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Unlocking the mRNA Platform Technology: Walking the Talk with Investment Protection

Bill of Health

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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Accessing COVID-19 mRNA Vaccines for Research: The Re-emergence of the Tragedy of the ‘Anticommons’

Bill of Health

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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Coding COVID for Uninsured Patients

AIHC

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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SQA Regulatory Surveillance Summary 2 | Monthly Update 2021

SQA

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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Health Provider News – May 20, 2022

Hall Render

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. Group home at center of Gilbert murder investigation fights to keep license to operate. CALIFORNIA.

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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

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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Health Provider News – February 18, 2022

Hall Render

CMS may now enforce its COVID-19 vaccination policy for healthcare workers in all 50 states. CMS responds to states seeking vaccination mandate waivers. Federal vaccination mandate begins for healthcare workers in 24 states. License wait times reach crisis levels for healthcare workers. The future St.