AstraZeneca announced on Monday that early data from the vaccine trials of the Oxford COVID-19 vaccine has shown 70% efficacy. In a release, AstraZeneca said that there were two different dosing regimens, of which one shows a better profile. The company will now prepare a regulatory submission for the data for conditional or early approval to authorities around the world. It also said it would be seeking an emergency use listing from the World Health Organization “for an accelerated pathway to vaccine availability in low-income countries”
It said that parallelly, a full analysis of the interim results is being submitted for publication in a peer-reviewed journal. The release said that in participants who were treated with the vaccine, called AZD1222, there have been no hospitalisations or severe cases of COVID-19.
A dosing regimen is how a drug is to be taken, how it is administered, what interval it is administered in and how long the duration of the said treatment is. AstraZeneca said that for one dosing regime where AZD1222 was given as a half dose, followed by a full dose at least a month apart, the efficacy was at 90%. Another dosing regimen where two full doses were given at least a month apart saw that efficacy at 62%. The combined analysis from both regimens resulted in an average efficacy of 70%.
“More data will continue to accumulate and additional analysis will be conducted, refining the efficacy reading and establishing the duration of protection,” the release stated.
AstraZeneca said that an independent Data Safety Monitoring Board determined that this primary analysis that has been conducted met its endpoint, “showing protection from COVID-19 occurring 14 days or more after receiving two doses of the vaccine. No serious safety events related to the vaccine have been confirmed. AZD1222 was well tolerated across both dosing regimens.”
Professor Andrew Pollard, Chief Investigator of the vaccine trial at Oxford, said: “These findings show that we have an effective vaccine that will save many lives. Excitingly, we’ve found that one of our dosing regimens may be around 90% effective and if this dosing regime is used, more people could be vaccinated with planned vaccine supply.”
AstraZeneca Chief Executive Officer Pascal Soriot said, “This vaccine’s efficacy and safety confirm that it will be highly effective against COVID-19 and will have an immediate impact on this public health emergency. Furthermore, the vaccine’s simple supply chain and our no-profit pledge and commitment to broad, equitable and timely access means it will be affordable and globally available, supplying hundreds of millions of doses on approval.”
AstraZeneca said it is building capacity of producing up to 3 billion doses of the vaccine in 2021 on a rolling basis pending regulatory approval.
While the cold storage conditions of some vaccines have made them unviable for a country such as India, AstraZeneca said that this vaccine can be stored, transported and handled at normal refrigerated conditions (2-8 degrees Celsius/36-46 degrees Fahrenheit) for at least six months. It said it can be administered within existing healthcare settings.