AstraZeneca continues to work with governments, multilateral organizations and collaborating partners around the world to ensure broad and equitable access to the vaccine without profit throughout the pandemic. A 2021 study found that decisions to suspend the vaccine have led to increased vaccine hesitancy in the West, even in countries that have not suspended the vaccine. [171] November 17, 2021 – The Malaysian Drug Control Agency grants conditional approval for covid-19 vaccine AstraZeneca solution for injection to a third manufacturer, SK Bioscience Co., Ltd., South Korea. The marketing authorisation holder for this vaccine is AstraZeneca Sdn. Bhd. DCA had previously granted conditional authorisation to the first manufacturer, AstraZeneca Nijmegen BV, the Netherlands, while the second producer was Siam Bioscience Co., Ltd., Thailand. In addition, conditional approval for the use of AstraZeneca as booster doses. To produce the vaccine, the virus is spread to HEK 293 cell lines and then purified several times to completely eliminate cell culture. [73] The safety and purity of the bulk vaccine substance are tested, and the efficacy, quality and uniformity of the finished product are tested. Some batches are also tested for stability to check how long they can be stored and that they are not affected by changes in air temperature or pressure or vibrations they may experience while traveling to patients in remote locations. AstraZeneca will now immediately prepare for the submission of data by regulators to authorities around the world that have a framework for conditional or early approval. The company will request an emergency room from the World Health Organization to find an accelerated path to vaccine availability in low-income countries. At the same time, the full analysis of the interim results will be submitted for publication in a peer-reviewed journal.
AstraZeneca continuously identifies and implements new ways of working that will accelerate the production of COVID-19 vaccines and shorten the time it takes to reach communities. The company will also conduct trials to provide additional assurance for pharmaceutical quality and vaccine testing as manufacturing continues to grow. Allergic reactions (hypersensitivity) have been observed in people who received the vaccine. Cases of anaphylaxis (severe allergic reaction) have also occurred. As with all vaccines, Vaxzevria should be administered under strict medical supervision, with appropriate medical treatment available in case of allergic reactions. People who have a severe allergic reaction when receiving the first dose of Vaxzevria should not receive the second dose. On February 24, 2021, by delivering the vaccine to Accra, Ghana, via COVAX, the vaccine became the first country in Africa to receive vaccines under this initiative. [282] July 7, 2021 – The NEJM published a study in three patients with vaccine-induced immunothrombotic thrombocytopenia after receiving the AstraZeneca vaccine, which improved through therapeutic plasma exchange.
Argatroban treatment was closely monitored before, during and after exchange, and minimal variation in aPTT was found with no attributable bleeding. Patients 1 and 2 recovered despite their heavy presentation. Patient 1 received rituximab after the fifth therapeutic plasma exchange. Patient 2`s platelet count did not improve until IVIg (0.5 g per kilogram of body weight) was administered after a therapeutic plasma exchange of 4 to 7. Patient 3 underwent an amputation above the knee, but therapeutic plasma exchange most likely prevented a more extensive resection. No other thrombosis occurred. We propose to consider therapeutic plasma exchange for thrombocytopenia and thrombosis, which do not disappear after 5 days and continue until platelet normalization. Earlier intervention could be considered. The usefulness of additional treatment with IVIg, glucocorticoids and rituximab requires further investigation.
At AstraZeneca, we are committed to supporting the truly global effort to combat the COVID-19 pandemic on multiple fronts. The need for an urgent response to the virus has challenged scientists around the world to accelerate large-scale global clinical research and the development of potential drugs and vaccines for the prevention or treatment of COVID-19. February 19, 2021 – The Lancet published a study that concluded: The results of this primary analysis of two doses of ChAdOx1 nCoV-19 were consistent with those observed in the interim analysis of the studies confirm that the vaccine is effective, with results varying according to the dose interval in the exploratory analyses. A 3-month dose interval could have advantages over a program with a short dose interval for the introduction of a pandemic vaccine to protect as many people in the population as possible as early as possible when supplies are scarce, while improving protection after receiving a second dose. The regulator recommended that the two-shot regimen be used in all adults, including the elderly, and noted that when administering the vaccine to people over 65 years of age, clinical trials should be considered due to limited data from this demographic group. [141] [142] On the same day, the World Health Organization (WHO) issued preliminary guidelines recommending the AstraZeneca vaccine for all adults, with its Strategic Advisory Group of Experts also reviewing its use in the presence of variants and concluding that it was not necessary not to recommend it. [143] This robust pandemic response has led our manufacturing and supply chain experts, engineers, technical scientists, and quality experts to work alongside clinical development to rapidly apply innovative thinking to commercial vaccine production. We have already started manufacturing the vaccine, so if clinical trials prove successful and the vaccine is approved by regulatory authorities, it will be available to support broad and equitable access. 19. January 2021 – Human trials of a coronavirus vaccine combining the Sputnik V vaccine with the vaccine jointly developed by AstraZeneca and oxford University are expected to begin in early February, the president of r-Pharm told Reuters. March 2, 2021 – The BBC has reported that France`s health minister, Olivier Véran, has said that people with pre-existing conditions – such as high blood pressure or diabetes – could get the Oxford-AstraZeneca vaccine from GP offices, hospitals and «within days» pharmacies. Those over 75 would be offered Pfizer or Moderna vaccines.
The vaccine is the result of a collaboration between the Jenner Institute at the University of Oxford and Vaccitech, a private company from the university funded by Oxford Sciences Innovation, Google Ventures and Sequoia Capital, among others. [78] The first batch of the COVID-19 vaccine produced for clinical trials was developed by the Jenner Institute at the University of Oxford and the Oxford Vaccine Group in collaboration with Italian manufacturer Advent Srl in Pomezia. [79] The team is led by Sarah Gilbert, Adrian Hill, Andrew Pollard, Teresa Lambe, Sandy Douglas and Catherine Green. [80] [79] Approval in India is an important step as it will supply India, but also a large number of countries around the world. .