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AstraZeneca's COVID-19 Vaccine Slightly Less Effective In Updated U.S. Trial Than First Reported

AstraZeneca Plc. (AZN) said U.S. Phase III primary analysis confirmed that its COVID-19 vaccine "AZD1222" was highly effective in adults, including those aged 65 years and over.

The company's primary analysis results come amid US health agency said earlier this week that the British drug major may had included outdated information in trial results of its COVID-19 vaccine.

The company said Wednesday that its vaccine has demonstrated a statistically significant vaccine efficacy of 76% at preventing symptomatic COVID-19 in the U.S. phase III trial. But the company had reported a symptomatic efficacy rate of 79%.

The updated report maintains that the vaccine is 100% effective at preventing severe or critical disease and hospitalization. It also demonstrated a 85% efficacy against symptomatic COVID-19 in participants aged 65 years and older.

The primary efficacy analysis included the accrual of 190 symptomatic cases of COVID-19 from the 32,449 trial participants, an additional 49 cases to the previously announced interim analysis. Participants were randomized on a 2:1 ratio between the vaccine and placebo group.

AstraZeneca noted that it looks forward to filing its regulatory submission for Emergency Use Authorization in the US and preparing for the rollout of millions of doses across America.

Co-invented by the University of Oxford and its spin-out company, Vaccitech and licensed by AstraZeneca, the vaccine also referred to as COVID-19 Vaccine AstraZeneca and Covishield, is approved for emergency use in more than 70 countries across six continents.

The vaccine is not approved in the U.S. yet. The company is preparing for the primary analysis to be submitted to the FDA for Emergency Use Authorization in the coming weeks.

Following reports of blood clots in people receiving COVID-19 Vaccine AstraZeneca, 13 European countries had temporarily paused vaccination. The UK and EU regulatory agencies, which have been investigating the side effects of the vaccine, reaffirmed last week that benefits of COVID-19 Vaccine AstraZeneca continue to far outweigh the risks. Some of the countries have resumed the use of the COVID-19 vaccine, following the assurance from the UK and EU regulators.

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