AstraZeneca scientist says COVID-19 boosters may be unnecessary for many

 The creator of the AstraZeneca COVID-19 vaccine told The Telegraph in an interview published Thursday that a booster shot may not be necessary for the majority of people.

Oxford University professor Sarah Gilbert told the news outlet that she could see certain situations in which those who were older or immunocompromised may need a third COVID-19 shot, but she stressed that “immunity is lasting well in the majority of people.” 

“As the virus spreads between people, it mutates and adapts and evolves, like the delta variant. With these outbreaks, we want to stop that as quickly as possible,” Gilbert told The Telegraph.

“We will look at each situation; the immunocompromised and elderly will receive boosters. But I don’t think we need to boost everybody. Immunity is lasting well in the majority of people.”

The Joint Committee on Vaccination and Immunisation, the vaccine advisory committee for the United Kingdom, is expected to make an announcement soon regarding whether COVID-19 booster can be given to the majority of Britons, according to the BBC. 

Those who are severely compromised immune systems have already been given the green light to get a third shot of the vaccine, Reuters reported.

On Thursday, the U.K. medical regulator said that the AstraZeneca and Pfizer-BioNTech vaccines could be used for COVID-19 boost shots. 

The news comes as the United States is also determining when and which people will be eligible for the COVID-19 booster shot. Last month, the Food and Drug Administration said that certain people who were immunocompromised could receive a third shot of either the Pfizer or Moderna vaccine.

Despite the fact that the Biden administration announced last month that booster shots would begin rolling out to the majority of Americans starting on Sept. 20, health officials have since sought a “pause” due to not enough data.

https://thehill.com/policy/healthcare/571656-astrazeneca-scientist-says-mass-covid-19-boosters-may-be-unnecessary-for

Pfizer to seek approval for vaccine in children 5 and over

 Pfizer and BioNTech announced this week that it will soon seek approval from global regulators for use of its coronavirus vaccine in children ages 5 and over.

The vaccine makers said in an interview published on Friday that they are looking to produce smaller doses of the vaccine for younger children.

“We will be presenting the results from our study on five- to 11-year-olds to authorities around the world in the coming weeks,” Ozlem Tureci, the co-founder of BioNTech and its chief medical officer, told German news outlet Der Spiegel.

The Food and Drug Administration (FDA) approved the Pfizer-BioNTech coronavirus vaccine for emergency use in adolescents 12 to 15 years old in May and granted full approval of the vaccine for recipients 16 and older last month.

Vaccines for children 12 and younger have yet to be approved by the FDA, according to The New York Times.

Scott Gottlieb, the former commissioner of the FDA and a Pfizer board member, said in August that the vaccine maker “could be in a position” to file an application for vaccine approval in children as early as October.

“This fall, Pfizer is going to be in a position ... to file data with the FDA at some point in September and then file the application potentially as early as October, so that'll put us on a time frame where the vaccine could be available at some point late fall, more likely early winter, depending on how long FDA takes to review the application,” Gottlieb said on CBS’s “Face the Nation” at the time.

Ugur Sahin, BioNTech’s chief executive, on Friday, called for people who are currently eligible to get the vaccine to do so ahead of an expected wave of COVID-19 infections this fall.

“There are still about 60 days left for us as a society to avoid a tough winter,” he said, according to the Times.

https://thehill.com/policy/healthcare/public-global-health/571678-pfizer-to-seek-approval-for-vaccine-in-children-5-and

Travel nurse demand up as pandemic intensifies full-time staffing shortages

The COVID-19 pandemic has intensified a nurse shortage in the U.S., leading hospitals to pay high rates for temporary staff like travel nurses.

April Hansen, group president of Workforce Solutions for Aya Healthcare, a San Diego-based healthcare staffing agency, said pandemic stress has led to nurse exhaustion and resignation. 

