The expert panel in the Central Drugs Standard Control Organisation (CDSCO) has recommended the Oxford COVID-19 vaccine for emergency use in India, according to reports. Pune-based Serum Institute of India (SII), the world's largest vaccine manufacturer, has entered into a tie-up with AstraZeneca to manufacture 'Covishield'. An official approval, however, is awaited from the drug regulator Drugs Controller General of India (DCGI).
The panel had met on Friday to deliberate on the emergency use authorisation applications by the Serum Institute of India for the Oxford COVID-19 vaccine and Bharat Biotech's 'Covaxin'.
While considering SII's application, the SEC on December 9 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 December 6 while the Hyderabad-based Bharat Biotech had sought a similar nod for its its indigenously developed Covaxin on December 7.
Pfizer had applied for a similiar approval for its vaccine on December 4.
Meanwhile, the UK on Wednesday had approved the COVID-19 vaccine developed by scientists at Oxford University and produced by AstraZeneca for human use, the second coronavirus vaccine to be cleared for rollout in Britain after the Pfizer/BioNTech jabs.
The Oxford vaccine, which also has a tie-up with the Serum Institute of India, was being evaluated by the British regulator - the Medicines and Healthcare products Regulatory Agency (MHRA) - after the final cut of data was submitted by the government last week.
The approval by the MHRA means the vaccine is both "safe and effective" and the government's Department of Health and Social Care (DHSC) said that the National Health Service (NHS) will prioritise giving the first of the two-dose vaccine to those in the most high-risk groups quickly.
The vaccine, codenamed AZD1222 or ChAdOx1 nCoV-19, was developed at Oxford University with support from the British-Swedish pharmaceutical giant AstraZeneca.
In a related update, people receiving the Oxford vaccine or the one from Pfizer/BioNTech, which is also being rolled out, will now receive their first dose of the vaccine followed by a second dose up to 12 weeks later rather than just four weeks.
Britain has ordered 100 million doses of the Oxford jab, with 40 million expected to be available by the end of March. ChAdOx1 nCoV-19 is made from a virus (ChAdOx1), which is a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees, that has been genetically changed so that it is impossible for it to replicate in humans.
Once inside a human cell, the genetic instructions for the spike protein need to be photocopied many times a process known as transcription .
Once the spike protein is made, the immune system will react to it and this pre-trains the immune system to identify a real COVID-19 infection. So, when the person vaccinated is confronted with the SARS-CoV-2 virus their immune system is pre-trained and ready to attack it.
The news of its approval comes amid increasing strain on hospitals in England, where the number of coronavirus patients is at its highest ever level during the pandemic.