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AstraZeneca (AZN) COVID-19 Vaccine Dosing Halted in Kids Study
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Per a Wall Street Journal report, The University of Oxford has paused dosing in a small U.K. study, evaluating its partner AstraZeneca’s (AZN - Free Report) COVID-19 vaccine in children and teenagers after fresh claims about links to blood clots.
The report states that no safety issues have cropped up in the pediatric study itself. However, recent concerns about rare blood clot issues in the brain in adults who had received the shot have prompted further reviews by regulators in the U.K. and European Unions to see if the events are linked to the vaccine. The Oxford University is waiting until the U.K. regulator, Medicines and Healthcare Products Regulatory Agency completes the review before resuming vaccinations in the study.
The pediatric study was started in mid-February and will test more than 200 children and teenagers aged 6 to 17 years.
This year so far, the company’s shares have declined 1.6% compared with a decrease of 0.3% for the industry.
AstraZeneca’s vaccine has been surrounded by controversies and negative reports for some time now.
In March, many European countries, including Germany, France and Italy, temporarily paused vaccinations with AstraZeneca’s jab following some reports of blood clots in people who had received the shot. However, the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) concluded there was no increase in the overall risk of blood clots with the use of AstraZeneca’s vaccine. Germany, France, Italy and some other European nations later resumed using AstraZeneca's COVID-19 vaccine after EMA’s report. Some countries however restricted its use in younger people.
However, the EMA is conducting another review of the vaccine and expects to release updated findings this week. The World Health Organization (WHO) has also backed the vaccine in the past and is also assessing the latest data on the AstraZeneca vaccine. Reportedly, on Tuesday, WHO said the risk-benefit balance for the vaccine is still largely positive.
In March, the National Institutes of Health’s (NIH) Data Safety Monitoring Board (DSMB) doubted that the late-stage data released by AstraZeneca from a large-scale U.S. study on its COVID-19 vaccine may have included “outdated” information. The outdated information, as a result, may have provided an incomplete picture of the efficacy data, the statement released by the DSMB said.
The DSMB’s statement was released just hours after AstraZeneca announced interim data from a U.S. late-stage study on its vaccine candidate, AZD1222, which showed that the candidate was, on average, about 79% effective in preventing COVID-19. Later the company updated the data to show that the vaccine was about 76% effective against symptomatic COVID-19.
AstraZeneca’s vaccine is approved for temporary/conditional use in more than 50 countries including the European Union. However, it has not yet received authorization from the FDA. On the other hand, vaccines of Pfizer (PFE - Free Report) /BioNTech, Moderna (MRNA - Free Report) and J&J (JNJ - Free Report) have already been approved (emergency approval) in the United States and vaccinations are in full swing.
Reportedly, AstraZeneca was unable to supply adequate doses of the vaccine to different member countries of the European Union due to difficulties with international supply chains.
Last year, it generated $24 billion in global revenues. By 2020, it's predicted to blast through the roof to $77.6 billion. Famed investor Mark Cuban says it will produce ""the world's first trillionaires,"" but that should still leave plenty of money for regular investors who make the right trades early.
Image: Bigstock
AstraZeneca (AZN) COVID-19 Vaccine Dosing Halted in Kids Study
Per a Wall Street Journal report, The University of Oxford has paused dosing in a small U.K. study, evaluating its partner AstraZeneca’s (AZN - Free Report) COVID-19 vaccine in children and teenagers after fresh claims about links to blood clots.
The report states that no safety issues have cropped up in the pediatric study itself. However, recent concerns about rare blood clot issues in the brain in adults who had received the shot have prompted further reviews by regulators in the U.K. and European Unions to see if the events are linked to the vaccine. The Oxford University is waiting until the U.K. regulator, Medicines and Healthcare Products Regulatory Agency completes the review before resuming vaccinations in the study.
The pediatric study was started in mid-February and will test more than 200 children and teenagers aged 6 to 17 years.
This year so far, the company’s shares have declined 1.6% compared with a decrease of 0.3% for the industry.
AstraZeneca’s vaccine has been surrounded by controversies and negative reports for some time now.
In March, many European countries, including Germany, France and Italy, temporarily paused vaccinations with AstraZeneca’s jab following some reports of blood clots in people who had received the shot. However, the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) concluded there was no increase in the overall risk of blood clots with the use of AstraZeneca’s vaccine. Germany, France, Italy and some other European nations later resumed using AstraZeneca's COVID-19 vaccine after EMA’s report. Some countries however restricted its use in younger people.
However, the EMA is conducting another review of the vaccine and expects to release updated findings this week. The World Health Organization (WHO) has also backed the vaccine in the past and is also assessing the latest data on the AstraZeneca vaccine. Reportedly, on Tuesday, WHO said the risk-benefit balance for the vaccine is still largely positive.
In March, the National Institutes of Health’s (NIH) Data Safety Monitoring Board (DSMB) doubted that the late-stage data released by AstraZeneca from a large-scale U.S. study on its COVID-19 vaccine may have included “outdated” information. The outdated information, as a result, may have provided an incomplete picture of the efficacy data, the statement released by the DSMB said.
The DSMB’s statement was released just hours after AstraZeneca announced interim data from a U.S. late-stage study on its vaccine candidate, AZD1222, which showed that the candidate was, on average, about 79% effective in preventing COVID-19. Later the company updated the data to show that the vaccine was about 76% effective against symptomatic COVID-19.
AstraZeneca’s vaccine is approved for temporary/conditional use in more than 50 countries including the European Union. However, it has not yet received authorization from the FDA. On the other hand, vaccines of Pfizer (PFE - Free Report) /BioNTech, Moderna (MRNA - Free Report) and J&J (JNJ - Free Report) have already been approved (emergency approval) in the United States and vaccinations are in full swing.
Reportedly, AstraZeneca was unable to supply adequate doses of the vaccine to different member countries of the European Union due to difficulties with international supply chains.
AstraZeneca currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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Last year, it generated $24 billion in global revenues. By 2020, it's predicted to blast through the roof to $77.6 billion. Famed investor Mark Cuban says it will produce ""the world's first trillionaires,"" but that should still leave plenty of money for regular investors who make the right trades early.
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