AstraZeneca Plc and Oxford University’s coronavirus vaccine candidate AZD1222 is found to be 70 percent effective on average against Covid-19, according to the British pharmaceutical giant.
AstraZeneca plans to immediately prepare regulatory submission of the data to worldwide authorities for conditional or early approval. The company will also ask for an Emergency Use Listing from the World Health Organization to make vaccine available in low-income countries.
The company revealed positive high-level results from an interim analysis of clinical trials of AZD1222 in the UK and Brazil. And the vaccine is found to be highly effective in preventing COVID-19, the primary efficacy endpoint.
As per an independent Data Safety Monitoring Board, the analysis met its primary endpoint showing protection from COVID-19 occurring 14 days or more after receiving two doses of the vaccine.
No hospitalizations or severe cases of the disease were reported in participants receiving the vaccine. There were a total of 131 COVID-19 cases in the interim analysis.
In the trials, two different dosing regimens demonstrated efficacy with one showing a better profile. AZD1222 was well tolerated across both dosing regimens.
One dosing regimen showed vaccine efficacy of 90% when AZD1222 was given as a half dose, followed by a full dose at least one month apart. Another dosing regimen showed 62% efficacy when given as two full doses at least one month apart.
The combined analysis from both dosing regimens showed an average efficacy of 70%.
Pascal Soriot, Chief Executive Officer, said, “..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.”
The pooled analysis included data from the COV002 Phase II/III trial in the UK and COV003 Phase III trial in Brazil.
The company is also conducting clinical trials in the US, Japan, Russia, South Africa, Kenya and Latin America with planned trials in other European and Asian countries. In total, up to 60,000 participants are expected to enroll in the trials globally.
AstraZeneca is planning to manufacture up to 3 billion doses of the vaccine in 2021 on a rolling basis, pending regulatory approval.
The positive news comes as competitor Pfizer Inc. and German biotech firm BioNTech SE filed for FDA’s Emergency Use Authorization last week of their mRNA-based coronavirus vaccine candidate, BNT162b2, which showed the vaccine to be 95 percent effective in preventing COVID-19.
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