In a big achievement, British pharmaceutical giant AstraZeneca has said that an interim analysis of its vaccine, which is being developed in association with the Oxford's University, has shown 70 per cent efficacy against the COVID-19 virus. Also, it has been found that one of the vaccine's dosing regimens may be around 90% effective and if this dosing regime is used, more people could be vaccinated with planned vaccine supply, AstraZeneca said. "Two different dosing regimens demonstrated efficacy with one showing a better profile," the AstraZeneca added.
"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. 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," said Pascal Soriot, Chief Executive Officer.
Professor Andrew Pollard, Chief Investigator of the Oxford Vaccine Trial at Oxford, said these findings show that the vaccine is effective and 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."
This is a positive news for Indians as the country's biggest vaccine maker Serum Institute of India (SII) has partnered with AstraZeneca and the Oxford's University to produce the vaccine on the mass level. India may get its first lot of the Oxford University's coronavirus vaccine by January-end and early February as the government is planning to give Pune-based SII emergency approval for the vaccine.
AstraZeneca's clinical trials are also being conducted in the US, Japan, Russia, South Africa, Kenya and Latin America with planned trials in other European and Asian countries. In total, the company expects to enrol up to 60,000 participants globally.
Here are findings of the high-level results of AstraZeneca's interim analysis of COVID-19 trials
- Positive high-level results from an interim analysis of clinical trials of AZD1222 in the UK and Brazil showed the vaccine was highly effective in preventing COVID-19, the primary endpoint, and no hospitalisations 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.
- One dosing regimen (n=2,741) showed vaccine efficacy of 90% when AZD1222 was given as a half dose, followed by a full dose at least one month apart, and another dosing regimen (n=8,895) showed 62% efficacy when given as two full doses at least one month apart. The combined analysis from both dosing regimens (n=11,636) resulted in an average efficacy of 70%. All results were statistically significant (p<=0.0001). More data will continue to accumulate and additional analysis will be conducted, refining the efficacy reading and establishing the duration of protection.
- An independent Data Safety Monitoring Board determined that the analysis met its primary 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.
- AstraZeneca will now immediately prepare regulatory submission of the data to authorities around the world that have a framework in place for conditional or early approval. The Company will seek an Emergency Use Listing from the World Health Organization for an accelerated pathway to vaccine availability in low-income countries. In parallel, the full analysis of the interim results is being submitted for publication in a peer-reviewed journal.
- The pooled analysis included data from the COV002 Phase II/III trial in the UK and COV003 Phase III trial in Brazil. Over 23,000 participants are being assessed following two doses of either a half-dose/full-dose regimen or a regimen of two full doses of AZD1222 or a comparator, meningococcal conjugate vaccine called MenACWY or saline. The global trials are evaluating participants aged 18 years or over from diverse racial and geographic groups who are healthy or have stable underlying medical conditions.