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About ‘Coronavirus Covid-19 Pandemic‘ ? :
Coronavirus disease (COVID-19) is an infectious disease caused by a newly discovered coronavirus.
 
Most people who fall sick with COVID-19 will experience mild to moderate symptoms and recover without special treatment.
 
 
HOW IT SPREADS
 
The virus that causes COVID-19 is mainly transmitted through droplets generated when an infected person coughs, sneezes, or exhales. These droplets are too heavy to hang in the air, and quickly fall on floors or surfaces.
 
You can be infected by breathing in the virus if you are within close proximity of someone who has COVID-19, or by touching a contaminated surface and then your eyes, nose or mouth.

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Moderna says its coronavirus vaccine is 94.5% effective against COVID-19, a crucial victory in the fight against the pandemic

  • Moderna’s experimental coronavirus vaccine was highly effective at preventing COVID-19 in its late-stage trial, the Massachusetts biotech company said on Monday.
  • The finding comes from a 30,000-person study that compared volunteers who got a two-dose regimen of Moderna’s shot with ones who got a placebo.
  • The vaccine was shown to be 94.5% effective in a preliminary analysis.
  • The announcement closely follows similar news from a rival vaccine program by Pfizer and BioNTech, which touted late-stage success a week ago.
  • The impact from these scientific successes won’t be immediate. Both vaccine candidates still need to secure regulatory approval, and initial supply will be extremely limited.
  • Still, it’s undeniably encouraging news in society’s fight against the pandemic.
  • For more stories like this, sign up here for Business Insider’s daily healthcare newsletter.

A second experimental coronavirus vaccine has succeeded at preventing COVID-19 in the final stage of clinical research, marking a victory in the fight against the pandemic.

The upstart biotech Moderna announced the success Monday morning in a press release, saying its vaccine was 94.5% effective at preventing COVID-19, the disease caused by the novel coronavirus. An independent group of experts found clear signs of effectiveness after reviewing preliminary data from an ongoing 30,000-person study, Moderna said.

Moderna’s shot is the second major vaccine program to announce success in a late-stage trial. Pfizer and its German partner BioNTech said on November 9 that their vaccine was found to be more than 90% effective at preventing COVID-19 in an early review of an ongoing study.

Both announcements provide much-needed good news, as the pandemic surges across the world, though it could be weeks before regulators review the shots and decide whether to make them more widely available. The US is now averaging more than 140,000 new coronavirus cases a day, and the healthcare system is showing troubling signs of strain as hospitalizations and deaths rise.

Moderna’s stock price gained more than 10% before markets opened Monday and was poised to hit an all-time high. US stock futures jumped as well, with the S&P 500 and the Dow Jones Industrial Average gaining 1.4% to 1.8% to trade around session highs.

Pair of ‘excellent vaccines’

“Those are two excellent vaccines that are going to help a lot of Americans and help a lot of people around the world,” Moderna CEO Stéphane Bancel said in a video interview with Business Insider.

Moderna’s release indicates its vaccine is broadly similar to Pfizer’s. Moderna said its vaccine appeared to be 94.5% effective, while Pfizer said its shot was more than 90% effective. Moderna’s analysis was based on 95 COVID-19 cases, while Pfizer’s review included 94 cases. Neither company’s data has been published in a scientific journal, and both are still collecting more information on how safe their shots are.

Moderna’s study starts counting cases of coronavirus two weeks after volunteers get their second shot, while Pfizer’s study records illnesses one week after volunteers finish the vaccination course.

It would be “naïve to compare the 90% to 94.5%,” Bancel told Business Insider, saying it’s too soon to compare the shots.

Volunteers in Moderna’s trial were randomly given a two-dose regimen of either Moderna’s experimental shot or placebo injections. The expert panel’s conclusion is based on 95 cases of the disease observed in the study.

Out of those 95 illnesses, 90 people on placebo got sick compared with five receiving Moderna’s vaccine. The vaccine also appeared to prevent serious illness. Researchers found 11 cases of severe COVID-19 among the placebo group and zero among people who got the vaccine.

Moderna’s vaccine has one crucial advantage over Pfizer’s shot: It can be stored for a month at typical fridge temperatures (36 degrees Fahrenheit to 46 degrees Fahrenheit), while Pfizer’s shot needs to be stored at minus 94 degrees Fahrenheit, requiring dry ice and special containers.

Moderna’s vaccine still needs to be evaluated by FDA

Both vaccines are still experimental and need to secure regulatory authorization before being rolled out to the public. Both companies plan to apply for emergency-use authorization later in November. It’s unclear how long the US Food and Drug Administration will take to evaluate the shots and decide whether to approve them.

Even if OK’d by regulators, vaccine supply will be extremely limited at first, though having two vaccines would be helpful.

