Serum Institute of India gets nod for phase 2,3 trials of Oxford covid vaccine

Agencies
August 3, 2020

The Drugs Controller General of India (DCGI) has given nod to the Serum Institute of India (SII) for conducting phase 2 and 3 human clinical trials of the Oxford University developed Covid-19 vaccine candidate in the country.

Government officials said that the approval for conducting phase 2 and 3 clinical trials by the SII was granted by DCGI Dr V G Somani late Sunday night after a thorough evaluation based on the recommendations of the Subject Expert Committee (SEC) on Covid-19.

"The firm has to submit safety data, evaluated by the Data Safety Monitoring Board (DSMB), to the CDSCO before proceeding to phase 3 clinical trials," a senior official said.

"As per the study design, each subject will be administered two doses four weeks apart (first dose on day one and second dose on day 29) following which the safety and immunogenicity will be assessed at predefined intervals," the official said.

As a rapid regulatory response, the expert panel at the Central Drugs Standard Control Organisation (CDSCO) on Friday, after a detailed deliberation and considering the data generated on the vaccine candidate in phase 1 and 2 of the Oxford University trial, had recommended granting permission for phase 2 and 3 clinical trials of the potential vaccine, 'Covishield', on healthy adults in India,  the officials said.

Currently, phase 2 and 3 clinical trials of the Oxford vaccine candidate is going on in the United Kingdom, phase 3 clinical trial in Brazil and phase 1 and 2 clinical trials in South Africa.

The officials said that the SII had submitted a revised proposal on Wednesday after the SEC on July 28, following deliberation over its application, had asked it to revise its protocol for the phase 2 and 3 clinical trials besides seeking some additional information.

The panel had also recommended that the clinical trial sites which have been proposed for the study be distributed across India.

According to the revised proposal by the SII, 1,600 people aged above 18 years will participate in the trials across 17 selected sites, including AIIMS-Delhi, B J Medical College in Pune, Rajendra Memorial Research Institute of Medical Sciences (RMRIMS) in Patna, Post Graduate Institute of Medical Education and Research in Chandigarh, AIIMS-Jodhpur, Nehru Hospital in Gorakhpur, Andhra Medical College in Visakhapatnam and JSS Academy of Higher Education and Research in Mysore.

"According to the application, it would conduct an observer-blind, randomised controlled study to determine the safety and immunogenicity of 'Covishield' on healthy Indian adults," the official said.

The SII, which has partnered with AstraZeneca, for manufacturing the Oxford vaccine candidate for Covid-19 had submitted its first application to the DCGI on July 25 seeking permission for conducting the phase 2 and 3 trials of the potential vaccine. 

Initial results of the first two-phases of trials of the vaccine conducted in five trial sites in the UK showed that it has an acceptable safety profile and homologous boosting increased antibody response, sources had said.

To introduce the vaccine, SII, the world's largest vaccine maker by number of doses produced and sold, has signed an agreement to manufacture the potential vaccine developed by the Jenner Institute (Oxford University) in collaboration with British-Swedish pharma company AstraZeneca. 

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Agencies
June 6,2020

United Nations, Jun 6: The coronavirus disease has not "exploded" in India, but the risk of that happening remains as the country moves towards unlocking its nationwide lockdown that was imposed in March to contain the Covid-19, according to a top WHO expert.

WHO Health Emergencies Programme Executive Director Michael Ryan on Friday said the doubling time of the coronavirus cases in India is about three weeks at this stage.

“So the direction of travel of the epidemic is not exponential but it is still growing,” he said, adding that the impact of the pandemic is different in different parts of India and varies between urban and rural settings.

“In South Asia, not just in India but in Bangladesh and...in Pakistan, other countries in South Asia, with large dense populations, the disease has not exploded. But there is always the risk of that happening,” Ryan said in Geneva.

He stressed that as the disease generates and creates a foothold in communities, it can accelerate at any time as has been seen in a number of settings.

Ryan noted that measures taken in India such as the nationwide lockdown have had an impact in slowing transmission but the risk of an increase in cases looms as the country opens up.

“The measures taken in India certainly had an impact in dampening transmission and as India, as in other large countries, open up and as people begin to move again, there's always a risk of the disease bouncing back up,” he said.

He added that there are specific issues in India regarding the large amount of migration, the dense populations in the urban environment and the fact that many workers have no choice but to go to work every day.

India went past Italy to become the sixth worst-hit nation by the COVID-19 pandemic.

India saw a record single-day jump of 9,887 coronavirus cases and 294 deaths on Saturday, pushing the nationwide infection tally to 2,36,657 and the death toll to 6,642, according to the health ministry.

The lockdown in India, was first clamped on March 25 and spanned for 21 days, while the second phase of the curbs began on April 15 and stretched for 19 days till May 3. The third phase of the lockdown was in effect for 14 days and ended on May 17. The fourth phase ended on May 31.

The country had registered 512 coronavirus infection cases till March 24.

The nation-wide lockdown in containment zones will continue till June 30 in India but extensive relaxations in a phased manner from June 8 are listed in the Union home ministry's fresh guidelines on tackling the Covid-19 pandemic issued last week.

WHO Chief Scientist Soumya Swaminathan said the over 200,000 current coronavirus cases in India, a country of over 1.3 billion people, "look big but for a country of this size, it's still modest.”

She stressed that it is important for India to keep track of the growth rate, the doubling time of the virus and to make sure that that number doesn't get worse.

