US A COVID-19 vaccine by Election Day? Here are the 3 things that would need to happen, and soon.

14:40  07 october  2020
14:40  07 october  2020 Source:   usatoday.com

Joe Biden’s plan to beat the coronavirus

  Joe Biden’s plan to beat the coronavirus Donald Trump botched America’s Covid-19 response. Joe Biden thinks he has a plan to fix it.President Donald Trump has badly botched the response thus far, according to most experts, and the numbers tell the tale: 200,000 Americans are dead. He’s tried to discredit the scientific institutions tasked with managing the response. Millions of people are still out of work. Thousands of businesses have closed that will never reopen.

guidelines for Covid - 19 vaccines , overriding White House resistance and making it all but impossible an approved jab will be available by Election Day . November 3 . The White House had complained the new guidelines would unacceptably delay the much-anticipated vaccine and attempted to prevent

COVID - 19 Vaccines Are Coming, but They’re Not What You Think. These novel approaches could fail in many ways. On Monday, Kaiser Permanente began soliciting volunteers to be injected with a mystery substance that will , if it works and does not cause unintended harm, release us all from

Could an approved coronavirus vaccine be released prior to Election Day on Nov. 3? It's extremely unlikely – but not impossible – experts say.

President Donald Trump on Monday said, "vaccines are coming momentarily," and he has promised on multiple occasions that one will be ready before the election, now less than a month away.

For that to happen, though, three things would be necessary:

Start the day smarter. Get all the news you need in your inbox each morning.

NFL reportedly discussing playoff bubble following coronavirus cases

  NFL reportedly discussing playoff bubble following coronavirus cases The NFL has already postponed one game and had players test positive for the coronavirus on multiple teams, which has led to talk of potentially needing a bubble plan going forward. That is still on the table, at least for the postseason. © Jasen Vinlove-USA TODAY Sports Discussions about playing games in a postseason bubble have picked up for the NFL internally, according to Jason La Canfora of CBS Sports. The most viable plan would involve the two conference championship games being played in a bubble.

COVID - 19 infections typically take hold in so-called mucosal tissues that line the upper respiratory tract, and to effectively prevent viral spread, "you need to Even if a COVID - 19 vaccine can jumpstart the necessary immune response, researchers aren ’t sure how long that immunity might last, Jacobs added.

Vaccine makers will also have to submit manufacturing process and controls information no less than one month prior to submitting an EUA request. Experts say this makes it near impossible that a COVID - 19 immunization will be approved by Election Day . New, stricter guidelines were submitted

  • First, extremely positive data from ongoing Phase 3 clinical trials would have to be released showing a candidate vaccine to be extraordinarily effective.
  • Second, the vaccine manufacturer would have to apply to the U.S. Food and Drug Administration for its approval.
  • And third, the FDA likely would have to ignore its own guidelines for companies seeking authorization.
a large building: This Aug. 2, 2018, file photo shows the U.S. Food and Drug Administration building behind FDA logos at a bus stop on the agency's campus in Silver Spring, Md. © Jacquelyn Martin, AP This Aug. 2, 2018, file photo shows the U.S. Food and Drug Administration building behind FDA logos at a bus stop on the agency's campus in Silver Spring, Md.

On Tuesday, the FDA updated those guidelines for COVID-19 vaccine emergency use authorizations, requiring at least two months of follow-up data after trial volunteers take the necessary doses.

NFL implements COVID policy changes; Raiders players fined

  NFL implements COVID policy changes; Raiders players fined In response to the growing number of positive COVID-19 tests around the league, the NFL is taking action. In a call with all 32 teams the league office laid out a slew of new policy changes, and sternly warned teams about the consequences of not following them. © Kirby Lee-USA TODAY Sports In the memo recapping the call, which you can read courtesy of this tweet from Tom Pelissero of NFL Network, they laid out some new protocols.

