AstraZeneca’s COVID-19 Vaccine Shows 79% Efficacy in US Trial, Eyes FDA Approval

As the US continues to religiously vaccinate its population with the three approved vaccines amidst growing viral variants, a fourth one seems to be on its way.

In a major boost to the company’s turbulent ride over their vaccine, AstraZeneca has announced that their Phase 3 trial (D8110C00001) conducted in the US, Peru, and Chile showed an overall 79% efficacy against symptomatic COVID-19 while providing 100% protection against severe diseases, hospitalizations, and deaths. The announcement led their stocks to rise by 1.4%.

Ann Falsey, Professor of Medicine, University of Rochester School of Medicine, US, and co-lead Principal Investigator for the trial, said, “These findings reconfirm previous results observed in AZD1222 trials across all adult populations, but it’s exciting to see similar efficacy results in people over 65 for the first time. This analysis validates the AstraZeneca COVID-19 vaccine as a much-needed additional vaccination option, offering confidence that adults of all ages can benefit from protection against the virus.”

Hiccups after Early Promise

Right at the beginning of the pandemic, the AstraZeneca vaccine was hailed as the gamechanger. However, since then, the vaccine has been shrouded in confusion over its efficacy, best dosing regimen, and possible side-effects.

Additionally, AstraZeneca is in the middle of a supply showdown with the European Union as the company battles concerns over blood clots in patients, which quickly forced a number of the EU countries to stop vaccinating their people. Although the European Medicines Agency declared the vaccine safe, not all of the countries have resumed vaccinations.

To further pile on to AstraZeneca’s misery, Europe has threatened to ban exports of the vaccine until the company can stick to its supply obligations.

Phase 3 Trial

AstraZeneca’s Phase 3 trial is a randomized, double-blind, placebo-controlled multicenter study that aimed to gauge the safety and efficacy of AZD1222 against COVID-19. A total of 32,449 participants across 88 trial centers were enrolled in the study consisting of people from the US, Peru, and Chile.

The study investigators randomized twice as many participants to receive vaccines as compared to placebo and used a four-week timeline for the two doses, although prior trials have shown better efficacy at the twelve-week mark.

The results from the trial further promote the vaccine’s efficacy which will play a significant role in fighting the pandemic. In the coming weeks, the company plans to file emergency use authorization with the US Food and Drug Administration (FDA) and expects to deliver at least 30 million doses after authorization.

The Road Ahead

If approved in the US, AstraZeneca’s vaccine will be entering a market already dominated by Pfizer, Moderna, and the recently approved Johnson and Johnson vaccine. What works in AstraZeneca’s favor is that it has already been approved in over 70 countries globally and that it intends to ramp up production of its vaccine to approximately three billion doses this year.

Additionally, the vaccine is easy to store and transport, unlike the frigid temperatures required by both Pfizer and Moderna, and the company is delivering it at cost during the pandemic. Market analysts claim that this vaccine will have the potential to be the ‘global’ vaccine based on cost, production, and effectiveness.

While a handful of vaccine makers have made their way onto the arms of people, others are going out and beyond to catch up and join the race. Daiichi Sankyo has started a phase 1/2 trial of its mRNA coronavirus vaccine candidate in Japan and has also agreed to manufacture 120 million of the AstraZeneca vaccines for distribution within the country.

Germany’s CureVac intends to expand the Phase 2b/3 trial to measure the efficacy of its vaccine in response to the highly contagious viral strains. Russia’s Sputnik V is looking for manufacturing help from India and has roped in manufacturers Stelis, Gland, and Hetero to provide approximately 750 million doses this year.

With several vaccines on the horizon, things are looking up, and there seems to be a flicker of light at the end of this COVID-19 tunnel.

Related Article: Quad Members Join Forces to Produce 1 Billion Vaccines for Indo-Pacific Countries

Author

Tulip Chakraborty