Moncef Slaoui, the chief advisor to the US government’s vaccine initiative, called Operation Warp Speed, recently estimated that 20 million Americans could be immunized in December if both shots were approved.

Moderna was a key component of Warp Speed’s vaccine plan, with the US government investing up to $2.48 billion to fund its development and secure a supply.

Pfizer has said it hopes to produce up to 50 million doses by the end of 2020, and Moderna should have 20 million doses available in the US by year’s end. Both shots are given as two-dose regimens.

Manufacturing will expand in 2021, with Pfizer saying it will have enough of its vaccine to immunize up to 650 million people and Moderna aiming to produce enough shots for 500 million worldwide. Vaccines from other drugmakers could become available next year as well if they succeed in clinical trials that are now underway.

Bancel predicted that a coronavirus vaccine would be widely available in the US by Memorial Day, at the end of May, based only on the results from Pfizer and from his company.

“Even if no other vaccines were going to make it, as a worst-case scenario, I think by Memorial Day, end of June, any Americans who want a vaccine will have their hands on a vaccine,” Bancel said.

Early success should bode well for other vaccine frontrunners

Moderna coronavirus vaccine trial participant Hans Pennink/AP

The effectiveness of Moderna’s shot should bode well for other vaccine frontrunners. All these experimental shots target the same part of the novel coronavirus, the spike protein.

Slaoui told Business Insider in October that he anticipated three waves of approvals over the next few months.

Moderna and Pfizer would make up the first wave. They could quickly be followed by shots from Johnson & Johnson and AstraZeneca. Slaoui said he expected results in December or January from those companies.

The third wave includes two more shots — one by Novavax and the other by Sanofi and GlaxoSmithKline. Those programs are expected to start the final stage of clinical trials in the US within the next few weeks.

Leading government scientists have said a vaccine should be widely available to Americans by April. Slaoui predicted in August that If people agreed to get the shots, we could return to normal in the second half of 2021.

Read more: EXCLUSIVE: The head of Operation Warp Speed shares his best timeline on the race for a COVID-19 vaccine and predicts a return to normal in the 2nd half of 2021

The announcements that both vaccines are effective is a validation for the new technology that both use, called messenger RNA. The technology platform uses only the genetic code of the virus to create a shot. The approach is promising yet novel: There are no federally approved mRNA vaccines to date.

Key questions remain unanswered, despite promising news

It’s too early to draw any conclusions on whether one vaccine is more efficacious or safer than the other. While Moderna provided far more detailed results than Pfizer, neither has published data in medical journals from its trials, which remain ongoing.

Both companies are still collecting and analyzing data, which means the exact effectiveness of the shots could differ from these preliminary results.

Moderna gave an overview of preliminary data on safety and side effects, while Pfizer didn’t provide that information.

Most side effects from Moderna’s shots were mild or moderate, but some volunteers did have severe side effects, which are medically significant but not life-threatening. These happened mainly after the second injection. The most common severe side effects were fatigue (9.7%), muscle pains or aches (8.9%), joint pain (5.2%), headache (4.5%), pain (4.1%), and redness at the injection site (2.0%).

While Moderna said these side effects were “generally short-lived,” specific details will be important, particularly in terms of how severe and long-lasting the side effects were.

There are some other unanswered questions.

On efficacy, it’s unclear whether either vaccine prevents asymptomatic infections. The studies probably won’t be able to answer that question definitively, as volunteers weren’t tested for the coronavirus unless they developed symptoms.

Neither company has provided detailed results by age group. Some vaccines have historically been less protective in older people.

Finally, we don’t know anything about how long protection might last. That information will only come with more time, as study volunteers are followed for many more months. It’s possible people will need to get booster shots, though no one knows whether those would be needed in six months, a year, or several years down the line.

A transformative moment for Moderna

Stephane Bancel Steven Ferdman/Getty Images

While Pfizer is a pharmaceutical giant known for treatments like Viagra and Lipitor, Moderna is a much smaller biotech upstart that has never developed an approved medication.

Still, Moderna, which has been around for only about a decade, has quickly became one of the buzziest startups in the drug industry.

Bancel, the CEO, has had grand visions of mRNA’s potential to work in a wide range of diseases. That has driven record levels of fundraising for Moderna, including the largest biotech initial public offering in history in December 2018.

The Cambridge, Massachusetts, company is working on several other vaccine candidates for Zika, influenza, cytomegalovirus, and respiratory syncytial virus.

Moderna is hoping its coronavirus success proves that the company’s foundational technology works, Bancel said.

“It’s copy and paste,” he said. “So the Zika vaccine, the CMV vaccine, if this vaccine shows high efficacy, they are going to have high efficacy. It’s just science.”

Responding to the pandemic has accelerated the company’s progress, and Moderna has worked closely with the US National Institutes of Health since January to develop and test a COVID-19 vaccine candidate. Moderna’s vaccine candidate was the first in the world to start human testing in March.

