Healthcare Dive

APRIL 7, 2022

About half of eligible Americans haven't received a booster and may be less protected should cases surge. Health officials hope to soon ready an updated shot, but experts on the committee struggled to identify the best approach.

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Healthcare Dive

APRIL 28, 2022

The biotech's shot would become the first available to children under 6, the last remaining age group currently ineligible for vaccination.

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Bill of Health

JANUARY 24, 2022

Centers for Disease Control and Prevention (CDC) is failing parents by preventing off-label use of our existing COVID-19 vaccines in the under-five set. The CDC, through its vaccine provider agreements, prevents physicians and parents from pursuing off-label use of COVID-19 vaccinations in young children.

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Healthcare Dive

MAY 23, 2022

The drugmaker, along with partner BioNTech, plans to submit the new data to the FDA this week. The agency has scheduled a meeting for outside experts to review the data in mid-June.

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Healthcare Dive

MAY 6, 2022

The agency is limiting use to adults who either can't or won't take another authorized vaccine after collecting more data on a rare and unusual clotting syndrome that has weighed on the shot's uptake.

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Hanys

JANUARY 14, 2022

The fact sheets for healthcare providers and recipients and caregivers were revised in response to new safety information regarding the serious risk of Immune Thrombocytopenia, which can cause easy or excessive bruising and bleeding due to very low levels of platelets, following administration of the Janssen COVID-19 vaccine.

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Bill of Health

APRIL 21, 2023

FDA lawsuit and its potential implications for pharmaceutical regulation, and an estimate of U.S. public investment in the development of mRNA COVID-19 vaccines. Eroding Judicial Deference to the FDA – Consequences for Public Health. Brown BL, Kesselheim AS, Sarpatwari A. 2023 Mar 6;20(3):e1004190.

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Modern Healthcare

DECEMBER 8, 2022

The Centers for Disease Control and Prevention is expected to sign off soon, the final step for shots to begin.

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Bill of Health

APRIL 7, 2023

By Aparajita Lath Two articles published last month in the BMJ analyze the public investment and financing of mRNA COVID-19 vaccines, highlighting the extensive government funding that has supported the development of mRNA technology from 1985 to 2022. government substantially de-risking the vaccine development process.

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Bill of Health

FEBRUARY 8, 2022

When news broke last week that Pfizer-BioNTech was submitting for Emergency Use Authorization (EUA) a two-dose COVID vaccine regimen for children under 5 to the U.S. Food and Drug Administration (FDA), many parents felt a glimmer of hope after a long time. Solutions for the Future.

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Healthcare IT News - Telehealth

AUGUST 27, 2021

Enterprise Taxonomy:

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Health Law Pulse

FEBRUARY 11, 2022

Although receiving the COVID-19 vaccine remains one of the best ways to combat the severity of one’s symptoms, Dr. Van Kerkhove warned that the vaccine could become less effective as the virus continues to evolve.

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American Medical Compliance

AUGUST 12, 2022

Food and Drug Administration is planning to develop updated versions of booster vaccines that are specifically targeted to protect against Omnicron and its variants. Furthermore, the FDA is encouraging COVID-19 vaccine manufacturers to update their booster shots to protect against BA.4 Second COVID-19 Booster.

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Medisys Compliance

APRIL 20, 2022

On 4 th April 2022, CMS announced that more than 59 million Americans with Medicare Part B, including those enrolled in a Medicare Advantage plan, now have access to Food and Drug Administration (FDA) approved, authorized, or cleared over-the-counter COVID-19 tests at no cost.

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Bill of Health

OCTOBER 31, 2022

Some COVID-19 vaccine manufacturers in the US have refused to share vaccine samples for research purposes , creating an access issue with the potential to delay comparator studies, follow-on research, and new vaccine / drug development. By Aparajita Lath.

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Healthcare IT Today

SEPTEMBER 21, 2024

Read more… FDA FHIR Pilot Automates Adverse Events Reporting and Validation. Jay Nakashima at eHealth Exchange detailed how California’s Cedars-Sinai used FHIR to send adverse events related to COVID-19 vaccines to the FDA – a process that replaced manual data entry and faxing.

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Bill of Health

FEBRUARY 16, 2022

Food and Drug Administration (FDA), bringing a drawn out and contentious process to a close. Califf will be the second-ever FDA Commissioner to serve non-consecutive terms, and the first to have been confirmed by the Senate on two separate occasions. Banning Menthol Cigarettes. Reviewing E-cigarettes.

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Healthcare It News

OCTOBER 13, 2021

"That same year, FDA approved smart pills. And last year, a COVID-19 vaccine was researched, developed and deployed almost four years ahead of the normal timeline for a new vaccine. "In 2017, gene therapy was used to cure a teenage boy of sickle cell disease," he said.

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Healthcare IT News - Telehealth

MAY 7, 2021

For example, the data analytics team designed an algorithm to sort and pull relevant data from the records of more than 100,000 patients who had been diagnosed with COVID-19, identifying those at highest risk of complications from the virus. "We decided to implement self-scheduling for the COVID-19 vaccine.

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AIHC

FEBRUARY 2, 2022

A separate program, the HRSA COVID-19 Coverage Assistance Fund, is available to reimburse providers for COVID-19 vaccine administration to underinsured individuals whose health plan either does not include COVID-19 vaccination as a covered benefit or covers COVID-19 vaccine administration but with cost-sharing.

