Vaxzevria COVID-19 Vaccine Clinical Trials, Dosage, Indication, Side Effects
Serum Institute of India Pvt. Ltd. Vaxzevria COVID-19 (AZD1222) (ChAdOx1 nCov-19) (C19VAZ) vaccine is made from a virus (ChAdOx1), a weakened version of a common cold virus (adenovirus). In addition, genetic material has been added to the ChAdOx1 construct and used to make proteins from the SARS-CoV-2 beta coronavirus called Spike glycoprotein (S). After vaccination, the surface spike protein is produced, priming the human immune system to attack SARS-CoV-2 if it later infects the body. SARS-CoV-2 uses its spike protein to bind to ACE2 receptors in human cells, enter the cells, and cause an infection. After vaccination, the surface spike protein is produced, priming the immune system to attack the coronavirus if it later infects the body and causes COVID-19. Vaxzevria does not contain coronavirus and cannot cause COVID-19, says the European Medicines Agency (EMA).
On June 28, 2021, the University of Oxford published a study on the preprint server of The Lancet that demonstrated that antibody levels remain elevated from baseline for at least one year following a single dose. In addition, a sub-analysis from the Oxford-led COV001 and COV002 trials with Vaxzevria found strong immune responses following a prolonged second dose interval of up to 45 weeks or a third boosting dose.
The European Medicines Agency (EMA) authorized Vaxzevria in February 2021. On March 26, 2021, the EMA posted 'Vaxzevria' for COVID-19 Vaccine AstraZeneca. The HUN-VE phase III clinical trial conducted across three continents published an interim analysis on November 25, 2021, the determinate the ChAdOx1 nCoV-19 showed significant 70.4% effectiveness against SARS-CoV-2 virus infection after two doses. In addition, on December 16, 2021, the NEJM published an ORIGINAL ARTICLE: Phase 3 Safety and Efficacy of the AZD1222 Vaccine - CONCLUSIONS: AZD1222 was safe and efficacious in preventing symptomatic and severe COVID-19 across diverse populations that included older adults in the significant phase 3 clinical trial. On May 23, 2022, Vaxzevria was granted approval by the EMA as a third-dose booster in adults. The WHO published The Oxford/AstraZeneca (ChAdOx1-S [recombinant] vaccine) COVID-19 vaccine: what you need to know, on June 13, 2022.
AstraZeneca announced on April 14, 2023, presentations regarding Vaxzevria's persistently high immunogenicity and between-country differences driven by hybrid immunity from primary-series AZD2816 or AZD1222 and Omicron infections; Relative effectiveness of a 2nd vs. 1st COVID-19 vaccine booster against hospitalization with SARS due to SARS-CoV-2 in high-risk individuals: a test-negative design case-control study (REFORCO) using Brazilian national data; COVIDRIVE: the first public-private partnership to conduct pan-European COVID-19 vaccine effectiveness studies. On June 30, 2023, a study concluded the primary-series AZD1222 vaccination confers protection against COVID-19 hospitalization with enduring levels of VE through ≥6 months.
Vaxzevria Accession Number: DB15656. The UNII Preferred Substance Name: B5S3K2V0G8. A listing of clinical trials is updated. As of October 2023, the EMA EMEA/H/C/005675 continues authorizing Vaxzevia.
On March 27, 2024, the European Commission withdrew the marketing authorization granted by Decision C(2021) 698(final) of 29 January 2021 for the medicinal product Vaxzevria - COVID-19 Vaccine (ChAdOx1-S [recombinant]).
AstraZeneca COVID-19 Vaccine Versions
Three versions of the Oxford-AstraZeneca vaccine are produced, including Vaxzeria, AstraZeneca-SKBio (Republic of Korea), and the Serum Institute of India (CoviShield) have been Listed for emergency use by WHO. On November 19, 2021, the Australian government published patient fact sheets in various languages about what to expect after being given the Vaxzevria (AstraZeneca) COVID-19 vaccine. It is authorized in Australia, Canada, Europe, the U.K., and over 100 countries and is Listed by the WHO.
Vaxzevria Availability
Since authorization in 2021, AstraZeneca and its partners released over two billion doses of their COVID-19 vaccine to more than 170 countries, such as Australia, Brazil, Canada, and the U.K. Vaxzevria is estimated to have helped prevent 50 million COVID-19 cases, about five million hospitalizations, and saved more than one million lives worldwide. In addition, about 69 million doses of Vaxzevria in adults were administered in the EU/EEA from authorization to May 15, 2022. On December 30, 2020, the U.K.'s Medicines and Healthcare products Regulatory Agency authorized an emergency supply of COVID-19 Vaccine AstraZeneca for the active immunization of individuals 18 or older. On January 6, 2021, the Serum Institute of India obtained emergency use authorization in India for AstraZeneca's COVID-19 vaccine. On January 12, 2021, the EMA received an application for conditional marketing authorization for COVID-19 Vaccine AstraZeneca. On January 29, 2021, the EMA recommended granting conditional marketing authorization for the COVID-19 Vaccine AstraZeneca to prevent coronavirus disease 2019 (COVID-19) in 18-year-olds.
CoviShield Vaccine
India granted emergenon January 1, 2021, cy approval for the vaccine co-developed by AstraZeneca Plc and the Universiuary 1, 2021. Covishield is the Serum Institute of India version of the AstraZeneca COVID-19 vaccine.