COVID - 19 vaccines developed by Pfizer/BioNTech and AstraZeneca/Oxford University are two of the leading candidates in the race to be first to get regulatory Trial kits for the Pfizer coronavirus disease vaccination study, which is also a leading candidate to be the first vaccine approved in the west, are

Stephen Miller, a senior adviser to Trump, is the latest person in the president’s orbit to test positive for Covid - 19 . The FDA said it will require at least two months of safety data before considering authorizing a coronavirus vaccine , thwarting Trump’s attempts to deliver a vaccine by election day .

“This is a scientific agency applying scientific standards,” said Gillian Woollett, a senior vice president and expert on FDA guidance and regulatory issues at the health care consulting firm Avalere Health.

Pfizer is furthest along in US Phase 3 vaccine trials after starting July 27

The updated guidance makes it a long shot that a vaccine could be approved for use before the election.

The timing is tight. There are four COVID-19 vaccines currently in Phase 3 clinical trials in the United States. The candidates from the two companies that started first, Moderna and Pfizer, both require two doses. Of those, the furthest along is the Pfizer vaccine. It requires two doses given 28 days apart.

Pfizer launched its U.S. Phase 3 trials on July 27. The second shots would have begun on Aug. 24. Two months of follow-up after that second shot would be Oct. 23.

Mike Pence tried to blame Kamala Harris for undermining a Covid-19 vaccine. But the public blames Trump.

  Mike Pence tried to blame Kamala Harris for undermining a Covid-19 vaccine. But the public blames Trump. Pence’s spin on a Covid-19 vaccine ignored the biggest obstacle to public trust: his boss.Moderator Susan Page asked Harris during the debate whether she would take a vaccine if one were to be approved by the Trump administration.

What is now happening is extremely disturbing. Covid - 19 has certainly been a serious disease, but the flu Yet, as Covid - 19 disappears, mask wearing and social distancing is being enforced as never before, and the This scientist contacted other laboratories, and they were seeing the same things .

Election rival Joe Biden, former First Lady Michelle Obama and medics criticise his upbeat statements. In case you missed them, here are some of today’s major developments from around the world Boris Johnson vowed to defeat Covid and build a better country over the next decade in his leader's “After three days , he was saying: ‘You don’t need to be afraid of it,’” says Stevie Storck of

President Donald Trump says COVID-19 vaccines are coming 'momentarily.' Scientists say they're not.

It's not clear, however, how many volunteers were immediately enrolled in the clinical trial but it likely started small. Such trials tend to start slowly so potential problems can be addressed.

It could take several weeks or months for Pfizer, or any COVID-19 vaccine maker, to have enough volunteers go through both doses followed by the two-month follow-up to have enough data to present to FDA.

That's when the real countdown begins. Only when a company, in this case, frontrunners Moderna, Pfizer, AstraZeneca, or Johnson & Johnson, applies for either a license or the more rapid emergency use authorization that the FDA can begin evaluating whether to allow a vaccine's release.

The heads of nine biopharmaceutical companies working on a COVID-19 vaccine issued a letter Sept. 8 pledging to fully vet their candidates before asking for federal approval to market them.

Once an application is made, it must be evaluated by FDA, approved and then reviewed by the agency's external review board, the Vaccines and Related Biological Products Advisory Committee.

171 countries are teaming up for a Covid-19 vaccine. But not the US.

  171 countries are teaming up for a Covid-19 vaccine. But not the US. Vaccine nationalism is real. But so is vaccine multilateralism.Today, there are 40 vaccine candidates for the coronavirus being studied in humans — including nine in the final phase of testing.

Here 's how to volunteer for a Covid - 19 vaccine trial. Federal law and NIH policy mandate inclusion of minorities into clinical trials because vaccines and Black leaders interviewed for this story said part of the problem is they were contacted by vaccine researchers just days or weeks ago, which didn't

A vaccine would normally take years, if not decades, to develop. Researchers hope to achieve the same amount of work in only a few months. That would be a huge scientific feat, and there are no guarantees it will work. But scientists are optimistic that, if trials are successful, then a small number of

For a vaccine to be available prior to the election, all of this would need to take place in 11 days.

There's a 'high likelihood' of success if vaccine trials go to their 'designed end'

There are some ways the process could go more quickly. Phase 3 clinical trials don't necessarily have to run their full course and include all 30,000 volunteers before a vaccine company makes an application to the FDA.

