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Congress chief Rahul Gandhi asks state govt, party workers to provide immediate relief

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Congress chief Rahul Gandhi asks state govt, party workers to provide immediate relief at Amritsar train accident site.

The disaster happened when a large number of people were watching the Ravan effigy in flames while standing on the railway tracks near Jora Phatak when the train crushed them.

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Moderna shares Covid-19 vaccine trial blueprints, will others follow?

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COVID-19 Vaccine

US biotech firm Moderna, one of nine companies in the late stages of clinical trials for a Covid-19 vaccine, has become the first to publish the complete blueprints of its study following calls for greater transparency.

The initiative puts pressure on other companies to follow suit, especially Pfizer, the other American company currently carrying out Phase 3 trials in the US.

This is the final stage before approval, in which a vaccine and a placebo are tested on thousands of participants to verify the medicine is safe and effective.

The vaccine race has become deeply politicized in the US in the run-up to the presidential election in November, as President Donald Trump touts one against criticism of his handling of the pandemic.

Trump repeated on Wednesday that the first vaccine would be approved by October, increasing concerns that the White House will place pressure on the approval body, the Food and Drug Administration (FDA).

“I don’t trust Donald Trump,” his rival from the Democratic party Joe Biden said Wednesday.

Experts and officials in the Republican president’s administration agree that it’s not possible to predict the results of the trials that are underway, and it’s highly unlikely to have strong data before the end of 2020.

Vaccine doses will be initially very limited, according to health authorities.

Moderna’s CEO Stephane Bancel said on Thursday his company would know whether their vaccine works by November.

October is possible but unlikely, he told CNBC.

The trial protocol published Thursday, which runs to 135 pages and is marked “confidential,” fixes the parameters of the experiment.

The most important of these is how it will judge whether results are conclusive.

The reality of an immunization trial is that it’s necessary to wait until a certain number of volunteers become naturally infected, in order to compare outcomes in the placebo group against the group given the vaccine.

So the decline in the rate of infection in the US could theoretically delay the results — possibly until December, said Bancel.

As of Thursday, Moderna had recruited 25,296 volunteers. Among them, 10,025 had received their second dose, 28 days after the first.

It’ll take a few more weeks to recruit the full quotient of 30,000 participants and for them to receive their second doses.

Only Covid-19 infections recorded two weeks or more after the second dose are counted, to give the vaccine sufficient time to take effect.

Interim analyses by a committee of independent experts are planned over the course of the trial to verify whether a high statistical threshold of effectiveness has been reached, and to monitor for serious side effects.

The FDA has stated its bar for approval is a vaccine that reduces the risk of falling sick with Covid-19 by 50 percent.

“This has the key information (for) stopping rules, interim analyses and efficacy assumptions. Applaud their transparency,” Eric Topol, director of the Scripps Research Institute and one of the critics leading the charge against possible political interference, told AFP.

Moderna also said that 28 percent of its participants were from racial minority groups.

Having sufficient participants among black and Hispanic people in particular is crucial in obtaining statistically representative results for these communities that have been disproportionately hit by the pandemic.

The decision by Moderna, which has received $2.5 billion in US government money, now leaves the spotlight on Pfizer, the other company in the running for the first US authorization.

Its CEO has repeatedly said the company will have its results by the end of October, which is in line with Trump’s wishes.

The other frontrunner is AstraZeneca, which has co-developed a vaccine with the University of Oxford.

The medicine’s global trials were suspended last week after a participant had an unexplained illness, but were later restarted in the UK, Brazil, and South Africa. The US remains the exception for reasons that aren’t yet known.

“Transparency is crucial to overcome vaccine hesitancy. Other vaccine makers should follow @moderna_tx lead,” tweeted Angela Rasmussen, a virologist at Columbia University.

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Free vaccine for Americans, but won’t be widely available till ’21 summer

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Covid 19 Vaccine

New York, Sep 17 : A 57 page “playbook” just in from the US government outlines a comprehensive plan to make the COVID-19 vaccine available free to all Americans once it is proven safe and effective.

At a hearing before a Senate subcommittee on Capitol Hill, CDC Direct Robert Redfield said any vaccine is unlikely to be widely available to most Americans before the summer or early fall of 2021, given initial constraints on supplies if and when a vaccine wins approval from the Food and Drug Administration (FDA).

“I think there will be vaccine that will initially be available some time between November and December, but very limited supply, and it will have to be prioritized,” Redfield told lawmakers. “If you’re asking me when is it going to be generally available to the American public so we can begin to take advantage of vaccine to get back to our regular life, I think we’re probably looking at late second quarter, third quarter 2021.”

His comments came after the Trump administration unveiled its plan to distribute a coronavirus vaccine soon after the FDA approves its use.

Federal officials from Operation Warp Speed, the government’s vaccine development task force, said on a call with reporters that vaccine distribution will be set in motion “within 24 hours” of the FDA authorizing a vaccine, different versions of which are being developed by major drug manufacturers. The strategy released by the Department of Health and Human Services (HHS) details plans to provide enough doses so that everyone who wants to be vaccinated can be, said Redfield.

The government has spent billions of dollars to secure millions of doses of potential vaccines, and “no American will be charged for either the COVID-19 vaccine or its distribution,” the HHS document said. The department is also developing plans under recent legislation to ensure that “no one will be charged any out–of-pocket expenses for the administration of the vaccine either.”

