The Serum Institute of India, Pune is all set to seek emergency regulatory approval by the Government of India authorities and go-ahead by year-end for Oxford COVID-19 vaccine AstraZeneca. The findings of the vaccine trials have shown 70% effectiveness in preventing people from getting infected from COVID-19.
The positive data of the AstraZeneca trial has raised hope for the faster rollout of the vaccine in India, as the data exceeds the 50% of primary efficacy endpoint which has been set by DGCI, Indian drug regulator, as part of its draft guidelines for Coronavirus vaccines.
According to SII CEO, Adar Poonawala, the company will be applying for the emergency licensure very soon and expects to get it in a month or so but the final approval depends on the decision of DGCI. He also informed that the company has stockpiled around 4 crore doses and will reach around 10 crore doses by January 2021.
Successful clinical trials of AstraZeneca:
The clinical trials of AZD1222, globally, which has evaluated participants over 18 years, has shown one dosing regimen with a vaccine efficacy of 90% when half a dose which was then followed by a full dose at a gap of one month was given.
The other dosing regimen has shown 62% efficacy when the two full doses vaccine was given, with a gap of at least 1 month. The combined analysis from both the dosing regimens of the vaccine has resulted in an average efficacy of 70%.
According to the CEO of AstraZeneca, Pascal Soriot, the efficacy, and safety of AstraZeneca confirms that it will be highly effective against COVID-19 and will also have an immediate effect on public health emergency.
What is next for AstraZeneca?
Even though the efficacy of the AstraZeneca vaccine is much lower than around 95% which was achieved by both Moderna and Pfizer, the vaccine holds more promise for India due to its simpler supply chain, price, and scalable platform.
AstraZeneca will now immediately be preparing for the regulatory submission of data to the authorities globally that have a framework in place for early approval. The company will also be seeking an emergency use listing from WHO for a pathway to vaccine availability in low-income countries.
Status of other vaccines in India:
CEO of Serum Institute of India, Adar Poonawala, stated that at this point, COVISHIELD, a logistically manageable, low-cost vaccine that will offer protection up to 90% in one type of dosage regime and 62% in other dosage regimes, will soon be widely available in the country.
COVISHIELD will be available in the market at the price of Rs. 500-600 per dose and at Rs. 220-300 for the Indian government and two doses of vaccine will be required.
The competing vaccines from Moderna and Pfizer are expected to be priced higher as Pfizer can cost up to Rs. 1,500 or $20 and Moderna can cost up to $37 or Rs. 2,775 per dose.
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