January 30, 2021/
BioValleyBIOON/--Currently, the COVID-19 epidemic overseas is still spreading rapidly. According to Baidu's "Real-time Epidemic Situation of Novel Coronavirus Pneumonia"
Big DataReport》, as of 12:00 on January 30, 2021, the global cumulative confirmed cases exceeded 100 million (102.63 million), with over 2.216 million deaths.
Recently,
AstraZeneca/Oxford University’s adenovirus vaccine, COVID-19 Vaccine AstraZeneca (formerly known as AZD1222), has received positive regulatory news. The European Commission (EC) has granted a conditional marketing authorization (CMA) for COVID-19 Vaccine AstraZeneca for active immunization in individuals aged 18 years and older to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). With this approval, AstraZeneca is now collaborating with the European Union to implement active immunization across all EU member states.
Following its review of the application, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion based on a rolling review of analytical data from the Phase 3 program led by the University of Oxford. Additional safety and efficacy data for the vaccine will continue to be collected from ongoing
Clinical Trialaccumulated in China, and is expected to be announced in the coming weeks.
CHMP Recommendation: Two doses of the COVID-19 Vaccine AstraZeneca should be administered at an interval of 4–12 weeks in individuals aged 18 years and older.
Clinical Trialsindicating that the immunization regimen is safe and effective in preventing symptomatic COVID-19, with no severe cases or hospitalizations occurring more than 14 days after the second dose.
It is worth noting that,The AstraZeneca COVID-19 vaccine can be stored, transported, and handled under standard refrigerated conditions (2–8°C/36–46°F) for at least 6 months and used within existing healthcare settings.and from
Pfizer/Although the two mRNA vaccines from BioNTech and Moderna exhibit high efficacy, their requirement for storage and distribution at -70°C imposes significant limitations.
AstraZeneca CEO Pascal Soriot stated, “Today’s approval underscores the value of AstraZeneca’s COVID-19 vaccine, which is not only effective and well-tolerated but also easy to administer. Importantly, it provides complete protection against severe disease and hospitalization. We are deeply grateful to the University of Oxford,”
Clinical Trial“Participants and AstraZeneca colleagues remain steadfast in their commitment to delivering this life-saving vaccine to millions of people across Europe.”
Professor Andrew Pollard, Director of the Oxford Vaccine Group and Chief Investigator of the Oxford vaccine trials, stated: “The European Commission’s approval marks a significant milestone in expanding the use of the Oxford/AstraZeneca vaccine in our region, providing further recognition that, following rigorous review by regulatory authorities, the vaccine can be used to help protect populations from the impact of the COVID-19 pandemic.”
AstraZeneca continues to collaborate with regulatory authorities worldwide, supporting their ongoing rolling reviews of emergency supply or conditional approvals during the health crisis. AstraZeneca is also seeking inclusion on the World Health Organization’s (WHO) Emergency Use Listing to accelerate access to vaccine supplies in low-income countries.
AstraZeneca is continuing to work with governments, international organizations and partners around the world to ensure broad and equitable access to vaccines during the COVID-19 pandemic, without seeking any profit.
The COVID-19 Vaccine AstraZeneca (formerly known as AZD1222) was jointly developed by the University of Oxford and its spin-off company, Vaccitech. It utilizes a weakened, replication-deficient chimpanzee adenovirus vector based on a common cold virus (adenovirus).
Carrier, the virus causes infection in chimpanzees and contains the SARS-CoV-2 spike protein
Hereditysubstance. After vaccination, surface spike proteins are produced, stimulating the immune system to attack the SARS-CoV-2 virus.
The CHMP’s recommendation is based on an analysis of 23,745 participants aged 18 years and older, who accumulated 232 cases of symptomatic COVID-19 infection in the Phase III trials conducted in the United Kingdom and Brazil by the University of Oxford.
To date, the published safety data are from the United Kingdom, Brazil, and South Africa
Clinical Trialsinvolving more than 20,000 participants. The article published in The Lancet confirmed that AstraZeneca’s COVID-19 vaccine was well tolerated, with no confirmed serious safety events related to the vaccine. Participants were drawn from diverse ethnic and geographic groups and were either healthy or had stable underlying medical conditions.
In addition to the trial led by the University of Oxford, AstraZeneca is conducting large-scale trials in the United States and globally. The University of Oxford and AstraZeneca expect to enroll up to 60,000 participants worldwide.
As of now, the AstraZeneca/University of Oxford COVID-19 vaccine has been granted Conditional Marketing Authorization (CMA) or Emergency Use Authorization (EUA) in nearly 40 countries across four continents, including the European Union, several Latin American countries, India, Morocco, and the United Kingdom.(Bioon.com)
Original Source: COVID-19 Vaccine AstraZeneca authorised for use in the EU
