India may grant emergency use authorisation for Oxford-AstraZeneca Covid-19 vaccine: report

Reports citing Dr Vinod Paul, Niti Aayog member and chairman of the National Expert Group on Vaccine Administration, has said that India may grant Serum Institute of India (SII) with the emergency use authorisation of Oxford-AstraZeneca’s Covid-19 vaccine.

An approval of the vaccine by UK regulators will gve Drugs Controller General of India (DCGI) an opportunity, Dr Paul said. 

"We expect emergency authorisation for Oxford-Astrazeneca vaccine to be sought in the UK. If so, it will give an opportunity for India regulator also," reports citing  Dr Paul was quoted as saying. He also said the Serum Institute vaccine, undergoing final-stage Phase III clinical trials in 16-17 cities in India, is "the closest in terms of market authorisation" among 5 vaccines that are undergoing various stages of clinical trials in India.

AstraZeneca said two different dosing regimens of its vaccine trial demonstrated efficacy with one showing a better profile. However, there was no case of hospitalisations or severe cases of Covid-19 in participants treated with the vaccine candidate `AZD1222’.

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 per cent 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 per cent efficacy when given as two full doses at least one month apart. The company said it will continue to analyse results as data continue to accumulate and refine the efficacy reading accordingly.

AstraZeneca is going ahead with preparation of 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.

Professor Andrew Pollard, Chief Investigator of the Oxford 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. 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.”

Pascal Soriot, chief executive officer, said: “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.”

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.

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.

AstraZeneca said it is making rapid progress in manufacturing with a capacity of up to 3 billion doses of the vaccine in 2021 on a rolling basis, pending regulatory approval. The vaccine can be stored, transported and handled at normal refrigerated conditions (2-8 degrees Celsius/ 36-46 degrees Fahrenheit) for at least six months and administered within existing healthcare settings.

AZD1222 was co-invented by the University of Oxford and its spin-out company, Vaccitech. It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein. After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body.