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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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India is ‘very inspiring’; its research, manufacturing critical to fighting Covid-19: Bill Gates

He also said although the RT-PCR test has high specificity, a lot of challenge is about the logistics.

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Bill Gates Covid Vaccine

India’s research and manufacturing will be critical to fighting Covid-19 especially for making vaccines on a large scale, billionaire philanthropist Bill Gates said on Monday.

Addressing the Grand Challenges Annual Meeting 2020, Gates delved upon the difficulties in vaccine development and diagnostics of Covid-19.

The American business magnate said India is “very inspiring” as it has made huge strides in improving the health of its people in the last two decades.

“And now, India’s research and manufacturing will be critical to fighting Covid-19 especially when it comes to making vaccines at large scale,” he said.
Gates said scientists all over the world are involved in a particular ‘grand challenge’ — ending the current pandemic.

He said researchers are breaking down silos and rather than waiting to go through the publication process, they are sharing data on a daily basis.

“Since the pandemic began, scientists have shared 1,37,000 viral COVID-19 genomic sequences,” the Microsoft Corp co-founder said. Even the pharmaceutical companies are cooperating on production ways that really have never been seen before, he added.

Talking about the challenges in vaccine development, he said mRNA vaccine is an area where many have seen “great promises”.

“Probably, the first approved vaccine for COVID-19 will be mRNA,” he said but added that the vaccine cannot be counted on alone because it is very hard to scale up and has a logistical problem because it requires a proper cold chain.

Gates expressed hope that the mRNA platform matures in the years ahead so that its vaccines can be scaled up that can bring down the costs as well the cold chain requirement.

He also stressed on the need for innovation in diagnostics platforms.

“Even when sometimes people are tested, results come back negative because some of the tests are not sensitive to the small nano virus,” he said, adding, this also leads to infection.

“So, the diagnostics are letting us down,” Gates said, stressing on the asymptomatic nature of the infection.

“Right now, the current business model is identifying people with symptoms and we need to change that. We need sensitive and specific diagnostic tests which matter and we need to make it easy to access,” he said.

He also said although the RT-PCR test has high specificity, a lot of challenge is about the logistics.

Gates suggested that there should be test kits that can be spread out into the community and can be stocked in medicine cabinets, community centres and pharmacies.

On cooperation by the scientific fraternity, he noted that international teams of scientists are collaborating with full speed on the vaccine clinical trials.

“One or more of these vaccines will be available by early next year and as there will be multiples vaccines, it is necessary to make sure to understand how exactly and where to use each of them,” he said.

Gates said the pace of science in fighting the pandemic has been remarkable.

“But despite all this work, right now, as fast as the science has moved…the pandemic is still ahead of us. The first COVID-19 vaccine will probably be the fastest that humans have ever gone from identifying the new disease to be able to immunise against it,” he said.

“Still we all know this virus has managed to plunge the entire global economy into a deep recession,” he added.

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60-70 polluting power plants to be closed soon: Javadekar

He also referred to the efforts to tackle the problem of pollution in the national capital through public transport services.

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Prakash Javadekar

New Delhi, Oct 18 : Union Environment, Forests and Climate Change Minister Prakash Javadekar on Sunday announced that 60-70 pollution-causing power plants would be identified and closed in the next two years as he discussed steps taken by the Narendra Modi government to tackle the pollution menace.

Launching a social media connection with people, he made the announcement in a question and answer session on Facebook Live.

The minister said that power plants of Badarpur and Sonipat in Delhi-NCR have already been shut down.

Javadekar said mainly 5-6 aspects contribute to the pollution — traffic, industry, garbage, dust, stubble burning and geographical factors.

Listing the steps taken by the Modi government, he said that the use of BS-VI fuel reduces pollution by 25-60 per cent, and a key step has been taken to promote BS-VI fuel at a cost of Rs 62,000 crore.

He also referred to the efforts to tackle the problem of pollution in the national capital through public transport services.

“In 2014, while 25-30 lakh people used to travel by Metro in Delhi and NCR, today 45-50 lakh people commute by Metro. This is a big achievement. The construction of Eastern-Western Peripheral Expressway has also taken care of around 60,000 pollution causing vehicles that used to pass through Delhi. Now, the metro and e-buses facilities are being increased in all cities.”

The Union Minister said during the Facebook Live interaction that in 2015, the Modi government launched the National Air Quality Index for the first time. From 2016, the monitoring of air quality began.

“In the year 2016, while there were 250 days of bad air, the count today has come down to 180.”

Javadekar said the cause of pollution in Delhi-NCR is also due to geographical factors.

“Due slow air-flow, the problem of pollution is more in Delhi. The pollution reduces whenever the wind blows,” he said.

He also said the Modi government also framed new rules for construction and demolition management in 2016 in Delhi to manage pollution.

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Britain records 16,171 new coronavirus cases in 24 hours

The data showed 150 new deaths from COVID-19, defined as having occurred within 28 days of a positive coronavirus test, compared to 136 on Friday.

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Britain Coronavirus

LONDON : Britain has recorded 16,171 new cases of coronavirus within 24 hours, according to government data published on Saturday, compared with 15,650 the previous day.

The infection rate has risen sharply in recent weeks, prompting British Prime Minister Boris Johnson and other regional leaders to introduce tighter restrictions and local lockdowns.

The data showed 150 new deaths from COVID-19, defined as having occurred within 28 days of a positive coronavirus test, compared to 136 on Friday.

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