To be able to have positive efficacy results from a late-stage study in less than a year is a scientific feat so far matched only by Pfizer and BioNTech.

Investors have noticed. Moderna’s stock has more than quadrupled this year, driven by its coronavirus vaccine progress. The company has hired hundreds of new employees, particularly to help run its Norwood, Massachusetts, manufacturing plant around the clock.

‘It’s just the beginning’

The company’s success has also drawn criticism. Top company executives and board members sold $236 million in stock over the first nine months of 2020, as some corporate-governance experts criticized the insider sales as bad optics.

And previous press releases about positive early data were criticized by some infectious-disease experts as “science by press release.” The eventual data was later published in a top medical journal and was in line with Moderna’s initial description.

Despite the criticism, Moderna’s late-stage success is the clearest validation of its technology to date.

“It’s just the beginning of a big wave of products,” Bancel said.

While there are major logistical challenges ahead in the fight against the pandemic, having effective vaccines will go a long way to defeating the virus.

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Covid-19 vaccine 90 percent effective in early analysis, Pfizer says

The drug company Pfizer said Monday that early analysis showed its vaccine candidate for Covid-19 is more than 90 percent effective at preventing infection.

The news from the U.S. pharmaceutical giant and its German partner, BioNTech SE, was welcomed as a major step in the fight against a virus that has plagued the global economy, upended daily life for billions and killed 1.26 million people — nearly 240,000 in the United States alone.

Pfizer and BioNTech said in a joint statement that their preliminary findings have shown higher success rates than many had expected. People who received two doses as part of the trial saw 90 percent fewer symptomatic cases of Covid-19 than participants who were given a placebo, they said.

Full coverage of the coronavirus outbreak

President-elect Joe Biden said he welcomed the news, which he said he learned Sunday night, but warned it was “important to understand that the end of the battle against Covid-19 is still months away.”

Even if “some Americans are vaccinated later this year, it will be many more months before there is widespread vaccination in this country,” Biden said in a statement. “Today’s news does not change this urgent reality. Americans will have to rely on masking, distancing, contact tracing, hand washing, and other measures to keep themselves safe well into next year.”

The companies have not released the data backing up the study, and many experts urged caution before those details have been independently scrutinized.

Still, Albert Bourla, Pfizer’s chairman and chief executive, called the news “a great day for science and humanity.”

“We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen,” he added.

John Bell, an Oxford University professor and vaccines adviser to the U.K. government, also welcomed the news, and went as far as to say life could begin to return to normal by spring.

“Yes, I’m probably the first guy to say that but I will say that with some confidence,” he said when asked by the BBC whether that timeline was now realistic.

In spite of the optimism, the news does not mean a vaccine will be immediately available. And many observers are holding judgment until more is known about this vaccine candidate.

Eleanor Riley, a professor of immunology and infectious disease at the University of Edinburgh in Scotland, cautioned that the details released so far did not say how old the participants were, or the severity of the cases observed.

“But, I think we have reason to be cautiously optimistic,” she said.

Pfizer said it plans to ask the U.S. Food and Drug Administration for emergency use authorization next week, when it has the required two months of safety data. There have been no serious safety concerns yet, it said, and the trial will continue in the meantime.

It is unclear how long any protection from a vaccine would last. BioNTech’s chief executive, Ugur Sahin, told Reuters, “We should be more optimistic that the immunization effect can last for at least a year.” He said that was based on earlier findings and research on recovered patients.

Pfizer said that based on current projections, it expects to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021.

Regardless of the unknowns, international markets welcomed the news, with stock futures on Wall Street surging after the announcement.

It came just days after Biden’s victory was confirmed over President Donald Trump, who had repeatedly said a vaccine might be ready before the election.

Trump tweeted “SUCH GREAT NEWS!” after the news was released, and Vice President Mike Pence credited “the public-private partnership forged” by Trump.

But unlike other vaccine front-runners, Pfizer has made a point of not taking any money for research and development from the federal government’s Operation Warp Speed program.

However, the program has agreed with Pfizer that it will pay $1.95 billion for production and delivery, securing the first 100 million doses subject to emergency approval, with the ability to acquire another 500 million.

Even if approved, rolling out the vaccine worldwide will be an unparalleled logistical challenge. Like many others, this vaccine must be kept at supercold temperatures, meaning distribution to remote parts of the world will be difficult.

Image: Alexander SmithAlexander Smith

Alexander Smith is a senior reporter for NBC News Digital based in London.

Laura Saravia contributed.


