AstraZeneca Plc will soon publish data showing that the effectiveness of its covid-19 vaccine increases up to 95% if the two injections are separated by approximately 2-3 months, said Adar Poonawalla, executive director of the Serum Institute of India (SII), partner. manufacturing company British.
“You will be getting good news from the UK very soon. It would be a 90-95% effective vaccine if a two to three month interval is maintained between dose 1 and dose 2. They will make it public with documentation, “Poonawalla said at a news conference Monday. Speaking at the launch of the company’s pneumococcal conjugate vaccine, the first indigenous vaccine of its kind, under the brand name Pneumosil.
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Poonawalla’s comments follow a statement from AstraZeneca CEO Pascal Soirot in an interview with Britain’s sunday time newspaper that the company has discovered a “winning formula to be effective with everyone else.” However, Soirot did not provide details to back up his claim and said the data will be released “at some point.”
The efficacy results for AstraZeneca’s vaccine, which it has developed jointly with the University of Oxford, sparked controversy after it claimed that a dosing error increased the vaccine’s efficacy. Soirot admitted in the interview: “We would have preferred a simpler result set.”
AstraZeneca’s clinical trials for its vaccine in the UK and Brazil included two separate dosing regimens. A lower dose gave a 90% greater efficacy, while two full doses one month apart gave a 62% efficacy.
The researchers could not explain why the lower dosing regimen (half dose followed by a full dose one month later) was more effective. Instead, the researchers said they had stumbled upon it by accident and called the superior results “serendipity.”
Serum Institute, the contract manufacturer of the vaccine, conducted its own phase 2 and 3 bridge study in India using two full doses, which showed an efficacy of 62% in the AstraZeneca trial. Bridging studies look at safety and immune response to show that the contract-manufactured version is the same as the original.
Poonawalla on Monday also said the vaccine is expected to obtain an emergency use license from the UK Medicines and Health Products Regulatory Agency and the Indian regulator in early January.
The company has manufactured between 40 and 50 million doses so far and would initially sell them primarily in India.
“During the first month, we can deliver most of the volumes to India because if we have to export, we have to go through the WHO prequalification procedure, which can take a month or so,” Poonawalla said.
The company is manufacturing between 50 and 60 million doses of Covishield per month and will increase its capacity to 100 million doses in March after the commissioning of its third plant. Poonawalla said he expects a vaccine shortage in the first six months, but after that, as more products are launched from vaccine manufacturers, the disparity between supply and demand will ease.
Currently, three manufacturers – SII, Bharat Biotech and Pfizer – have applied for emergency licenses and a panel of subject matter experts created by the Comptroller General of Drugs of India is expected to review the proposals soon. Earlier this month, SII and Bharat Biotech had approached the panel with their proposals, but were asked to submit more data, while Pfizer asked for more time to make their presentation.
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