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American Medical Compliance

AUGUST 18, 2022

Receiving one negative test result does n0t necessarily mean that someone doesn’t have COVID-19. According to the FDA, people conducting at home tests should perform multiple COVID-19 tests over the course of several days. However, a PCR COVID-19 test has a higher detection rate of 95%.

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HIT Consultant

AUGUST 26, 2021

In our work studying individual immune responses to COVID-19 and COVID-19 vaccination, we’ve consistently found that the immediacy, strength, and duration of individual responses can vary widely – even when many variables are constant. Traditional SARS-CoV-2 antibody tests do not provide this level of granularity.

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HIT Consultant

NOVEMBER 30, 2021

To date, Labcorp has performed nearly 54 million COVID-19 PCR tests to detect the virus, provided instrumental data to government agencies like the CDC and the U.S. Food and Drug Administration (FDA), and worked with companies to develop COVID-19 vaccines and therapies. Labcorp became the first U.S.

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Dot Compliance

FEBRUARY 1, 2022

The race to develop a COVID-19 vaccine highlighted the power of artificial intelligence (AI) and machine learning (ML) as Johnson & Johnson, Moderna and Pfizer employed these technologies to swiftly get their vaccines to market. The next evolution is for companies to implement Industry 4.0 References. References.

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HIT Consultant

AUGUST 18, 2021

The world has been in urgent need of COVID-19 vaccines, treatments, and diagnostic tools. Social distancing and occupancy restrictions have expedited the digital transformation of clinical trial study design and execution as industry players have raced toward COVID-19 vaccine and treatment development.

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Health Populi

JUNE 24, 2021

On the pharma supply side, mRNA vaccines will dominate the market, proving more effective than others at stemming a further outbreak. With growing global supply and competition, we can expect prices for COVID-19 vaccines to fall, anticipating additional volumes from Sinopharm, Moderna, Sinovac, Gamaleya Institute, among others.

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HIT Consultant

MAY 2, 2022

The FDA is attempting to address this, having issued guidelines related to diversity in clinical trials in November 2020 – perhaps prompted by widespread media coverage of the fact that the black members of the society and other people of color were underrepresented in clinical trials for COVID-19 vaccines.

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YouCompli

MARCH 29, 2023

In this article, she discusses several issues that hospitals and health systems need to consider as a result of the scheduled end of the COVID-19 public health emergency. population previously received at least one COVID-19 vaccination. Department of Health & Human Services (HHS) reports that 80% of the U.S.

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SQA

MARCH 25, 2021

United States Food and Drug Administration (FDA) – Regulations and Guidances for Biologics and the Bioresearch Monitoring Program (BIMO). Manufacturing Considerations for Licensed and Investigational Cellular and Gene Therapy Products During COVID-19 Public Health Emergency, January 2021.

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American Medical Compliance

JUNE 30, 2022

Soon, children aged 6 months and older will be eligible to receive one of two FDA approved vaccines: Moderna and Pfizer BioNTech. Starting Friday June 24th, doses will begin shipping and millions of kids will have access to COVID-19 vaccines. Vaccine Availability. Response from Families and Health Officials.

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American Medical Compliance

JUNE 30, 2022

Soon, children aged 6 months and older will be eligible to receive one of two FDA approved vaccines: Moderna and Pfizer BioNTech. Starting Friday June 24th, doses will begin shipping and millions of kids will have access to COVID-19 vaccines. Vaccine Availability. Response from Families and Health Officials.

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Bill of Health

OCTOBER 27, 2022

Newsom a legal principle that threatens to upend over a century of legal precedent recognizing the authority of state governments to ensure public health by mandating vaccines. By Donna Gitter. In 2021, the Supreme Court articulated in Tandon v.

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Bill of Health

AUGUST 29, 2022

Despite pediatric COVID-19 vaccine availability, many youth remain unvaccinated , and are thus at higher risk of life-altering outcomes as a result of contracting COVID-19. [1]. Specific to the COVID-19 vaccine, children under age 18 in most jurisdictions will require parental consent. [8].

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Bill of Health

DECEMBER 14, 2022

Food and Drug Administration (FDA). For example, physicians and companies offering cytoplasmic and mitochondrial transfer have received Untitled Letters from the FDA. After receiving the letters, these individuals and entities have ceased to provide these techniques in the United States. using administrative law: (1) adapting the U.K.’s

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Bill of Health

SEPTEMBER 28, 2023

Despite having an outsized role in the discovery, development, manufacturing, and procurement of COVID-19 vaccines, therapeutics, and diagnostics, the federal government has generally not exercised any leverage in ensuring fair pricing and affordable access to these essential medical products.

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Bill of Health

JUNE 1, 2022

Food and Drug Administration (FDA) Commissioner Robert M. ” By starting with an endorsement of baseless statements by COVID minimizers, he weakened what was otherwise a compelling call to get kids boosted. If it didn’t, there would be no justification for a vaccine in the first place.

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Hall Render

MAY 20, 2022

COVID-19 public health emergency set to be extended. Covid-19 remains a public health emergency in US, administration says. FDA Bill Includes Medical Device Security Requirements For Manufacturers. Free telehealth to access COVID-19 antiviral drug offered in Massachusetts.

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