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Sunday, March 14, 2021

AstraZeneca finds no evidence of increased blood clot risk from vaccine

 AstraZeneca Plc said on Sunday a review of safety data of people vaccinated with its COVID-19 vaccine has shown no evidence of an increased risk of blood clots.

AstraZeneca’s review, which covered more than 17 million people vaccinated in the United Kingdom and European Union, comes after health authorities in some countries suspended the use of its vaccine over clotting issues.

“A careful review of all available safety data of more than 17 million people vaccinated in the European Union and UK with COVID-19 Vaccine AstraZeneca has shown no evidence of an increased risk of pulmonary embolism, deep vein thrombosis or thrombocytopenia, in any defined age group, gender, batch or in any particular country,” the company said.

Authorities in Ireland, Denmark, Norway and Iceland have suspended the use of the vaccine over clotting issues, while Austria stopped using a batch of AstraZeneca shots last week while investigating a death from coagulation disorders.

European Medicines Agency has said there is no indication that the events were caused by the vaccination, a view that was echoed by the World Health Organisation on Friday.

The drugmaker said, 15 events of deep vein thrombosis and 22 events of pulmonary embolism have been reported so far, which is similar across other licensed COVID-19 vaccines.

The company said additional testing has and is being conducted by the company and the European health authorities and none of the re-tests have shown cause for concern. The monthly safety report will be made public on the EMA website in the following week, AstraZeneca said.

The AstraZeneca vaccine, developed in collaboration with Oxford University, has been authorised for use in the European Union and many countries but not yet by U.S. regulators.

The company is preparing to file for U.S. emergency use authorisation and is expecting data from its U.S. Phase III trial to be available in the coming weeks.

https://www.reuters.com/article/us-health-coronavirus-astrazeneca-vaccin/astrazeneca-finds-no-evidence-of-increased-blood-clot-risk-from-vaccine-idUSKBN2B60KO

Visually Impaired Face Roadblocks Booking Online Vaccine Appointments

 Chris Reighard, a 62-year-old retired employee of the Arkansas Division of Services for the Blind who lives in Altoona, Pennsylvania, considers herself and her husband, Dave, to be pretty tech savvy. But she was unable to book vaccination appointments for them, both who are blind, through the Pennsylvania Health Department website while using one of the most commonly used screen readers.

“Their page is very accessible until you get to where you need to find the locations of the vaccines, and those are done like colored dots on a map,” she said. “Of course, the screen readers won’t do colored dots, they pretty much do text, and the colored dots did not have any text associated with them. That was a problem.”

But the Reighards are far from alone in their struggles to get vaccinated. Blind and visually impaired Americans are finding it difficult, and in some cases impossible, to schedule vaccination appointments because so many are being scheduled online. Even though they have software that enables them to do many things digitally, they’re finding that these new registration sites suffer from low-contrast coloring, minimal text options, screen reader incompatibility and supplemental electronic forms that must be filled out.

Currently, about 12 million people above the age of 40 in the United States have vision impairment, including 1 million who are blind, according to the Centers for Disease Control and Prevention. Over 3 million people who are top contenders for the shot — aged 65 and older — have a vision disability, according to the 2019 American Community Survey.


The booking problems are so widespread that a recent survey by nonprofit WebAIM and Kaiser Health News found technological accessibility barriers on all but 13 of 94 state webpages that included information about the vaccine, lists of providers and sign-up forms.

These barriers violate Title II of the Americans With Disabilities Act, which prohibits discrimination against individuals with disabilities in all state and local government programs, activities and services.

They also violate Section 504 of the Rehabilitation Act of 1973, which requires equal access to the benefits and services of programs, like state and local governments, receiving federal financial assistance.

Cyndi Rowland, WebAIM executive director, estimated that the barrier number is even higher because her group used an automated tool that only identifies “about a third” of accessibility issues. She emphasized that these problems are not new and should have been addressed long ago.

“It is, I think, a sad reflection of our times, that accessibility is still not part of what is top of mind for developers. We've had web accessibility guidelines and standards for 20 years,” she said. “This has been a real rough year for folks with the kinds of disabilities that affect computer and internet use.”

Widespread problems

When contacted about the Reighards' challenges, Pennsylvania Department of Health deputy press secretary Maggi Barton acknowledged that there are problems.

