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On March 18, the MHRA published its review of a small number of thromboembolic events that occurred among more than 11 million people in the UK who were vaccinated with the COVID-19 AstraZeneca vaccine. The agency confirmed that the benefits of this vaccine in preventing COVID-19 far outweigh the risks, and people should continue to receive this vaccine when it is necessary to get vaccinated. After a strict scientific review. MHRA concluded that there is no evidence that the incidence of venous thrombosis exceeds expectations in the absence of vaccination.
Currently, 5 reports of a very rare and special type of blood clot (sinus vein thrombosis) and thrombocytopenia (thrombocytopenia) in cerebral veins reported in the UK are being reviewed in detail. So far less than one in a million people who have been vaccinated in the UK have this condition, and it can occur naturally; The causal relationship with the vaccine has not yet been determined.
Subsequently, the EMA Pharmacovigilance Risk Assessment Committee (PRAC) concluded that vaccination with the COVID-19 AstraZeneca vaccine will not increase the overall risk of blood clots (thromboembolic events). However, the PRAC also concluded that for very rare serious thromboembolic events with thrombocytopenia, the causal relationship with the vaccine has not been confirmed, but is possible and worthy of further analysis. In addition, there is no evidence of problems related to specific vaccine lots or specific production sites.
AstraZeneca will continue to work closely with health authorities to ensure the proper use of the COVID-19 AstraZeneca vaccine. The company recognizes and implements the PRAC recommendations, including updates to product information, while continuing to understand the nature and relevance of these events to ensure that vaccines continue to be delivered safely during this public health crisis. AstraZeneca’s safety database analyzed tens of millions of AstraZeneca vaccination records with the COVID-19 vaccine, and the results showed that among millions of people, the frequency of these incidents did not exceed expectations.
Patient safety remains AstraZeneca’s top priority, and the company has robust processes in place for collecting, analyzing and reporting adverse events, which are shared with regulatory agencies around the world.
Ann Taylor, AstraZeneca’s chief medical officer, said: “Vaccine safety is of the utmost importance. We welcome the decisions of regulatory agencies. These decisions affirm the great benefits of our vaccines in preventing the COVID-19 pandemic. After the agency has made a cautious decision, vaccination work across Europe can resume again. “
In February this year, this vaccine was included in the Emergency Use List (EUL) by the World Health Organization (WHO) for the active immunization of people over 18 years of age (including people over 65 years of age) for prevent COVID-19. It is worth mentioning that the COVID-19 Vaccine AstraZeneca vaccine can be stored, transported and processed under conventional refrigeration conditions (2-8 ° C / 36-46 ° F) for at least 6 months and used in the existing medical environment.
So far, this vaccine has obtained approval for conditional marketing or emergency use in more than 70 countries on six continents. With the recent WHO inclusion of this vaccine in the EUL, this will accelerate access to the vaccine through COVAX facilities in 142 countries.
The WHO authorization of the AstraZeneca vaccine of the COVID-19 vaccine produced by AstraZeneca and the COVISHIELD vaccine produced by the Serological Institute of India (SII) (the trade name of the AstraZeneca vaccine of the COVID-19 vaccine in India ) will allow the world to fight COVID -19 This vaccine was obtained during the epidemic.
AstraZeneca is committed to providing its COVID-19 vaccine to as many countries as possible during the pandemic without realizing any benefit. In June 2020, the company announced that it had entered into a sublicense agreement with SII to produce and supply up to 1 billion doses of vaccines to low- and middle-income countries.
AstraZeneca is the first global pharmaceutical company to join COVAX (the new WHO Coronary Pneumonia Vaccine Implementation Plan) in June 2020. This global mechanism is working hard to accelerate the development and production of new COVID tools. -19, and to allow all participating countries, regardless of income level, to have fair access to these tools worldwide.
Now AstraZeneca and SII will work with the COVAX Facility to begin supplying vaccines worldwide, most of which will be shipped to low- and middle-income countries as soon as possible. In the first half of 2021, COVAX is expected to provide more than 300 million doses of vaccine to 145 countries. These doses will be distributed equally according to the COVAX distribution framework. (Bioon.com)
原文 出处 ： UK and EU regulatory agencies confirm COVID-19 AstraZeneca vaccine is safe and effective
