POLICY BRIEFINGS

FDA Authorizes Pfizer Vaccine for Ages 5-11

The Food and Drug Administration (FDA) has authorized the Pfizer-BioNTech COVID-19 vaccine for emergency use in children ages 5 through 11. The vaccine will be administered as a two-dose series, three weeks apart, at a lower dose (10 micrograms) than that used for individuals 12 years of age and older (30 micrograms). The data supporting the authorization indicates that the immune response of children 5 through 11 is comparable to that of individuals 16 to 25, and that the vaccine is 90.7% effective in preventing COVID-19 in the younger age group. An ongoing study of 3,100 children in this age range reported no serious side effects. The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) had previously voted to recommend the EUA for children with 17 panel members in favor and one abstention. The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) will meet this week to make their clinical recommendation. The CDC would then issue the agency’s final guidance, potentially making pediatric vaccinations available as early as the end of this week.

HRSA Releases Health Workforce Strategic Plan

The U.S. Department of Health and Human Services (HHS) and the Health Resources and Services Administration (HRSA) have released the Health Workforce Strategic Plan, as required by the Coronavirus Aid, Relief, and Economic Security (CARES) Act. The framework aims to coordinate efforts to strengthen the health care workforce, and with the goals of expanding the health workforce to meet evolving community needs, improving the distribution of the health workforce to reduce shortages, enhancing health care quality through professional development, collaboration, and evidence-informed practice, and developing and applying data and evidence to strengthen the health workforce. Implementation of the strategic plan will involve evaluating the performance of health workforce development programs, identifying opportunities to strengthen programs, eliminating redundancies where possible, and implementing improvements. HHS will produce a report to Congress on those activities, as required by the CARES Act.

WH Details Vaccine Requirements for International Travelers

The Biden administration has announced that it will not define a standard proof of vaccination for international travelers to the U.S. but will instead rely on airline carriers to determine if an individual’s credentials were issued by an official source. Carriers will also be responsible for confirming that a passenger’s name and date of birth match their proof of vaccination. Digital credentials will be accepted if they meet the necessary requirements and technical specifications. Passengers traveling to the U.S. must also align with the Centers for Disease Control and Prevention’s (CDC) definition of fully vaccinated. Very limited exceptions will be made for children and people from countries with low levels of vaccine availability (less than a 10% vaccination rate). Once international travel resumes on November 8, foreign travelers will also have to show proof of a negative COVID-19 test taken within three days of flying. In contrast with the planned U.S. verification process, Canada has announced that it will use SMART Health Cards as a national standard, and the E.U. is using a standardized COVID-19 certificate; almost 600 million credentials have already been issued.

Upcoming Congressional Hearings and Markups

Senate Judiciary Committee hearing “Cleaning Up Online Marketplaces: Protecting Against Stolen, Counterfeit, and Unsafe Goods;” 10:00 a.m.; November 2

House Veterans’ Affairs Subcommittee on Technology Modernization hearing “Next Steps: Examining Plans for the Continuation of the Department of Veterans Affairs Electronic Health Record Modernization Program;” 10:00 a.m.; November 2

House Homeland Security Committee hearing “Evolving the U.S. Approach to Cybersecurity: Raising the Bar Today to Meet the Threats of Tomorrow;” 10:00 a.m., November 3

Senate Health, Education, Labor, and Pensions (HELP) Committee hearing “Next Steps: The Road Ahead for the COVID-19 Response;” 10:00 a.m.; November 4

Recently Introduced Health Legislation

H.R.5703 — To amend the Robert T. Stafford Disaster Relief and Emergency Assistance Act to authorize the President to provide professional counseling services to victims of emergencies declared under such Act, and for other purposes. Sponsor: Rep. Pressley, Ayanna [D-MA-7]; House - Transportation and Infrastructure

H.R.5702 — To prohibit Federal agencies from granting a work authorization to any alien for the purpose of replacing unvaccinated U.S. healthcare workers, and for other purposes. Sponsor: Rep. Perry, Scott [R-PA-10]; Committees: House - Judiciary

H.R.5699 — To expand the definition of qualified persons for purposes of the Public Readiness and Emergency Preparedness Act to include health professional students. Sponsor: Rep. O’Halleran, Tom [D-AZ-1]; Committees: House - Energy and Commerce

H.R.5697 — To authorize the Attorney General to make grants to, and enter into cooperative agreements with, States and units of local government to develop, implement, or expand one or more programs to provide medication-assisted treatment to individuals who have opioid use disorder and are incarcerated within the jurisdictions of the States or units of local government. Sponsor: Rep. Kuster, Ann M. [D-NH-2]; Committees: House – Judiciary