FDA officials have said it might be acceptable to stop a clinical trial earlier on if a vaccine's Data Safety Monitoring Board finds it is working so well it would be immoral to hold it back.

Data Safety Monitoring Boards are outside groups of experts allowed to take "peeks" at the data before a clinical trial has finished to make sure the vaccine or medicine being tested is working and is not harmful.

It is rare, but not unheard of, for a clinical trial to be stopped because the results are so good the monitoring board feels the manufacturer should immediately apply for a license so that it can be made available.

When will children get a COVID-19 vaccine? It's going to be a while

But stopping a trial early could mean there might not be enough data available to show a vaccine candidate was safe and effective in older people at greatest risk for severe disease and illness, said Dr. Larry Corey, a professor of medicine at the University of Washington School of Medicine in Seattle.

Q&A: How far can Trump go in pushing a COVID-19 vaccine that isn't ready?

  Q&A: How far can Trump go in pushing a COVID-19 vaccine that isn't ready? The Trump administration seems to be going to great lengths to get a COVID-19 vaccine produced by election day. How much can they get away with?President Trump has made clear that his top priority is speed. For a time, his administration rejected the Food & Drug Administration's proposed criteria for assessing vaccine candidates — criteria which make it all but impossible to have a vaccine available by election day.

Adding only a few more weeks could have a huge difference in what's known about the vaccine, he said.

Keeping a trial running just seven additional weeks triples the amount one can learn about vaccine efficacy, he said during a program Tuesday on scientific integrity in vaccine trials sponsored by Johns Hopkins University and the University of Washington.

"Allowing the trial to go to its designed end would provide a high likelihood that we would be able to determine that vaccine efficacy appears to benefit the elderly, those with health disparity and importantly reduce health complications," Corey said.

Could HHS Secretary Alex Azar bypass FDA and 'put a vaccine out there'?

The final arbiter of the process will be the Vaccines and Related Biological Products Advisory Committee, which has a meeting scheduled for Oct. 22. According to the committee's agenda, "no specific application will be discussed at this meeting."

Dr. Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia, is a member of the committee. He said he can't see a way for a COVID-19 vaccine to go through the necessary oversight prior to the election.

Where will your family be? Expert panel recommends who should be first in line for COVID-19 vaccine

The only way for that to happen, he said, would be if the head of the U.S. Department of Health and Human Services were to make the decision himself. In a memo published Sept. 15, HHS Secretary Alex Azar declared he has final authority over the nation's health agencies, including the FDA.

China Covid-19 vaccine: Inside the company at the forefront of China's push to develop a coronavirus vaccine

  China Covid-19 vaccine: Inside the company at the forefront of China's push to develop a coronavirus vaccine Inside the white, sterile walls of a new building on the southern outskirts of Beijing, two employees donning masks and rubber gloves are busy pipetting a clear, colorless liquid into rows of small vials. © NICOLAS ASFOURI/AFP/AFP via Getty Images In this picture taken on April 29, 2020, an engineer shows an experimental vaccine for the COVID-19 coronavirus that was tested at the Quality Control Laboratory at the Sinovac Biotech facilities in Beijing.

The memo said the power to sign new rules is reserved to the secretary, a Trump appointee.

"Alex Azar could say, ‘We’re in the midst of the pandemic, I am choosing to put a vaccine out there, I am bypassing the FDA,'" said Offit.

Contact Elizabeth Weise at eweise@usatoday.com

This article originally appeared on USA TODAY: A COVID-19 vaccine by Election Day? Here are the 3 things that would need to happen, and soon.

India: Hundreds of thousands of tea pickers in Assam on indefinite strike .
© Biju BORO / AFP Tea pickers joined farmers in protesting the liberalization of the sale of fruits and vegetables. The strike began this Friday, October 9 to demand wage increases. These workers joined the farmers, who have been protesting for two weeks now against the new selling prices for fruit and vegetables. With our correspondent in Bangalore, Côme Bastin The State of Assam produces nearly 50% of India's tea, and it is found on many tables around the world.

usr: 3
This is interesting!