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EU approved the COVID-19 vaccine from AstraZeneca/Oxford University
EU approved the COVID-19 vaccine from AstraZeneca/Oxford University. AstraZeneca/Oxford University AZD1222 has been approved by the European Union: conventional cold storage, 2-dose immunization, no profit supply worldwide!
Recently, AstraZeneca/Oxford University’s adenovirus vaccine COVID-19 Vaccine AstraZeneca (formerly known as AZD1222) has received good news in terms of supervision. The European Commission (EC) has granted a conditional marketing authorization (CMA) for COVID-19 Vaccine AstraZeneca for active immunization of people aged 18 and above to prevent new coronavirus pneumonia caused by the new coronavirus (SARS-CoV-2) ( COVID-19). With this approval, AstraZeneca is now cooperating with the European Union on active immunization in all EU member states.
After reviewing the application, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion based on the rolling review of the analysis data of the Phase 3 project led by Oxford University. Other safety and effectiveness data of the vaccine will continue to accumulate from ongoing clinical trials and is expected to be announced in the next few weeks.
CHMP recommends: In people 18 years and older, inject 2 doses of COVID-19 Vaccine AstraZeneca vaccine at an interval of 4-12 weeks. Clinical trials have shown that the immunization program is safe and effective in preventing symptomatic COVID-19. 14 days after the second immunization, no serious cases and hospitalizations occurred.
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. Although the two mRNA vaccines from Pfizer/BioNTech and Moderna are highly efficient, they need to be stored and distributed at minus 70°C, which has great limitations.
Pascal Soriot, CEO of AstraZeneca, said: “Today’s approval highlights the value of AstraZeneca’s COVID-19 vaccine. It is not only effective and well-tolerated, but also easy to manage. Importantly, it can completely prevent serious diseases and Hospitalized. We are very grateful to Oxford University, clinical trial participants, and AstraZeneca colleagues for their unwavering commitment to providing this life-saving vaccine to millions of Europeans.”
Professor Andrew Pollard, director of Oxford Vaccine Group and principal investigator of Oxford Vaccine Trials, said: “The approval of the European Commission is an important milestone in expanding the use of Oxford/AstraZeneca vaccines in our region, and provides further recognition, namely After rigorous review, the vaccine can be used to help protect people from the COVID-19 pandemic.”
AstraZeneca is continuing to work with regulators around the world to support their continuous rolling review of emergency supplies or conditional approvals during a health crisis. AstraZeneca is also seeking the World Health Organization’s (WHO) Emergency Use Listing (Emergency Use Listing) to accelerate access to vaccine supplies in low-income countries.
AstraZeneca is continuing to work with governments, international organizations, and collaborators around the world to ensure widespread and fair access to vaccines during the COVID-19 pandemic, without any profit.
COVID-19 Vaccine AstraZeneca (formerly AZD1222) was invented by Oxford University and its spin-off company Vaccitech. It uses a replication-deficient chimpanzee virus vector based on a weakened version of the common cold virus (adenovirus), which causes infection in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein. After vaccination, a surface spike protein is produced, which stimulates the immune system to attack the SARS-CoV-2 virus.
The CHMP’s recommendations are based on an analysis of 23,745 participants aged 18 and over who have accumulated 232 cases of symptomatic COVID-19 infections in the UK and Brazil Phase III trials conducted by the University of Oxford.
The safety data published so far come from more than 20,000 participants in four clinical trials in the United Kingdom, Brazil and South Africa. The article on The Lancet confirms that AstraZeneca’s COVID-19 vaccine is well tolerated, and no serious safety incidents related to the vaccine have been confirmed.
Participants come from different ethnic and geographic groups, they are healthy or have stable underlying diseases. In addition to the program led by Oxford University, AstraZeneca is also conducting large-scale experiments in the United States and around the world. Oxford University and AstraZeneca are expected to recruit up to 60,000 subjects worldwide.
As of now, AstraZeneca/Oxford University’s COVID-19 vaccine has been granted CMA or Emergency Use Authorization (EUA) in nearly 40 countries, covering four continents, including the European Union, some Latin American countries, India, Morocco and the United Kingdom
(source:internet, reference only)