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The World Health Organization (WHO) on Monday announced it was approving a COVID-19 vaccine developed by pharmaceutical company AstraZeneca and the University of Oxford for emergency use, a big step forward for manufacturers and the millions of people who could now access protection against the novel coronavirus.
According to a WHO statement, it has approved the vaccine made by the South Korean company AstraZeneca-SKBio and the Serum Institute of India.
“We now have all the pieces in place for rapid vaccine distribution. But we still need to increase production,” WHO director-general Tedros Adhanom Ghebreyesus told reporters at a press briefing. “We continue to call on COVID-19 vaccine developers to submit their dossiers to the WHO for review at the same time as they submit them to regulators in high-income countries.”
The AstraZeneca / Oxford vaccine has had a bumpy road. In September, the company had to send a “safety signal” during the phase III trial of its tests, or the phase just before the publication of a vaccine in which its manufacturers “confirm and develop the results of Safety and Effectiveness of Phase 1 and Two Trials, ”according to the US Department of Health and Human Services. The company has suspended testing to deal with a serious neurological event that occurred in one of the patients the vaccine was tested on. Ultimately, it was found that there was no connection between this event and the vaccine candidate, meaning that the trial could be resumed.
By November, AstraZeneca and Oxford had made enough progress in developing their vaccine candidate for the prestigious medical journal The Lancet to approve an article confirming that the vaccine was both safe and produced a strong immune response in elderly patients. The AstraZeneca / Oxford vaccine is both cheaper and easier to distribute than those of many of its competitors, because mRNA vaccines produced by Moderna and Pfizer must be stored at sub-zero temperatures; AstraZeneca / Oxford vaccine can be stored at normal refrigerator temperature. As a result, the company says its goal is to distribute 300 million doses of its vaccine to 145 countries – most of them the poorest – in the first half of 2021. The company’s vaccine requires two doses, this would allow them to inoculate 150 million people.
The WHO also announced in particular that it had convened a panel which considered that the vaccine could also be used in countries with the South African variant of the virus, B.1.351. This is an important development as the South African government earlier this month suspended use of the AstraZeneca / Oxford vaccine after claiming the vaccine failed to protect volunteers in clinical trials against the mutated virus, which is more contagious.
The AstraZeneca / Oxford vaccine is an adenovirus vector vaccine, which means it uses a harmless version of the common cold virus that has been altered to be both weak and also contain a gene for the SARS-CoV spike protein -2. The spike protein is what causes the little buttons that protrude from the spherical center of the coronavirus like the spines of a sea urchin. AstraZeneca / Oxford Adenovirus Vector Vaccine helps the immune system recognize this protein and thereby create antibodies to protect against the development of COVID-19. In contrast, mRNA vaccines directly introduce a modified version of a single-stranded RNA molecule that complements one of the DNA strands of a gene into cells in the body. In this way, the cells will produce proteins like those of the SARS-CoV-2 virus which can be recognized by the immune system as a threat and, likewise, help it to develop an effective response to protect itself.
Earlier this month, the AstraZeneca / Oxford vaccine was approved for all adults in the European Union (EU), but has not received the same authorization in the United States (US).
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