Indian regulator seeks more time as UK authorises Oxford COVID-19 jab; six things about cheap, easy to store vaccine
In India, a decision on emergency usage of the vaccine, which is being manufactured by Pune-based Serum Institute of India, is likely to come next year with the Subject Expert Committee (SEC) on COVID-19 seeking more time today
British regulator granted emergency usage authorisation to the easy to store and cheap AstraZeneca/Oxford vaccine on Wednesday.
Though the Indian authorities on Wednesday sought more time to decide on the emergency authorisation of the vaccine, which is manufactured in India as 'Covishield' by Pune-based Serum Institute of India in a tie-up with AstraZeneca, the UK's authorisation has given a shot in the arm to the global fight against coronavirus.
Here are six facts about the much-anticipated vaccine.
The AstraZeneca/Oxford vaccine has the major advantages of being inexpensive, costing about £2.50 (Rs 250, $3.40, 2.75 euros) per dose, and easy to store.
It can be kept at normal refrigerator temperatures of between two and eight degrees Celsius, making it ideal for large-scale vaccination programs.
By contrast, the Moderna vaccine needs to be stored at -20C, while the Pfizer/BioNTech product must be kept at -70C.
The vaccine should be capable of fighting the new variant of the coronavirus responsible for a surge of cases in the United Kingdom, according to AstraZeneca chief executive Pascal Soriot.
"So far, we think the vaccine should remain effective. But we can't be sure, so we're going to test that," he told the Sunday Times.
New versions are being developed just in case, he revealed, adding: "You have to get prepared."
The vaccine developed by British firm AstraZeneca, working alongside Oxford University, is the second to be approved by the independent Medicines and Healthcare products Regulatory Agency (MHRA).
The Pfizer/BioNTech vaccine has been deployed in Britain since 8 December, with almost 800,000 receiving their first dose, according to British Prime Minister Boris Johnson.
His government is battling one of the world's worst outbreaks, with more than 71,000 deaths so far of those testing positive for the disease.
Britain has ordered 100 million doses of the AstraZeneca/Oxford vaccine, 40 million of which will be available by the end of March, with vaccinations scheduled to begin on 4 January.
AstraZeneca said it expects to be able to manufacture about three billion doses of its vaccine worldwide in 2021.
The Pune-based Serum Institute of India has already produced around 50 million dosages of the Oxford-AstraZeneca COVID-19 vaccine 'Covishield' and plans to scale it up to 100 million by March next year
India's decision expected soon
An expert panel in the Central Drugs Standard Control Organisation (CDSCO) that met on Wednesday to consider emergency use authorisation applications by the SII for the Oxford COVID-19 vaccine, Bharat Biotech's 'Covaxin' and Pfizer/BioNTech's mRNA will reconvene on 1 January to further deliberate on the matter.
"The Subject Expert Committee (SEC) in the CDSCO met today in the afternoon to consider the emergency use authorisation (EUA) request of Pfizer, SII, and Bharat Biotech Pvt. Ltd," the Health Ministry said in a statement.
"Further time was requested on behalf of Pfizer. The additional data and information presented by SII and Bharat Biotech Pvt Ltd was perused and analysed by the SEC. The analysis of the additional data and information is going on. The SEC will convene again on 1 January, 2021," it said.
While considering SII's application, the SEC on 9 December had recommended that the firm should submit updated safety data of phase 2 and 3 clinical trials in the country, immunogenicity data from the clinical trial in the UK and India, along with the outcome of the assessment of the UK MHRA for grant of EUA.
As for Hyderabad-based Bharat Biotech, after detailed deliberation, the committee had recommended that the firm should present the safety and efficacy data from the ongoing phase 3 clinical trial in the country for further consideration.
SII had applied to the Drugs Controller General of India (DCGI) for emergency use authorisation for Covishield on 6 December while the Hyderabad-based Bharat Biotech had sought a similar nod for its indigenously developed Covaxin on 7 December. Pfizer had applied for a similar approval for its vaccine on 4 December.
The vaccine is "virus-vectored", meaning it is a version of a virus that normally infects chimpanzees and has been modified with a portion of the Covid-19 coronavirus called the "spike protein" to fire the immune system.
Once in human cells, the vaccine should help stimulate the production of antibodies that recognizee the virus.
The vaccine is "safe and effective", according to data published by The Lancet medical journal on December 8, with only one of the of the 23,754 volunteers who participated in the trials experiencing "possibly-related severe side effects".
This was a case of rare neurological condition transverse myelitis that forced the temporary suspension of trials.
The British laboratory announced in interim findings in November that its vaccine was on average 70 percent effective, compared with more than 90 percent for Pfizer/BioNTech and Moderna.
The efficacy of the AstraZeneca/Oxford vaccine was 90 percent for volunteers who first received only a half-dose and then a full dose one month later, but only 62 percent for another group that was vaccinated with two full doses one month apart.
The injection of a half-dose was conducted by accident, raising criticism over the robustness of the results and prompting the company to announce on 26 November that an "additional study" would be held into the efficacy of the reduced dosage.
"We think we have figured out the winning formula and how to get efficacy that, after two doses, is up there with everybody else," Soriot told The Sunday Times.
With inputs from agencies
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