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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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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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