AstraZeneca is developing a COVID-19 prevention shot for those who cannot take the vaccines, and it shows 'robust efficacy and long-term prevention' according to a statement released by the company on Thursday, 18 November.
The preventive treatment is an antibody cocktail therapy and is being called AZD7442 or Evusheld.
According to the statement, interim data from phase 3 clinical trails show that just one dose (300 mg) of the AZD7442 reduces the risk of developing symptomatic COVID-19 by 83 percent, for at least 6 months.
According to AstraZeneca, The AZD7442 PROVENT trial is the first time the monoclonal antibody therapy has been tested in phase 3 clinical trials for use as a prophylactic for symptomatic COVID, rather than a treatment.
FIT breaks down what we know about the shot.
Key Points About the Trials
The AZD7442 PROVENT trial is a randomised, double-blind, placebo-controlled, multi-centre trial meant to access the safety and efficacy of the
The trial was conducted in 87 sites in the US, UK, Spain, France and Belgium.
The trial involved around 5,197 unvaccinated participants over the age of 18.
3,460 of these participants were given the AZD7442 shot, while 1,737 participants received a saline placebo.
More than 75 percent of the participants at baseline had co-morbidities and were at high risk of suffering severe illness.
One 300 gm shot of AZD7442 in uninfected, unvaccinated people wear found to elicit an 83 percent efficacy in protecting against symptomatic COVID-19 for at least 6 months.
No cases of severe COVID-19 or COVID-19-related deaths were reported in the vaccine arm of the study, either in the primary analysis or six-month mark.
On the other hand, . A total of five cases of severe COVID-19 and two COVID-related deaths were found in the placebo arm, according to the company.
“These compelling results give me confidence that this long-acting antibody combination can provide my vulnerable patients with the long-lasting protection they urgently need to finally return to their everyday lives," said Hugh Montgomery, Professor of Intensive Care Medicine at University College London, UK and principal investigator of the trial, in the statement.
"Importantly, six months of protection was maintained despite the surge of the Delta variant among these high-risk participants who may not respond adequately to vaccination.”Hugh Montgomery, Professor of Intensive Care Medicine at University College London, UK
Who is it meant for?
People who can't take the COVID vaccines, or for whom the vaccines are inadequate, which, according to the company's statement make up around 2 percent of the world's population.
People with blood cancers or other cancers being treated with chemotherapy
Patients on dialysis
People taking medications after an organ transplant
Those taking immunosuppressive drugs for conditions including multiple sclerosis and rheumatoid arthritis.
Does it Work For Those Who Are Already Infected?
The company also carried out a separate clinical trial called TACKLE to test the efficacy of the same shot, AZD7442, in preventing severe illness in those who have already been infected with COVID.
In the TACKLE phase 3 trials, the shot was found to reduce the risk of severe COVID and death by 88 percent in patients with mild to moderate COVID-19 after one dose of 600mg.
In this trial, 90 percent of the participants from populations were reportedly at high risk of progression to severe COVID-19.
When Will It Be Available?
AstraZeneca announced that it will be releasing the trial results for publication in a peer-reviewed medical journal soon.
Last month, the company applied for approval of the shots from US and European health authorities.
AstraZeneca has agreed to supply the US Government with 700,000 doses of AZD7442 if granted an Emergency Use Authorization by the FDA, and has agreements to supply to other countries.