AstraZeneca: Peer-reviewed analysis shows Covid-19 vaccine to be effective

232
Advertisement

AstraZeneca says a peer-reviewed report on its coronavirus vaccine’s  Phase III trial shows it to be safe and effective.

The interim analysis for efficacy was based on 11,636 participants from Phase III UK and Brazil trials conducted by Oxford University.

The company has been criticized for trials that included the use of a dose and a  half that turned out to be more effective than two full doses. The dose and a half was the result of an apparent accident. Regulators later gave the go-ahead to continue the one ahd a half dose sutdy.

The pooling of the two dosing regimens showed that the vaccine is 70.4 percent effective, with the dose and half at 90 percent, comparable to the Pfizer and Moderna vaccines that are on the verge of emergency approval in the U.S.

Further analysis showed that when the vaccine was given as two full doses, vaccine efficacy was 62.1 percent and 90 percent in participants who received a half dose followed by a full dose.

Advertisement

More data will continue to accumulate as part of the upcoming primary analysis and further follow-up.

Questions over AZ-Oxford trials have led to speculation that the vaccine would not be approved by the U.S. Food and Drug Administration.

The AZ-Oxford vaccine, if approved by regulators,  would come with advantages that include the ability to be stored at slightly above freezing temperatures. The vaccines is also less expensive than the Pfizer and Moderna candidates.

The safety data published so far is from more than  20,000 participants enrolled across four clinical trials in the UK, Brazil and South Africa.

The  Lancet medical journal confirmed that the vaccine was well tolerated.

Pascal Soriot,  CEO  said: “Today’s peer-reviewed publication enables a full disclosure of the Oxford program interim analysis. The results show that the vaccine is effective against Covid-19, with in particular no severe infections and no hospitalizations in the vaccine group, as well as safe and well-tolerated. We have begun submitting data to regulatory authorities around the world for early approval and our global supply chains are up and running, ready to quickly begin delivering hundreds of millions of doses on a global scale at no profit.”

Submission of the data to regulatory authorities around the world has already begun, as part of their ongoing rolling reviews of the vaccine data for temporary use or conditional approval during this health crisis. The Company is also seeking Emergency Use Listing from the World Health Organization for an accelerated pathway to vaccine availability in low-income countries.

In addition to the Oxford led program,  AstraZeneca is conducting a large study in the US and globally. In total, Oxford University and AstraZeneca expect to enrol more than 60,000 participants globally.

The company also reported  rapid progress in manufacturing with a capacity of up to 3 billion doses of the vaccine in 2021 pending regulatory approval. 

AstraZeneca employs 1,500 in Delaware.

Advertisement
Advertisement