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Israel to Purchase COVID Vaccine From AstraZeneca for Five Million Residents

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Sunday, November 22, 2020 at 4:15 am | ו’ כסלו תשפ”א

A chemist works at AstraZeneca’s headquarters in Sydney, Australia, in August. (AAP Image/Dan Himbrechts via Reuters)

The Health Ministry on Friday reached an understanding with Swedish-British biopharmaceutical company AstraZeneca to receive some ten million doses of the coronavirus vaccine, and the two parties are discussing the final details of the agreement.

It is expected most of the early vaccines will require two doses, so ten million doses will suffice five million people.

AstraZeneca is one of the leading pharmaceutical companies in the world and has recently published encouraging results on the effectiveness of its vaccine among senior citizens.

An initial supply of vaccines is expected to arrive in Israel in the first half of 2021, subject to approval by regulatory authorities in Europe, the US, and Israel.

Israel is currently negotiating multiple vaccine-related deals with the aim of providing first-class vaccines for every Israeli who wishes to be vaccinated. Contrary to previous media reports, the Health Ministry stressed that no one will be forced to vaccinate should they chose not to.

“This is another important achievement for Israel. We want to make sure that anyone who wishes to be vaccinated will be able to do so as soon as possible. It is better to overachieve in this case,” Prime Minister Binyamin Netanyahu said in a statement.

Meanwhile, it is unclear if children will be able to receive any coronavirus vaccinations purchased from Pfizer, Moderna, and AstraZeneca as none of the companies included children under the age of 12 in their clinical trials.

“Including children in such studies is more complex in terms of ethical approvals. Also, most children who contract the virus recover easily, therefore they are not common participants in COVID-19 vaccine trials. I suppose the study will be expanded later,” Dr. Zachi Grossman, president of the Israel Ambulatory Pediatric Association, told Yisrael Hayom. “I can’t imagine anyone giving a child a vaccine that has only been tested on adults.”

The Pediatric Association has asked the Health Ministry to include its specialists in the team that will regulate the vaccination process, in light of their experience in dealing with those who are hesitant or outright refuse to be vaccinated.

“A significant part of the population is hesitant or opposed to vaccination. The polls state that 20% of the population does not intend to get vaccinated. There is a lot of misinformation in the media and on social networks,” Dr. Grossman added.

The Health Ministry’s Advisory Committee on Infectious Diseases is currently discussing the prioritization of risk groups. The ministry’s pandemic task force has held a similar discussion about at-risk populations and mentioned healthcare workers, including nursing home workers, as an additional group.


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Israel’s First Coronavirus Vaccine Volunteer Leaves Hospital

Fifteen-million shots of the vaccine, called Brilife are already being produced by the Defense Ministry-run Israel Institute for Biological Research.

“Hello everybody, good morning, thank you all for your support,” Segev Harel said after being released from the Sheba Medical Center in Ramat Gan on Sunday, The Times of Israel reported.

“I’m here after spending the night in Sheba Medical, and now I’m going home and I feel great, and I hope we will bring the vaccine to Israel and to the whole world.”

Eytan Ben-Ami, a Sheba doctor conducting the trial, told newspaper: “The first patient was kept in hospital for 24 hours to observe him in case of any adverse effects and there were none.

“Everything has been really smooth. It’s very early in the process, but until now, everything is going according to plan.”

A second volunteer who was inoculated also reported feeling well and had no symptoms or side effects.

The first phase of the clinical trial will last approximately a month and will involve some 80 healthy volunteers ages 18 to 55, the report said.

The second phase beginning in December will vaccinate around 1,000 volunteers ages 18 to 85 at eight hospitals around the country. This phase will also allow volunteers with preexisting conditions to participate.

If that phase goes well and antibodies are detected in the volunteers’ blood, vaccinations will then be given to some 30,000 people in April or May 2021. Following that, it will receive approval for general use around July.

In May, the IIBR made headlines around the world for isolating an antibody that neutralizes the COVID-19 virus.


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Coronavirus Vaccine Could Bring U.S. Back to Normalcy By May

Breaking NewsCNN

Light at the end of the tunnel!!! Maybe. Because there’s now a plan to vaccinate like crazy and get this country back to something that resembles normal by May, 2021.

Dr. Moncef Slaoui, the chief scientific advisor to Operation Warp Speed, told Jake Tapper Sunday on CNN, the drug companies — notably Pfizer and Moderna — are ready to ship out millions of doses of their vaccines as early as December 11, the day after anticipated FDA approval.

Dr. Slaoui went on to say 20 million doses would be shipped out in December, and 30 million a month thereafter. When you do the math, by May … around half the country would be vaccinated and the good Doc thinks that opens the door to a restoration of normal life.

The problem … May could be the sunset month for the vaccine, since half the country seems opposed to getting the shot. Nonetheless, if the vaccines do indeed provide 95% protection from the virus — and especially if you choose the people with whom you interact face-to-face based on their inoculation status … there would be reason to feel relatively safe from COVID.

