The World Health Organization (WHO) announced on Monday that it is approving for emergency use a COVID-19 vaccine developed by the pharmaceutical company AstraZeneca and the University of Oxford, a big step for manufacturers and for the millions of people who can now be able to access the protection of the new coronavirus.
According to a WHO note, the vaccine manufactured by the company at AstraZeneca-SKBio in South Korea and at the Serum Institute in India was approved.
“We now have all the parts ready for the rapid distribution of vaccines. But we still need to increase production,” WHO Director-General Tedros Adhanom Ghebreyesus told reporters during a news conference. “We continue to request that developers of the COVID-19 vaccine send their dossiers to WHO for review while submitting them to regulators in high-income countries.”
The AstraZeneca / Oxford vaccine had a rough road. In September, the company had to address a “safety signal” during the Phase Three trial of its tests, or the phase just before a vaccine was released to the public, during which its manufacturers “confirm and expand the safety results. and effectiveness of Phase One and Two trials, “according to the United States Department of Health and Human Services. The company suspended testing to address a serious neurological event that occurred in one of the patients in which the vaccine was tested. Ultimately, it was discovered that there was no connection between that event and the candidate vaccine, which means that the trial could be resumed.
In November, AstraZeneca and Oxford had made enough progress in developing their vaccine candidate that the prestigious medical journal The Lancet approved an article confirming that the vaccine was safe and had produced a strong immune response in elderly patients. The AstraZeneca / Oxford vaccine is cheaper and easier to distribute than many of its competitors, as the mRNA vaccines produced by Moderna and Pfizer need to be stored at below freezing temperatures; the AstraZeneca / Oxford vaccine can be stored at normal refrigerator temperatures. As a result, the company says its goal is to distribute 300 million doses of its vaccine to 145 countries – most of them poorest – in the first half of 2021. Since the company’s vaccine requires two doses, this would allow it to inoculate 150 million people .
WHO also announced that it had convened a panel that 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 because the South African government earlier this month suspended the use of the AstraZeneca / Oxford vaccine because it claimed that the vaccine failed to protect volunteers from clinical trials of the mutant virus, which is more contagious.
The AstraZeneca / Oxford vaccine is an adenovirus vector vaccine, which means that it uses a harmless version of the common cold virus that has been modified to be weak and also contains a SARS-CoV-2 spike protein gene. The spike protein is what causes the small protuberances that protrude from the spherical center of the coronavirus, like the spines of a sea urchin. The AstraZeneca / Oxford adenovirus vector vaccine helps the immune system recognize this protein and thereby build antibodies to protect itself from the development of COVID-19. On the other hand, 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. Thus, 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 to build an effective response to protect themselves.
Earlier this month, the AstraZeneca / Oxford vaccine was approved for all adults in the European Union (EU), but did not receive the same release in the United States (USA).