WHO Grants Emergency Use Listing to AstraZeneca’s AZD1222 COVID-19 Vaccine: Standard Refrigeration, Two-Dose Regimen, and Not-for-Profit Global Supply

February 16, 2021 News /Bio ValleyBIOON/ -- At present, the COVID-19 epidemic overseas is still spreading rapidly. According to Baidu's "Real-time Data on the Novel Coronavirus Pneumonia Epidemic"Big DataReport》, as of 22:00 on February 16, 2021, the global cumulative confirmed cases exceeded 100 million (109.76 million), with more than 2.42 million deaths.

Recently,AstraZeneca(AstraZeneca) announced that the adenovirus vaccine COVID-19 Vaccine AstraZeneca (formerly known as AZD1222), developed by the company and the University of Oxford, has been included in the World Health Organization’s (WHO) Emergency Use Listing (EUL) for active immunization to prevent COVID-19 in individuals aged 18 years and older (including those aged 65 years and above). Notably,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.

The authorization of the COVID-19 Vaccine AstraZeneca, produced by AstraZeneca, and COVISHIELD (the brand name for the COVID-19 Vaccine AstraZeneca in India), produced by the Serum Institute of India (SII), will enable global access to this vaccine during the COVID-19 pandemic.

EUL allows for the administration of 2 vaccine doses every 4–12 weeks.Clinical TrialThe results indicate that this regimen is safe and effective in preventing symptomatic COVID-19, with no severe cases or hospitalizations reported 14 days after the second dose. The World Health Organization’s Strategic Advisory Group of Experts (SAGE) on Immunization recommends an dosing interval of 8–12 weeks. Furthermore, they recommend the use of this vaccine in countries where new variants, including the South African B.1.351 variant, are prevalent.

AstraZeneca has committed to providing its COVID-19 vaccine to as many countries as possible during the pandemic without making any profit. In June 2020, the company announced a sub-licensing agreement with SII to produce and supply up to 1 billion doses of the vaccine to low- and middle-income countries.

AstraZeneca was the first global pharmaceutical company to join COVAX (the WHO COVID-19 Vaccines Global Access initiative) in June 2020. This global mechanism is working to accelerate the development and production of new COVID-19 tools and ensure equitable worldwide access to these tools for all participating countries, regardless of income level.

AstraZeneca and SII will now collaborate with the COVAX Facility to begin supplying vaccines worldwide, with the majority of doses being shipped to low- and middle-income countries as soon as possible. In the first half of 2021, more than 300 million vaccine doses are expected to be delivered to 145 countries through COVAX. These doses will be allocated equitably in accordance with the COVAX allocation framework.

AstraZeneca CEO Pascal Soriot stated, “Today’s approval recognizes that this vaccine can be used to help protect the global population, including individuals aged 65 and older, as well as those in countries where different variants of SARS-CoV-2 are circulating. This is a major step toward ensuring global access to our vaccine and helping us fulfill our public health commitment to provide broad, equitable, and not-for-profit access to vaccines during the pandemic.”

Adar Poonawalla, CEO of the Serum Institute of India (SII), stated, “We have been awaiting this final milestone. I am pleased and relieved that, with the WHO’s Emergency Use Listing (EUL), we will be able to immediately begin delivering vaccines to Africa and other low- and middle-income countries. Countries with large populations must be protected as soon as possible.”

COVID-19 Vaccine AstraZeneca (formerly AZD1222) was jointly developed by the University of Oxford and its spin-out company, Vaccitech. It utilizes a replication-deficient chimpanzee adenovirus vector based on a weakened version of the common cold virus (adenovirus).Carrier, this virus causes infection in chimpanzees and contains the spike protein of the SARS-CoV-2 virusHereditysubstance. After vaccination, surface spike proteins are produced, triggering the immune system to attack the SARS-CoV-2 virus.

The World Health Organization (WHO) approval was based on a pooled efficacy analysis of 11,636 participants aged 18 years and older from the Phase III trials conducted by the University of Oxford in the United Kingdom and Brazil, which accumulated 131 cases of symptomatic COVID-19 infection.Overall safety was based on four studies conducted in the United Kingdom, Brazil, and South Africa.Clinical TrialInterim analysis of the pooled data, including 23,745 participants aged 18 years or older.AstraZeneca’s COVID-19 vaccine was well tolerated, with no vaccine-related serious safety events reported. Participants were drawn from diverse racial and geographic groups and were either healthy or had stable underlying medical conditions.

In addition to the Oxford University-led program, AstraZeneca is also conducting large-scale trials in the United States and globally. Oxford University and AstraZeneca expect to enroll up to 60,000 participants worldwide.

AstraZeneca’s COVID-19 vaccine has received conditional marketing authorization or emergency use approval in more than 50 countries, and the World Health Organization’s Emergency Use Listing (EUL) will now accelerate access to this vaccine through the COVAX Facility in up to 145 countries.(Bioon.com)

Original Source: AstraZeneca COVID-19 Vaccine Authorised for Emergency Use by the World Health Organization