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Southwest Airlines Collaborating with Stanford University School of Medicine for Guidance Regarding the Southwest Promise

DALLAS, Oct. 12, 2020 /PRNewswire/ — Southwest Airlines Co. (NYSE: LUV) is working with the Stanford University School of Medicine to review the carrier’s multi-layered approach to supporting the well-being of Customers and Employees during the ongoing COVID-19 pandemic. The Southwest Promise encompasses the changes the airline has made to its around-the-clock operations, cleaning procedures, and physical-distancing measures, and representatives from Stanford Medicine will now offer medical advice and protocol recommendations to guide the airline’s ongoing and future efforts during the pandemic.

As part of the collaboration, Southwest will have access to an advisory council comprised of Stanford Medicine’s physician-scientists with knowledge and expertise in infectious diseases, prevention and testing protocols, and the latest medical research about COVID-19. This advisory council will provide insights to support Southwest’s commitment to keeping Safety as an uncompromising priority.

“We look forward to working with Stanford Medicine as we continue utilizing a science-based approach to develop and bolster our operational policies and practices during the ongoing pandemic,” said Gary Kelly, Southwest’s Chairman of the Board and Chief Executive Officer. “This collaboration adds to our advisory partners and brings a team of physician-scientists into our ongoing discussions and will infuse the latest medical research and public health recommendations into our mission of supporting the well-being of our Customers and Employees.”

Stanford Medicine is advising organizations and companies like Southwest as they evaluate their practices during the ongoing pandemic,” said Lloyd Minor, MD, Dean of the Stanford School of Medicine. “We look forward to providing our insights to the airline.”

The Southwest Promise: A Multi-Layered Approach to Cleaning and Comfort

Stanford Medicine will serve as a trusted advisor, in addition to Southwest’s current relationship with UT Southwestern Medical Center, to review elements of The Southwest Promise, which are implemented to create a comfortable travel experience and support the well-being of Employees and Customers. The commitment to cleaning and distancing measures encompasses the following elements:

Prior to Travel:

Face Coverings Required: All Southwest Customers and Employees over the age of two are required to wear a covering over their mouth and nose throughout the travel journey. If a Customer does not have a face covering, Southwest will have face masks available at the airport and onboard its aircraft.

Customer Health Declaration: Customers are required to acknowledge an awareness of the carrier’s face covering policy and confirm they do not have symptoms of COVID-19 and have not been diagnosed with, or exposed to, COVID-19 in the 14 days prior to travel. They also are required to confirm they do not have a fever when they travel. The declaration appears during the online check-in process via the Southwest app, Southwest.com, the carrier’s mobile website, SWABIZ.com, and airport kiosks.

At the Airports:

Airport Cleaning: Southwest is cleaning ticket counters, gates, kiosks, and baggage claim areas multiple times a day. Additionally, the airline is utilizing electrostatic sprayers to apply a disinfectant to airport areas at least once per week. 

Physical Distancing in Airports: Southwest is boarding

Former British Cycling Doctor Hadn’t Read All Anti-Doping Guidance

MANCHESTER—The former medical doctor for British Cycling and Team Sky has told a tribunal he had not read the crucial guidance on anti-doping rules when he ordered a prohibited substance.

Dr Richard Freeman admits ordering sachets of Testogel to the Velodrome in Manchester in May 2011 but insists he was bullied into obtaining it for coach Shane Sutton to help with his erectile dysfunction.

Today Dr Freeman continued his evidence at the Medical Practitioners’ Tribunal Service where he denied Testogel was ordered for an athlete and said the suggestion was “offensive”. He also claimed for the first time, after giving three separate statements, that he had destroyed the package at the time.



Record Keeping

Previously Dr Freeman had already admitted lying in the aftermath, getting an employee of Fit For Sport to say the drug had been sent in error, and a series of poor record keeping.