“While our website is accessible for those with vision impairment who are using a screen reader, the vaccine map may not be, as it’s embedded through a different platform,” she said. Barton added that the state also offers help booking through its telephone hotline.

But the problems with these sites are also happening outside of Pennsylvania.

Robert Jaquiss, a 67-year-old blind Montana resident who serves as the state’s National Federation of the Blind chapter secretary, said he had trouble with multiple drop-down or “combo” boxes in both sign-up portals for shot slots provided by the Missoula City-County Health Department and University of Montana that he found on the county’s website. In one instance, Jaquiss said he used a series of keystrokes to try and interact with a box that asked about the number of people requesting a shot slot. But nothing happened.

Robert Jaquiss, 67, of Missoula, Mont., has been blind since birth.
Robert Jaquiss recently ran into technological barriers while trying to sign-up for a Covid-19 vaccine appointment.Rebecca Stumpf / for NBC News

“I couldn't get through the form,” he said. By the time he figured it out “all the appointments were gone.”

Paula Short, associate vice president of campus preparedness and response at the University of Montana, said she asked that the drop-down box be removed. As of Friday, it was still there. For now, Short said the University of Montana added screen-reader-compatible language at the top of its sign-up portal to direct anyone with accessibility issues to the Missoula County call center and is currently testing an alternative registration process.

“The ability for everyone to have access to vaccines (and be able to schedule vaccination) is a top priority and we will work to remove any barriers to the online sign-up and continue to provide access over the phone,” Short said.

Missoula City-County Health Department spokeswoman Hayley Devlin said the drop-down box found in the sign-up portal for the MCCHD vaccination site is an “optional field that is not required to book an appointment.” Like Short, she also directed blind and visually impaired residents to the county’s call center and noted that the health department reserves 20 percent of shot slots there, so people with vision impairments or lack of internet access can book appointments.

Like Reighard, Jaquiss had to turn to someone with sight for help.

“One of my friends helped me out,” Jacquiss said. “I gave him my particulars and because he could see and work the web fast enough, he got me an appointment.”

Seeking help

But not everybody feels comfortable asking for help.

Yolanda Thompson, a blind 63-year-old Colorado resident who ran into screen reader incompatibility issues when trying to select appointment times on the Safeway and King Soopers websites, said she would “rather die” than ask her sighted husband for help.

“Because of not choosing to have a co-dependent relationship, I don’t use his sight to assist me,” Thompson said. “It changes your relationship. It’s not healthy.” 

Thompson also said she was hesitant to call a technology assistance program like Aira out of personal and medical privacy concerns.

Yolanda Thompson Using a Vario Ultra Braille Note Taking device connected to her computer.
Yolanda Thompson Using a Vario Ultra Braille Note Taking device connected to her computer.Courtesy Yolanda Thompson

Boulder Community Health, where Thompson also hit another roadblock with a CAPTCHA box, said it was “not aware” that the portal had a barrier for people who are blind or visually impaired, according to its director of marketing and public relations, Richard Sheehan. He said Friday that the company added a new link near the existing CAPTCHA box that “can be read by the readers used by blind and visually impaired people” and “provides the same function as CAPTCHA.”

Political intervention

The inaccessibility plaguing these websites is prompting outrage from politicians, advocates and health professionals alike.

Thirteen United States senators wrote a letter on March 3 to the Department of Justice and the Department of Health and Human Services asking the agencies to address some of these problems.

“In order to make sure that everyone in the United States is able to access these vaccines, we must attend to sectors of the population that have access needs, in particular individuals with disabilities who may need accommodations to access vaccination sites and register for an appointment,” the senators wrote.

In addition to telling the agencies that websites should be compatible with screen readers, the senators asked that they adhere to the law and “the most up to date Web Content Accessibility Guidelines.”

“Since each state has the option to develop its own vaccine registration system and distribution process, we ask that you ensure that these processes meet or exceed the requirements of the Americans with Disabilities Act and Section 504 and 508 of the Rehabilitation Act (29 U.S.C. 794d), as amended in 1998,” they wrote.

Laura Epstein, press secretary for Sen. Maggie Hassan, D-N.H., said her office has not received a response yet and noted that the agencies have until Wednesday to give one.

