FDA advisers recommend Pfizer, Moderna COVID-19 vaccines for youngest children
Healthcare Dive
JUNE 15, 2022
Independent experts unanimously supported use of both shots in children aged 6 months to 5 years old, clearing the way for an FDA decision.
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FDA clears Novavax's COVID-19 vaccine as 4th option in US
Healthcare Dive
JULY 13, 2022
The regulator’s decision comes more than a year after the main part of the principal trial was completed, raising questions about the shot’s effectiveness against omicron.
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Pfizer, BioNTech begin process of asking FDA for COVID-19 vaccine clearance in young kids
Healthcare Dive
FEBRUARY 2, 2022
The companies said the FDA, in an unusual step, requested they submit the clinical trial data they currently have while testing of a third dose in children under 5.
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US health officials propose annual COVID-19 vaccination for most Americans
Modern Healthcare
JANUARY 23, 2023
The FDA's simplified approach aims to make COVID-19 vaccinations more like the annual flu shot.
FDA delays review of Pfizer's COVID-19 vaccine for young children in surprise shift
Healthcare Dive
FEBRUARY 14, 2022
The agency pushed back plans to expedite review of the shot in children under 5, seeking more data on a third dose. An advisory meeting scheduled for next week has been postponed as a result.
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FDA authorizes Pfizer, Moderna COVID-19 vaccines for young children
Healthcare Dive
JUNE 17, 2022
The much-anticipated decision follows two days after a panel of independent experts unanimously recommended expanding the shots’ use. A CDC panel is meeting Friday and Saturday to develop specific recommendations.
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FDA advisers grapple with how to update COVID-19 vaccines
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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Remember the Babies: The Need for Off-Label Pediatric Use of COVID-19 Vaccines
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.
Moderna seeks FDA clearance for COVID-19 vaccine in young children
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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FDA FHIR Pilot Automates Adverse Events Reporting and Validation with Cedars-Sinai and the VA Through eHealth Exchange
Healthcare IT Today
SEPTEMBER 20, 2024
The following is a guest article by Jay Nakashima, President at eHealth Exchange An FDA project aims to make it as easy as possible for clinicians to report adverse drug events and share important clinical data with public health agencies to investigate the event.
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Pfizer says 3 doses of its COVID-19 vaccine works in youngest children
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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FDA places stricter limits on J&J's COVID-19 vaccine after review of rare side effect
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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FDA revises Janssen COVID-19 vaccine fact sheets to reflect ITP risk
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.
COVID-19 Booster Updates
American Medical Compliance
AUGUST 12, 2022
Cases of COVID-19 are still occurring across the United States due to more contagious Omnicron variants. Doctors and scientists worry about the effectiveness of current vaccines in protecting older populations against Omnicron infections. Therefore, experts are highly recommending booster vaccines. 5 sub-variants.
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Monthly Round-Up of What to Read on Pharma Law and Policy
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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Accessing COVID-19 mRNA Vaccines for Research: The Re-emergence of the Tragedy of the ‘Anticommons’
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. This “patent linkage” issue can trigger patent litigation.
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FDA authorizes updated COVID-19 vaccines for kids under age 5
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.
Reflections on Procedural Barriers to Pediatric COVID Vaccine Access
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. Advocacy for Vaccine Access. By Fatima Khan. While over 11.5
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COVID-19 Update: New Variants and Vaccine Research
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. The post COVID-19 Update: New Variants and Vaccine Research appeared first on Health Law Pulse.
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Unlocking the mRNA Platform Technology: Walking the Talk with Investment Protection
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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COVID-19 Tests With Inaccurate Results
American Medical Compliance
AUGUST 18, 2022
Many people use rapid at home COVID-19 tests to ensure that they have not contracted the virus. Receiving one negative test result does n0t necessarily mean that someone doesn’t have COVID-19. Repeat COVID-19 Tests. However, a PCR COVID-19 test has a higher detection rate of 95%.
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Updated CMS Guidelines for COVID-19 Tests and Booster Shot
Medisys Compliance
APRIL 20, 2022
Billing and coding guidelines for various medical specialities are constantly getting updated due different COVID-19 variants. In fact, concerned authority extended the current COVID-19 pandemic telehealth waivers for five months beyond the end of the public health emergency. Shop & Stop, Walgreens and Walmart.
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Why We Need a Personalized Approach to COVID-19 Immunity Testing
HIT Consultant
AUGUST 26, 2021
To date, the battle against COVID-19 has been waged largely in the field of public health, using a series of binary, black-and-white thresholds to measure progress. we have found macro, population-wide trends that largely echo those that have been reported by the CDC and vaccine manufacturers themselves. As the U.S.
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Labcorp Offers Observed Collections of COVID-19 PCR testing in Over 500 Patient Service Centers
HIT Consultant
NOVEMBER 30, 2021
What You Should Know: Labcorp announced that it is offering an observed collection of COVID-19 PCR testing in over 500 patient service centers nationwide. In addition, Labcorp COVID-19 PCR tests may be conducted at doctors’ offices, hospitals and health systems, urgent care facilities and many drive-thru testing sites.
