AstraZeneca’s PROVENT and TACKLE stage 3 trials show its vaccine AZD7442 significantly reduced the risk of severe or fatal COVID-19, even among high-risk populations.
One dose of AstraZeneca‘s vaccine, AZD7442, reduced the risk of symptomatic COVID-19 by 83-88%, according to results from the PROVENT and TACKLE trials.
New data from the recent stage 3 PROVENT and TACKLE trials show high efficacy of AZD7442. AZD7442 is a long-acting antibody (LAAB) combination administered intramuscularly.
Hugh Montgomery, Professor of Intensive Care Medicine at University College London, UK and principal investigator for AZD7442, 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.”
Both PROVENT and TACKLE are randomized, double-blind, placebo-controlled, multi-center, trials. The trials prioritized enrolling study participants from high-risk populations to ensure high efficacy among those most vulnerable to severe COVID-19. In PROVENT and TACKLE, AZD7442 was well-tolerated.
The PROVENT trial is the first stage 3 intended to evaluate a monoclonal antibody for pre-exposure prophylaxis of symptomatic COVID-19. PROVENT participants were given 1 300 mg dose of AZD7442. Patient follow-up 6 months after administration showed an 83% reduced risk of developing symptomatic COVID-19. No new safety issues were reported at the 6-month checkpoint.
Over 75% of PROVENT participants had comorbidities putting them at high risk of severe COVID-19 if contracted, including the immunocompromised and other persons likely to have a reduced immune response to vaccination. There were no cases of severe or fatal COVID-19 among the among those treated with AZD7442 at the primary or 6-month analyses. Among the PROVENT placebo group, there were 2 additional cases of severe COVID-19 at the 6-month follow-up, for a total of 5 cases of severe COVID-19 and 2 deaths.
In the TACKLE trial, 90% of participants were from populations at high risk for severe or fatal COVID-19. Participants were given 1 600 mg intramuscular dose of AZD7442 or placebo. Among participants with mild or moderate COVID-19, AZD7442 reduced the risk of severe COVID-19 or death by 88%.
According to Mene Pangalos, Executive Vice President of BioPharmaceuticals Research and Development at AstraZeneca, “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.”