Rachel Seeger, senior adviser for public affairs and outreach at the HHS Office for Civil Rights, said, “HHS is in receipt of the letter and will respond to Congress on this important issue.”

Mark Riccobono, president of the National Federation of the Blind, sent a letter to all 50 governors last month demanding action and offering help.

“It is imperative that blind and low-vision Americans receive the same opportunities and tools to participate in ending this public-health threat as others do,” he wrote.

Riccobono “has received no substantive responses to the letter to governors, although he has received some pro forma acknowledgements that they received it,” NFB spokesperson Chris Danielsen said.

Potential answers

Some individual states and academic institutions are also stepping in to help fix this problem.

Johns Hopkins University recently created an accessible all-text vaccine dashboard to combat tech barriers. The Covid-19 Vaccine Prioritization Dashboard, updated every Wednesday, provides screen-reader-compatible vaccine eligibility information for all U.S. states and territories and is accessible in multiple formats such as Excel, PDF and CSV.

“Accessibility certainly has been an afterthought for a lot of the sites,” said Bonnie Swenor, director of the Johns Hopkins Disability Health Research Center, who helped build the dashboard. “This conversation around gaps and access, differences and prioritization, is a really call-to-action moment for us, for our community.”


States like Arizona are trying to make the changes on their own. Arizona officials recently redesigned the state's vaccine finder to allow residents to search for providers using an all-text list rather than just a map that, as seen in Reighard’s case in Pennsylvania, is incompatible with screen reader technology.

Amy Porterfield, secretary of the Arizona Governor’s Council on Blindness and Visual Impairment, has been working with the state’s health department to help make this change and modify other areas of the portal that are still inaccessible.

“It takes people from being in a place where they know they can get a shot but they have no idea how to where they can get on the website and see what their potential for getting the shot is and where they can go and what their resources are,” she said. “Knowledge is power, and this provides the empowerment for blind people to have equality with everyone else.”

https://www.nbcnews.com/business/consumer/blind-americans-face-roadblocks-booking-online-vaccine-appointments-n1260954

UK seniors may get third 'booster' jab in August

 A Covid-19 booster vaccine is likely to be rolled out in the autumn to avoid another winter surge, a top government vaccination adviser has said.

Anthony Harnden, acting chair of the Joint Committee on Vaccination and Immunisation, told the BMJ that the booster would be needed either to protect against a new variant or as a safety net as the duration of protection is unknown.

He said that the booster could be given to certain vulnerable groups or the entire population.

"We certainly don't want to see a winter like we've seen this winter," he said. "And if we've got new variants circulating and we've got dropping levels of immunity due to the vaccination, then that becomes an imperative to do a booster."

Mr Harnden suggested that the booster could be rolled out in August or September "rather than later in the year, because of this worry about a large third wave affecting the elderly". 

He added: "I think we're likely to make a bold decision to recommend a booster dose, even if we haven't got all the evidence of the necessity, just because I think the consequences of not immunising with the booster doses are so big.

"If it's proved that it's needed months later it may be too late."

https://www.telegraph.co.uk/global-health/science-and-disease/coronavirus-news-covid-astrazeneca-vaccine-lockdown-variant/

Israel plans to start injecting 12-15 year olds with Pfizer's mRNA shot

 Israel's Ministry of Health plans to extend its vaccination campaign to include 12 to 15 year olds even before FDA approval is issued for the injection on that age group, according to a Channel 12 report.

Israel will likely approve the vaccine for its younger population as soon as Pfizer releases preliminary results of its safety studies on children - and before the U.S. Food and Drug Administration approves the drug - leading the way yet again in the global rollout of the anti-COVID-19 shot.

The vaccine is currently approved for emergency use only by the FDA and restricted to ages 16 and up.

This is not terribly surprising if you've been following the news these past few months. Prime Minister Benjamin Netanyahu said last week he planned that children, starting from age 12, would all be vaccinated by June. And as early as January, Israel's coronavirus czar Prof. Nachman Ash predicted that vaccines would be approved and rolled out for children as early as March.

“The fact that children under the age of 16 are not currently getting vaccinated is certainly troubling, in terms of the ability to achieve herd immunity,” he said at the time. “I reckon that, in another month or two, there will be another cohort — the aged-12 and higher — that we can vaccinate.”

