Moderna Is Applying for Emergency F.D.A. Approval for Its Coronavirus Vaccine


“Be thinking people in nursing homes, the most vulnerable, be thinking health care workers who are on the front lines,” Alex M. Azar II, the secretary for health and human services, said on the CBS program “This Morning” on Monday.

He said the C.D.C. advisers would base their recommendations on the latest data on virus cases across the country. Asked about the role of states in the distribution process, he said that doses would be shipped out through normal vaccine distribution systems, and governors would be “like air traffic controllers,” determining which hospitals or pharmacies receive shipments.

Although governors will determine which groups are prioritized, he said he hoped that they will follow the federal recommendations. He added that he would speak to governors on Monday afternoon with Vice President Mike Pence. In response to a question about how officials could guard against people using money or connections to jump the proverbial line, Mr. Azar vowed to “call out any inequities or injustices that we see.”

The White House moved quickly to take credit for the progress on vaccines. “President Trump’s Operation Warp Speed is rapidly advancing on a trajectory of success to save millions of American lives — five times faster than any other vaccine in history,” Michael Bars, a spokesman for Mr. Trump, said in a statement.

Over all, about 13.3 million Americans have contracted the virus, and more than 265,900 have died. In November alone, there were more than four million new cases and 25,500 deaths in the United States. Worldwide, there have been nearly 62 million cases and almost 1.5 million deaths.

More than 70 coronavirus vaccines are being developed around the world, including 11 that, like Pfizer’s and Moderna’s vaccines, are in large-scale trials to gauge effectiveness.

One of those is made by AstraZeneca, which announced positive but puzzling preliminary results on Nov. 23: Its vaccine was 90 percent effective in people who received a half dose and then a full one, but 62 percent effective in those who received two full doses. Researchers are waiting for more data.



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Lexington, Kentucky, mayor under fire for taking funds from the emergency rental program


A Kentucky mayor has come under fire for a proposal that would see funds being taken from an emergency rental assistance program and instead be used to provide city employees with diversity training. 

The Mayor of Lexington, Linda Gorton, is proposing to use the funds that had been earmarked for people suffering financial hardship during the pandemic and instead redirect them towards Critical Race Theory training. 

‘Lexington’s woke mayor is taking funds for poor people and using them to pay a rich white woman so she can teach city employees how to become woke… this is progressivism in the 21st century,’ author Ryan James Girdusky said on Twitter.

Mayor of Lexington, Linda Gorton, is proposing to use funds from an emergency rental assistance program and instead give council members diversity training

Mayor Gorton, is proposing to use the funds that had been earmarked for people suffering financial hardship during the pandemic and instead redirect them towards Critical Race Theory training

Mayor Gorton, is proposing to use the funds that had been earmarked for people suffering financial hardship during the pandemic and instead redirect them towards Critical Race Theory training

Author Ryan James Girdusky did not appear to be impressed by the proposals

Author Ryan James Girdusky did not appear to be impressed by the proposals

The funds would see $120,000 which was specifically for housing assistance, taken out of its $1.9m budget and used for diversity training.

The Lexington Housing Justice Collective said that the money ended up being ‘unallocated’ because of bureaucratic slowness and not because the funds are unneeded.  

Instead, the money would be put towards diversity training sessions at a cost of $2,000 a day for 35 council employees at a time

Critical Race Theory teaches that American laws and institutions are inherently racist.

The theoretical framework has risen in popularity in recent years. 

The theory suggests that racism is the dominant component of American society resulting in minorities being denied many constitutional rights.    

The Lexington Housing Justice Collective said that the money ended up being 'unallocated' because of bureaucratic slowness

The Lexington Housing Justice Collective said that the money ended up being ‘unallocated’ because of bureaucratic slowness

The charity which is fighting to end homelessness explained in detail what happened

The charity which is fighting to end homelessness explained in detail what happened

$120,000 part of a $1.9million budget for housing assistance could be used

$120,000 part of a $1.9million budget for housing assistance could be used

The money would be put towards diversity training sessions at a cost of $2,000 a day for 35 council employees including both in-person and online

The money would be put towards diversity training sessions at a cost of $2,000 a day for 35 council employees including both in-person and online

The mayor’s plan was published by a charity, the Lexington Housing Justice Collective, on social media which stated how the city was going through the ‘worst eviction crisis in at least a decade.’

