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▎The content team editor of WuXi AppTec today, AstraZeneca announced that the new crown vaccine AZD1222 jointly developed by the company and the University of Oxford has obtained positive results in a phase 3 clinical trial conducted in the United States.
The interim analysis showed that AZD1222 was effective in preventing symptomatic COVID-19 at 79%, and at preventing serious diseases and hospitalizations at 100%.
In addition, the Independent Data Security Monitoring Board (DSMB) found no safety issues related to the vaccine, and no serious thrombotic events were found in the vaccinated subjects.
In previous phase 3 clinical trials conducted in the United Kingdom, South Africa and Brazil, two doses of AZD1222 vaccine were administered 21 days apart, and the effectiveness of preventing symptomatic COVID-19 was 62.
1%.
In addition, there have been very few thrombotic events in the European population who received the AZD1222 vaccine recently.
These news have raised doubts about the effectiveness and safety of AZD1222.
This latest Phase 3 clinical result provides new evidence to support the efficacy and safety of AZD1222.
The study was conducted in the United States, Peru, and Chile, and a total of 32,449 subjects were recruited.
They were inoculated with two doses of AZD1222 or normal saline control at a ratio of 2:1 and 4 weeks apart.
The interim analysis is based on data from 141 COVID-19 patients with symptoms.
Among the subjects participating in the clinical trials, nearly 20% are elderly people over 65, and nearly 60% carry comorbidities that may increase the risk of COVID-19 progressing to serious diseases, including diabetes, severe obesity, or heart disease.
AZD1222 showed good efficacy in subjects of different ethnicities and ages.
Among the elderly over 65, the effectiveness of preventing symptoms of COVID-19 has reached 80%.
Based on recent reports of thrombotic events, the Independent Data Security Monitoring Committee specifically reviewed thrombotic events, including the review of cerebral venous sinus thrombosis (CVST) with the assistance of an independent neurologist.
The Data Safety Monitoring Committee found no increased risk of thrombosis in 21,583 subjects who received at least one dose of the vaccine, and no CVST event was found in this clinical trial.
Picture source: 123RF Recently, the British Medicines and Health Products Administration (MHRA) and the European Medicines Agency (EMA) have announced that the benefits of AstraZeneca's new crown vaccine outweigh the risks.
The MHRA conducted a rigorous scientific evaluation of a small number of thrombotic events in more than 11 million people who were vaccinated with AstraZeneca in the UK.
The conclusion is that there is no evidence that the risk of thrombosis in the vaccinated population is higher than that of the unvaccinated population.
In the UK, the probability of severe sinus thrombosis and thrombocytopenia events is less than one in 1 million.
Since this situation may occur naturally in people who have not been vaccinated, there is currently no causal relationship between its appearance and vaccination.
.
The EMA's Pharmacovigilance Risk Assessment Committee (PRAC) evaluation also believes that AstraZeneca's new crown vaccine does not increase the risk of thrombotic events.
There is currently no evidence that there is a causal relationship between severe thrombosis and thrombocytopenia and vaccination.
This possibility requires further research.
Dr.
Mene Pangalos, Executive Vice President of AstraZeneca Biomedical Research and Development, said: “These data provide more evidence that this vaccine is well tolerated and is resistant to different severity of COVID-19 among people of different ages.
It is highly protective.
We are preparing to submit these findings to the US FDA.
If emergency use authorization is obtained, we will prepare to deliver millions of vaccines. "Reference: [1] UK and EU regulatory agencies confirm COVID-19 Vaccine AstraZeneca is safe and effective.
Retrieved March 22, 2021, from https:// releases/2021/uk-and-eu-regulatory-agencies-confirm-covid-19-vaccine-astrazeneca-is-safe-and-effective.
html[2] AZD1222 US Phase III trial met primary efficacy endpoint in preventing COVID-19 at interim analysis.
Retrieved March 22, 2021, from https:// Note: This article is intended to introduce the progress of medical and health research, not a treatment plan recommendation.
