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
April 3,2020

New Delhi, Apr 3: The total number of coronavirus cases in Delhi has risen to 384, including 259 who were evacuated from Nizamuddin Markaz, Chief Minister Arvind Kejriwal said on Friday.

In last 24 hours, 91 new cases were reported in the national capital and one more person evacuated from the Markaz died due to coronavirus, taking the total number of deaths in the city to five, he said.

Of the 384 cases, 58 had recent foreign travel history and 38 contracted the virus after coming in contact with them, he added.

Kejriwal said community spread of the virus is not taking place in Delhi yet and there is no need to panic as the situation is under control.

The government has made preparations if the virus starts spreading among people, he said.

The chief minister also launched a WhatsApp helpline - 8800007722 for people to enquire about COVID-19, food banks, shelters among others.

Meanwhile, Kejriwal, deputy chief minister Manish Sisodia and experts will interact with students and answer their queries related to the virus at 3 pm on Saturday.

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News Network
January 28,2020

Jan 28: After Union minister Anurag Thakur, on Tuesday, BJP MP Parvesh Verma has stoked a controversy by saying that "Shaheen Bagh protesters will enter houses and rape sisters, daughters." The BJP MP even went on to say that if BJP is voted to power in Delhi, they "will clear Shaheen Bagh protest within an hour."

"If the BJP comes to power in Delhi on February 11, we will clear Shaheen Bagh of all protests and protesters within one hour. Not a single person will be visible," Parvesh Verma said during a meeting at Vikaspuri assembly constituency.

"Lakhs of people gather there [Shaheen Bagh]. People of Delhi will have to think and take a decision. They will enter your houses, rape your sisters and daughters, kill them. There's time today, Modi ji & Amit Shah won't come to save you tomorrow..." the BJP MP told news agency ANI.

"If our government is formed, then give me just a month after February 11, and I will remove all mosques built on government land in my Lok Sabha constituency," the BJP parliamentarian added.

Well, these statements didn't go down well with the netizens, who took to Twitter to express what they felt about the BJP leader's comments. A user wrote, "This is pure, unadulterated hate speech." While other user said, "Only when you thought BJP couldn't stoop any lower."

Earlier, on Monday, BJP leader and Union Minister Anurag Thakur triggered a row after he led the crowd to raise an incendiary slogan that "traitors should be shot". At the rally, Thakur, the Minister of State (MoS) for Finance, shouted: "desh ke gaddaron ko" to which the crowd responded, "goli maro saalo ko" (shoot down the traitors).

Addressing the meeting in support of BJP candidate from Rithala, Manish Chaudhary, Thakur raised the pitch of nationalism as he linked opposition parties with anti-CAA protests in Shaheen Bagh and with alleged anti-India slogans, and then asked the crowd to raise the controversial slogan.

For more than a month, over 200 women have been joined by hundreds of others every day at South East Delhi's Shaheen Bagh at a sit-in protest against the CAA which promises citizenship to only non-Muslim refugees from three neighbouring countries.

Protests have been ongoing in different parts of the country against the amended Citizenship Act (CAA) which grants citizenship to Hindus, Sikhs, Jains, Parsis, Buddhists and Christians fleeing religious persecution from Pakistan, Afghanistan, and Bangladesh if they entered India on or before December 31, 2014.

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Agencies
July 16,2020

New Delhi, Jul 16: A group of 174 Indian nationals, including seven minors, has filed a lawsuit against the recent presidential proclamation on H-1B that would prevent them from entering the United States or a visa would not be issued to them.

Judge Ketanji Brown Jackson at the US District Court in the District of Columbia issued summonses on Wednesday to Secretary of State Mike Pompeo and acting Secretary of Homeland Security Chad F Wolf, along with Labor Secretary Eugene Scalia.

The lawsuit was filed in the US District Court on Tuesday.

"The proclamation 10052's H-1B/H-4 visa ban hurts the United States' economy, separates families and defies the Congress. While the two former points render it unseemly, the latter point renders it unlawful," said the lawsuit filed by lawyer Wasden Banias on behalf of the 174 Indian nationals.

The lawsuit seeks an order declaring the presidential proclamation restriction on issuing new H-1B or H4 visas or admitting new H-1B or H-4 visa holders as unlawful. It also urges the court to compel the Department of State to issue decisions on pending requests for H-1B and H-4 visas.

In his presidential proclamation on June 22, Trump temporarily suspended issuing of H-1B work visas till the end of the year.

"In the administration of our nation's immigration system, we must remain mindful of the impact of foreign workers on the United States labor market, particularly in the current extraordinary environment of high domestic unemployment and depressed demand for labor," said the proclamation issued by Trump.

In his proclamation, Trump said the overall unemployment rate in the United States nearly quadrupled between February and May of 2020 -- producing some of the most extreme unemployment ever recorded by the Bureau of Labor Statistics.

While the May rate of 13.3 per cent reflects a marked decline from April, millions of Americans remain out of work.

The proclamation also extends till year-end his previous executive order that had banned issuance of new green cards of lawful permanent residency. Green Card holders, once admitted pursuant to immigrant visas, are granted "open-market" employment authorisation documents, allowing them immediate eligibility to compete for almost any job in any sector of the economy, Trump said.

Forbes, which first reported the lawsuit filed by the Indian nationals, said the complaint points out that the Congress specified the rules under which H-1B visa holders could work in the US and balanced the interests of US workers and employers.

"The complaint seeks to protect H-1B professionals, including those who have passed the labor certification process and possess approved immigrant petitions. Such individuals are waiting for their priority date to obtain permanent residence, a wait that can take many years for Indian nationals," Forbes reported.

Meanwhile, several lawmakers urged Scalia on Tuesday to reverse the work visa ban.

"Throughout this administration, the president has continued to lament the alleged abuses of the immigration system while failing to address the systemic problems that have persisted and allowed businesses and employers to exploit and underpay immigrant workers, guest workers and American workers," the lawmakers wrote.

"This misguided attempt by the president to scapegoat immigrants for policy failures during the pandemic not only serves to hurt immigrants, but dismisses the true problem of a broken work visa program that is in desperate need of reform," said the letter, which among others was signed by Congressmen Joaquin Castro, Chair of the Congressional Hispanic Caucus; Bobby Scott, Chair of the Education and Labor Committee; Karen Bass, Chair of the Congressional Black Caucus; Judy Chu, Ra l Grijalva, Vicente Gonzalez, Yvette Clarke and Linda S nchez.

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