‘The city’s rental assistance program is already deeply underfunded. Now Mayor Gorton wants to cut funding even more,’ the group said in a tweet. ‘This will lead to even more Lexingtonians losing their homes in the coming months, after hundreds have already been evicted since August 24.’

Although the group argued it did not disagree with the training, it did not wish to see funds pulled away from rental assistance programs.

‘The proposal is part of Mayor Gorton’s response to the Commission for Racial & Equality. But Black and Brown people are disproportionately evicted,’ the group said. ‘Taking $ from rental assistance does not advance racial justice. It means more Black and Brown people will lose their homes. 

Mayor Gorton's plans come despite worries that the city's rental assistance program is already deeply underfunded

Mayor Gorton’s plans come despite worries that the city’s rental assistance program is already deeply underfunded

Critical Race Theory made headlines a few months ago after the U.S. State Department suspended all training programs for employees related to diversity and inclusion after President Donald Trump directed federal agencies last month to end programs deemed as ‘divisive’ by the White House.

‘Beginning Friday, October 23, 2020, the Department is temporarily pausing all training programs related to diversity and inclusion in accordance with Executive Order … on Combating Race and Sex Stereotyping,’ the cable said.

‘The pause will allow time for the Department and Office of Personnel Management (OPM) to review program content,’ it said.

Trump’s executive order forbid the teaching by federal agencies of ‘divisive concepts’ including that the United States is ‘fundamentally racist or sexist.’

Mayor Gorton is currently dealing with Lexington's coronavirus pandemic crisis and fully intends to implement State Gov Andy Beshear's restrictions on businesses and gatherings

Mayor Gorton is currently dealing with Lexington’s coronavirus pandemic crisis and fully intends to implement State Gov Andy Beshear’s restrictions on businesses and gatherings

It also banned the use of taxpayer dollars to fund so-called ‘un-American propaganda sessions’ including the idea of white privilege or ‘taught that the United States is an inherently racist or evil’ country.

News of the money being diverted away from Lexington’s housing assistance program comes as the state of Kentucky deals with a surge of COVID-19 cases.

It has led to Governor Andy Beshear restricting businesses and gatherings.

Gorton appears to be fully behind the emergency rules.

‘We can overcome this surge of COVID-19 cases in our community,’ she said.

‘Let’s all do our part to be safe and healthy by following the rules, wearing a mask, washing our hands, and maintaining social distance.’



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Canada’s Experience With Emergency Support Programs Put in Place During the Pandemic May Be the Best Argument Yet for a Guaranteed Minimum Income


 

By Evelyn Forget

When public health measures put the economy on hiatus in March, Employment Insurance (EI) showed itself to be totally inadequate to the task of ensuring that displaced workers had access to enough money to meet their basic needs. As a consequence, the Canada Emergency Response Benefit (CERB) was quickly put in place.

A simple application process that made use of on-line accounts, coupled with a directive to administrators to wait until peoples’ lives had stabilized before assessing eligibility, ensured that applicants had money in their accounts within days.

After such a smooth ride with the CERB, it was reasonable to expect that the transition off the CERB to other benefits might work equally well. So what happened?

On 26 September, the CERB ended but replacement benefits were not yet in place. Two weeks later, those whose jobs had still not returned were able to apply to replacement programs – a more generous EI and the Canada Recovery Benefit (CRB).

In order to ensure that the CRB only went to people who “deserved” it, applicants were required to attest that they are willing and able to work, even though such a claim is unenforceable. Those with caregiving responsibilities turned to the Canada Recovery Caregiving Benefit (CRCB), while those required to isolate sought out the Canada Recovery Sickness Benefit (CRSB). Each paid a minimum of $500 per week, but the treatment of earned income and tax obligations differed dramatically.