If you need treatment plan guidance, please go to a regular hospital for treatment.
The interim analysis showed that AZD1222 was effective in preventing symptomatic COVID-19 at 79%, and at preventing serious diseases and hospitalizations at 100%.
In addition, the Independent Data Security Monitoring Board (DSMB) found no safety issues related to the vaccine, and no serious thrombotic events were found in the vaccinated subjects.
In previous phase 3 clinical trials conducted in the United Kingdom, South Africa and Brazil, two doses of AZD1222 vaccine were administered 21 days apart, and the effectiveness of preventing symptomatic COVID-19 was 62.
1%.
In addition, there have been very few thrombotic events in the European population who received the AZD1222 vaccine recently.
These news have raised doubts about the effectiveness and safety of AZD1222.
This latest Phase 3 clinical result provides new evidence to support the efficacy and safety of AZD1222.
The study was conducted in the United States, Peru, and Chile, and a total of 32,449 subjects were recruited.
They were inoculated with two doses of AZD1222 or normal saline control at a ratio of 2:1 and 4 weeks apart.
The interim analysis is based on data from 141 COVID-19 patients with symptoms.
Among the subjects participating in the clinical trials, nearly 20% are elderly people over 65, and nearly 60% carry comorbidities that may increase the risk of COVID-19 progressing to serious diseases, including diabetes, severe obesity, or heart disease.
AZD1222 showed good efficacy in subjects of different ethnicities and ages.
Among the elderly over 65, the effectiveness of preventing symptoms of COVID-19 has reached 80%.
Based on recent reports of thrombotic events, the Independent Data Security Monitoring Committee specifically reviewed thrombotic events, including the review of cerebral venous sinus thrombosis (CVST) with the assistance of an independent neurologist.
The Data Safety Monitoring Committee found no increased risk of thrombosis in 21,583 subjects who received at least one dose of the vaccine, and no CVST event was found in this clinical trial.
Picture source: 123RF Recently, the British Medicines and Health Products Administration (MHRA) and the European Medicines Agency (EMA) have announced that the benefits of AstraZeneca's new crown vaccine outweigh the risks.
The MHRA conducted a rigorous scientific evaluation of a small number of thrombotic events in more than 11 million people who were vaccinated with AstraZeneca in the UK.
The conclusion is that there is no evidence that the risk of thrombosis in the vaccinated population is higher than that of the unvaccinated population.
In the UK, the probability of severe sinus thrombosis and thrombocytopenia events is less than one in 1 million.
Since this situation may occur naturally in people who have not been vaccinated, there is currently no causal relationship between its appearance and vaccination.
.
The EMA's Pharmacovigilance Risk Assessment Committee (PRAC) evaluation also believes that AstraZeneca's new crown vaccine does not increase the risk of thrombotic events.
There is currently no evidence that there is a causal relationship between severe thrombosis and thrombocytopenia and vaccination.
This possibility requires further research.
Dr.
Mene Pangalos, Executive Vice President of AstraZeneca Biomedical Research and Development, said: “These data provide more evidence that this vaccine is well tolerated and is resistant to different severity of COVID-19 among people of different ages.
It is highly protective.
We are preparing to submit these findings to the US FDA.
If emergency use authorization is obtained, we will prepare to deliver millions of vaccines. "Reference: [1] UK and EU regulatory agencies confirm COVID-19 Vaccine AstraZeneca is safe and effective.
Retrieved March 22, 2021, from https:// releases/2021/uk-and-eu-regulatory-agencies-confirm-covid-19-vaccine-astrazeneca-is-safe-and-effective.
html[2] AZD1222 US Phase III trial met primary efficacy endpoint in preventing COVID-19 at interim analysis.
Retrieved March 22, 2021, from https:// Note: This article is intended to introduce the progress of medical and health research, not a treatment plan recommendation.
If you need treatment plan guidance, please go to a regular hospital for treatment.