There are currently nine companies with vaccines in phase three efficacy trials, and five approved for early or limited use. Two prominent U.S. companies, Pfizer and Moderna, are both in phase three trials.

Pfizer CEO Albert Bourla said in an interview with “Face the Nation” on Sunday that the company has already manufactured hundreds of thousands of doses of its vaccine, and has a “good chance” of knowing whether it works by the end of October. Bourla said Pfizer is preparing for approval from the federal government and initial distribution of a vaccine before the end of the year.

On Labor Day, President Trump asserted that a coronavirus vaccine could be ready “during the month of October” — just weeks before the presidential election on November 3. The president’s truncated timeline raised concerns about political pressure on the normal regulatory process of vetting a vaccine.

Dr. Scott Gottlieb, the former commissioner of the FDA and a member of Pfizer’s board of directors, said on “Face the Nation” last week that despite the rapid pace, he has “absolute confidence in the scientific staff” tasked with approving any vaccine. “I don’t think politics should get in the way at all, and I don’t think it will,” he said. “There’s a very rigorous process around the development and approval of a vaccine.”

Gottlieb has stressed he does not believe a vaccine will be widely available until 2021.

“This is likely to be a very staged market entry,” he said on “Face the Nation.” “I think that’s what people should expect. But for most people, they will not have access to a vaccine until 2021. I think maybe the first quarter of 2021, probably the first half of 2021. And that’s assuming that these vaccines are demonstrated to be safe and effective in these large trials.”

The strategy for eventual vaccine distribution released by HHS on Wednesday outlines a “phased structure” that relies on cooperation between public and private entities. The relationship hinges on a shared database of vaccination history for all Americans opting to receive the coronavirus vaccine.

Any vaccine will likely require two doses, administered about a month apart, in order to be effective. Officials noted that the time lapse will inevitably force some people to be vaccinated at two different locations, therefore requiring all vaccination centers to be in communication with each other through a shared database.

Combining existing vaccination databases from states and private pharmacies is the next hurdle, according to officials. “The databases exist. The hard part is getting the databases to talk to each other,” said Lieutenant General Paul Ostrowski, who oversees logistics for Operation Warp Speed.

The first phase of distribution — after FDA approval — has the goal of “maximizing vaccine acceptance and public health protection while minimizing waste and inefficiency.” The initial supply for the vaccine will be limited. “Final decisions about prioritization” have yet to be made, according to the strategy document, but federal officials have begun developing plans “specific to focused populations” most in need of a vaccine.

“As the volume of available vaccine increases, distribution will expand, increasing access to the larger population,” reads the phase two outline. “When larger quantities of vaccine become available, there will be two simultaneous objectives: 1) to provide widespread access to vaccination and achieve coverage across the United States population and 2) to ensure high uptake in target populations, particularly those who are at high risk for severe outcomes from COVID-19.”

Phase three acknowledges that initial vaccine distribution may not be widespread enough to stamp out the virus. According to HHS, “if the risk of COVID-19 persists such that there remains a public health need for an ongoing vaccination program,” the vaccine will ultimately be made “universally available and integrated into routine vaccination programs, run by both public and private partners.”

Redfield noted that the framework is not final, and will be updated as more information is known. He called planning for distribution a a “critical next step” in order to “restore our normal way of life.”

“CDC is drawing on its years of planning and cooperation with state and local public health partners to ensure a safe, effective, and life-saving COVID-19 vaccine is ready to be distributed following FDA approval,” Redfield said in a press release. “CDC will play a vital role in deciding, based on input from experts and stakeholders, how initial, limited vaccine doses will be allocated and distributed while reliably producing more than 100 million doses by January 2021.”

According to HHS, the process for distributing the vaccine “will be adjusted based on experience from COVID-19, real-time data on the virus and its impact on populations, performance of each vaccine, and the ongoing needs of the essential workforce.”

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Rajasthan: A boat carrying around 45 devotees to a temple capsize in Chambal river

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Rajasthan Boat Capsize

Jaipur: At least 14 people were missing as a boat carrying around 40 pilgrims capsized in the Chambal river in Rajasthan’s Kota district on Wednesday early morning.

Local administration, villagers, and police teams swung into action to carry out the rescue operations. A State Disaster Response Force (SDRF) team also reached there to accelerate the rescue work.

District Collector Ujjawal Singh Rathore said around three dozen villagers of Gothda Kala were going to Kamleshwar Dham across the Chambal River when the boat capsized near Khatoli.

Some of them managed to swim to the shore, but 14 persons were reported missing, including children, said Rathore.

Chief Minister Ashok Gehlot condoled the deaths reported in the incident.

In a tweet, he said, “The incident of overturning a boat near Chambal Dhibari in Khatoli area of Thana in Kota is very sad and unfortunate. My deepest condolences to the families of the victims.”

“Have spoken to the Kota administration to get updates on the issue. Also have directed officials to trace missing people with immediate relief and rescue operations. Local police and administration are at the site. The affected families shall get help from CM’s Relief fund,” he added.

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Corona Virus (COVID-19) Live Data

COVID-19 affects different people in different ways. Most infected people will develop mild to moderate illness and recover without hospitalization.