Earlier in the week he claimed Mr Sutton swore him to secrecy about his erectile dysfunction. He says he got him Viagra and Cialis to deal with the condition and claimed he wrote him a prescription  which his personal assistant would use to pick up packages from Asda or Boots.

Representing the General Medical Council, Simon Jackson QC asked Dr Freeman how this squared with his claim that Mr Sutton was secretive about it.

Dr Freeman said the details of the prescription would only be known by the pharmacist and it would be placed in a sealed bag. 
He was then asked about how records would be kept on this.

He said: “I would expect them to keep them for a long time and for them to be easily accessible.”

Mr Jackson then asked about the order of Testogel and why this procedure was not applied, saying: “That might be a reason for not writing a prescription for which there would be a record showing you had signed it and that had Mr Sutton’s name on it.”

Dr Freeman replied: “It is not the reason I would have considered but I can see the point.”

Anti-Doping

He was quizzed about his knowledge of anti-doping legislation, and whether he should have known that possession of Testogel was a breach of the rules.

Mr Jackson asked: “He [Shane Sutton] would fall under the WADA code as an athlete support person?”

Dr Freeman responded: “I wasn’t particularly proficient in the code.”

Mr Jackson said it had been in place since 2009 and Dr Freeman said he believed that was the case and claimed he had “not read the small print about rider’s health”.

The GMC representative then asked:  “You must have realised that on the face of it you’re not supposed to be in possession of testosterone unless … do you accept that?”

The doctor said: “I fully accept testosterone is a banned drug for athletes, at the time I was thinking of Mr Sutton as a patient not as a rider or ex-rider.”

Knowledge

Mr Jackson then took exception to his claim of not knowing

FDA guidance – The Washington Post

One of the pharmaceutical companies at the forefront of efforts to develop a vaccine, Pfizer, on Tuesday declared its support for the agency in its struggle with the White House. Albert Bourla, the company’s chief executive, said on Twitter, “Pfizer has never discussed [FDA’s] vaccine guidelines with the White House and will never do so as it could undermine the agency’s independence.” He said the agency’s independence “is today more important than ever as public trust in [coronavirus] vaccine development has been eroded by the politicization of the process.”

The delayed clearance by the White House occurred days after President Trump accused the FDA of being “political” in fashioning the guidance and after The Washington Post reported that White House Chief of Staff Mark Meadows was demanding detailed justification from the agency about the criteria. Meadows’s action raised fears the White House would thwart or block standards designed to boost public trust in a vaccine, according to people familiar with the situation who spoke on the condition of anonymity to discuss internal deliberations.

The FDA, as requested, provided the White House with additional data, but nothing happened, according to a senior administration official who spoke on the condition of anonymity because they did not have permission to talk publicly about the issue. On Tuesday, tired of the delay, the FDA circumvented the White House by publishing the criteria online as part of a briefing package for a meeting with its vaccine advisory committee that is scheduled for Oct. 22.

Shortly after the standards were published, the White House approved the vaccine guidance, according to the official.

The guidance is far more rigorous than what was used for emergency clearance of hydroxychloroquine, an anti-malaria drug used in the early days of the coronavirus pandemic, or convalescent plasma, which is taken from people who have recovered from covid-19 and whose antibodies might offer a measure of protection to other patients. It is an effort to shore up confidence in the vaccine development process and the FDA, which has made missteps during the pandemic.

The guidelines recommend that participants in late-stage vaccine clinical trials be followed for a median of at least two months, starting after they receive a second vaccine shot — which experts said could make it difficult, though not impossible, for a vaccine to be authorized before the election.

The Post reported Sept. 22 that the FDA was poised to issue a tough new standard for an emergency authorization of a coronavirus vaccine. As a sign the vaccine works, the agency said it would want to see at least five severe cases of covid-19, the disease caused by the novel coronavirus, in the placebo group for each trial, and some cases of the disease in older people. Assuming there weren’t cases — or not as many — in the group receiving the vaccine, that would be a signal that a shot is working.

