European drug regulators Oxford-AstraZeneca Covid-19 Shots A rare blood clot as British authorities recommended that people under the age of 30 be vaccinated with an alternative vaccine.
European Medicines Agency (EMA) Said on wednesday Certain combinations of abnormal blood clots and low platelet counts should be listed as side effects of the vaccine, but it has not been recommended to limit their use. The benefits of shots outweigh the risks, COVID-19 He added that it was a “very serious illness.”
UK regulators have taken a more cautious approach, stating that other vaccines should be provided to healthy adults under the age of 30. Authorities described the move as a “course modification” that would not upset the country’s rapid vaccination program.
The findings can have significant implications for developing and middle-income countries, many of whom have access to AstraZeneca shot-throughs. Covax, Vaccine sharing scheme.
An EMA official said the analysis examined 18 deaths. These deaths were reported in 62 cases of coagulation in the sinuses, which drain blood from the brain, and 24 cases of coagulation in the abdomen. Cases were reported in the EU safety database of European countries, including the United Kingdom, and a total of approximately 25 million people were vaccinated with AstraZeneca.
“We want to start with the Safety Commission (Pharmacovisilance and Risk Assessment Committee or PRAC) confirming that the benefits of the AstraZeneca vaccine in the prevention of Covid-19 outweigh the overall risk of side effects. I think, “EMA Emer Cook, Secretary-General, said at a press conference.
PRAC Chair Sabine Straus reiterated that cases of severe coagulation with low platelet counts are extremely rare, but when journalists disagree, the EMA benefits certain groups of age-specific risks. Admitted that there was no data to understand the range that could exceed. Or sex, for example.
“At this point, it’s very difficult to answer for clinical trials … Not all age group data are available,” Straus said, and agencies take that data for further analysis. I added that it was planned.
Cook said the Safety Commission looked at the ages and genders of people reporting these rare side effects and found no clear risk profile. Age within 2 weeks of vaccination. “
The EMA statement states to health care workers and vaccinated people that they “continue to recognize the possibility of very rare blood clots combined with low levels of platelets that occur within two weeks of vaccination.” I asked for.
British officials also concluded that benefits outweigh the risks in most age groups, but in scenarios where exposure to the virus is restricted, benefits to people under the age of 30 slightly outweigh the risks. I presented the data to show that. But those who have already received the first shot of AstraZeneca should be offered a second shot, they said.
EMA findings and new UK advice follow the move in Germany, which was discontinued last week. AstraZeneca vaccine in people under the age of 60 After 31 reports of CVST. Twenty-nine of the 31 women were women between the ages of 20 and 63, and nine patients died, according to a Reuters report citing national drug regulators.
After reviewing data from the EMA and the United Kingdom, the World Health Organization said in a statement Wednesday: “Based on current information, the causal link between vaccines and the development of low-platelet thrombosis is believed to be plausible, but has not been confirmed. A potential link between vaccination and possible risk factors Professional research is required to fully understand. “
What do you mean by the data?
Jonathan Bantam, UK Deputy Chief Medical Officer, released a chart on Wednesday showing the balance between the risks and benefits of each age group when vaccinated with AstraZeneca in the United Kingdom.
Vaccines have been shown to offer slightly higher benefits than the risk of people under the age of 30 in less exposed scenarios, such as those who work from home. The analysis considered the likelihood of being admitted to the intensive care unit as a key indicator.
People near the recommended age limit need to “decide for themselves” whether to accept the AstraZeneca vaccine, said Weishenlim, chairman of the UK’s Joint Committee on Vaccination and Immunization. I am.
“For people aged 31 and 32, I think I have to decide for myself what I want to do about vaccination,” he said. “Because of the risks of Covid-19 and the protection that the vaccine provides, balance is in favor of vaccination.”
“Identification of rare cases of blood clots that may be associated with a vaccine indicates that the safety system is working,” Oxford University said Wednesday.
“Safety was our priority during the development of the vaccine at Oxford University in 2020. As the vaccine is deployed worldwide, it will be under close scrutiny by regulators and public health authorities. We are confident that surveillance will continue, “said Andrew Polard, a professor of childhood infections and immunity, in a statement.
AstraZeneca said Wednesday that it was “working with regulators” to update product information on possible side effects following announcements by UK and European regulators.
“Renewal of the UK and EU labels for vaccines is required by regulators. Neither agency has identified risk factors such as age or gender, or the exact cause of these very rare events. However, they came to the view that these events may be related to vaccines and demanded that they be listed as very rare potential side effects. “
“Overall, both of these reviews reaffirmed that the vaccine provided a high level of protection against all severity of COVID-19 and that these benefits far outweighed the risks.” The statement added.
Vaccine safety concerns have fallen tens of millions of times below the EU’s delivery target, causing the latest headache for pharmaceutical company AstraZeneca, which is at the center of the public language dispute between the European Union and the United Kingdom. It is a seed. It looks like you’re making a profit from the supply to the UK.
The company is also under the supervision of drug regulators, including the US Food and Drug Administration, presenting old clinical trial data and previously mixing data from separate trials conducted in different ways.
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