She said that India is a “heterogeneous and huge country” with very densely populated cities and much lower density in some rural areas and varying health systems in different states and these offer challenges to the control of Covid-19.

Swaminathan added that as the lockdown and restrictions are lifted, it must be ensured that all precautions are taken by people.

“We've been making this point repeatedly that really if you want behaviour change at a large level, people need to understand the rationale for asking them to do certain things (such as) wearing masks,” she said.

In many urban areas in India, it's impossible to maintain physical distancing, she said adding that it then becomes very important for people to wear appropriate face coverings when they are out, in office settings, in public transport and educational institutions.

“As some states are thinking about opening, every institution, organisation, industry and sector needs to think about what are the measures that need to be put in place before you can allow a functioning and it may never be back to normal.”

She said that in many professions working from home can be encouraged but in several jobs, people have to go to work and in such cases measures must be put in place that allow people to protect themselves and others.

“I think communication and behaviour change is a very large part of this whole exercise,” she added.

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News Network
January 6,2020

Jan 6: India’s Finance Ministry has delivered a challenge to its revenue collectors: meet tax targets despite $20 billion of corporate tax cuts.

Through a video conference on Dec. 16, officials were exhorted to meet the direct tax mop-up target of 13.4 trillion rupees ($187 billion), a government official told reporters. Collection in the eight months to November grew at 5% from a year earlier, against the desired 17%.

The missive shows Prime Minister Narendra Modi’s urgent need to buoy public finances in a slowing economy where April-November tax collections were half the amount budgeted. Authorities withheld some payments to states and have capped ministries’ expenditure as the fiscal deficit ballooned beyond the target.

The government’s efforts to maintain its deficit goal goes against advice from some quarters, including central bank Governor Shaktikanta Das, who urged more spending to spur economic growth.

It’s uncertain though how much room Modi’s administration has to boost expenditure, given that it may already be borrowing as much as 540 billion rupees through state-run companies, a figure that isn’t reflected on the federal balance sheet. Uncertainty about public finances pushed up sovereign yields in November and December, compelling Das to announce unconventional policies to keep costs in check.

“This is not a time to conceal the fiscal deficit by off-budget borrowing or deferring payments,” said Indira Rajaraman, an economist and a former member of the Reserve Bank of India’s board. “If they were to stick to the target, that would be catastrophic because there is so much pump-priming that is needed right now.”

GDP grew 4.5% in the quarter ended September, the slowest pace in more than six years as both consumption and investments cooled in Asia’s third-largest economy. Only government spending supported the expansion, piling pressure on Modi to keep stimulating.

S&P Global Ratings warned in December it may downgrade India’s sovereign ratings if economic growth doesn’t recover. Government support seems to be waning now, with ministries asked to cap spending in the final quarter of the financial year at 25% of the amount budgeted rather than 33% allowed earlier. This new rule will hamstring sectors including agriculture, aviation and coal, where not even half of annual targets have been disbursed.

As the federal government runs short of money, it’s been delaying payouts to state administrations.

Private hospitals have threatened to suspend cash-less services to government employees over non-payment of dues, while a builder informed the stock exchange about delayed rental payments from no less than the tax office itself.

India is considering a litigation-settlement plan that will allow companies to exit lingering tax disputes by paying a portion of the money demanded by the government, the Economic Times newspaper reported Saturday.

The move will help improve the ease of doing business besides unlocking a part of the almost 8 trillion rupees ($111 billion) caught up in these disputes. The step, which is being considered as part of the annual budget, could also bridge India’s fiscal gap.

Finance Minister Nirmala Sitharaman has refused to comment on the deficit goal before the official budget presentation due Feb. 1.

A deviation from target, if any, “will need to be balanced with a credible consolidation plan further-out,” said Radhika Rao, an economist at DBS Group Holdings Ltd. in Singapore.

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Agencies
February 11,2020

New Delhi, Feb 11: Senior Delhi Congress leader and national spokesperson of the party Sharmishtha Mukherjee alleged delay in decision making and lack of strategy and unity at the state level for the party's humiliating performance reflected in the Assembly poll results on Tuesday.

Mukherjee, president of Delhi Mahila Congress, stated that it was high time that the party takes some action. She added that she too was responsible for the Congress' poor show.

The Congress is on the verge of drawing blank again in the Assembly polls as all its candidates were way far behind their AAP and BJP opponents on all the 70 seats. In the 2015 Assembly elections too, Congress failed to win any seat.

"We r again decimated in Delhi. Enuf of introspection, time 4 action now. Inordinate delay in decision making at the top, lack of strategy & unity at state level, demotivated workers, no grassroots connect-all r factors. Being part of d system, I too take my share of responsibility (sic)," Mukherjee tweeted as the results came out.

She also accused the BJP of playing divisive politics while crediting Delhi Chief Minister Arvind Kejriwal for playing "smart politics" as the results showed a clean sweep by the AAP to return to power.

"BJP playing divisive politics, Kejriwal playing ‘smart politics’ & what r we doing? Can we honestly say that we’ve done all 2 put our house in order? We r busy capturing Congress whereas other parties are capturing India. If we r 2 survive, time 2 come out of exalted echo chambers! (sic)," she said in another tweet.

The Congress contested the Delhi polls in alliance with the Rashtriya Janta Dal (RJD), fielding candidates on 66 seats and leaving four to its partner.

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