Premature hallelujah.


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Moderna says its coronavirus vaccine is 94.5% effective against COVID-19, a crucial victory in the fight against the pandemic

Moderna says its coronavirus vaccine is 94.5% effective against COVID-19, a crucial victory in the fight against the pandemic

  • Moderna’s experimental coronavirus vaccine was highly effective at preventing COVID-19 in its late-stage trial, the Massachusetts biotech company said on Monday.
  • The finding comes from a 30,000-person study that compared volunteers who got a two-dose regimen of Moderna’s shot with ones who got a placebo.
  • The vaccine was shown to be 94.5% effective in a preliminary analysis.
  • The announcement closely follows similar news from a rival vaccine program by Pfizer and BioNTech, which touted late-stage success a week ago.
  • The impact from these scientific successes won’t be immediate. Both vaccine candidates still need to secure regulatory approval, and initial supply will be extremely limited.
  • Still, it’s undeniably encouraging news in society’s fight against the pandemic.
  • For more stories like this, sign up here for Business Insider’s daily healthcare newsletter.

A second experimental coronavirus vaccine has succeeded at preventing COVID-19 in the final stage of clinical research, marking a victory in the fight against the pandemic.

The upstart biotech Moderna announced the success Monday morning in a press release, saying its vaccine was 94.5% effective at preventing COVID-19, the disease caused by the novel coronavirus. An independent group of experts found clear signs of effectiveness after reviewing preliminary data from an ongoing 30,000-person study, Moderna said.

Moderna’s shot is the second major vaccine program to announce success in a late-stage trial. Pfizer and its German partner BioNTech said on November 9 that their vaccine was found to be more than 90% effective at preventing COVID-19 in an early review of an ongoing study.

Both announcements provide much-needed good news, as the pandemic surges across the world, though it could be weeks before regulators review the shots and decide whether to make them more widely available. The US is now averaging more than 140,000 new coronavirus cases a day, and the healthcare system is showing troubling signs of strain as hospitalizations and deaths rise.

Moderna’s stock price gained more than 10% before markets opened Monday and was poised to hit an all-time high. US stock futures jumped as well, with the S&P 500 and the Dow Jones Industrial Average gaining 1.4% to 1.8% to trade around session highs.

Pair of ‘excellent vaccines’

“Those are two excellent vaccines that are going to help a lot of Americans and help a lot of people around the world,” Moderna CEO Stéphane Bancel said in a video interview with Business Insider.

Moderna’s release indicates its vaccine is broadly similar to Pfizer’s. Moderna said its vaccine appeared to be 94.5% effective, while Pfizer said its shot was more than 90% effective. Moderna’s analysis was based on 95 COVID-19 cases, while Pfizer’s review included 94 cases. Neither company’s data has been published in a scientific journal, and both are still collecting more information on how safe their shots are.

Moderna’s study starts counting cases of coronavirus two weeks after volunteers get their second shot, while Pfizer’s study records illnesses one week after volunteers finish the vaccination course.

It would be “naïve to compare the 90% to 94.5%,” Bancel told Business Insider, saying it’s too soon to compare the shots.

Volunteers in Moderna’s trial were randomly given a two-dose regimen of either Moderna’s experimental shot or placebo injections. The expert panel’s conclusion is based on 95 cases of the disease observed in the study.

Out of those 95 illnesses, 90 people on placebo got sick compared with five receiving Moderna’s vaccine. The vaccine also appeared to prevent serious illness. Researchers found 11 cases of severe COVID-19 among the placebo group and zero among people who got the vaccine.

Moderna’s vaccine has one crucial advantage over Pfizer’s shot: It can be stored for a month at typical fridge temperatures (36 degrees Fahrenheit to 46 degrees Fahrenheit), while Pfizer’s shot needs to be stored at minus 94 degrees Fahrenheit, requiring dry ice and special containers.

Moderna’s vaccine still needs to be evaluated by FDA

Both vaccines are still experimental and need to secure regulatory authorization before being rolled out to the public. Both companies plan to apply for emergency-use authorization later in November. It’s unclear how long the US Food and Drug Administration will take to evaluate the shots and decide whether to approve them.

Even if OK’d by regulators, vaccine supply will be extremely limited at first, though having two vaccines would be helpful.

Moncef Slaoui, the chief advisor to the US government’s vaccine initiative, called Operation Warp Speed, recently estimated that 20 million Americans could be immunized in December if both shots were approved.

Moderna was a key component of Warp Speed’s vaccine plan, with the US government investing up to $2.48 billion to fund its development and secure a supply.

Pfizer has said it hopes to produce up to 50 million doses by the end of 2020, and Moderna should have 20 million doses available in the US by year’s end. Both shots are given as two-dose regimens.