Israel has already preempted other nations and world health organizations by becoming the first country to approve - and even encourage - pregnant women to take the vaccine.

Nearly 90% of Israeli adults have been given at least one of the two vaccine doses since the nation's warp-speed campaign began over two months ago, or else have recovered from the coronavirus.

Israel has also began rolling out its green pass system, whereby access to certain public venues is limited to citizens with proof of full immunization. The passes – also known as passports – expire after six months, but Netanyahu has already ordered 36 million additional vaccines for Israel's population of 9.3 million, he said earlier this week, and plans for booster shots twice a year.

Some high school students have been barred from returning to school, taking matriculation exams and getting driving lessons if they have not been vaccinated.

Channel 12 reported on Thursday that as soon as data from Pfizer's safety trials on children from age 12 is completed, Israel will likely approve the vaccine for all youth.

“Committee members told us that they will not wait for the end of the experiment to determine its effectiveness and emphasize that the assumption is that the vaccine is effective,” Channel 12 said. “This means that once preliminary results regarding the safety of the vaccine for children are completed, this will be sufficient for the Vaccine Prioritization Committee.”

Some 200 Israeli children from 12 to 15 received exemptions and have already been vaccinated. No side effects were reported among these 200 children who were already vaccinated, Channel 12 said, which may tip the scales in favor of a quick approval.

House Overwhelmingly Backs Expanding Who VA Vaccinates

 The House on Tuesday evening unanimously passed a measure that would broaden the Veterans Affairs Department’s responsibilities in vaccinating Americans, adding to the millions of individuals it is already tasked with inoculating. 

The 2021 VA Veterans’ and Caregivers’ COVID-19 Immunizations Now Expanded (VA VACCINE) Act (H.R. 1276) would allow any veteran to receive a novel coronavirus vaccine through the department, even if they are not enrolled in VA health care. It would also enable any caregiver of veterans enrolled in several VA long-term care programs to receive an inoculation from the department. 

The measure, which now heads to the Senate after receiving broad, bipartisan backing in the House, would ensure that veterans not eligible for care through the VA system could receive the vaccine. That includes veterans without compensable service-connected disabilities, those with incomes above VA’s threshold and those living abroad. Veteran service organizations requested legislation and lawmakers moved quickly to usher it through the House. 

“The House took swift action to ensure VA can provide COVID-19 vaccines to all veterans and caregivers who walk through its doors,” said Rep. Mark Takano, D-Calif., who chairs the House Veterans Affairs Committee. “We must get more shots in arms—our VA VACCINE Act makes sure that VA can.”

Rep. Mike Bost, R-Ill., the top Republican on the committee, said it was "painful" to hear stories of veterans being turned away from receiving the vaccine at their local VA facility. He called the measure a "lifeline" that would give VA the "authority it needs to meet this moment." 

VA has so far provided an initial dose of a vaccine to nearly 1.9 million people. It is now vaccinating about 300,000 people per week. The Centers for Disease Control and Prevention has allocated 6.5 million doses to VA, a figure that will have to be increased to reach the newly eligible population. Richard Stone, VA’s acting undersecretary for health, recently told Congress the department did not have enough vaccine supply to inoculate veterans ineligible for its care. 

VA is currently assisting the Homeland Security Department in vaccinating its employees, so far delivering first doses to about 15,000 of those staffers. The joint initiative has been slow to get off the ground and has left those located outside a 50-mile radius from designated facilities on their own to receive a shot. Then-acting Homeland Security Secretary David Pekoske emailed staff in January to launch Operation Vaccinate Our Workers (VOW), saying the department would eventually help get all employees who want a COVID-19 vaccine get one. VA has said it will maintain its partnership with DHS until vaccines are widely available, but the two agencies have not yet opened up the appointments to all Homeland Security personnel. Randy Noller, a VA spokesman, said the department will be expanding the number of facilities accepting DHS personnel from 31 to 71 in the coming weeks.

VA has so far provided at least an initial dose of the vaccine to 275,000 of its own employees, more than two-thirds of its workforce. The department has similarly promised to eventually make the vaccine available to any employee who wants it. VA, which runs the largest hospital network in the country, has delivered more vaccine doses than all other agencies receiving direct distributions combined.


https://www.govexec.com/management/2021/03/house-overwhelmingly-backs-expanding-who-va-vaccinates/172590/

China 1st Major Economy to Start Withdrawing Pandemic Stimulus Efforts

 As the first major economy to beat back Covid-19, China is now taking the global lead in moving to unwind its pandemic-driven economic stimulus efforts.

