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.
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.
COVID-19 Vaccine 
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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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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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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 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 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.
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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Google dismantles health division; FDA grants first full approval of a COVID-19 vaccine
Healthcare IT News - Telehealth
AUGUST 27, 2021
Enterprise Taxonomy:
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.
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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.
Updated CMS Guidelines for COVID-19 Tests and Booster Shot
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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Coding COVID for Uninsured Patients
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.
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.
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. Solutions for the Future.
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Can Children Consent to the COVID Vaccine? The Case of Foster Care and Juvenile Justice
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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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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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. "In 2017, gene therapy was used to cure a teenage boy of sickle cell disease," he said.
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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.
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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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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.
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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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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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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Labcorp Offers Observed Collections of COVID-19 PCR testing in Over 500 Patient Service Centers
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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SQA Regulatory Surveillance Summary 4 | Monthly Update 2021
SQA
JUNE 10, 2021
Backgrounder – Government of Canada Investments in Biomanufacturing, Development of COVID-19 Vaccines and Therapeutics, and Research, 18 May 2021. That’s why the government is implementing a multi-faceted procurement strategy to provide a COVID-19 vaccine to every Canadian who wants one by September.
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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.
The Healthcare and Macro-Economic Impacts of Living with Endemic COVID – Listening to Fitch
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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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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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. 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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SQA News | Spring 2021
SQA
MAY 24, 2021
Even with more of the world receiving their Covid-19 vaccinations, there are some countries lagging behind or dealing with a different strain. These continued hurdles are met with passion to succeed from SQA clients producing more vaccines to increase supply, and other options to fight Covid-19.
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Why We Need a Personalized Approach to COVID-19 Immunity Testing
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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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.
SQA Regulatory Surveillance Summary 2 | Monthly Update 2021
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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A Timeline of Biden’s Pandemic Response, Part 3: We Have the Tools (Sept. – Dec. 2021)
Bill of Health
JANUARY 7, 2022
The American booster push was controversial, because the scientific evidence on the need for and effectiveness of boosters was limited, and the White House exerted an unprecedented level of pressure on the FDA and CDC’s ‘independent’ scientific review processes. Ultimately, both the FDA and CDC gave their blessing to boosters.
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IT execs talk new strategies for analytics, patient engagement, telehealth and more
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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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
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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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.
Reasonable Pricing Clauses: A First Step Toward Ensuring Taxpayers a Fair Return on their Public R&D Investment
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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Mainstreaming Reproductive Genetic Innovation
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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The Race to Create a COVID-19 Vaccine: Acceleration and Collaboration
Health Law Gurus
JULY 7, 2020
Vaccine development is typically a lengthy process—with years of laboratory research, the need to obtain approval by the Food and Drug Administration (FDA), and at least three (3) phases of clinical trial testing to ensure safety, efficacy, and the appropriate dosage. The full FDA guidance is available here.
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