Manufacturing will expand in 2021, with Pfizer saying it will have enough of its vaccine to immunize up to 650 million people and Moderna aiming to produce enough shots for 500 million worldwide. Vaccines from other drugmakers could become available next year as well if they succeed in clinical trials that are now underway.

Bancel predicted that a coronavirus vaccine would be widely available in the US by Memorial Day, at the end of May, based only on the results from Pfizer and from his company.

“Even if no other vaccines were going to make it, as a worst-case scenario, I think by Memorial Day, end of June, any Americans who want a vaccine will have their hands on a vaccine,” Bancel said.

Early success should bode well for other vaccine frontrunners

Moderna coronavirus vaccine trial participant Hans Pennink/AP

The effectiveness of Moderna’s shot should bode well for other vaccine frontrunners. All these experimental shots target the same part of the novel coronavirus, the spike protein.

Slaoui told Business Insider in October that he anticipated three waves of approvals over the next few months.

Moderna and Pfizer would make up the first wave. They could quickly be followed by shots from Johnson & Johnson and AstraZeneca. Slaoui said he expected results in December or January from those companies.

The third wave includes two more shots — one by Novavax and the other by Sanofi and GlaxoSmithKline. Those programs are expected to start the final stage of clinical trials in the US within the next few weeks.

Leading government scientists have said a vaccine should be widely available to Americans by April. Slaoui predicted in August that If people agreed to get the shots, we could return to normal in the second half of 2021.

Read more: EXCLUSIVE: The head of Operation Warp Speed shares his best timeline on the race for a COVID-19 vaccine and predicts a return to normal in the 2nd half of 2021

The announcements that both vaccines are effective is a validation for the new technology that both use, called messenger RNA. The technology platform uses only the genetic code of the virus to create a shot. The approach is promising yet novel: There are no federally approved mRNA vaccines to date.

Key questions remain unanswered, despite promising news

It’s too early to draw any conclusions on whether one vaccine is more efficacious or safer than the other. While Moderna provided far more detailed results than Pfizer, neither has published data in medical journals from its trials, which remain ongoing.

Both companies are still collecting and analyzing data, which means the exact effectiveness of the shots could differ from these preliminary results.

Moderna gave an overview of preliminary data on safety and side effects, while Pfizer didn’t provide that information.

Most side effects from Moderna’s shots were mild or moderate, but some volunteers did have severe side effects, which are medically significant but not life-threatening. These happened mainly after the second injection. The most common severe side effects were fatigue (9.7%), muscle pains or aches (8.9%), joint pain (5.2%), headache (4.5%), pain (4.1%), and redness at the injection site (2.0%).

While Moderna said these side effects were “generally short-lived,” specific details will be important, particularly in terms of how severe and long-lasting the side effects were.

There are some other unanswered questions.

On efficacy, it’s unclear whether either vaccine prevents asymptomatic infections. The studies probably won’t be able to answer that question definitively, as volunteers weren’t tested for the coronavirus unless they developed symptoms.

Neither company has provided detailed results by age group. Some vaccines have historically been less protective in older people.

Finally, we don’t know anything about how long protection might last. That information will only come with more time, as study volunteers are followed for many more months. It’s possible people will need to get booster shots, though no one knows whether those would be needed in six months, a year, or several years down the line.

A transformative moment for Moderna

Stephane Bancel Steven Ferdman/Getty Images

While Pfizer is a pharmaceutical giant known for treatments like Viagra and Lipitor, Moderna is a much smaller biotech upstart that has never developed an approved medication.

Still, Moderna, which has been around for only about a decade, has quickly became one of the buzziest startups in the drug industry.

Bancel, the CEO, has had grand visions of mRNA’s potential to work in a wide range of diseases. That has driven record levels of fundraising for Moderna, including the largest biotech initial public offering in history in December 2018.

The Cambridge, Massachusetts, company is working on several other vaccine candidates for Zika, influenza, cytomegalovirus, and respiratory syncytial virus.

Moderna is hoping its coronavirus success proves that the company’s foundational technology works, Bancel said.

“It’s copy and paste,” he said. “So the Zika vaccine, the CMV vaccine, if this vaccine shows high efficacy, they are going to have high efficacy. It’s just science.”

Responding to the pandemic has accelerated the company’s progress, and Moderna has worked closely with the US National Institutes of Health since January to develop and test a COVID-19 vaccine candidate. Moderna’s vaccine candidate was the first in the world to start human testing in March.

To be able to have positive efficacy results from a late-stage study in less than a year is a scientific feat so far matched only by Pfizer and BioNTech.

Investors have noticed. Moderna’s stock has more than quadrupled this year, driven by its coronavirus vaccine progress. The company has hired hundreds of new employees, particularly to help run its Norwood, Massachusetts, manufacturing plant around the clock.

