The European Medicines Agency (EMA) has no longer amended the guidelines on the use of the vaccine, while the overall benefits still outweigh the risks, while some European countries restrict the use of the shot only to older age groups.
On the same day, British authorities also confirmed the link and stressed that the benefits of the AstraZeneca shot outweigh the risk overall, but followed a different course of action for people under the age of 30, and advised to get different vaccines , if available.
The regulators cleared up some questions surrounding the AstraZeneca shot, but raised many others. Here are the answers to some of them.
EMA said these serious blood clotting events are reported at about 1 in 100,000. Without age and gender data, it is not known whether the risk for specific groups is higher or lower. The overall rate can also change upwards or downwards, as more people are vaccinated and a clearer picture emerges.
In the UK, there were reports of 79 severe blood clots, along with a low platelet count. Nineteen of the people died on March 31, the Regulatory Agency of Medicines and Healthcare Products (MHRA) said. Some of these deaths may have been calculated in the previous EMA analysis.
In terms of the blood clotting events with a low platelet count, the overall risk is about 1 in 250,000, when about 20 million people received the AstraZeneca vaccine in the UK. As the blood clots appear to infect younger men and women in higher numbers, it is possible that the risk may be greater once the data are reduced to specific groups.
Are blood clots more common in women?
The number of reported blood clots is relatively small and the data on it is limited, so it is difficult to draw any conclusions about who suffers the most from the side effects.
Sabine Straus, chair of the EMA’s safety committee, has said so far that most cases have occurred so far in women under the age of 60, but warned that the agency does not have enough data on age and gender to be sure of any specific risk profile.
For example, the agency may not be sure that women are not experiencing these coagulation events in higher numbers simply because more women are being vaccinated. But it also means that it has not ruled out the possibility that women are at greater risk.
British regulators have said something similar. Of the 79 cases documented, 51 were women and 28 men. But more women have been vaccinated. Authorities did not provide information on Wednesday on what they believe could be a blood clot.
When EMA says that the benefits outweigh the risks, it means that this is the case when looking at the big picture, and putting them all together, regardless of age or gender.
Straus admits that journalists on Wednesday challenged that EMA does not have the data to understand the extent to which the benefits may still outweigh the risks for specific groups, such as for women or younger age groups.
Women are more prone to certain coagulation events, such as CVST, than men, so a question for further analysis is whether women in particular experience these coagulation events with a higher incidence than usual.
Are younger people more likely to get these blood clots?
British health authorities had clearer information on age than sex and said on Wednesday that the incidence of these blood clotting events in younger adults has a slightly higher incidence. And if you think that Covid-19 younger people are less likely to get serious, the risks will outweigh the benefits in some situations.
Therefore, Britain decided to give people under the age of 30 alternatives to the AstraZeneca vaccine.
An analysis by the Winton Center for Risk and Evidence Communication at the University of Cambridge, which was shared at the UK Government’s news conference on Wednesday, found that the vaccine was more likely to cause serious harm to 20- to 29-year-olds. to prevent them from becoming so ill that they require intensive care.
Approximately: for every three people the vaccine helps to prevent the need for intensive care treatment, four others will cause serious damage as a result of the shot in a situation where the virus is exposed.
As the exposure to the virus increases, just as when the restrictions on closure diminish, the situation is reversed. People in this age group are twice as likely to benefit from the shot – in terms of avoiding the need for intensive care – than to be seriously harmed by it. And in a high exposure situation – say, if things were normal again – these benefits would be more than six times higher than these risks.
According to UK experts, the potential side effects of blood clotting in older age groups appear to be less likely, in contrast to the increasing dangers of Covid-19 among older people.
Their data suggested that 0.2 people per 100,000 for those in their 60s would suffer severe damage as a result of the vaccine – about 2 people per million people.
But for all those cases, 70 people would have been admitted to the intensive care units (ICUs) in their 60s last month, when the risk of Covid-19 was relatively low.
At the height of the UK’s second wave, according to this data, it counts balloons for around 640 ICU admissions for every person in their 60s to get vaccine complications.
As loosening facilitates, the threat of Covid-related complications is likely to increase due to increased transmission, while the threat of dangerous side effects on the vaccine should remain at the same low level.
What if I’re more at risk of getting blood clots?
Blood clots are common, and a significant portion of the population is more likely to develop them due to underlying conditions, genetics, lifestyle or other medications they are taking.
But the blood clots that are considered unusual by the authorities are specific severe clotting around the brain and abdomen, and this is accompanied by a low number of platelets. This is an unusual combination because platelets usually help the body’s blood clot in a good way to stop bleeding, for example. Usually a high number of platelets and severe clotting together.
In the UK, regulators say people “of any age who are at higher risk for blood clots due to their medical condition” should only get the vaccine as a precaution “if the benefits of protection against Covid-19 infection outweigh as potential risks. “
If I had a first dose, should I get a second dose?
Unless you have experienced blood clotting after your first dose of AstraZeneca, the UK authorities say you should still take your second, while EMA still advises everyone to take the chance, with the exception of people with conditions advised against it.
“Anyone who has not had these side effects should come forward after their second dose,” the MHRA said.
Most cases of blood clotting occurred within two weeks after someone received the first dose, EMA said, although of course there is less evidence about second doses because less was administered. In the UK, so far there have been no reports of a second dose. But again, much less second doses were administered.
However, both agencies say the benefits of the vaccine outweigh the risks, so the advice remains to continue vaccinating AstraZeneca unless otherwise stated.
If you are concerned, it is worth talking to your healthcare provider about this.
EMA also warns that there is not yet enough data on switching vaccines for your second dose. Some ongoing trials are investigating the effect of taking two different vaccines.
How can I identify a blood clot?
Regulators have recommended that patients be informed of the potential side effects of the AstraZeneca vaccine, such as for any medicines or vaccinations that pose potential risks.
It is important to remember that mild to moderate side effects are relatively common in the hours and days after taking any of the approved Covid-19 vaccines.
It is less common for side effects to last longer than a few days, and EMA recommends that patients seek medical help urgently if they experience symptoms such as shortness of breath, chest pain, swelling in the leg, persistent abdominal pain. neurological symptoms, such as severe headache or dull face, or small blood stains under the skin. These may be signs of a blood clot or other adverse reaction.
Is the vaccine still safe?
Reports of blood clots added to the information countries have about the AstraZeneca vaccine, but they have not changed the prevailing conclusion that the shot saves more lives than it endangers.
As mentioned, in the United Kingdom, the percentage of people who have these unusual blood clots with a low platelet count is about 1 in 250,000 or 4 in a million.
“The reported combination of blood clots and low platelets is very rare, and the overall benefits of the vaccine to prevent Covid-19 outweigh the risks of side effects,” EMA concluded Wednesday.
Again, this conclusion takes a complete picture of what is happening, and UK data shows that age is a factor worth considering. Younger people may also consider their role in transmitting the virus to older people, who are at greater risk of becoming seriously ill.
Actual data show that the vaccine reduces hospitalizations and deaths due to Covid-19. A public health analysis in England estimates that by the end of February, 6,100 deaths had occurred in people aged 70 and over in England, after the first few weeks of the UK’s vaccination program.