"Nurses are in a state of despair right now and they're burned out. The pandemic level of fatigue and stress is unlike anything they've faced before," Hansen said. "What we heard from nurses through research is that they didn't feel well supported throughout the pandemic journey from a mental health perspective, from a physical health perspective."

In some cases, nurses have also left the bedside because they don't want to comply with vaccine mandates.

At the same time, lucrative pay has also led some full-time nurses to quit and become travel nurses, fueling a cycle that only adds to the nurse shortage of according to critics of the industry. Travel nurses earning anywhere from $3,000 to $7,000 a week per assignment, according to Hansen. 

The job search page for Aya Healthcare, a travel nurse staffing agency, lists more than 50,000 job postings. (Aya Healthcare)

Hansen told Fox News Aya Healthcare has recently seen the demand for travel nurses increase to a point where it outpaces supply.

"We’re experiencing almost 50,000 open job orders for travel nurses even though the industry has grown," Hansen said.

Thombreka Turner, 26, was working full-time job at an Ohio hospital when she decided to become a travel nurse in February 2020. 

"It was a calling I would say, because I just wanted to help people honestly," Turner said. "We don’t know what we’re going into. Things are constantly changing, a patient could go from one condition to another in seconds but this is what we're trained to do."

In the past 17 months, Turner has worked in COVID-19 or psychology units in New Jersey, Texas, Missouri, Maryland, Ohio and Washington. Each assignment was three months long followed by time off.

Throughout the pandemic, Turner has worked with doctors to manage the symptoms of COVID-19 patients, juggling as many as eight patients at time. She even learned to speak Spanish in Dallas, Texas, to work with the Hispanic patients of the hospital she was assigned to.

Turner's career switch comes as the ongoing U.S. nursing shortage reaches critical levels — with millions of nurses needed to meet demand in the next few years according to the U.S. Department of Health and Human Services. 

Dr. Eddie Grant, president of the American Nurses Association, told Fox News the need for nurses outpaces the supply of nurses available and could for some time. In a letter this month, the ANA asked the Biden administration to declare the U.S nursing shortage a national crisis.

"There was a nursing shortage before, COVID only exacerbated what we are seeing as a shortage," Grant said. "There's an estimated need of over 2 million nurses in the next five years, so there's no way we're going to get that many people through nursing schools — so there's a lot of issues we need to address." 

https://www.foxbusiness.com/healthcare/travel-nurse-demand-increases

Blue Shield of Cal., Walgreens Collaborate on 'Innovative Healthcare and Wellness Services to Communities'

  Blue Shield of California and Walgreens today announced a new collaboration to expand access to health care, lower costs, and bring innovative services to enhance the consumer experience for individuals, families, and communities throughout California.

The initial phase of the collaboration will center on Walgreens Health Corner™ services – a personalized experience for Blue Shield commercial members to improve their health outcomes. The Health Corner locations will include health advisors – pharmacists, dieticians, or nurses – to inform and assist with health, nutrition, fitness, and disease management care coordination for either real-time or future care.

The healthcare services will focus on condition management and whole-person care. At launch, Blue Shield members in eligible plans will have access to blood pressure screenings, administration of A1C blood tests, and mammography care coordination. They will also be able to pick up take-home health screening tests with in-person assistance from health advisors for instruction on how to use and complete the kits, as well as support to locate new health and wellness products. Health advisors will also be present to help members set up their digital health applications on their mobile devices.

The program’s first phase will begin in late 2021 with the goal to expand Blue Shield’s service offerings to help close care gaps for members in Walgreens stores, virtually, and at home, in early 2022.

https://news.blueshieldca.com/2021/09/10/blue-shield-of-california-walgreens-collaborate-to-bring-innovative-healthcare-and-wellness-services-to-communities-in-golden-state

