NEW DELHI: The UK Medicines and Healthcare products Regulatory Agency (MHRA) on Wednesday authorised emergency use of AstraZeneca’s covid-19 vaccine for immunising people 18 years or older. The authorisation recommends two full doses administered with an interval of between four and 12 weeks, the Anglo-Swedish firm said.
The authorisation for the shots, developed under the codename AZD1222, paves the way for an emergency licensure by the Drug Controller General of India V.G. Somani for Serum Institute of India’s version of the vaccine, branded ‘Covishield’.
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Serum Institute had submitted its proposal for emergency licensure for the vaccine earlier this month, but an independent expert committee set up by the DCGI to vet submissions had asked the company to return with updated data and after an approval was given by the UK MHRA to AstraZeneca for the original version. The original version was co-developed by AstraZeneca and the University of Oxford, with the former having commercial rights.
AstraZeneca had signed a pact with Serum Institute earlier this year, under which the Indian firm would contract manufacture and supply 1 billion doses of the vaccine for low-and-middle-income countries, with a commitment to provide 400 million shots before the end of 2020.
Along with its pact with other makers globally, AstraZeneca has lined up a manufacturing capacity of up to 3 billion doses of the vaccine in 2021.
The AstraZeneca-Serum vaccine is by far the most significant so far in the global fight against covid-19 as it will be priced at as little as $3 per dose, compared to the two messenger RNA vaccines by US firms Pfizer and Moderna that are charging at least six times the amount. Also, unlike the mRNA vaccines that require sub-zero temperatures, AstraZeneca-Serum vaccine can be stored at 2-8 degree Celsius.
A comment from Serum Institute CEO Adar Poonawalla was not immediately available at the time of publishing.
Efficacy results of AstraZeneca’s vaccine, which it has co-developed with Oxford University, had sparked a controversy after it claimed that a dosing error increased the effectiveness. Soriot admitted that in an interview with Britain’s Sunday Times newspaper earlier this week: “We would have preferred a simpler set of results.”
AstraZeneca’s clinical trials for its vaccine in the UK and Brazil included two separate dosing regimens. A lower dosage gave a greater efficacy of 90% while two full doses a month apart gave a 62% efficacy.
Researchers were unable to explain why the lower dosing regimen—a 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 bridging study in India using two full doses, which showed a 62% efficacy in AstraZeneca’s trial. Bridging studies look at safety and immune response to prove that the version being contract manufactured is the same as the original.
Poonawalla on Monday also said the vaccine is expected to get an emergency-use licence from the UK Medicines and Healthcare products Regulatory Agency and the Indian regulator by early January.
The company has manufactured 40-50 million doses so far and would sell these shots primarily in India initially.
The company is manufacturing 50-60 million doses of Covishield a month and will increase its capacity to 100 million doses by March after commissioning its third plant. Poonawalla said he expects a shortage of vaccines in the first six months, but after that, as more shots are launched, the supply-demand mismatch will ease.