AstraZeneca’s COVID-19 Vaccine Meets Primary Endpoints

AstraZeneca recently announced positive results from an interim analysis of clinical trials testing its COVID-19 vaccine, AZD1222, in the UK and Brazil. 

Specifically, AZD1222 met the primary endpoint of preventing COVID-19, and no hospitalizations or severe cases of the disease were reported in participants receiving the vaccine. 

One dosing regimen showed efficacy of 90 percent when AZD1222 was given as a half dose, followed by a full dose at least one month apart, while the second dosing regimen showed 62 percent efficacy when given as two full doses at least one month apart, AstraZeneca said.

The combined analysis found that AZD1222 was well-tolerated across both dosing regimens, generating an average efficacy of 70 percent.

And while no serious events related to the vaccine have been found, researchers will conduct additional analyses as more data accumulates

“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,” Andrew Pollard, chief investigator of the Oxford Vaccine Trial at Oxford, said in the announcement. 

“Today’s announcement is only possible thanks to the many volunteers in our trial, and the hard working and talented team of researchers based around the world,” he continued.  

The pooled analysis included data from the COV002 Phase 2/3 trial in the UK and Phase 3 trial in Brazil of patients 18 years or older who were either healthy or had stable underlying conditions. 

In total, researchers will assess overall 23,000 participants following two doses of either a half-dose and full-dose regimen or a regimen of two doses of AZD1222, or a comparator, the company said. 

The full analysis of the interim results will be submitted for publication in a peer-reviewed journal once available.  

“Today marks an important milestone in our fight against the pandemic. 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,” said Pascal Soriot, chief executive officer of AstraZeneca. 

“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,” Soriot concluded. 

AstraZeneca stated that it will now prepare regulatory submission of the data to authorities globally that have a framework in place for conditional or early approval. 

At the beginning of September, AstraZeneca announced that AZD1222 expanded into a Phase 3 clinical trial in the US to assess its safety, efficacy, and immunogenicity. 

The trial enrolled nearly 30,000 adults aged 18 years or older from different racial, ethnic, and geographic groups who are healthy or at increased risk of contracting COVID-19, such as individuals with HIV.

Participants were randomized into two groups and received either AZD1222 or saline control, four weeks apart. Twice as many participants received the vaccine than the saline control.

Local and systemic reactions and immune responses will be assessed in 3,000 patients, researchers said.

AstraZeneca stated that it will provide at least 400 million doses of the vaccine and has already secured total manufacturing capacity for one billion doses. 

Additional clinical trials of AZD122 are also being conducted in Japan, Russia, South Africa, Kenya and Latin America, with trials planned to start in other European and Asian countries in the near future. 

In total, AstraZeneca anticipants to enroll a total of 60,000 participants globally and manufacture with capacity nearly 3 billion doses of the vaccine in 2021, pending FDA approval. 

Results from the trials are expected later this year.