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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News Network
July 22,2020

New Delhi, Jul 22: With a spike of 37,724 cases and 648 deaths reported in the last 24 hours, the total number of COVID-19 cases in India stands at 11,92,915, according to the Union Ministry of Health and Family Welfare.

The total number of cases includes 4,11,133 active cases, 7,53,050 cured/discharged/migrated and 28,732 deaths, the Health Ministry informed.

Maharashtra remains the worst affected state with 3,27,031 cases and 12,276 deaths.
The second worst-hit state, Tamil Nadu has reported 1,80,643 COVID-19 cases so far while Delhi has reported 1,25,096 cases, according to the Ministry.

Other states that have witnessed a higher number of COVID-19 positive cases include, Andhra Pradesh with 58,668 cases, Karnataka with 71,069 while Telangana has reported 47,705 COVID-19 positive cases.

Meanwhile, as per the information provided by the Indian Council of Medical Research (ICMR), the total number of samples tested up to July 21 is 1,47,24, 546 including 3,43,243 samples tested yesterday.

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Agencies
July 21,2020

New Delhi, Jul 21: Air India trade unions have complained to Civil Aviation Minister Hardeep Puri that the government has now turned a blind eye to the management's ethnic cleansing at lower levels through compulsory leave without pay (LWP), redundancies and wage cuts.

In a letter to Puri, the Joint Action Forum of Air India unions said, "We are deeply ashamed to say that it seems that after praising our Air Indian Corona Warriors at grand functions, respectfully, the government has now turned a blind eye to this management's ethnic cleansing of Air Indians at the lower levels, through compulsory LWP, redundancies and wage cuts."

The Joint Action Forum of Air India unions strongly opposes this Compulsory Leave without pay scheme as it is an illegal practice and is not a voluntary scheme.

"In fact the Board resolution itself empowers the Chairman and Managing Director with extraordinary powers, which seem akin to a High Court, to pack off employees on 2 years leave (extended to 5 years) at CMD's discretion or at the arbitrary whim of the Regional heads," the trade unions said.

"This said Compulsory LWP scheme violates every labour law put in place by Parliament and orders of the Supreme Court and various other courts and seeks to dispossess the lower categories workers of their legally guaranteed rights," it added.

The trade unions have pointed out that the redundancies are at the elite management cadre level and not the workers.

"We are indeed shocked that the management of Air India could prepare and formulate a scheme for compulsorily sending workers on leave without pay, which is akin to an illegal lay-off, under the garb of a Leave Without Pay, when ironically the redundancy actually lies in the upper echelons of management and not with the humble workers of Air India, who have slogged to make our Airline the treasure it is," they complained to Puri.

"It must be noted that out of 11,000 permanent employees, our management occupies almost 25% as Executive Cadre, with little or no accountability. Solely amongst the Elite Management Cadre, we have 121 top officers ranking from DGMS, GMs, EDs to Functional Directors, most of whom are either performing duplicate job functions or are indeed redundant and not to mention the retired relics serving as consultants and also the CEOs of various subsidiary companies," they added.

Trade unions said the redundancy or compulsory leave without pay scheme if any at all, has to apply only to these Executives, more so, when they do not even have protection of labour laws or Supreme Court orders.

Strangely, the topmost corporate executive cadre and the backroom Generals, have saved themselves from the axe of wage cuts, by sacrificing a piffling of a few grand, whilst the frontline warriors of flying cabin crew, engineers, ground staff have borne the biggest brunt head on, the unions said.

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News Network
July 1,2020

Patna, July 1: A wedding ceremony in rural Patna a fortnight ago where the groom was running high fever, two days before he died and his body cremated without being tested for COVID 19, appears to have set off the biggest infection chain in Bihar so far, health department officials said on Tuesday.

More than 111 people have tested positive in Paliganj sub-division of Patna district, about 55 km from the state capital, in the last few days, out of over 350 who have been tested upon contact tracing, they said. Fifteen of his relatives who attended the wedding tested positive for the contagion and apparently infected others.

The officials, who requested anonymity, said the groom was a software engineer based in Gurugram and had returned home for his marriage in the last week of May. A few days after the ''tilak'' ceremony, he started showing symptoms of the disease.

On June 15, the date of wedding, he was running high fever and wanted the ceremony to be deferred, but relented upon the insistence of family members who made him swallow paracetamol tablets and go through the rituals.
On June 17, his condition deteriorated significantly and family members made a dash to AIIMS, Patna, but he died on the way.

The body was cremated in a huff, without the authorities being informed. But somebody telephoned the district magistrate and narrated the whole episode. All close relatives of the deceased, who attended the ceremony, were tested on June 19. Of them 15 tested positive, the officials said.

As a measure to contain the spread of the disease, a special camp was set up at the village where the marriage took place on June 24-26 during which samples of 364 people were collected. Of them, 86 tested positive, the officials added.

The sudden explosion of the dreaded coronavirus has triggered panic in the area. Although most who tested positive were asymptomatic, they have been admitted to isolation centres in Bihta and Phulwarisharif.

Block Development Officer Chiranjeev Pandey said Meetha Kuan, Khagari Mohalla and parts of Paliganj Bazaar have been sealed for thorough sanitisation.

Patna district happens to be the worst-affected in Bihar with 699 confirmed cases till date and five casualties, according to figures provided by the administration. The number of active cases is 372.

On Monday, when the state witnessed its biggest single day spike with 394 cases, Patna district accounted for more than 20 per cent of these. About eighty cases were reported from Paliganj alone.

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