Those on EI had taxes withheld at source, while those on the CRB were expected to calculate and pay tax on the benefit in April. CRB benefits were not reduced until other income reached $38,000 a year, at which point applicants faced a whopping marginal effective tax rate, while EI benefits were reduced by 50 per cent of earned income from the first dollar.

Application was a bureaucratic nightmare: applicants had to wait for eligibility to be verified, which further delayed payment. Applications were not automatically transferred to the appropriate program; applying to the wrong one meant rejection with no additional information, and an hours-long wait on the telephone.

All of these programs, from the CERB to the CRB, the CRSB, the CRCB and EI, omitted the poorest Canadians – those subsisting well below the poverty line on provincial disability or income assistance. Even though many faced higher costs throughout the pandemic because they were unable to access the charities that supplemented their meager incomes, they had no emergency support. A miserly one-time $600 payment for people with disabilities was still mired in bureaucracy six months after the initial shutdown.

So, how would a Guaranteed Minimum Income help?

A permanent program would be an automatic stabilizer for a volatile economy. If someone loses income, the program would step in to assure they have enough money to meet their basic needs, whether that income loss is due to a society-wide issue like a pandemic or recession, or a personal crisis, like a job loss or a death in the family.

We wouldn’t have to rely on politicians and civil servants to dream up emergency programs to be offered on a one-time basis to meet long-standing gaps in the system. Since there is no need to determine whether someone deserves support or not, there is no need to have three different programs – the CRB, the CRSB and the CRCB – to meet a common need for enough income to survive until an applicant is back on their feet.

Applicants would not be confused about where or how to apply or what their tax obligations may be. A single program, rather than a raft of slightly different programs, means that the bureaucracy involved in adjudicating eligibility would be much simpler and, presumably, faster.

Applicants could report their income from all sources monthly or bimonthly through on-line accounts. Income tax could be withheld at source, so there are no unwelcome surprises in April when income taxes are due. The benefit could be reduced gradually as other income increases so there is no barrier or risk involved in accepting a job offer.

Expanding the program to replace income assistance for people without a sufficient job history would improve their lives and allow everyone to access job training programs.

Most importantly, it would be an automatic stabilizer.

A permanent Guaranteed Minimum Income would be available whenever a calamity like COVID-19 strikes, automatically ramping up to meet needs. It would also automatically contract as the pandemic wanes and jobs return.

When people have other opportunities, research shows they accept jobs and, with a regular wage, they need less support or none at all from a Guaranteed Minimum Income. But the program would be permanent, ensuring financial security whenever the need appears.

***

About the author:

Evelyn L. Forget is author of Basic Income for Canadians: From the COVID-19 Emergency to Financial Security for All and Professor of Economics in the Rady Faculty of Health Sciences, University of Manitoba.

This post was previously published on Quoimedia.com and is republished here under a Creative Commons Attribution-NoDerivatives 4.0 International License.

***

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Emergency exit – Britain’s vaccine roll-out takes shape | Britain


LOTS OF SPACE and vinyl flooring—that is what local directors of public health want. “The last time you went into an NHS appointment…the floor would have been a certain type of splash-proof vinyl in case you bled all over it or threw up,” says one. It is the sort of floor a mass vaccination centre requires.

The search for suitable venues has just become more urgent. On November 23rd the Oxford/AstraZeneca vaccine team announced positive results (though there are some concerns about the data—see article). A cheap, transportable vaccine would be good news for the world. It would also be good news for Britain, and not just because it would be the product of a British university and an Anglo-Swedish firm.

The government has ordered 40m doses of vaccine from Pfizer and 5m from Moderna, the two other firms to have announced phase-three-trial results. Both require two doses per person. It has ordered 100m from AstraZeneca, which may need just one-and-a-half. If all are approved, the AstraZeneca vaccine would thus accelerate the country’s journey to herd immunity.

