officials are pushing to move "educators, teachers and employees of the public health service” up on the priority list.
With all the negative PR coming from medical circles, it is not at all surprising that there is uncertainty among everyday people. But AstraZeneca’s vaccine is the one that is intended to help bring the pandemic to an end as quickly as possible. Chancellor Angela Merkel’s plan to offer every person in Germany a vaccine by September will be jeopardized if not enough people want this one. In contrast to the substances from BioNTech and Modern, the AstraZeneca vaccine doesn’t have to be transported at extremely cold temperatures. It will also be possible to administer it in normal doctors’ offices soon.
Supplies of the BioNTech and Moderna vaccines may not be sufficient for vaccinating more than 50 million people in Germany by autumn. More education is thus needed about the different types of vaccines, because the cacophony of the past few weeks has been partly the result of a communications disaster in which almost everyone involved has some blame: the pharmaceuticals industry, politicians, the medical profession and the media.
Viewed objectively, AstraZeneca’s vaccine is quite capable of slowing down the pandemic, regardless whether it is administered to bus drivers, cashiers or nurses. The summary results of the studies conducted as part of the approval process showed 60 percent efficacy for the vaccine after the administration of two doses. That may sound low, especially when compared to BioNTech and Moderna, which came in at around 95 percent. However, the percentage does not indicate in how many people the vaccine works and in how many it does not. It describes the percentage by which vaccinated people’s risk of contracting COVID-19 decreases compared to unvaccinated people.
A little bit of math can contribute to a better understanding. It’s a subject that many doctors usually aren’t very well versed in, as Gerd Gigerenzer of the Max Planck Institute for Human Development has discovered: "Many doctors don’t even understand basic statistics because they aren’t taught enough. There is a widespread and totally unnecessary collective blindness to numbers.”
In the coronavirus pandemic, and this is the basic consideration of any risk calculation, the risk of getting sick isn’t 100 percent, even without the vaccine. Not every infected person falls ill; in many cases, the virus remains undetected.
So, to find out how well a vaccine works, manufacturers divide up to tens of thousands of test subjects into two comparable groups in large studies. One group receives the vaccine and the other gets the placebo. Then it is a matter of waiting until a statistical meaningful number of illnesses have occurred.
A comparison of the two groups reveals how many cases of disease the vaccine prevented. If it is ineffective, then you see about the same number of sufferers in both groups. If it provides protection, then the number of people who get infected is lower in the vaccinated group than it is in the placebo group.
The AstraZeneca vaccine: In Berlin, people are no longer given a choice as to the vaccine they receive. Foto: Jens Schlueter / AFP
AstraZeneca supplied around 10,500 people with the active ingredient or a placebo during the pre-authorization trials. Some 218 subjects developed COVID-19, with 154 in the placebo group and 64 in the vaccine group. So, during the study period, the vaccination prevented 90 cases of the disease and reduced the risk of contracting the disease by around 60 percent.
There is no question: The results from BioNTech and Moderna are better, but the AstraZeneca vaccine still significantly reduces the risk. Even more important is the rate of severe illness prevented by vaccination. And it is becoming apparent that all vaccines that have been approved in the European Union to date provide almost 100 percent protection against severe courses of the disease. This is particularly true for AstraZeneca: According to a recent review, after the second dose, not a single study participant became so severely ill with COVID-19 that they had to be hospitalized or died.
This week, the three leading voices in Germany on health policy right now – Health Minister Jens Spahn, Christian Drosten and Karl Lauterbach – all hastened to confirm the reliability of a vaccine of which the German government has purchased millions of doses. Spahn assured that he would get vaccinated immediately with AstraZeneca once it was his turn. Drosten, who has gained fame in Germany not only for his science, but also for his highly regarded explanatory podcast about developments in the pandemic, said that many things had been misunderstood in the public discussion in Germany and that AstraZeneca’s vaccine was very good and not "second rate.” Lauterbach, a member of parliament and health policy expert with the center-left Social Democrats (SPD), said he would return to work starting next week as a doctor administering vaccinations in the city of Leverkusen, his electoral district. "The whole team, including myself, will be vaccinated using the Astra vaccine,” he said. "We trust it.”
The pleas in support of the product seemed urgently necessary after medical staff at German hospitals and ambulance services started refusing to take the AstraZeneca vaccine. Within days, reports of severe side effects popped up around the country.
Herzogin Elisabeth Hospital in the city of Braunschweig was hit especially hard. The hospital had set up a special vaccination station for employees, with a staff member receiving an injection every five minutes. At shortly before 10 a.m., Hristina Markova freed her upper arm. She thought it would be a small prick and nothing more. "Then, about 12 hours later, I suddenly got chills and a fever, and at night it went up to 40.3 degrees," the resident reports. The next morning, she had dragged herself to the hospital on fever-reducing medication, before calling in sick at noon. "I just couldn’t do it.”