H.R.5694 — To reduce the threshold for mandatory minimum penalties for fentanyl-related offenses under the Controlled Substances Act and the Controlled Substances Import and Export Act, and for other purposes. Sponsor: Rep. Grothman, Glenn [R-WI-6]; Committees: House - Judiciary; Energy and Commerce

H.R.5687 — To authorize a private right of action for an individual who suffers a vaccine-related injury or death as a result of receiving a COVID-19 vaccine, as required by their employer, and for other purposes. Sponsor: Rep. Cloud, Michael [R- TX-27]; Committees: House - Judiciary

H.R.5686 — To permit civil actions against the United States for COVID-19 vaccination mandates. Sponsor: Rep. Cloud, Michael [R-TX-27]; Committees: House - Judiciary

H.R.5678 — To require federally licensed firearms manufacturers, importers, and dealers and their employees to undergo annual training to be eligible to sell a firearm, to require a notice to be posted at retail firearms locations that describes the signs of unlawful firearms purchases, to require such licensees to maintain physical security elements to prevent theft and a minimum level of business liability insurance, and for other purposes. Sponsor: Rep. Crow, Jason [D-CO-6]; Committees: House – Judiciary

H.Res.742 — Supporting the designation of October 23, 2021, as “AADC Deficiency Awareness Day”. Sponsor: Rep. Murphy, Gregory [R-NC-3]; Committees: House - Energy and Commerce

S.3057 — A bill to amend title 18, United States Code, to enhance criminal penalties for health related stalking, and for other purposes; Sponsor: Sen. Klobuchar, Amy [D-MN]; Committees: Senate – Judiciary

S.3061 — A bill to amend title XVIII of the Social Security Act to eliminate the 190-day lifetime limit on inpatient psychiatric hospital services under the Medicare Program; Sponsor: Sen. Collins, Susan [R-ME]; Committees: Senate – Finance

S.3062 — A bill making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for the fiscal year ending September 30, 2022, and for other purposes; Sponsor: Sen. Murray, Patty [D- WA]; Committees: Senate – Appropriations

H.R.5710 — To amend title 18, United States Code, to enhance criminal penalties for health related stalking, and for other purposes; Sponsor: Rep. Jackson Lee, Sheila [D-TX-18]; Committees: House – Judiciary

H.R.5719 — To require the Secretary of Health and Human Services to publicly disclose information regarding adverse effects of COVID-19 vaccines; Sponsor: Rep. Perry, Scott [R-PA-10]; Committees: House - Energy and Commerce

H.R.5721 — To amend title 38, United States Code, to improve research conducted within the Department of Veterans Affairs, and for other purposes; Sponsor: Rep. Takano, Mark [D-CA-41]; Committees: House - Veterans’ Affairs

S.3064 — A bill to authorize a White House Conference on Food, Nutrition, Hunger, and Health, and for other purposes; Sponsor: Sen. Booker, Cory [D-NJ]; Committees: Senate - Agriculture, Nutrition, and Forestry

S.3065 — A bill to establish national data privacy standards in the United States, and for other purposes; Sponsor: Sen. Cortez Masto, Catherine [D-NV]; Committees: Senate - Commerce, Science, and Transportation

S.3073 — A bill to prohibit discrimination in health care and require the provision of equitable health care, and for other purposes; Sponsor: Sen. Padilla, Alex [D-CA]; Committees: Senate - Health, Education, Labor, and Pensions

S.3079 — A bill to exempt essential workers from Federal COVID-19 vaccine mandates; Sponsor: Sen. Blackburn, Marsha [R-TN]; Committees: Senate - Health, Education, Labor, and Pensions

H.R.5724 — To authorize a White House Conference on Food, Nutrition, Hunger, and Health, and for other purposes; Sponsor: Rep. McGovern, James P. [D-MA-2]; Committees: House - Agriculture; Rules

H.R.5728 — To prohibit the Secretary of Labor from using funds to draft, promulgate, or enforce a rule mandating that employers require employees to be vaccinated against COVID-19, and for other purposes; Sponsor: Rep. Cawthorn, Madison [R-NC-11]; Committees: House - Education and Labor

H.R.5730 — To amend part E of title IV of the Social Security Act to require States to prohibit genital surgery on foster children with variations in sex characteristics who are under six years of age as a condition of receiving grants under such part; Sponsor: Rep. Garcia, Sylvia R. [D-TX-29]; Committees: House - Ways and Means

H.R.5741 — To provide an exemption to any Federal COVID-19 vaccine mandate for any Federal employee or contractor who provides proof of COVID-19 antibodies, and for other purposes; Sponsor: Rep. Newhouse, Dan [R-WA-4]; Committees: House - Oversight and Reform

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