That approval is in the hands of Britain’s medicines regulator, the MHRA, which is reviewing data from all three firms. AstraZeneca had planned to have 30m doses ready by September; it missed that target, but is expected to have tens of millions ready when approval is granted. One insider says the hope is to deliver 5m jabs a week by mid-January.

The Joint Committee on Vaccination and Immunisation, which advises the government, has drawn up a prioritisation list, with care-home residents and workers at the top, followed by the over-80s and health-care workers. The MHRA will probably at first offer an emergency-use authorisation, which may restrict vaccination to the most at-risk until more evidence is in.

The British state’s lacklustre response to the covid-19 pandemic provides plenty of reason for trepidation about the roll-out. But unlike the testing programme or track-and-trace, the National Health Service will be running things, removing the need to set up a leadership structure and local organisation from scratch.

It is not an entirely new exercise for the health service. Britain dishes out nearly 15m flu jabs a year. The need to store the Pfizer vaccine at -70°C limits the role of general practitioners (GPs) who deliver much of the flu campaign, since few surgeries have sufficiently icy freezers. But the AstraZeneca vaccine can be kept at 8°C.

Around half of the vaccines will be delivered in the community, the other half in mass vaccination centres. They will spring up in places like hospitals, sports halls and universities. Paramedics, physiotherapists and student medics will be called upon to staff them. So, too, may vets, dentists and trained volunteers, for whom the government has tweaked human medicines regulation to allow them to administer jabs.

All of this is a big ask for the NHS at a time of year when it is normally most stretched. This year’s expanded flu vaccine campaign suffered from distribution problems. GPs are in discussions with NHS leadership about what parts of their job can be put on hold to allow them to focus on vaccination. “We would want to protect patient-facing services,” says Steve Mowle of the Royal College of General Practitioners.

Perhaps the biggest challenge will be the IT system. It will need to contact people at the right time for their first and second jabs, and to integrate information with medical records. This is important, says Penny Ward of the Faculty of Pharmaceutical Medicine, a professional body, so that analysts can trawl the records for unidentified side effects. Not all are optimistic. A scientist advising the government says he cannot think of anything since the start of the pandemic “where we relied on digital support and it happened in a timely way”.

In a programme of this scale, things will almost certainly go wrong. But if enough goes right, there is a glittering prize on offer. By spring, vaccination and increased testing “should reduce the need for economic and social restrictions”, in the words of Boris Johnson. “We should be able to render obsolete the very notion of a covid-19 lockdown.”

Editor’s note: Some of our covid-19 coverage is free for readers of The Economist Today, our daily newsletter. For more stories and our pandemic tracker, see our hub

This article appeared in the Britain section of the print edition under the headline “Emergency exit”

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Finnish government to tackle night cafés, may turn to emergency powers


THE FINNISH GOVERNMENT is expected to introduce restrictions to the operations of so-called night cafés as soon as this week, reports YLE.

The public broadcasting company wrote yesterday that the government will today present a decree limiting the opening hours of night cafés and other restaurants to 5am to 11pm in response to concerns the new operating model has kindled especially in Uusimaa, the most populated region of Finland.

The decree is to enter into force at midnight on Thursday, 26 November, according to Helsingin Sanomat.

Night cafés have sprouted across the country due to a clause in restrictions on the restaurant sector that enables an establishment to re-open its doors one hour after closing and staying open into the small hours of the night by taking alcoholic beverages off the menu.


Early reports from establishments that have taken advantage of the possibility indicate that the clause may not have had the desired impact.

YLE on Monday revealed the government is set to prohibit restaurants in the capital region from serving alcoholic beverages beyond 10pm. Establishments that primarily serve alcohol would also be obligated to limit their capacity to 50 per cent and those that primarily serve food to 75 per cent of their usual maximum capacity.