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Google dismantles health division; FDA grants first full approval of a COVID-19 vaccine
Healthcare IT News - Telehealth
AUGUST 27, 2021
Enterprise Taxonomy:
IT execs talk new strategies for analytics, patient engagement, telehealth and more
Healthcare IT News - Telehealth
MAY 7, 2021
might be finally turning a corner in the COVID-19 pandemic. Overall, the COVID-19 pandemic has catapulted the importance of data analytics and data in general, said Lupu of Sanford Health. The director of the Centers for Disease Control and Prevention said recently that the U.S. " Dr. Roxana Lupu, Sanford Health.
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Coding COVID for Uninsured Patients
AIHC
FEBRUARY 2, 2022
Written by: AIHC Blogger This article is to communicate information from the Health Resources & Services Administration (HRSA) regarding the coding of COVID-19 claims for uninsured patients. Encounter for screening for COVID-19, asymptomatic Z20.822 Contact with and (suspected) exposure to COVID-19/ SARS-CoV-2 Z86.16
Cerner CEO pledges to zero-out 'noise' from EHRs, population health and revenue cycle
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. "COVID-19 showed the world what's wrong: Not enough focus on public health, prevention and equity.
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Weekly Roundup – September 21, 2024
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.
The Healthcare and Macro-Economic Impacts of Living with Endemic COVID – Listening to Fitch
Health Populi
JUNE 24, 2021
The economic and healthcare system impacts of this were explored in the Post-Covid Healthcare Landscape , delivered by Fitch Solutions’ Jamie Davies and Beau Noafshar, leaders in the Pharmaceuticals, Healthcare, and Medical Devices groups. The forecast is that these backlogs could persist “for years” in the NHS.
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Preparing for the End of the Public Health Emergency
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.
3 Lessons Learned from Pandemic-Era Clinical Development Regulatory Practices
HIT Consultant
AUGUST 18, 2021
The world has been in urgent need of COVID-19 vaccines, treatments, and diagnostic tools. Here’s a look at what we’ve learned from COVID-19 era regulatory practices in clinical development. These approaches have combined to help accelerate FDA review and study commencement timelines to as low as 30 days.
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Tobacco Issues Awaiting Robert Califf at the FDA
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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It’s Time for the Federal Government to Get Back to Protecting the Nation Against COVID-19
Bill of Health
JUNE 1, 2022
But, to do that, it must make a commitment to the truth about COVID as it is in real time, a very serious current threat to health that is likely to be raging uncontrolled for quite some time, not, as we all might hope, a minimal annoyance fading into irrelevance. Food and Drug Administration (FDA) Commissioner Robert M.
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How the Life Sciences Industry Can Boost Diversity and Inclusion Efforts
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.
The Supreme Court Threatens to Undermine Vaccination Decisions Entrusted to the States
Bill of Health
OCTOBER 27, 2022
The ruling lays the groundwork for courts to force states to include religious exemptions to mandatory vaccines whenever they include secular exemptions, such as medical ones. Tandon , a religious rights case unrelated to vaccines, arose in March 2020 during the start of the COVID-19 pandemic in the U.S.,
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SQA Regulatory Surveillance Summary 2 | Monthly Update 2021
SQA
MARCH 25, 2021
COVID-19 Pandemic Triggers Development of New Standard for Ventilators, 12 January 2021. When the COVID-19 pandemic took hold, so too did the demand for ventilators. Revision of PIC/S Aide Memoires (PI 009-4, 024-3, 028-2, and 038-2), PIC/S Website, 19 January 2021.
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Future Trends and Regulatory Challenges in Pharma
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.
4 Years into the COVID-19 Pandemic: Where We Stand
Bill of Health
MARCH 27, 2023
Bard The White House is preparing to shut down their COVID Task Force this May, in conjunction with ending the public health emergency — the latest in a series of astounding and shortsighted decisions that put individual Americans at as great a risk from serious harm as a result of catching COVID-19 as at any stage in the pandemic.
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Health Provider News – May 20, 2022
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. State Actions to Address Nursing Home Staffing During COVID-19. Arkansas Gets $3.9M CONNECTICUT.
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COVID-19 Vaccines for Children Under 5
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.
COVID-19 Vaccines for Children Under 5
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.
Health Provider News – May 13, 2022
Hall Render
MAY 13, 2022
FDA limits J&J COVID-19 vaccine due to rare blood clot risk. Travel nurses raced to help during Covid. Alabama hospital rationing medical supplies due to COVID disruptions in China. Alabama sees bump in COVID-19 cases, state health department monitoring. Colorado’s COVID cases keep rising.
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Reasonable Pricing Clauses: A First Step Toward Ensuring Taxpayers a Fair Return on their Public R&D Investment
Bill of Health
SEPTEMBER 28, 2023
By Nikhil Chaudhry and Reshma Ramachandran Earlier this month, the Department of Health and Human Services announced that it had successfully included a reasonable pricing provision in a $326M investment contract with Regeneron for development of a next generation monoclonal antibody therapy for COVID-19. pharmaceutical market.
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