Gennova has also got permission for phase-2 and 3 clinical trials for its lyophilised mRNA vaccine for injection from the subject expert committee advising the Central Drugs Standards Control Organisation, reports Sohini Das.
A longer shelf life is critical, given many makers have started manufacturing vaccines and stockpiling them, so as to make them available in the market immediately after approval, reports Sohini Das.
By January-February, it's expected to have at least 100 million doses for the Indian government, reports Sohini Das.
The company has developed detailed logistical plans and tools to support effective vaccine transport, storage, and temperature monitoring. Sohini Das and Ruchika Chitravanshi report.
The study by a group of doctors showed that after two shots of the vaccines, 98 per cent recipients of Covishield showed antibody response, while the same was 80 per cent among Covaxin recipients. Sohini Das and Ruchika Chitravanshi report.
Lack of clarity on data-sharing persists, public health experts sceptic about the pilot that was run in six Union territories as benchmark for national roll-out
While Covishield supplies would meet the target of 500 mn doses between August and December, it looks like Covaxin would miss the target of 400 mn unless the partner sites of Bharat Biotech ramp up very rapidly, reports Sohini Das.
In India, Opposition parties along with healthcare professionals have urged the government, including Prime Minister Narendra Modi and top leaders, to take either of the Covishield or Covaxin doses, which could help in drastically reducing trust and fear issues amongst citizens., reports Sohini Das.
Initial data has shown immunity triggered by the two mRNA vaccines -- Pfizer-BioNTech and Moderna -- lasts for at least six months
Pfizer can show the FDA approval to the Indian regulator and present a case that based on whatever data submitted, the US regulator has granted a full marketing nod, says Sohini Das.
The second wave of the pandemic has not only crippled medical infrastructure in terms of hospital beds, but has also led to bottlenecks in invasive ventilators and medical oxygen capacities and supplies.
The global trials were halted after a study participant suffered a 'potentially unexplained illness, reports Sohini Das.
The telecast was viewed by 197 million Indians, higher than the Indian Premier League final which was watched by 133 million, reports Sohini Das.
'There will be ups and downs, and we have to plan how we live with it now.'
With the dizzying rise in the number of Covid-19 cases in the country, India Inc has transitioned from a wait-and-watch policy to full-on emergency mode, bringing back remote and flexi work, stringent safety protocols, and allowing only essential travel. Companies - especially in metros like Delhi, Mumbai and Kolkata - that had adopted a hybrid work model during the last few months when the caseload remained low, are either switching back entirely to work-from-home (WFH), or calling skeletal staff to office on select days. Take the case of cigarettes-to-hotels major, ITC, which had been on a hybrid work model over the last few months.
Bharat Biotech is in the middle of conducting a phase 3 trial with 22,000 subjects.
Anybody over 50 years of age or with co-morbidities can get a date, place and time of choice for getting the vaccine shots.
India expects 2.16 billion doses of Covid-19 vaccines between August and December, including the jabs that are currently in clinical trials, reports Sohini Das
The API of Paracetamol, a fever and pain medication, has grown 25 per cent from Rs 450-480 per kg in December 2020 to Rs 580-600 per kg in April. When compared to the pre-Covid prices of December 2019, the surge is much steeper -- around 140 per cent, reports Sohini Das.
Business executives are finally dusting off their long-unused suitcases to resume travel, thanks to a good vaccination rate, a drop in fresh cases, and an easing of travel restrictions. It comes as a huge relief for the ravaged aviation, travel and hospitality sectors. "We are witnessing a 40 per cent recovery on pre-covid volumes from our business travellers, signalling the return of corporate confidence in air travel," said Indiver Rastogi, president & group head, Global Business Travel, Thomas Cook (India) & SOTC.
The committee has recommended Rs 8,000-10,000, Rs 13,000-15,000, and Rs 15,000-18,000 including PPE costs for isolation beds, and ICUs with or without ventilator, respectively, to all hospitals. Currently, hospitals are charging Rs 24,000-25,000, Rs 34,000-43,000 & Rs 44,000-54,000 (excluding PPE cost).
'I have done enough work for many years.' 'This is a decision that many people at my age need to review.' 'I may become an exit example for people to study.'
Will syringe shortage puncture India's Covid vaccine plans?
It has taken 51 days to reach a daily caseload of 84,000 from 11,000, as against 85 days taken in the first wave, report Abhishek Waghmare and Sohini Das.
The Covishield maker's forte throughout the past half a century has been a combination of affordable vaccines and high volumes. Its tetanus, diphtheria and measles vaccines are known throughout the world, reports Sohini Das.
'Almost 70 per cent production time of a vaccine is dedicated to quality control, which is done through several hundred tests.'
Commercial launch and supply to major government and private hospitals is expected in mid-June.
Mumbai, with an estimated population of nearly 20 million, has been testing 1,200-1,400 people per day. Delay in the delivery of rapid antibody test kits has forced the BMC to restrict its testing net.
Pune's Mylab Discovery Solutions' CoviSelf, which gives results in 15 minutes, gets ICMR nod
This apart, to further increase capacities, Bharat Biotech has partnered with Indian Immunologicals (IIL) to manufacture the drug substance for Covaxin. The technology transfer process is underway and IIL has the 'capabilities and expertise' to manufacture the inactivated viral vaccines at commercial scale.
'This government did not have any plan for safety stocks of essential medicines.'
While Bharat Biotech's Covaxin is in trials among children already, Serum Institute of India will begin Novavax vaccine trials on children from July, whereas the Pfizer vaccine has been approved for adolescents in the United States; and Cadila Healthcare's ZyCoV-D has done trials on 12 year-olds and above already, reports Sohini Das.
One challenge for many laboratories in ramping up is the shortage of trained manpower for collecting samples, report Sohini Das, Vinay Umarji and Virendra Singh Rawat.
While virologists say theoretically the vaccine that works on Delta should work on the Delta Plus variant as well, more research is needed.
In September, Bharat Biotech aimed to supply 35 million doses, and take this up to 55 million by October. This is still less than what the Indian government expects from the company.
'Safety is my first priority.' 'I need to ensure that any drug or vaccine that our citizens get is first safe.'
'The government should put the whole road map together for the vaccine and decide how industry can support...' 'They should allow the private sector to vaccinate.'
At $37 per dose, the Pfizer vaccine is much more expensive compared to $3 per dose for the Covishield.
Each state has its own weak areas that need attention. Some states have already identified the gaps and sought the Centre's help. Vinay Umarji, Ishita Ayan Dutt, Samreen Ahmad and Sohini Das report.
The ICMR has already approved a bunch of rapid test kits for launch. The health ministry admitted that clusters of COVID-19 had appeared in many states and the risk of further spread remains very high.
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