At a news conference Sept. 23, Trump said the FDA plan sounded like “a political move”

FDA issues new vaccine guidance that pushes approval past election

The Food and Drug Administration has released its long-awaited guidance on how it will issue Emergency Use Authorizations (EUAs) for COVID-19 vaccines. The FDA says safety data on any vaccine will need to be monitored for at least two months after Phase 3 clinical trials are completed, likely closing the door on the possibility of approving a vaccine before Election Day.

“Data from Phase 3 studies should include a median follow-up duration of at least two months after completion of the full vaccination regimen to help provide adequate information to assess a vaccine’s benefit-risk profile,” the agency wrote in a briefing document for an upcoming vaccine advisory committee meeting. 

An EUA does not require as much proof as the more exhaustive, standard FDA approval process, but can expedite treatments deemed beneficial in an emergency.

The FDA’s Center for Biologics Evaluation and Research oversees the vaccine approval process and often consults with an outside advisory committee. The expert committee, set to meet on October 22, is made up of scientists, physicians, biostatisticians, and a consumer representative who are tasked with advising the FDA on the safety and efficacy of the vaccine. According to the FDA, the purpose of the meeting is not to “discuss any particular vaccine candidate.”

By providing the committee with two months of data on risks and benefits after the Phase 3 trial is completed, the panel of experts will have more time to screen for severe COVID-19 disease and adverse events among study participants, according to the guidance. 

FDA Commissioner Stephen Hahn said in a statement that he hoped the guidelines would help “the public understand our science-based decision-making process that assures vaccine quality, safety and efficacy.”

Time is essential in vaccine trials. Most adverse effects from a vaccine occur within the first month or two, but issues can also crop up long after they are administered, which is why companies continue to follow participants for at least two years, according to William Moss, executive director of Johns Hopkins’ International Vaccine Access Center. 

Approval of any EUA will require a “trade-off decision” between a vaccine’s societal value and “potential, rare, delayed side effects,” Moss told CBS News. 

President Trump has repeatedly asserted that a vaccine is imminent. On Labor Day, he said it could be ready “during the month of October.” On Monday, upon returning to the White House after a four-day stint in the hospital for his own coronavirus diagnosis, the president said that a vaccine is coming “momentarily.” 

“We have the best medicines in the world. And they all happened very shortly, and they’re all getting approved, and the vaccines are coming momentarily,” he said.


COVID-19, Trump and the race to a vaccine: Vo…

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The FDA noted in its briefing document that the guidance is not legally enforceable. “Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited,” it said. 

The agency almost always follows the panel’s advice,

New FDA COVID-19 vaccine guidance requires two months of follow-up data for approval

Oct. 6 (UPI) — New guidelines issued by the U,S. Food and Drug Administration on Tuesday require manufacturers of potential new COVID-19 vaccines to provide two months’ worth of “follow-up” data on safety and possible adverse events.

The mandate would appear to dash President Trump’s hopes of having a new vaccine approved by the Nov. 3 election.

The two-month period was decided upon because agency research suggests that most adverse events or severe side effects with vaccines emerge within two to three months after administration, an FDA administrator said.

“Ideally, we’d like to have longer-term safety follow-up, but we are in the middle of a pandemic and people are dying,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.

Marks was among several top public health officials who spoke during a virtual symposium Tuesday entitled “Preserv[ing] the Scientific Integrity of COVID-19 Vaccine Development and Allocation,” hosted by Johns Hopkins University and the University of Washington.

The FDA released the new guidance earlier in the day amid reports suggesting that Trump administration officials were pressuring the agency to streamline the vaccine approval process, with an eye toward the presidential election.

The new guidance focuses on the FDA’s emergency use authorization process, which allows the agency to more quickly approve products in response to a national crisis.