Prime Minister Sanna Marin (SDP) on Monday said in Pirkkala, Pirkanmaa, that the government may have to resort to the emergency powers act if the epidemic continues to worsen. The current legislative instruments prevent it from, for example, locking down specific regions.

“We’re not yet at a point where we’d be able to make another decision on locking down Uusimaa, for example,” she said. “The state of emergency and emergency powers act are not in place, meaning we can’t use these kinds of measures under the normal legislation,” she commented to YLE.

If regions fail to bring the epidemic under control, however, the government may declare a state of emergency similarly to last spring, according to Marin.

“If regions can’t bring the situation under control and it worsens significantly, it’s possible that we find ourselves in a situation where we’ll again have to resort to a state of emergency and the emergency powers act. That’s why I’m imploring regions and municipalities in not only Uusimaa but also other parts of Finland to take action in time.”

YLE on Monday also reported that the government is presently investigating whether a state of emergency could be declared without invoking the emergency powers act. Declaring a state of emergency would enable the government to resort to a broader range of tools to steer the coronavirus responses of regional authorities.

Aleksi Teivainen – HT



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COVID-19: Experimental drug used on Donald Trump receives emergency approval by FDA | Science & Tech News


An experimental drug used by Donald Trump when he had COVID-19 has received emergency approval by US health authorities.

The antibody drug developed by Regeneron Pharmaceuticals is administered in a single intravenous dose, and can be now used in coronavirus patients in the US even though studies examining how safe and effective it is are still ongoing.

Regeneron hopes the drug will be able to prevent COVID-19 patients with mild to moderate symptoms being hospitalised by boosting their immune system response.

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Kicked into the long grass? Trump plays golf

The US Food and Drug Administration (FDA) is permitting the drug to be used to treat adults and children aged 12 and over, as long as they weigh at least 88 pounds (40kg), and are at high risk of severe illness from COVID-19.

According to Regeneron, initial doses will be available for roughly 300,000 patients through a federal government allocation program. Although those patients won’t be charged for the drug, they may have to pay part of the cost of giving the IV.

Demand for the drug is expected to vastly outweigh the initial supplies, with the US surging past 12 million reported cases in recent days.

More than 100,000 new cases have been reported every day since 4 November and health experts warn the country faces a challenging winter due to the uncontrolled spread of the virus.

It is impossible to know whether the Regeneron drug helped Mr Trump recover from COVID-19 as it was one treatment among a host that he received, and most patients recover on their own.

The FDA used its emergency powers to authorise the drug as the total number of coronavirus-related deaths in the US passed 256,000 amid a lack of treatments for the novel disease.

During non-emergency times the FDA required “substantial evidence” before approving a drug as safe and effective, but these standards have been lowered during the public health emergency.

Now the only requirement is that the experimental treatment’s potential benefits outweigh its risks.

As an emergency authorisation, the approval will only last for the duration of the COVID-19 pandemic, and afterwards Regeneron will need to submit additional research to define how safe and effective it is.

The White House described the FDA’s decision as a victory for Mr Trump’s efforts “to deliver cutting-edge treatments with highly promising results to protect the health and safety of the most vulnerable Americans”.



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FDA allows emergency use of antibody drug Trump received


The FDA allowed its use in adults and children 12 and over who weigh at least 40 kilograms and who are at high risk of severe illness

U.S. health officials Saturday agreed to allow emergency use of a second antibody drug to help the immune system fight COVID-19, an experimental medicine that President Donald Trump was given when he was sickened last month.

The Food and Drug Administration authorized use of the Regeneron Pharmaceuticals Inc. drug to try to prevent hospitalization and worsening disease from developing in patients with mild-to-moderate symptoms.

 

The drug is given as a one-time treatment through an IV. The FDA allowed its use in adults and children 12 and over who weigh at least 88 pounds (40 kilograms) and who are at high risk of severe illness from COVID-19 because of age or certain other medical conditions.

Emergency authorization allows use of the drug to start while studies are continuing to establish safety and effectiveness. Early results suggest the drug may reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression, the FDA said.

