While not currently approved for emergency use in the United States, AstraZeneca says it plans to file an application with the Food and Drug Administration (FDA) in the coming weeks.
On Monday, AstraZeneca reported that its COVID-19 vaccine has demonstrated a “statistically significant vaccine efficacy of 79% at preventing symptomatic COVID-19 and 100% efficacy at preventing severe disease and hospitalization.”
The long-awaited clinical trial in the United States has shown that a fourth vaccine could be on the horizon, as officials at AstraZeneca aim to apply for an emergency use authorization (EUA) with the FDA in the coming weeks. AstraZeneca also hopes to alleviate concerns over the vaccine’s safety and efficacy, such as rare blood clots found in some European nations, which have caused more than a dozen countries to temporarily halt all AstraZeneca vaccinations.
“There are very many countries in Europe and throughout the world who have already authorized this, so the fact that a United States-run study has confirmed the efficacy and the safety of this vaccine I think is an important contribution to global health in general,”
The U.S. study was conducted on a group of 32,449 participants, of which, only 141 (0.4%) cases of symptomatic COVID-19 were documented. Researchers stated that the vaccine was “well-tolerated” and that it showed no signs of any vaccine-related safety concerns. The study also showed, for the first time in its testing, 80% efficacy in participants aged 65 years and over; a reassuring statistic for countries that have restricted the vaccine to younger age groups.
“There are very many countries in Europe and throughout the world who have already authorized this, so the fact that a United States-run study has confirmed the efficacy and the safety of this vaccine I think is an important contribution to global health in general,” stated Dr.Anthony Fauci, the country’s top infectious disease expert, in regards to the ongoing stage three clinical trials.
Currently, over 70 countries have approved the AstraZeneca vaccine for emergency use. With its clinical trials coming to an end, the U.S. could likely join that list sometime in mid-April, barring an approval by the FDA. If approved, AstraZeneca has stated it would deliver 30 million doses immediately, and an additional 20 million within the first month of use.
While these results are promising, it is unclear whether or not an EUA approval will be granted, or even needed for that matter. The Biden administration has stated previously that it plans to have enough vaccines for the entire country by the end of May—thanks, in part, to increasing supplies of both Pfizer and Moderna, and the FDA approval of the Johnson & Johnson vaccine.
The AstraZeneca vaccine is similar to the J&J vaccine, a type of vaccine known as a “viral-vector.” The shots are made using a harmless cold virus that typically infects chimpanzees, acting as a decoy to trigger the immune system into fighting the virus. It is administered in two doses, four to twelve weeks apart, and can be kept in a refrigerator for up to six months.
For now, AstraZeneca is still preparing its case for an EUA in the U.S., with an approval serving as not only news for Americans, but those in countries awaiting further confirmation on the vaccine’s safety.
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