Vaxzevria Dosing
Vaxzevria should be administered intramuscularly as two 0.5 mL doses given four to 12 weeks apart, with an interval greater than eight weeks preferable to maximize its efficacy. On September 17, 2021, the EMA's recommendation remained to continue giving the second dose of Vaxzevria between 4 and 12 weeks after the first, in line with the product information. There is no evidence delaying the second dose influences the risk of TTS. Where the second dose of Vaxzevria is not given, no definitive recommendations cusing on the use of a different vaccine for the second dose (see EMA/ECDC Joint Statement).
Vaxzevria Boosters
AstraZeneca's COVID-19 vaccine, Vaxzevria, was granted approval in the European Union by the EMA as a third-dose vaccine for adults on May 23, 2022. As a result, healthcare professionals can now use Vaxzevria as a third dose booster in patients previously given a primary vaccine schedule of either Vaxzevria or an EU-approved mRNA COVID-19 vaccine.
Vaxzevria Side Effects
As of June 17, 2022, the EMA reported available evidence does not support a causal relationship between myocardial infarction, pulmonary embolism, and thrombosis with Vaxzevria. A total of 276,697 cases of suspected side effects were spontaneously reported from EU/EEA countries; 1,529 of these reported a fatal outcome, and about 69 million doses of Vaxzevria had been given to people in the EU/EEA. The EMA confirmed that the benefits of Vaxzevria continue to outweigh its risks. On February 1, 2022, the Annual of Internation Medicine published Original Research that concluded an exploratory retrospective cohort study among frontline personnel in Denmark that found the receipt of the AZD1222 vaccine was associated with a small excess risk for deep venous thrombosis.
Vaxzevria History
Oxford University's Jenner Institute developed the Vaxzevria (AZD1222) vaccine, working with the Oxford Vaccine Group. AZD1222 was co-invented by the University of Oxford and Vaccitech. Vaccitech owns the rights to the viral vector technology ChAdOx, used in the Oxford vaccine, and was co-founded by Professor Sarah Gilbert, who has led the project. On November 18, 2020, The Lancet published a study review that describes this vaccine's safety and immunogenicity in a broader range of participants, including adults aged 70 years and older. The vaccine candidate, ChAdOx1 nCoV-19, appears to be better tolerated in older adults than younger adults and has similar immunogenicity across all age groups after a booster dose.
Vaxzevria Ingredients
Vaxzevria AstraZeneca COVID-19 Vaccine contains in one dose (0.5 ml) COVID-19 Vaccine (ChAdOx1-S recombinant) 5 × 10^10 viral particles (vp). ChAdOx1-S is a Recombinant, replication-deficient chimpanzee adenovirus vector encoding the SARS CoV 2 Spike (S)It is producedotein. Produced in the genetically modified human embryonic kidney (HEK) 293 cells.
Produced in the genetically modified human embryonic kidney (HEK) 293 cells and by recombinant DNA technology. This product contains genetically modified organisms. Vaxzevria - AstraZeneca COVID-19 Vaccine (AZD1222) (C19VAZ): The complete list of ingredients is on this University of Oxford websitis comprisedrof ia comprises another virus (adenovirus family) modified to contthat makesne for making a protein from SARS-CoV-2. The vaccine does not contain the SARS-CoV-2 coronavirus and cannot cause COVID-19.
Vaxzevria Indication
The Vaxzevria - AstraZeneca (AZD1222) (ChAdOx1 nCoV-19) vaccine candidate is being tested to prevent infection of SARS-CoV-2, which causes COVID-19 disease.
Vaxzevria Women
While pregnancy puts women at higher risk of severe COVID-19, very little data are available to assess vaccine safety in pregnancy, wrote the WHO on September 2, 2021. Therefore, pregnant women may receive the vaccine if the benefit of vaccinating a pregnant woman outweighs the potential vaccine risks.
Vaxzevria Children
The peer-reviewed journal The Lancet published on June 11, 2022, the findings from - Safety and immunogenicity of the ChAdOx1 nCoV-19 (AZD1222) vaccine in children aged 6–17 years: a preliminary report of COV006, a phase 2 single-blind, randomized, controlled trial - that concluded - 'ChAdOx1 nCoV-19 is well tolerated and immunogenic in children aged 6–17 years, inducing concentrations of antibody that are similar to those associated with high efficacy in phase 3 studies in adults. No safety concerns were raised in this trial.'
Vaxzevria Storage
The Vaxzevria vaccine can be stored, transported, and handled under normal refrigerated conditions (2-8 degrees Celsius/ 36-46 degrees Fahrenheit) for at least six months and administered within existing healthcare settings.
Vaxzevria Vaccine News
February 8, 2024 - AstraZeneca announced -$17m for Vaxzevria revenues resulting from historic contracts.
April 27, 2023 - AstraZeneca reported $28 million in revenues from Vaxzevria (Q1 2022: $1,145m).
November 10, 2022 - AstraZeneca announced it withdrew its application for approval in the U.S.
May 21, 2020 - AstraZeneca has received more than $1 billion from the U.S. Health Department's Biomedical Advanced Research and Development Authority developed a coronavirus vaccine from the University of Oxford called AZD1222. AstraZeneca has initially agreed to supply at least 400 million vaccine doses and secured total manufacturing capacity to produce 1 billion doses, with first deliveries in September.
April 30, 2020 - AstraZeneca and the University of Oxford announced an agreement to develop and distribute the recombinant adenovirus vaccine to prevent COVID-19 from SARS-CoV-2 coronavirus infections.
Vaxzevria (AstraZeneca) COVID-19 Vaccine Clinical Trials
AZD1222 is undergoing late-stage clinical trials in Japan, Russia, South Africa, Kenya, and Latin America, as well as other European and Asian countries. Clinical trials appendix Q3 2021 results update. Visit AstraZeneca for more sponsored trials.
