India is likely to see the Oxford-AstraZeneca vaccine being approved for emergency use in next few days as the updated data submitted by Serum Institute of India (SII) appears “satisfactory”, top government sources said. Once evaluation of data is complete, the regulator may not wait for the vaccine to get approval from UK’s Medicines and Healthcare products Regulatory Agency (MHRA).
“We can take our regulatory decisions independently. The company has submitted the same data here from clinical trials in the UK and Brazil and rolling reviews are going on. The updated information shared by Serum Institute also appears satisfactory. We are hopeful that based on regulatory assessment, the vaccine will be approved in a day or two,” a senior official said. However, it is possible that the UK may also, meanwhile, grant emergency use authorisation as MHRA is already reviewing data for the vaccine developed by Oxford University and pharma major AstraZeneca.
According to a report, Pascal Soriot, the CEO of the drug major, has reported that the Covishield vaccine has achieved a “winning formula” for efficacy. He added that he believes trials will show his firm has achieved a vaccine efficacy equal to Pfizer-BioNTech at 95% and Moderna at 94.5 per cent. “We think we have figured out the winning formula and how to get efficacy that, after two doses, is up there with everybody else,” the chief executive said, while only adding that data would be published at “some point”. He also said that the vaccine “should be” effective against the new highly transmissible variant of the coronavirus.
India plans to inoculate around 300 “priority” population in the first phase of the vaccination drive that is expected to roll out in the first week of January and end latest by July. The government plans to conduct a mock drill in four states - Punjab, Assam, Andhra Pradesh and Gujarat to assess the readiness for the massive vaccination exercise. During the dry runs, the government will also check the usage of Co-WIN in field environment as the platform is expected to play asignificant role in real-time co-ordination including cold chain management, beneficiary registration and intimation and even organising vaccination sessions.
The exercise will also include testing of cold storage and transportation arrangements for Covid-19 vaccine and crowd management at session sites with proper physical distancing. Each state will plan the dry run in two districts and preferably in five different session type settings - district hospital, community health centre (CHC) or primary health care centre (PHC), urban site, private health facility and rural outreach.
"This exercise will enable end-to-end mobilisation and testing of vaccination process (except the vaccine) and check the usage of Co-WIN in field environment, linkages between planning, implementation and reporting mechanisms, identify challenges and guide the way forward prior to actual implementation including improvements that may be required in the envisaged process," the health ministry said.
Weekly cases fall in all states
For the first time since the Covid-19 virus spread through India in March, all states and Union Territories (UT) registered a week-on-week decline in fresh cases last week, indicating that the pandemic was receding across India, at least for now. The only exception was the UT of Dadra and Nagar Haveli, Daman and Diu, which reported all of nine cases through the week (December 21-27), two more cases than the count in the previous seven days.
Meanwhile, just 16,143 fresh cases were reported in India on Monday, the lowest single-day count in more than six months since June 23. Deaths too dipped to 251, the lowest daily toll from the virus since June 2, nearly seven months ago. While weekly cases have been falling for the past seven weeks and in 14 of the last 15 weeks, this was the first time that all states had registered a decline. In the previous week (December 14-20), Kerala had seen a surge in infections, logging an increase of more than 3,300 cases over the week before. Overall, cases had risen in six states/UTs during that week, although the surge was marginal in most.
Kerala only state where positivity rate still rising
Kerala is the only state in India where the Covid-19 positivity rate is still rising, a matter of concern as it had shown some moderation early this month but has once again touched 10% in the 14-day period between December 13-26. This is up from 9.4% in the fortnight before (Nov 30-Dec 13).
If the positivity rate, number of confirmed Covid cases per 100 tests, is above 5% measured over a 14-day period, the state is considered to be in the red zone. Besides Kerala, Goa at 6% is the only other state which has a positivity rate above the 5% level. But it has improved, bringing down the positivity compared to previous fortnight’s 6.4%. The all-India positivity rate has come down, too, from 3% (Nov 30-Dec 13) to 2.2% (Dec 13-26).
Maharashtra, West Bengal, Chhattisgarh, Himachal Pradesh and Rajasthan have brought their positivity rates below 5%, a major improvement from the previous fortnight when they were all in the red zone. Delhi at 1.4% is doing better than Gujarat (1.8%) and Tamil Nadu (1.5%).
A month-and-half ago (November 8-21), there were nine states that had positivity rates between 7% and 15%, over a 14-day period. Leading the pack was Himachal Pradesh at 15%, followed by Delhi-13%, Rajasthan-11%, Haryana-10%, Kerala-10%, Goa-9%, West Bengal-8%, Maharashtra-8% and Chhattisgarh-7%. Now, barring Kerala and Goa, all other states have managed to restrict the pandemic to a manageable limit by increasing testing and tracing of the infected population.
