- August 23, 2021
Sen. Marshall Demands ALL Seniors Immediately be Eligible for COVID Booster Shots
(Washington, D.C., August 23, 2021) – U.S. Senator Roger Marshall, M.D. sent a letter to President Joe Biden calling on him to make ALL seniors eligible for COVID-19 vaccine booster shots immediately. While the U.S. Food and Drug Administration (FDA) announced booster shots for select immunocompromised patients earlier this month, it did not include ALL seniors. Additionally, the Biden Administration announced last week plans to offer booster shots for fully vaccinated patients beginning September 20th. However, under this plan, ALL seniors would have to wait another month alongside less vulnerable patient populations.
“With the Delta variant ripping across our country, the FDA and CDC must immediately make the COVID-19 vaccine booster available for ALL seniors. We know that seniors and those at high risk are affected significantly greater from COVID-19, and we can’t wait one more day to increase their immunity to this horrible virus,” said Senator Marshall. “Additionally, I urge the FDA to remain committed to the full approval of ALL available COVID-19 vaccines. With full FDA approval, health care providers will be able to better serve their patients in discussing the benefits of the vaccine, resulting in more shots in arms and our country defeating this virus sooner rather than later.”
You may click HERE or scroll below to read Senator Marshall’s letter in its entirety.
Background:
Data out of Israel shows a COVID-19 booster shot improves immunity for senior citizens. According to the Wall Street Journal, “Israel was one of the first countries late last month to authorize a third Pfizer dose for the elderly who were fully vaccinated with the recommended two shots, after indications that vaccine protection against severe illness has waned. The booster shot reduced the risk of infection in the 60-plus age group by 86% and against severe infection by 92%, according to an observational study by Israel’s second largest healthcare provider, Maccabi Health Services, released Wednesday.”
Earlier this month, Senator Marshall send a letter to the U.S. Department of Health and Human Services Secretary Becerra and FDA Acting Commissioner Janet Woodcock, urging them to expedite the full FDA approval of COVID-19 vaccines and to prioritize research on the effectiveness of booster shots for vulnerable patients.
In January 2020, then Congressman Marshall was the first member of Congress to sound the alarm on the House floor about the spread of COVID-19. As a physician, he would later go on to serve on the frontlines as a volunteer treating patients in Wyandotte County and Seward County.
In April 2021, Senator Marshall led a group of doctors and other health care providers in Congress in launching a public service campaign to boost COVID-19 vaccine participation. You may click HERE or on the image below to watch the PSA.
Senator Marshall also penned an op-ed urging the National Institutes of Health and the FDA to prioritize testing that would identify a patient’s level of immunity to COVID-19 by measuring t-cells.
Full text of Senator Marshall’s letter to President Biden:
The Honorable Joe Biden
U.S. President
The White House
1600 Pennsylvania Avenue, N.W.
Washington, D.C. 20500
President Biden:
Thank you for your contribution in helping to address the COVID-19 pandemic. This week, you took an additional step forward in America’s vaccine strategy by declaring a plan to offer COVID-19 booster shots to fully vaccinated individuals, beginning the week of September 20.[1] This plan, if implemented, would bring us one step further on our road to recovery. However, time is of the essence. As each week passes, so increases the risk exposure for individuals with an insufficient level of protection getting infected from the delta variant. Therefore, I strongly urge you to direct the U.S. Department of Health and Human Services (HHS) and its relevant sub-operating agencies to consider real-world evidence and other clinical data to ensure all seniors are prioritized immediately.
America’s seniors, ranging from the Greatest Generation to the early Baby Boomers, make up a considerable percent of our population and an even greater percent of those most vulnerable to COVID-19. Specifically, 95 percent of COVID-19 deaths in the U.S. occurred for patients over 50 years of age, with about 8 in 10 deaths representing patients 65 years of age and older.[2] It is especially concerning for seniors in long-term care facilities as data shows COVID-19 efficacy against the delta variant has declined from 74.7 percent to 53.1 percent.[3] Other data shows similar declines in efficacy for seniors.[4] Across the state of Kansas, seniors have been calling my office, imploring the federal government to take further action and reconsider the availability of booster shots to be available sooner than announced.
