Oxford-AstraZeneca-Vaccine-Clinical-Trials-Protocol-Document-(19th-February-2021)
(https://t.me/covidvaccinevictims)
If you would like to read Oxford-AstraZeneca's own document of the Covid vaccine clinical trials protocol design you can do so here:
https://www.pfizer.com/science/drug-product-pipeline
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Vaccine name: AZD1222 (also known as Covishield in India)
Efficacy: 79% in a U.S. study.
Dose: 2 doses
Type: Muscle injection
Storage: Stable in refrigerator for at least 6 months
On March 22, the University of Oxford and the British-Swedish company AstraZeneca became the fourth team to deliver results from a large-scale Phase 3 trial that could lead the F.D.A. to issue emergency use authorization for a coronavirus vaccine. In the 32,000-person trial — which included volunteers in the United States, Chile, and Peru — the vaccine showed a 79 percent efficacy against Covid-19 with any symptoms. The researchers also announced that it had a 100 percent efficacy against severe Covid-19. But that night, the National Institute of Allergy and Infectious Diseases said that experts overseeing the trial had “expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data.”
The full results of the trial are expected to come in the next few weeks in advance of the F.D.A.’s decision on the vaccine.
This confusing turn of events came after a turbulent year in which the vaccine was dogged by murky data, supply shortfalls, and temporary halts to investigate safety concerns.
Researchers at the University of Oxford developed the vaccine in early 2020 by genetically engineering an adenovirus that normally infects chimpanzees. When they gave the vaccine to monkeys, they found that it protected the animals from the disease.
Teaming up with AstraZeneca, they followed up with a Phase 1/2 trial. The vaccine developers did not detect any severe side effects in the trial, while observing that the vaccine raised antibodies against the coronavirus as well as other immune defenses. AstraZeneca and Oxford then embarked on late-stage trials in the United Kingdom, South Africa, and elsewhere. But the researchers ran the trials independently, making it difficult to combine their results into a single clear picture of how well the vaccine worked. Making matters murkier, they gave different amounts of the vaccine to different people and also waited anywhere from four to twelve weeks to deliver the second dose.
On Dec. 8, AstraZeneca and Oxford published the first scientific paper on a Phase 3 clinical trial of a coronavirus vaccine. The trial demonstrated that the vaccine can protect people from Covid-19, but it left many questions unresolved about the results. Nevertheless, the vaccine’s low cost and ease of storage made it an attractive solution to the pandemic. The United Kingdom and Argentina were the first countries to give the vaccine emergency authorization, on Dec. 30, and since then a number of other countries have also done the same. On Jan. 3, India, approved a version called Covishield, made by the Serum Institute of India. On Feb. 16 the World Health Organization recommended the vaccine for emergency use in adults 18 or older. Brazil gave full approval to the vaccine on March 13. In the same month, Covax began delivering millions of doses of the vaccine to low- and middle-income countries. The company expects a total annual manufacturing capacity of two billion doses.
Yet even after millions of people began receiving the vaccine, new concerns arose. In South Africa, a small trial failed to demonstrate that it protected people against the variant B.1.351, which has become predominant in the country. On Feb. 7, South Africa halted plans for a rollout of 1 million doses of the AstraZeneca vaccine. The following month, a number of countries in Europe and elsewhere halted their use of the vaccine after a small number of people who received it developed blood clots. The European Medicines Agency reviewed the cases and determined the vaccine was safe.
Meanwhile, AstraZeneca and Oxford are continuing research on the vaccine. On Feb. 14, they announced they would start trials on children as young as six.
Approved for use in: Brazil.
Emergency use in: Algeria, Argentina, Australia, Bahamas, Bangladesh, Bahrain, Bhutan, Botswana, Brazil, Canada, Chile, Colombia, Dominican Republic, Egypt, El Salvador, European Union, Ghana. Hungary, Iceland, India, Indonesia, Iran, Iraq, Kuwait, Liechtenstein, Malaysia, Maldives, Mexico, Moldova, Mongolia, Morocco, Nepal, Nigeria, Norway, Pakistan, Papua New Guinea, Philippines, Saudi Arabia, Seychelles, Sri Lanka, South Africa, South Korea, Taiwan, Thailand, Ukraine, United Kingdom, Vietnam. Emergency use validation from the World Health Organization. Endorsed by Africa Regulatory Taskforce. Caribbean Regulatory System.
(Updated March 20th 2021 - https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html)
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