Regeneron said that initial doses will be made available to roughly 300,000 patients through a federal government allocation program. Those patients will not be charged for the drug but may have to pay part of the cost of giving the IV.

 

Initial supplies will likely be vastly outstripped by demand as the U.S. has surged past 12 million reported cases, with the country facing what health experts say will be a dark winter due to uncontrolled spread of the virus.

Antibodies are proteins the body makes to target and help eliminate viruses, but it can take weeks for the best ones to form after an infection occurs. The drugs are concentrated versions of ones that proved best able to do this in lab and animal tests, and in theory help the body start to fight the virus right away.

The Regeneron drug is a combo of two antibodies to enhance the chances it will prove effective. Earlier this month, the FDA gave emergency authorization to a single-antibody drug from Eli Lilly that also is still being studied.

 

There’s no way to know whether the Regeneron drug helped Trump recover; he received a host of treatments and most COVID-19 patients recover on their own.

FDA regulators authorized the Regeneron drug using their emergency powers to quickly speed the availability of experimental drugs and other medical products during public health crises.

In normal times the FDA requires “substantial evidence” to show that a drug is safe and effective, usually through one or more large, rigorously controlled patient studies. But during public health emergencies the agency can lower those standards and require only that an experimental treatment’s potential benefits outweigh its risks.

 

The emergency authorization functions like a temporary approval for the duration of the COVID-19 pandemic. To win full approval, Regeneron will have to submit additional research to fully define the drug’s safety and benefit for patients.

The White House cast the decision as a victory for Trump’s efforts “to deliver cutting-edge treatments with highly promising results to protect the health and safety of the most vulnerable Americans,” according to a statement from spokesman Michael Bars.

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South Australia’s coronavirus cluster detected by junior doctor who heard a cough in hospital emergency department


South Australia’s Chief Public Health Officer Nicola Spurrier has praised an “astute young doctor” in a hospital emergency department for preventing a full-blown coronavirus outbreak in the state.

The junior doctor, who Professor Spurrier did not name, picked up that a woman in her 80s had a slight cough when she turned up at the Lyell McEwin Hospital, in Adelaide’s northern suburbs, last Friday night.

The woman had coronavirus and now so do 25 of her family members and their close contacts.

They are now known as the Parafield cluster, but so far there have been no new coronavirus cases in South Australia not directly linked with the elderly woman and one of her children, who worked at the Peppers Waymouth medi-hotel.

Nicola Spurrier has become a popular figure with SA Health creating cartoons of her to promote hygiene measures.(ABC News)

When asked about whether the doctor was a hero at a press conference this morning, Dr Spurrier said she was actually a “heroine”.

“She has done a fantastic job,” she said.

“She is one of our junior doctors, but I’d say like all our staff at SA Health they do a great job. She was on the ball. She knew what she had to do.

“She heard this person cough a couple of times and thought ‘they’re not getting away without having a swab’ and went ahead and swabbed the person.

Lyell McEwin Hospital testing line
People wait to get tested for coronavirus at the Lyell McEwin Hospital on Tuesday after the cluster was revealed.(ABC News: Claire Campbell)

The woman presented at the hospital “not feeling herself” and “weak”, an SA Health spokeswoman said, but otherwise did not present any obvious COVID–19 symptoms, which can include a cough, a runny nose and a fever.

The spokeswoman said only people with symptoms in South Australian hospitals were tested; however, all patients are asked screening questions, such as if they are feeling unwell or have been overseas recently.

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Dr Spurrier said the elderly woman’s case “came out of the blue, suddenly in the middle of the night”.

“The real reason we picked that up was not because somebody had classic COVID symptoms and came to the emergency department, it was because of our astute young doctor — junior doctor — who heard a bit of a cough and thought they would take the swab and that is where we started,” she said.