Uneven Distribution Of Federal COVID-19 Relief Funds To US Hospitals

 Abstract

People of color, immigrants, and those relying on the safety net have experienced a disproportionate share of the death and disease resulting from COVID-19 in the US. At the same time, Congress delegated great power to the Trump administration to distribute $178 billion in funding to health care providers. We studied the relationship between the relief received by 2,709 hospitals and community- and hospital-level characteristics. Funding through early February 2021 averaged $25.7 million per hospital. Our findings offer a mixed picture. Some correlates of real-world need, including serving a community with a very high share of Black residents or having a very high ratio of Medicaid revenue to beds, were associated with meaningfully increased funding. Other correlates of need—including serving a very high share of Hispanic residents or a Medically Underserved Area—were associated with decreased funding or no difference in funding. Our findings emphasize that funding formulas reflect consequential political judgments. In future allocations, the relationship between need and aid should be strengthened by de-emphasizing historical net patient revenue in favor of a broader set of community and hospital characteristics.

https://www.healthaffairs.org/doi/full/10.1377/hlthaff.2020.02018

Newsom Opposed Vaccine Mandates Just Two Years Ago; Biden And Fauci Also Said 'No'

 A common mistake people make is assuming the lying liar isn't lying this time.

For example, Joe Biden and Anthony Fauci have both previously said they wouldn't require, or 'couldn't see' a Covid-19 vaccine mandate in the United States.

And as recently as July...

Now, Human Events' Jack Posobiec reveals that California Governor Gavin Newsom - who's essentially campaigning against his recall on mandatory vaccinations - had deep reservations over government officials 'making a decision that is very personal.'

Read:

California Gov. Gavin Newsom announced in July that healthcare workers and state employees must be vaccinated or succumb to weekly testing and wear masks; however, back in 2019, Newsom opposed the same kind of mandate. 

“I believe in immunizations,” Newsom said at the meeting, “however I do legitimately have concerns about a bureaucrat making a decision that is very personal.” 

“We don’t measure character or leadership by a commander’s posture during moments of comfort, but by his willingness to stand against the tides and storms of collective opinion during eras of controversy and hysteria,” Kennedy Jr. wrote in a Facebook post. “California Gov. Gavin Newsom has just passed that test with his wise and sober opposition to a draconian proposal to forcibly vaccinate medically fragile children against the wishes of their parents and the medical advice of their physician.” 

“He expressed his concern about giving faceless government officials (with no medical training) veto power over vaccine exemptions deemed medically necessary by a child’s doctor,” Kennedy Jr. continued. “Gavin argued that those decisions should be made between patients and doctors without government involvement.”

https://www.zerohedge.com/political/gavin-newsom-opposed-vaccine-mandates-just-two-years-ago-biden-and-fauci-also-said-no

FDA to 'Follow The Science' On COVID-19 Vaccines For Young Children

 

For Immediate Release:

September 10, 2021

Statement From:

Janet Woodcock, M.D.
Acting Commissioner of Food and Drugs - Food and Drug Administration

Peter Marks, M.D., PhD.
Director - Center for Biologics Evaluation and Research (CBER)

As schools around the country are re-opening for in-person learning and families are returning to their busy school year schedules, we know many parents are anxious about the pandemic and protecting their children. Many parents have questions about COVID-19 and when vaccines will be available for children younger than 12 years of age. 

Many of our team at the FDA are parents and grandparents themselves, and our team shares the same concerns as many in our country about protecting our loved ones from COVID-19. We are therefore also eager to see COVID-19 vaccines available for young children. We also know that we all share the interest in making sure this process is done with safety at top of mind. As regulators, we recognize we have an important task ahead of us that will require us to act expeditiously while undertaking an extremely meticulous and thoughtful review once we receive requests to authorize a COVID-19 vaccine for emergency use or submissions for approval of a COVID-19 vaccine for this population.

We know there have been questions and public commentary on the process surrounding vaccines for young children, so we think it’s important to share information about the process and the necessary considerations involved to provide greater clarity to the public about this effort. 

