AstraZeneca Finds Covid Vaccine 79% Effective In US Trial; Stock Up In Pre-market
British drug major AstraZeneca Plc announced positive late-stage trial results of its covid-19 vaccine AZD1222 in the United States. The company said the U.S. trial met the primary efficacy endpoint in preventing COVID-19 at interim analysis.
It demonstrated statistically significant vaccine efficacy of 79 percent at preventing symptomatic COVID-19 and 100 percent efficacy at preventing severe disease and hospitalization. AstraZeneca shares were gaining around 2 percent in London trading as well as in pre-markect activity on Nasdaq.
The interim safety and efficacy analysis was based on 32,449 participants accruing 141 symptomatic cases of COVID-19. The trial had a 2:1 randomization of vaccine to placebo.
In participants aged 65 years and over, vaccine efficacy was 80 percent.
AstraZeneca is preparing for the primary analysis to be submitted to the US Food and Drug Administration for Emergency Use Authorization in the coming weeks. The company said it is getting ready to roll out millions of doses across America once it gets US Emergency Use Authorization.
Today’s development follows several European countries’ decision last week to resume the AstraZeneca vaccinations after the European Medicines Agency concluded that the anti-COVID vaccine is safe and effective. At least 13 European countries had either temporarily halted AstraZeneca vaccine AZD1222 inoculations or delayed its roll out as a precaution following reports of patients developing thrombosis or blood clots after receiving AstraZeneca vaccine jabs.
Amid the European events following thrombosis concerns, the independent data safety monitoring board or DSMB had conducted a specific review of thrombotic events, as well as cerebral venous sinus thrombosis or CVST with the assistance of an independent neurologist. The DSMB found no increased risk of thrombosis or events characterized by thrombosis among the 21,583 participants receiving at least one dose of the vaccine. The specific search for CVST found no events in this trial.
In a statement, AstraZeneca said the US Phase III trial of AZD1222, called D8110C00001, included two doses administered at a four week interval. AZD1222 was co-invented by the University of Oxford and its spin-out company, Vaccitech.
In the trial, the vaccine was well tolerated, and the DSMB identified no safety concerns related to the vaccine.
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said, “These results add to the growing body of evidence that shows this vaccine is well tolerated and highly effective against all severities of COVID-19 and across all age groups. We are confident this vaccine can play an important role in protecting millions of people worldwide against this lethal virus.”
The vaccine has been granted a conditional marketing authorization or emergency use in more than 70 countries across six continents. It is also included in the Emergency Use Listing of the World Health Organization that gives access in up to 142 countries through the COVAX Facility.
In pre-market activity on Nasdaq, AstraZeneca shares were trading at $50.03, up 1.7 percent. In London, the shares were trading at 7,248 pence, up 1.9 percent.
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