AstraZeneca's COVID-19 Vaccine Shows 100% Efficacy Against Severe Disease and Hospitalization in U.S. Phase III Trial Amid Global Cases Surpassing 123 Million

March 23, 2021 /Bio ValleyBIOON/ -- 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 01:00 on March 23, 2021, the global cumulative confirmed cases exceeded 100 million (123.96 million), with more than 2.729 million deaths.

Recently,AstraZeneca(AstraZeneca) announced the U.S. Phase III trial of its adenovirus vaccine, COVID-19 Vaccine AstraZeneca (formerly known as AZD1222), developed in collaboration with the University of OxfordClinical Trials(D8110C000011) interim analysis data. The results showed that,This vaccine has an efficacy of 79% in preventing symptomatic COVID-19., inThe efficacy in preventing severe or critical illness and hospitalization is 100%., inThe efficacy rate in the population aged 65 years and older is 80%., the data were statistically significant. Furthermore, AZD1222 demonstrated favorable reactogenicity and overall safety.

D8110C00001 is a Phase III, randomized, double-blind, placebo-controlled, multicenter study evaluating the safety, efficacy, and immunogenicity of AZD1222 versus placebo for the prevention of COVID-19 in 32,449 participants across 88 trial sites in the United States, Peru, and Chile. In this trial, participants aged 18 years or older who were healthy or had medically stable chronic conditions and were at increased risk of exposure to SARS-CoV-2 and COVID-19 were randomized in a 2:1 ratio to receive two intramuscular injections of either AZD1222 (5 × 10¹⁰ viral particles) or placebo (saline), administered 4 weeks apart.

This interim safety and efficacy analysis was based on 141 cumulative cases of symptomatic COVID-19 among 32,449 participants. Among the participants in the interim analysis, approximately 79% were White/Caucasian, 8% were Black/African American, 4% were Native American, 4% were Asian, and 22% were Hispanic.Approximately 20% of participants were aged 65 years or older, and approximately 60% of participants had conditions associated with severe COVID-19 (such asDiabetes, comorbidities associated with an increased risk of progression (e.g., severe obesity or heart disease).

Data show that vaccine efficacy is consistent across races and age groups. Notably, vaccine effectiveness was 80% among participants aged 65 years and older.In this trial, the AZD1222 vaccine was well tolerated, and the independent Data Safety Monitoring Board (DSMB) identified no vaccine-related safety concerns. With assistance from an independent neurologist, the DSMB conducted a focused review of thrombotic events and cerebral venous sinus thrombosis (CVST). The DSMB found no increased risk of thrombosis or thrombosis-characterized events among the 21,583 participants who received at least one dose of the vaccine. A targeted search for CVST in this trial did not identify any cases.

AstraZeneca will continue to analyze the data and prepare to submit the preliminary analysis to the U.S. in the coming weeksFDA, to obtain Emergency Use Authorization (EUA). Meanwhile, preliminary analyses will be submitted to peer-reviewed journals for publication.

This US Phase III trial, led by AstraZeneca, involved two doses administered four weeks apart. Previous trials indicated that dosing intervals of up to 12 weeks demonstrated greater efficacy, a finding further supported by immunogenicity data. This evidence suggests that extending the interval beyond four weeks for the second dose could further enhance efficacy and accelerate the number of individuals able to receive their first dose.

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

Notably, the AstraZeneca COVID-19 Vaccine can be stored, transported, and handled under standard refrigerated conditions (2–8°C/36–46°F) for at least six months, allowing for its use within existing healthcare settings. AstraZeneca continues to collaborate with governments around the world, multilateral organizations, and partners to ensure broad and equitable access to vaccines during the COVID-19 pandemic on a not-for-profit basis.

In February this year, the vaccine was 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. To date, the vaccine has received conditional marketing authorization or emergency use approval in more than 70 countries across six continents. With its recent inclusion in the WHO EUL, access to the vaccine through the COVAX Facility will be accelerated in up to 142 countries.

The World Health Organization’s authorization of the COVID-19 Vaccine AstraZeneca, produced by AstraZeneca, and COVISHIELD, produced by the Serum Institute of India (SII) (the brand name for the COVID-19 Vaccine AstraZeneca in India), 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 the regimen is safe and effective in preventing symptomatic COVID-19, with no severe cases or hospitalizations reported 14 days after the second dose. The Strategic Advisory Group of Experts (SAGE) on Immunization of the World Health Organization (WHO) 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 Facility) in June 2020. This global mechanism is working to accelerate the development and production of new COVID-19 tools and ensure equitable global access to these tools for all participating countries, regardless of income level.

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

Original Source: AZD1222 US Phase III Trial Met Primary Efficacy Endpoint in Preventing COVID-19 at Interim Analysis