It’s important that the public recognize that, because young children are still growing and developing, it’s critical that thorough and robust clinical trials of adequate size are completed to evaluate the safety and the immune response to a COVID-19 vaccine in this population. Children are not small adults – and issues that may be addressed in pediatric vaccine trials can include whether there is a need for different doses or different strength formulations of vaccines already used for adults.  

Steps the FDA will take to ensure the safety and efficacy of these products for children:

• First, vaccine manufacturers have reported that the necessary clinical trials involving children as participants are currently underway. Some have stated that they are still enrolling, and some are still administering doses or following participants. This process is expected to include a follow-up period of at least about two months, to allow for proper safety monitoring following the administration of vaccine doses for at least half of the clinical trial vaccine recipients.
• Once the manufacturers complete the relevant portion of their clinical trials, they have to complete the analysis of the data from the studies to understand how safe the vaccine is and how well it works in the clinical trial participants. The FDA will work closely with each manufacturer to ensure this data analysis is robust and meets regulatory standards. After manufacturers analyze their clinical trial data, they will compile the information and may request an emergency use authorization (EUA) or submit for approval a biologics license application (BLA), as appropriate, for this young population to the FDA. 
• When a completed request for EUA or approval has been received by the FDA, the agency will carefully, thoroughly and independently examine the data to evaluate benefits and risks and be prepared to complete its review as quickly as possible, likely in a matter of weeks rather than months. However, the agency’s ability to review these submissions rapidly will depend in part on the quality and timeliness of the submissions by manufacturers.  

Just like every vaccine decision we’ve made during this pandemic, our evaluation of data on the use of COVID-19 vaccines in children will not cut any corners. Conducting clinical trials to determine an appropriate vaccine dose in children requires additional work over that done in the adult studies, including ensuring that the vaccine dosage and formulation strength used is the appropriate one from the perspective of safety and generating an immune response. Our multi-disciplinary teams of doctors, scientists, statisticians and other experts will thoroughly assess this complex data in making any determination about COVID-19 vaccines in young children. We may also consult with our Vaccines and Related Biological Products Advisory Committee on any questions that warrant a public discussion by external experts. Importantly, once a decision to authorize or approve a vaccine for a younger population has been made, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet to discuss further clinical recommendations. 

Parents may be wondering if they can ask their health care providers to go ahead and vaccinate their kids using one of the currently available vaccines outside of the FDA-authorized or approved uses. Parents need to remember that the vaccine doses that are currently being studied in younger children are not necessarily the same vaccine doses that were authorized for individuals 12 years and older or approved for individuals 16 years of age and older—there are different dosing regimens being investigated. It is important for the clinical trials to be completed before vaccinating young kids, so the FDA’s team can conduct a thorough evaluation and ensure the data show that the vaccine under consideration is likely to work to prevent COVID-19 in young children and doesn’t cause unexpected safety issues separate from those that have already been observed in adolescents and adults.

Just like you, we are eager to see our children and grandchildren vaccinated against COVID-19 as soon as possible. We have to let the science and data guide us. The FDA is working around the clock to support the process for making COVID-19 vaccines available for children. As outlined above, this process is complex and relies on robust manufacturer trials and data, and while we cannot offer a specific date or timeline for when it may be completed for the various manufacturers’ vaccine candidates, we can assure the public we are working as expeditiously as possible to meet this critical public health need and we very much hope to have pediatric COVID-19 vaccines available in the coming months. 
 
Until we authorize or approve a vaccine for this younger population, it’s especially important that parents and others who interact closely with children under 12 years of age get vaccinated, wear masks, and follow other recommended precautions so that we can protect those who cannot yet protect themselves through vaccination.

Related Information

• FDA: COVID-19 Vaccines 
• FDA Frequently Asked Questions on COVID-19 and Vaccines
• Vaccines and Related Biological Products Advisory Committee | FDA
• Advisory Committee on Immunization Practices (ACIP) | CDC

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

https://www.fda.gov/news-events/press-announcements/fda-will-follow-science-covid-19-vaccines-young-children