Unlike the U.S. and Europe, which are still flooding their economies with liquidity and spending, China has started reining in credit in some corners.

The shift puts China at the vanguard in confronting a challenge other economies will face in coming years as their economies recover: how to withdraw stimulus without snuffing out growth or causing broader market instability.

China's policy makers have expressed concern about an overheating housing market and want to prevent bigger imbalances. They are also eager to resume a multiyear campaign to curb debt that started building during the previous global recession.

If mishandled, China's tightening could impair its recovery, which would crimp the global economy. China's plans could also create wider problems if they trigger more debt defaults or a bigger correction in China's stock markets, at a time when global investors are already jittery.

For those reasons, economists say, China is likely to move slowly, gradually tightening credit in certain parts of the economy while avoiding more blunt-force moves like raising interest rates.

"It is very clear that China's policy makers intend to unwind stimulus and tighten policies," said Ding Shuang, chief economist for Greater China at Standard Chartered Bank, "but they've been treading ahead carefully without making a sudden U-turn."

China signaled its intentions during annual parliamentary meetings held earlier this month. It set its target for 2021 gross domestic product growth at "above 6%," a relatively low rate given the economy's momentum and a sign that Beijing wants flexibility to withdraw stimulus in the coming months, economists said. The International Monetary Fund projects China's economy will expand by around 8% this year.

China lowered its fiscal deficit target -- the gap between government spending and revenue -- to 3.2% of GDP this year, from 3.6% in 2020. A smaller deficit suggests a more restrictive fiscal policy. The government also cut the quota for local government special bonds, a type of off-budget financing to fund local investments like infrastructure, to approximately $560 billion, down from $576 billion last year.

Beijing didn't announce further issuance of special central government bonds this year, after selling approximately $154 billion of such bonds in 2020.

"As the economy resumes growth, we will make proper adjustments in policy but in a moderate way," China's premier, Li Keqiang, said at a news conference March 11. "Some temporary policies will be phased out, but we will introduce new structural policies like tax and fee cuts to offset the impact."

Those moves followed earlier steps and were interpreted by investors as signaling tighter credit. In January, the central bank mopped up more liquidity than expected through daily open-market operations, a tool used to control the money supply available to commercial banks. That briefly sent a key short-term money rate to its highest level in five years, making it costlier for banks to borrow funds.

To tame rising property prices, China's financial regulators recently imposed new rules making it more difficult for property developers, who are typically highly leveraged, to obtain new bank loans.

Broad credit growth picked up some in February, after declining for four consecutive months. Still, analysts expect lending will slow again given Beijing's recent signals.

In contrast, last week the U.S. enacted a fresh $1.9 trillion economic aid package and the European Central Bank said it would boost its purchases of eurozone debt.

The different approaches reflect how Beijing views the pandemic as a temporary disruption, while Western policy makers are still trying to revive their economies and prevent long-term damage from the pandemic's effects.

Beijing's emergency measures last year included cutting taxes to help small businesses and ordering banks to extend more loans. Still, China's fiscal measures amounted to far less as a share of GDP than those of the U.S. and many developed economies.

At the end of 2020, China's total fiscal spending on pandemic stimulus was about 6% of its GDP, versus 19% for the U.S., according to IMF calculations.

China's economy had recovered its pre-pandemic momentum in the last quarter of 2020, largely because of its success in containing Covid-19 and strong exports.

Now its leaders worry more about controlling debt and other long-term economic issues, analysts say. Last year China's overall leverage ratio, which measures the ratio of total debt to GDP, rose 24% -- the fastest pace since 2009 -- to 270%, according to official data.

Many economists expect China's central bank, the People's Bank of China, to tame the pace of new credit issuance rather than raise key interest rates, which would risk attracting speculative money inflows that can fuel dangerous asset bubbles. The central bank has pledged to keep its monetary policy prudent and flexible, while avoiding flood-like stimulus.

"The market widely interprets PBOC's tone as more hawkish" than before, said Mr. Ding of Standard Chartered. That could lead to risks, he said, if inadequate communication leads to market overreactions.