The normal safety and effectiveness requirements for drugs, vaccines and medical devices approved under the emergency use program are “deliberately set lower,” Marks said. However, the “known and potential benefits [still] have to outweigh risks,” he said.

To receive an emergency authorization based on the new guidance, potential vaccines will have to provide an “interim analysis” of data proving effectiveness from Phase 3 clinical trials — the final stage of the drug evaluation process.

In addition, data from Phase 3 studies must “include a median follow-up duration of at least two months after completion of the full vaccination regimen to help provide adequate information to assess a vaccine’s benefit-risk profile,” the guidelines state.

This includes information on adverse events, cases of severe COVID-19 disease among study participants and cases of COVID-19 “occurring during the time frame when … the vaccine would be responsible for a protective effect.”

During Tuesday’s symposium, Moncef Slaoui, the scientific head of Operation Warp Speed — the Trump administration’s initiative to spur COVID-19 drug treatment and vaccine research and development — said that several candidate vaccines have begun Phase 3 trials.

However, although he and his colleagues are “reasonably pleased with the progress,” the vaccines farthest along in the process won’t have their “first results” on effectiveness until late November or early December.

Still, “we feel comfortable that we will have one or two vaccines and we will have enough doses to immunize 30 million people in November and December and another 50 million in January and have a serious impact this pandemic,” Slaoui said.

He had told Science magazine in September that he would resign if politics interfered with the vaccine evaluation process.

CDC revises coronavirus guidance to acknowledge that it spreads through airborne transmission

3D illustration of coronavirus on a colored background.

Leonello Calvetti | Stocktrek Images | Getty Images

The Centers for Disease Control and Prevention revised its coronavirus guidance Monday, acknowledging that it can sometimes spread through airborne particles that can “linger in the air for minutes to hours” and among people who are more than 6 feet apart.

The CDC cited published reports that demonstrated “limited, uncommon circumstances where people with COVID-19 infected others who were more than 6 feet away or shortly after the COVID-19-positive person left an area.”

“In these instances, transmission occurred in poorly ventilated and enclosed spaces that often involved activities that caused heavier breathing, like singing or exercise,” the CDC said in a statement. “Such environments and activities may contribute to the buildup of virus-carrying particles.”

The agency added that it is “much more common” for the virus to spread through larger respiratory droplets that are produced when somebody coughs, sneezes, sings, talks, or breathes. People are infected through such droplets mostly when they are in close contact with an infected person, the CDC said. 

“CDC’s recommendations remain the same based on existing science and after a thorough technical review of the guidance,” the agency said. “People can protect themselves from the virus that causes COVID-19 by staying at least 6 feet away from others, wearing a mask that covers their nose and mouth, washing their hands frequently, cleaning touched surfaces often and staying home when sick.”

The updated guidance comes after the agency mistakenly posted a revision last month that said the virus could spread through aerosols, small droplets that can linger in the air. The guidance was quickly removed from the CDC’s website because it was just “a draft version of proposed changes,” the agency said.

To what degree the coronavirus can spread through airborne particles has been a contentious debate among scientists for months. Some epidemiologists have charged that the World Health Organization as well as federal regulatory agencies in many countries have been slow to accept that the virus can spread by air. It’s a debate that could have implications for the importance of air filtration in reopening businesses and schools. 

Dr. Bill Schaffner, an infectious disease specialist at Vanderbilt University, said the new guidance is largely in line with what he says the science indicates about the coronavirus spreading through the air. He said in a phone interview after reviewing the new guidance that airborne transmission is something of a “side street” for spread. 

“Some cars do get through on the side street,” he said. “But the highways of transmission are close in, usually within enclosed spaces and for periods of time longer than 15 minutes with people standing within 3 to 6 feet of each other.”

Schaffner added that the new guidance doesn’t necessarily change how he thinks about reducing the risk of infection for most people. Wearing a mask, socially distancing and avoiding large indoor gatherings remain the most important steps people can take, he said. 

