MUMBAI: Armed with interim findings from the AstraZeneca-Oxford Covid-19 vaccine trials, which showed 70% effectiveness in preventing people from becoming infected, the Pune-based Serum Institute of India (SII) is ready to look for emergency regulatory approval and hopes to get the go-ahead by the end of the year.
The ‘positive’ data raises hopes for a more rapid deployment of the vaccine in India, as the AstraZeneca The data exceed the primary efficacy endpoint of 50% set by the Indian drug regulator DCGI as part of its draft guidelines for Covid-19 vaccines.
“We will apply for the emergency license very soon and hope to obtain it in a month or so. Final approval depends on DCGI’s decision, ”SII Executive Director Adar Poonawalla told TOI. He added that the company has stocked around 4 crore doses so far and will have around 10 crore doses in January. Most of these will be marked as a priority for India.
Covishield will be available on the market at Rs 500-600 per dose, and Rs 220-300 ($ 3-4) to the government, he added. Two doses of the vaccine will be required. Competitive vaccines from Pfizer and Moderna are expected to be priced higher. The Moderna vaccine can cost up to $ 37 or Rs 2,775 per dose, while Pfizer could cost its offer around $ 20 or Rs 1,500.
“At this point, I am delighted that Covishield, a low-cost, logistically manageable and soon to be widely available Covid-19 vaccine, will offer protection by up to 90% in one type of dosage regimen and by 62% in the other. regime, ”he said.
Worldwide, clinical trials on ‘AZD1222‘, which evaluated participants older than 18 years, showed a dosing regimen with 90% vaccine efficacy when given half a dose, followed by a full dose at least one month apart. The other dosing regimen showed an efficacy of 62% when two full doses of the vaccine were administered, with an interval of at least one month. the combined analysis of both dosing regimens resulted in a mean efficacy of 70%.
Although the efficacy of the vaccine is much less than the 95% achieved by Pfizer and Moderna, the vaccine holds more promise for India due to its price, simpler supply chain and scalable platform. The vaccine can be stored at normal refrigerated temperature (2-8 ° C) and does not require the accumulation of a subzero cooling chain, which facilitates its transport, storage and distribution even in remote areas, unlike the other two.
Covishield’s phase III clinical trials in 1,600 participants are ongoing across India and are expected to be complete by mid-December. Interim data from the trials, which have been running since October, are promising, Poonawalla said.
High-level positive results from an interim analysis of AZD1222 clinical trials in the UK and Brazil showed that the vaccine was highly effective in preventing Covid-19, the primary endpoint, with no hospitalizations or serious cases reported disease in participants who received the treatment. vaccine. There were a total of 131 Covid-19 cases in the interim analysis.
“The efficacy and safety of this vaccine confirm that it will be very effective against Covid-19 and will have an immediate impact on this public health emergency. Additionally, the vaccine’s simple supply chain and our non-profit promise and commitment to broad, equitable and timely access mean it will be affordable and available globally, supplying hundreds of millions of doses with approval, ”said Pascal Soriot , CEO of AstraZeneca.
AstraZeneca will now immediately prepare for regulatory submission of the data to authorities globally who have a framework in place for advance or conditional approval. The company will search for an emergency use list at World Health Organization for an accelerated path to vaccine availability in low-income countries, added a statement.
More than 23,000 participants are being evaluated following two doses of a half dose / full dose regimen or a two full dose regimen of AZD1222 or a comparator, meningococcal conjugate vaccine, or saline.
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