Many have had experiences similar to Markova’s. Of 88 employees who were vaccinated, 37 called in sick. "I felt like someone had put me through a meat grinder,” says intensive care nurse Kati Schmidt. She spent two days in bed. As word of the side effects spread through the hospital and the number of people calling in sick grew, no one wanted to be vaccinated anymore. Senior physician Nikolas Bollenbach, a passionate cyclist, was one of the last to get his shot – and he, too, suffered the usual symptoms the following night. "On Saturday, I was exhausted, like I'd done a 200-kilometer bike race,” he says.
Strictly speaking, neither Bollenbach nor his colleagues had any side effects. They aren’t really side effects – they are reactions to the vaccine that were observed and published in all studies that, as in Braunschweig, went away after a few days.
As early as last year, New York researcher Florian Krammer noted that both the mRNA vaccines from BioNTech and Moderna and DNA vector vaccines like the one from AstraZeneca cause stronger reactions than classical vaccines made from attenuated viruses. "This has to be communicated very clearly,” says Krammer, otherwise people who get vaccinated will think, "the vaccination has made me sick.”
To prevent hospital departments or ambulance services from suddenly being understaffed for a day or two, government ministries are now recommending that vaccinations be spread out to a greater degree. Microbiologist Christian Bogdan, a member of the Standing Committee on Vaccination, an independent scientific advisory group that is part of RKI, says that because AstraZeneca’s drug is being administered mainly to younger people, there are more reactions among them. "Their immune systems are more active than those of older people, which is why they have stronger reactions to vaccinations.”
“Germany needs to make every effort to vaccinate widely as quickly as possible.”
But will scientific explanations like that suffice when large numbers of people already have it in their heads that AstraZeneca is second-rate compared to BioNTech or Moderna?
At the beginning of the week, a union representing police officers in Bavaria demanded that only "the best vaccine” be used for police employees. "The constant operational readiness of the police must not be endangered by a possibly unreliable vaccine under any circumstances," the organization stated. And a dentist in Saarland addressed his health minister directly: "I have the most dangerous job in the world, you can't give me the worst vaccine." In the forum of the Ärztezeitung, a publication for doctors, a physician from Dortmund complained that the AstraZeneca vaccine shouldn’t have been approved because of the "extremely poor quality of the data.”
Is it any wonder then, that the German Red Cross in Saxony says that in some vaccination centers, the consultations with doctors administering the vaccines "take longer” if the vaccine being administered is from AstraZeneca? Or that, according to a survey taken by online pollster Civey, only 2.8 percent of Germans willing to get vaccinated would be most likely to choose the AstraZeneca vaccine?
Related Articles
The Third Wave: Coronavirus Mutants Are Spreading Fast By Rafaela von Bredow und Veronika Hackenbroch
BioNTech Executive on New Vaccine Plant: "It Will Take a Few Months before We Reach Full Capacity" Interview Conducted by Martin U. Müller und Thomas Schulz
In Berlin, there was so little demand for appointments to get the AstraZeneca vaccine that the city’s health minister, Kalayci, felt compelled to abolish any right to what vaccine people choose. Effective immediately, residents of Berlin must accept the vaccine that is offered to them. Virologist Drosten just shakes his head at such news. "Germany needs to make every effort to vaccinate as widely and as quickly as possible.”
Experts like Drosten believe the real risks like in the virus mutants. More the one from South Africa than the British mutant, but also other variants that are to be expected.
It is still unclear how the vaccines approved so far will work against the mutations. South Africa has temporarily halted vaccinations with AstraZeneca after laboratory tests indicated the vaccine was only moderately effective against the variant first discovered there. BioNTech and Moderna were still exuding optimism after the first mutations were announced, but skepticism is now spreading. BioNTech CEO Uğur Şahin has assured that his company’s vaccine will be further developed to address the mutations, but that could take up to six weeks.
However, just adding a third, modified version on top of the first two doses may not easily lead to the desired result. In the case of the mRNA vaccines, for example, vaccination reactions could be so severe that the risk-benefit assessment becomes negative. Experts like Michael Hoelscher, an infectious diseases doctor in Munich, are therefore recommending a third way apart from mRNA or vector vaccines: protein vaccines.
The great advantage they offer, says Hoelscher, who is a professor at the city’s university hospital, is that they can be administered several times, probably without loss of efficacy or tolerability, and adapted to the new mutants. "This will prove to be an important feature as the epidemic progresses,” Hoelscher says.
Two pharmaceutical companies, Novavax and Sanofi/GlaxoSmithKline, have been developing these protein vaccines for months. None has been authorized for use in the European Union yet. But the date doesn’t seem too far off when the rankings of vaccines will be reordered with the potential for new claims and myths about them.
No comments:
Post a Comment