But places of

CDC revises guidance, says COVID-19 can spread through virus lingering in air

By Vishwadha Chander

(Reuters) – U.S. Centers for Disease Control and Prevention (CDC) on Monday said COVID-19 can spread through virus lingering in the air, sometimes for hours, acknowledging concerns widely voiced by public health experts about airborne transmission of the virus.

The CDC guidance comes weeks after the agency published – and then took down – a similar warning, sparking debate over how the virus spreads.

In Monday’s guidance, CDC said there was evidence that people with COVID-19 possibly infected others who were more than 6 feet away, within enclosed spaces with poor ventilation.

Under such circumstances, CDC said scientists believe the amount of infectious smaller droplet and particles, or aerosols, produced by the people with COVID-19 become concentrated enough to spread the virus.

The CDC has long warned of transmission through small droplets that shoot through the air and generally fall to the ground, which resulted in the six-feet social distancing rule. Aerosol droplets are much smaller still, and can remain suspended in the air, like smoke.

While CDC stresses close-contact transmission is more common than through air, a group of U.S. scientists warned in an unrelated open letter published in medical journal Science on Monday that aerosols lingering in the air could be a major source of COVID-19 transmission. (https://bit.ly/34pSPbH)

“The reality is airborne transmission is the main way that transmission happens at close range with prolonged contact,” the researchers said in a press call.

Viruses in aerosols can remain in the air for seconds to hours, travel more than two meters and accumulate in poorly ventilated indoor air, leading to superspreading events, the researchers said.

Since individuals with COVID-19 release thousands of virus-laden aerosols and far fewer droplets while breathing and talking, the scientists said the focus must be on protecting against airborne transmission.

They also said that public health officials should clearly differentiate between droplets ejected by coughing or sneezing and aerosols that can carry the virus to greater distances

Public health officials must highlight the importance of moving activities outdoors and improving indoor air, along with wearing mask and social distancing, the letter said.

(Reporting by Vishwadha Chander in Bengaluru; Editing by Shinjini Ganguli)

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New guidance to ensure medicine label claims are genuine

The FDA guidance is titled “Providing Regulatory Submissions in Electronic and Non Electronic Format — Promotional Labeling and Advertising Materials for Human Prescription Drugs.” The focus of the document is to provide guidance for pharmaceutical manufacturers, packers and distributors in relation to promotional materials for human

prescription drugs.

By promotional labeling this generally refers to any labeling, other than the FDA-required labeling, that is devised for promotion of the product and can include TV ads, brochures, booklets, websites and any other source, be that paper-based or digital.

The guidance considers appearance, layout, format, and visible impression of promotional materials submitted, and, in tune with the modern age, embraces everything from the style of a promotional booth to the marketing of medicines through the use of video games.

An example of inaccurate marketing is provided by Forbes. This relates to the company Allergan which produced a new eyelash thickening drug Latisse in 2019, promoted by Brooke Shields. While the marketing material showcased the actor’s longer, thicker lashes from the drug, it was called up by the FDA for not mentioning the possible side effects, which can include “hair growth outside of the treatment area, a permanent darkening of eye color and bacterial infections that can lead to blindness.”

Not only is it important to get marketing material right, it is also of necessary to ensure that fake medicines do not get onto the market.

Concerns with misleading or falsified medicines is a global problem and one which pharmaceutical companies and regulators are seeking to address.

One of the important characteristics, according to the website Healthcare Packaging, is the use of unique identifiers for each item of medicines. This helps with the track and tracing of the product. Such an approach also fits in with the growing interest in technologies like blockchain.

A blockchain is a time-stamped series of immutable record of data that is managed by a cluster of computers not owned by any single entity (this means it is ‘decentralized’).This makes the technology ideal for tracking supplies, and ensuring that required storage conditions have been achieved and that goods have not been tampered with.