‘It’s just the beginning’

The company’s success has also drawn criticism. Top company executives and board members sold $236 million in stock over the first nine months of 2020, as some corporate-governance experts criticized the insider sales as bad optics.

And previous press releases about positive early data were criticized by some infectious-disease experts as “science by press release.” The eventual data was later published in a top medical journal and was in line with Moderna’s initial description.

Despite the criticism, Moderna’s late-stage success is the clearest validation of its technology to date.

“It’s just the beginning of a big wave of products,” Bancel said.

While there are major logistical challenges ahead in the fight against the pandemic, having effective vaccines will go a long way to defeating the virus.

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Moderna says its coronavirus vaccine is 94.5% effective against COVID-19, a crucial victory in the fight against the pandemic

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Covid-19 vaccine 90 percent effective in early analysis, Pfizer says

Covid-19 vaccine 90 percent effective in early analysis, Pfizer says

The drug company Pfizer said Monday that early analysis showed its vaccine candidate for Covid-19 is more than 90 percent effective at preventing infection.

The news from the U.S. pharmaceutical giant and its German partner, BioNTech SE, was welcomed as a major step in the fight against a virus that has plagued the global economy, upended daily life for billions and killed 1.26 million people — nearly 240,000 in the United States alone.

Pfizer and BioNTech said in a joint statement that their preliminary findings have shown higher success rates than many had expected. People who received two doses as part of the trial saw 90 percent fewer symptomatic cases of Covid-19 than participants who were given a placebo, they said.

Full coverage of the coronavirus outbreak

President-elect Joe Biden said he welcomed the news, which he said he learned Sunday night, but warned it was “important to understand that the end of the battle against Covid-19 is still months away.”

Even if “some Americans are vaccinated later this year, it will be many more months before there is widespread vaccination in this country,” Biden said in a statement. “Today’s news does not change this urgent reality. Americans will have to rely on masking, distancing, contact tracing, hand washing, and other measures to keep themselves safe well into next year.”

The companies have not released the data backing up the study, and many experts urged caution before those details have been independently scrutinized.

Still, Albert Bourla, Pfizer’s chairman and chief executive, called the news “a great day for science and humanity.”

“We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen,” he added.

John Bell, an Oxford University professor and vaccines adviser to the U.K. government, also welcomed the news, and went as far as to say life could begin to return to normal by spring.

“Yes, I’m probably the first guy to say that but I will say that with some confidence,” he said when asked by the BBC whether that timeline was now realistic.

In spite of the optimism, the news does not mean a vaccine will be immediately available. And many observers are holding judgment until more is known about this vaccine candidate.

Eleanor Riley, a professor of immunology and infectious disease at the University of Edinburgh in Scotland, cautioned that the details released so far did not say how old the participants were, or the severity of the cases observed.

“But, I think we have reason to be cautiously optimistic,” she said.

Pfizer said it plans to ask the U.S. Food and Drug Administration for emergency use authorization next week, when it has the required two months of safety data. There have been no serious safety concerns yet, it said, and the trial will continue in the meantime.

It is unclear how long any protection from a vaccine would last. BioNTech’s chief executive, Ugur Sahin, told Reuters, “We should be more optimistic that the immunization effect can last for at least a year.” He said that was based on earlier findings and research on recovered patients.

Pfizer said that based on current projections, it expects to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021.

Regardless of the unknowns, international markets welcomed the news, with stock futures on Wall Street surging after the announcement.

It came just days after Biden’s victory was confirmed over President Donald Trump, who had repeatedly said a vaccine might be ready before the election.

Trump tweeted “SUCH GREAT NEWS!” after the news was released, and Vice President Mike Pence credited “the public-private partnership forged” by Trump.

But unlike other vaccine front-runners, Pfizer has made a point of not taking any money for research and development from the federal government’s Operation Warp Speed program.

However, the program has agreed with Pfizer that it will pay $1.95 billion for production and delivery, securing the first 100 million doses subject to emergency approval, with the ability to acquire another 500 million.

Even if approved, rolling out the vaccine worldwide will be an unparalleled logistical challenge. Like many others, this vaccine must be kept at supercold temperatures, meaning distribution to remote parts of the world will be difficult.

Image: Alexander SmithAlexander Smith

Alexander Smith is a senior reporter for NBC News Digital based in London.

Laura Saravia contributed.


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Israel to Purchase COVID Vaccine From AstraZeneca for Five Million Residents

Israel to Purchase COVID Vaccine From AstraZeneca for Five Million Residents

YERUSHALAYIM-

Sunday, November 22, 2020 at 4:15 am | ו’ כסלו תשפ”א

A chemist works at AstraZeneca’s headquarters in Sydney, Australia, in August. (AAP Image/Dan Himbrechts via Reuters)

The Health Ministry on Friday reached an understanding with Swedish-British biopharmaceutical company AstraZeneca to receive some ten million doses of the coronavirus vaccine, and the two parties are discussing the final details of the agreement.