“The second part of this is that the contact tracing very quickly on Sunday was able to identify that it was linked to a medi-hotel and subsequent to that we did this huge blitz of testing in the medi-hotel, and that is how we picked up the additional cases at that medi-hotel.”

The woman was later admitted to the Royal Adelaide Hospital as a precaution.

She and her husband have now been released from hospital to a medi-hotel.

The doctor is also staying in a medi-hotel after being identified as a close contact.



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FDA approves Emergency Use Authorization for COVID-19 drug combo


A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland. (Photo by Sarah Silbiger/Getty Images)

OAN Newsroom
UPDATED 6:45 PM PT – Friday, November 20, 2020

The FDA granted an Emergency Use Authorization for a coronavirus drug combination to treat moderate and seriously ill patients.

FDA Commissioner Dr. Stephen M. Hahn said this action demonstrates the agency’s steadfast efforts to make potential coronavirus treatments available in a timely manner.

On Thursday, the FDA gave approval for the mix of ‘remdesevir’ and rheumatoid arthritis drug ‘baricitinib.’ This came after studies found the drug combination shortened the recovery time for COVID-19 to about a week.

According to a double-blind trial, the combination also increased the chances of survival by 35 percent when compared to patients that only took ‘remdesivir.’

MORE NEWS: Trump Campaign: Americans Don’t Trust Mainstream Media Election Coverage





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COVID-19: Pfizer requests emergency authorisation for coronavirus vaccine in US | UK News


Pfizer and BioNTech are submitting an emergency authorisation request in the US which could allow its coronavirus vaccine to be used to treat high-risk populations in the country by mid-December.

The UK has already ordered enough of the vaccine to treat 20 million people but it has not yet been approved by the Medicines and Healthcare Products Regulatory Agency (MHRA).

BioNTech told Sky News it had not submitted its vaccine for approval in the UK yet.

If the vaccine is approved in the US, it suggests a similar rollout of the treatment could soon take place in the UK.

Pfizer and BioNTech will submit its emergency use authorisation request to the US Food and Drug Administration (FDA), and is also seeking approval for their vaccine in other countries across the world including Australia, Canada and Japan.

The companies intend to submit applications to other regulatory agencies worldwide in the coming days.

Live COVID-19 updates from the UK and around the world

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Pfizer boss: ‘Light at the end of the tunnel’

Pfizer and BioNTech expect to produce up to 50 million doses globally in 2020 and up to 1.3 billion doses by the end of 2021, and have said they will be ready to distribute the vaccine candidate within hours after authorisation.

The vaccine demonstrated an efficacy rate of 95% in the companies’ phase 3 clinical study.

There were no serious safety concerns observed in those who took part in the trials, with the treatment tested on people with and without a prior coronavirus infection.

Pfizer and BioNTech’s submission to the FDA is supported by safety data from a randomised group of around 8,000 participants less than 18 years of age.

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Vaccine inventor: December rollout ‘possible’

It is also supported by data from around 38,000 trial participants who have been followed for an average of two months following a second dose of the vaccine candidate.

The submission includes data on approximately 100 children 12 to 15 years of age.

Around 42% of participants around the world and 30% of US participants in the phase 3 study were from racially and ethnically diverse backgrounds.

Some 41% of global and 45% of US participants were between 56 and 85 years of age.

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UK ‘weeks away’ from vaccine rollout

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Dr Albert Bourla, Pfizer’s chairman and chief executive, said: “Our work to deliver a safe and effective vaccine has never been more urgent, as we continue to see an alarming rise in the number of cases of COVID-19 globally.

“Filing in the US represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential.”

Ugur Sahin, the chief executive and co-founder of BioNTech, said: “Filing for emergency use authorization in the US is a critical step in making our vaccine candidate available to the global population as quickly as possible.

“We intend to continue to work with regulatory agencies worldwide to enable the rapid distribution of our vaccine globally.

“As a company located in Germany in the heart of Europe, our interactions with the European Medicines Agency [EMA] are of particular importance to us and we have continuously provided data to them as part of our rolling review process.”



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