Another possible land mine is the potential for tighter credit to cause more defaults among state-owned enterprises. Many are heavily indebted, and local governments, which have their own debt problems, are increasingly wary of bailing them out.

"As China exits supportive measures, some of the problems that got glossed over last year may show up this year," said Wang Tao, China economist at UBS. "We expect to see more corporate bond defaults and a higher bad loan ratio."

https://www.marketscreener.com/news/latest/China-Becomes-First-Major-Economy-to-Start-Withdrawing-Pandemic-Stimulus-Efforts--32681242/

Lawmakers mull greater federal healthcare worker protections

 Lawmakers and government agencies are exploring greater protections for healthcare workers amid outcry over pandemic-related safety concerns that have persisted for a year.

During a House Education and Labor subcommittee hearing Thursday on strategies for protecting workers from COVID-19 infections, a registered nurse with National Nurses United urged greater federal protections for healthcare workers, first by recognizing aerosol transmission of COVID-19 and having the Occupational Safety and Health Administration issue an emergency temporary standard.

"If these recommendations had been implemented one year ago, my colleague Celia, along with thousands of other healthcare workers, would be alive today," Pascaline Muhindura, a registered nurse in the critical care unit at HCA's Research Medical Center in Kansas City, Missouri, told lawmakers.

As of Friday, the Centers for Disease Control and Prevention had counted more than 422,000 cases of COVID-19 among healthcare workers in the U.S and 1,397 deaths. That's almost certainly an undercount, however, as that occupation information was only available in fraction of the data.

There's still some uncertainty, though, about how at risk healthcare workers are to COVID-19 exposure at their jobs. A recent JAMA Network Open study found most healthcare workers who tested positive got the virus from community spread.

OSHA so far has declined to exercise its power to implement emergency standards, an option available to it under certain circumstances. Throughout the pandemic, hospitals and health systems have operated on guidance, not standards.

On Jan. 21, President Joe Biden issued an executive order asking the agency to consider an Emergency Temporary Standard, including with respect to mask wearing if necessary, and if so issue an ETS by Monday. It also instructs OSHA to launch a national program focused on enforcement for violators that put the largest number of workers at serious risk.

The American Hospital Association said in a letter to the committee such a move would create a rigid new standard that has "real potential to add for hospitals and health systems a new layer of conflicting and impractical regulatory burden at precisely the wrong time."

"Enacting these new standards could force hospitals and their staffs into a nearly impossible decision — to either not comply with the standards in order to treat all of the patients who need help or comply with the standards and stop treating patients when supplies of OSHA-required equipment are exhausted," AHA said.

But virus testing, personal protective equipment, safe staffing and workplace violence issues remain largely unchecked for working nurses, according to an NNU survey from 9,200 registered nurses, including both union members and non-union members, conducted in February.

More than 80% of nurses said they are forced to reuse single-use PPE, which is nearly unchanged from NNU's November survey. About half reported that all patients at their hospital are screened for COVID-19, and while more nurses have been tested since November's survey, that "still falls short of the regular and on-demand testing that nurses should be able to access," NNU said.

The survey also found that 22% of nurses reported facing increased violence on the job, which they attribute to decreased staffing levels, changes in the patient population and visitor restrictions.

"Violence has gotten worse in the past year," Muhindura said at the hearing. "You see an increase in anxiety and agitation in patients with COVID related to the strict isolation."

Rep. Joe Courtney, D-Conn., reintroduced the Workplace Violence Prevention for Health Care and Social Service Workers Act on Feb. 22, which would direct OSHA to create a national standard requiring healthcare and social service employers to develop and implement a comprehensive workplace violence prevention plan.

Courtney mentioned the Feb. 11 shooting at Allina Health Clinic in Buffalo, Minnesota, that left one employee dead and four others injured.

Hospital employees had "no sort of early warning systems or measures in place which OSHA has developed as volunteer guidelines for many, many years," Courtney said.

"But again because we don't have a national standard, are just not being implemented," he said.

Muhindura testified that her hospital has panic buttons in case of emergencies, but "not everyone has these protections throughout the country."

https://www.healthcaredive.com/news/lawmakers-mull-greater-federal-healthcare-worker-protections/596632/