It is expected most of the early vaccines will require two doses, so ten million doses will suffice five million people.

AstraZeneca is one of the leading pharmaceutical companies in the world and has recently published encouraging results on the effectiveness of its vaccine among senior citizens.

An initial supply of vaccines is expected to arrive in Israel in the first half of 2021, subject to approval by regulatory authorities in Europe, the US, and Israel.

Israel is currently negotiating multiple vaccine-related deals with the aim of providing first-class vaccines for every Israeli who wishes to be vaccinated. Contrary to previous media reports, the Health Ministry stressed that no one will be forced to vaccinate should they chose not to.

“This is another important achievement for Israel. We want to make sure that anyone who wishes to be vaccinated will be able to do so as soon as possible. It is better to overachieve in this case,” Prime Minister Binyamin Netanyahu said in a statement.

Meanwhile, it is unclear if children will be able to receive any coronavirus vaccinations purchased from Pfizer, Moderna, and AstraZeneca as none of the companies included children under the age of 12 in their clinical trials.

“Including children in such studies is more complex in terms of ethical approvals. Also, most children who contract the virus recover easily, therefore they are not common participants in COVID-19 vaccine trials. I suppose the study will be expanded later,” Dr. Zachi Grossman, president of the Israel Ambulatory Pediatric Association, told Yisrael Hayom. “I can’t imagine anyone giving a child a vaccine that has only been tested on adults.”

The Pediatric Association has asked the Health Ministry to include its specialists in the team that will regulate the vaccination process, in light of their experience in dealing with those who are hesitant or outright refuse to be vaccinated.

“A significant part of the population is hesitant or opposed to vaccination. The polls state that 20% of the population does not intend to get vaccinated. There is a lot of misinformation in the media and on social networks,” Dr. Grossman added.

The Health Ministry’s Advisory Committee on Infectious Diseases is currently discussing the prioritization of risk groups. The ministry’s pandemic task force has held a similar discussion about at-risk populations and mentioned healthcare workers, including nursing home workers, as an additional group.


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Israel’s First Coronavirus Vaccine Volunteer Leaves Hospital

Israel’s First Coronavirus Vaccine Volunteer Leaves Hospital

Fifteen-million shots of the vaccine, called Brilife are already being produced by the Defense Ministry-run Israel Institute for Biological Research.

“Hello everybody, good morning, thank you all for your support,” Segev Harel said after being released from the Sheba Medical Center in Ramat Gan on Sunday, The Times of Israel reported.

“I’m here after spending the night in Sheba Medical, and now I’m going home and I feel great, and I hope we will bring the vaccine to Israel and to the whole world.”

Eytan Ben-Ami, a Sheba doctor conducting the trial, told newspaper: “The first patient was kept in hospital for 24 hours to observe him in case of any adverse effects and there were none.

“Everything has been really smooth. It’s very early in the process, but until now, everything is going according to plan.”

A second volunteer who was inoculated also reported feeling well and had no symptoms or side effects.

The first phase of the clinical trial will last approximately a month and will involve some 80 healthy volunteers ages 18 to 55, the report said.

The second phase beginning in December will vaccinate around 1,000 volunteers ages 18 to 85 at eight hospitals around the country. This phase will also allow volunteers with preexisting conditions to participate.

If that phase goes well and antibodies are detected in the volunteers’ blood, vaccinations will then be given to some 30,000 people in April or May 2021. Following that, it will receive approval for general use around July.

In May, the IIBR made headlines around the world for isolating an antibody that neutralizes the COVID-19 virus.


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Coronavirus Vaccine Could Bring U.S. Back to Normalcy By May

Coronavirus Vaccine Could Bring U.S. Back to Normalcy By May

Breaking NewsCNN

Light at the end of the tunnel!!! Maybe. Because there’s now a plan to vaccinate like crazy and get this country back to something that resembles normal by May, 2021.

Dr. Moncef Slaoui, the chief scientific advisor to Operation Warp Speed, told Jake Tapper Sunday on CNN, the drug companies — notably Pfizer and Moderna — are ready to ship out millions of doses of their vaccines as early as December 11, the day after anticipated FDA approval.

Dr. Slaoui went on to say 20 million doses would be shipped out in December, and 30 million a month thereafter. When you do the math, by May … around half the country would be vaccinated and the good Doc thinks that opens the door to a restoration of normal life.

The problem … May could be the sunset month for the vaccine, since half the country seems opposed to getting the shot. Nonetheless, if the vaccines do indeed provide 95% protection from the virus — and especially if you choose the people with whom you interact face-to-face based on their inoculation status … there would be reason to feel relatively safe from COVID.

Premature hallelujah.


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