READ MORE: Blockchain helps pharma with product traceability

According to a NASDAQ article, the application of blockchain could save the pharmaceutical sector billions of dollars as well as providing a securer supply of medicnes for patients.

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CDC slowing pace on releasing new coronavirus health guidance

For the last week, the Centers for Disease Control and Prevention has stopped issuing new health information related to the novel coronavirus after altering the procedure by which that information was being shared with the American people, sources with direct knowledge of the change told ABC News.



a blue sign sitting on the side of a building: A general view of the U.S. Centers for Disease Control and Prevention (CDC) headquarters in Atlanta, Georgia, on April 24, 2020.


© Tami Chappell/AFP via Getty Images
A general view of the U.S. Centers for Disease Control and Prevention (CDC) headquarters in Atlanta, Georgia, on April 24, 2020.

The type of information that has been withheld has previously been vital to hospitals, health officials and local leaders on the front lines providing updated guidance on how to treat, test and slow the spread of the illness, which has claimed over 200,000 American lives. A source told ABC News that includes additional “guidance on who should be tested and when,” adding, “That stuff won’t get updated.”

From at least Sept. 24 to Sept. 30, the CDC has stopped updating new health guidance and recommendation information, according to the sources. An ABC News review of the CDC website shows a timeline that supports the lack of information being updated.

­­A CDC source familiar with the COVID response called the halt in information flow to the American public a “moratorium,” adding, “Scientists are prevented from updating the CDC website with new information, recommendations and policies surrounding COVID.” A separate source confirmed CDC guidance updates are not currently being published, but disagreed with the categorization of a “moratorium” and instead insisted “agency leadership is just ensuring the review process is being followed.”

MORE: CDC director, despite Trump criticism, sticks to timeline that most Americans to get vaccine by summer 2021

“If any updates are made to existing guidance or new guidance is made, the CDC is requiring every piece to have approved talking points and maybe a summary statement,” CDC employees and scientists learned on a CDC conference call Wednesday morning according to a source that was on the briefing call.

The source told ABC News, “We know we have new science, but updates based on new and emerging science are not updated or able to be shared,” including CDC “recommendations on best practices and guidance on how to protect yourself and others from getting and spreading COVID.”

This new requirement will create a backlog of information from over a week ago, according to the sources.



Robert R. Redfield wearing a suit and tie: Centers for Disease Control and Prevention (CDC) Director Dr. Robert Redfield speaks at a hearing of the Senate Appropriations subcommittee reviewing coronavirus response efforts, Sept. 16, 2020, in Washington, D.C.


© Andrew Harnik/Pool via Getty Images
Centers for Disease Control and Prevention (CDC) Director Dr. Robert Redfield speaks at a hearing of the Senate Appropriations subcommittee reviewing coronavirus response efforts, Sept. 16, 2020, in Washington, D.C.

One source told ABC News within the last several days more precise testing guidance for nursing homes was cleared and has yet to be posted. This delay is in sharp contrast to previous action, when guidance was being posted quickly, the source added.

“If this information is true, it is truly chilling. Political interference with CDC is one of the major reasons why our response to this pandemic has been such a disaster,” said Dr.

Test Your Knowledge on NICE Abdominal Aortic Aneurysm Guidance

NICE advises considering an aortic ultrasound for women aged 70 and over if AAA has not already been excluded on abdominal imaging and they have COPD, or coronary, cerebrovascular or peripheral arterial disease, or a family history of abdominal aortic aneurysm, or hyperlipidaemia, or hypertension, or if they smoke or used to smoke.

Men aged 66 and over who have not already been screened should be encouraged to self-refer to the NHS abdominal aortic aneurysm screening programme if they have chronic obstructive pulmonary disease (COPD), or coronary, cerebrovascular or peripheral arterial disease, or a family history of abdominal aortic aneurysm, or hyperlipidaemia, or hypertension, or if they are current or ex-smokers.

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