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AstraZeneca develops new vaccine reducing COVID-19 risk symptoms by 83%
AstraZeneca developed new vaccine (AZD7442) that proved to be effective in reducing COVID-19 risk symptoms by 83 percent.
New data from the AZD7442 COVID-19 PROVENT prevention and TACKLE outpatient treatment Phase III trials both showed robust efficacy from a one-time intramuscular (IM) dose of the long-acting antibody (LAAB) combination.
In an analysis of the ongoing PROVENT trial evaluating a median six months of participant follow-up, one 300mg IM dose of AZD7442 reduced the risk of developing symptomatic COVID-19 compared to placebo by 83%.
About 2% of the global population is considered at increased risk of an inadequate response to a COVID-19 vaccine.1 This includes people with blood cancers or other cancers being treated with chemotherapy, patients on dialysis, those taking medications after an organ transplant or who are taking immuno-suppressive drugs for conditions including multiple sclerosis and rheumatoid arthritis.2-6
The AZD7442 PROVENT trial is the first Phase III trial prospectively designed to evaluate a monoclonal antibody for pre-exposure prophylaxis of symptomatic COVID-19, with targeted inclusion of high-risk and immune compromised participants. More than 75% of PROVENT participants at baseline had co-morbidities that put them at high risk for severe COVID-19 if they were to become infected, including people who are immune compromised and may have a reduced immune response to vaccination.
There were no cases of severe COVID-19 or COVID-19-related deaths in those treated with AZD7442 at either the primary or six-month analyses. In the placebo arm, there were two additional cases of severe COVID-19 at the six-month assessment, for a total of five cases of severe COVID-19 and two COVID-related deaths.
An exploratory analysis of the TACKLE outpatient treatment trial, in patients with mild-to-moderate COVID-19, showed that one 600mg IM dose of AZD7442 reduced the risk of developing severe COVID-19 or death (from any cause) by 88% compared to placebo in patients who had been symptomatic for three days or less at the time of treatment.
A total of 90% of participants enrolled in TACKLE were from populations at high risk of progression to severe COVID-19 if they became infected, including those with co-morbidities.
In both PROVENT and TACKLE, AZD7442was generally well tolerated. No new safety issues were identified in the six-month analysis of PROVENT.
Hugh Montgomery, Professor of Intensive Care Medicine at University College London, UK and AZD7442 principal investigator, said: “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. 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.”
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said “AZD7442 is the only long-acting antibody with Phase III data to demonstrate benefit in both pre-exposure prophylaxis and treatment of COVID-19 with one dose. These new data add to the growing body of evidence supporting AZD7442’s potential to make a significant difference in the prevention and treatment of COVID-19. We are progressing regulatory filings around the world and look forward to providing an important new option against SARS-CoV-2 as quickly as possible.”
Full results from PROVENT and TACKLE will be submitted for publication in a peer-reviewed medical journal and presented at a forthcoming medical meeting.
On 5 October 2021, the Company announced that it had submitted a request to the US Food and Drug Administration for Emergency Use Authorization for AZD7442 for prophylaxis of COVID-19.
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.
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