Current dosing and administration for booster shots vary across patient populations in the U.S. and across the world. On August 12, the U.S. Food and Drug Administration (FDA) authorized a booster shot for certain immunocompromised individuals 28 days or more after completing the initial two-dose regimen.[5] Overseas, Israel, United Kingdom, Canada, France, Hungary, Germany, and other countries have issued various strategies for boosters. In early July, Israel announced they would offer booster shots to immunocompromised individuals, and later in the month, their health ministry authorized booster shots to patients over 60 at least five months following a two-dose regimen.[6] This past week, they extended the boosters to patients over 40 and teachers. This is after they dropped the eligibility age to 50 earlier this month, and their strategy followed a thorough review of vaccine and breakthrough infection data.[7], [8], [9] The United Kingdom and Germany also recently announced that their health agencies are preparing to offer COVID-19 vaccine boosters as early as next month.[10] The United Kingdom released a report on their potential booster program prioritizing vulnerable patients as noted above, but also included household contacts for immunosuppressed patients.[11] Hungary began their booster shot campaign early this month for seniors and certain immunocompromised individuals four months after their two-dose regimen.[12] Many of these countries’ health agencies justified their recommendations based on data including the risk of complications, exposure, waning immunity, and the risk of the virus’ variants. And the overwhelming majority of these agencies began or will begin with their seniors and immunocompromised patients.
Given the above, I ask you have the CDC publish and provide additional rationale as to why our dosing regimens vary across our global allies. If we are following and applying the science, why is the U.S. coming up with such dissimilar conclusions on clinical appropriateness on boosters? In medicine, recommendations and labeling for routine vaccines are not so dissimilar across countries. And while it is not always the case, we are utilizing clinical data and other real-world evidence across other countries to inform our COVID-19 vaccine strategy. To end the pandemic, we should be working as a global community to come up with a common understanding of what the dosing and administration of COVID-19 boosters should be. And I urge to you to have the CDC Advisory Committee on Immunization Practices (ACIP) take into account international data when making recommendations, particularly for the boosters.
The ACIP, our nation’s counsel tasked with issuing recommendations on vaccines, released information last Friday on what should be considered for boosters.[13] While I question the inconsistency on the dosing timeline and patient population for the boosters, it appears ACIP is considering data the potential need for boosters for residents of long-term care facilities, seniors over 65 years of age, and health care personnel. ACIP was scheduled to meet on Tuesday, August 24 to discuss these policy considerations, however, it was announced yesterday on their website that this meeting has been delayed until August 30.[14] While no additional details were provided, this lag between your announcement and the appropriate scientific review, approval, and recommendations to support boosters adds increased confusion among these vulnerable populations. I urge you to ensure that as further recommendations and prioritizations are made, our seniors and other vulnerable populations remain at the front of the line.
The now-dominant delta variant is surging and in order to combat it, federal agencies must remain committed to providing expeditious, consistent, and complementary patient-centered solutions. As you consider my concerns, please also work to ensure that the FDA remains laser-focused on prioritizing the full approval of the vaccines. This can help physicians and other health care providers better serve their patients in discussing the benefits of the vaccines and the benefits of boosters for patients who have an insufficient level of protection. Thank you for considering this urgent request. I look forward to your reply.
Sincerely,
Roger Marshall, M.D.
U.S. Senator
Cc: The Honorable Xavier Becerra, Secretary, HHS
Dr. Rochelle Walensky, Director, CDC
Dr. Janet Woodcock, Acting Director, FDA
Dr. David Kessler, Chief Scientific Officer for COVID-19 Task Force, HHS
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[1] The White House, Fact Sheet: President Biden to Announce New Actions to Protect Americans from COVID-19 and Help State and Local Leaders Fight the Virus, August 18, 2021, https://www.whitehouse.gov/briefing-room/statements-releases/2021/08/18/fact-sheet-president-biden-to-announce-new-actions-to-protect-americans-from-covid-19-and-help-state-and-local-leaders-fight-the-virus/.
[2] AJMC, Contributor: Links Between COVID-19 Comorbidities, Mortality Detailed in FAIR Health Study, by Robin Gelburd, November 11, 2020, https://www.ajmc.com/view/contributor-links-between-covid-19-comorbidities-mortality-detailed-in-fair-health-study.
[3] U.S. Centers for Disease Control and Prevention, Morbidity and Mortality Weekly Report, Effectiveness of Pfizer-BioNTech and Moderna Vaccines in Preventing SARS-CoV-2 Infection Among Nursing Home Resident Before and During Widespread Circulation of the SARS-CoV-2 B.1.617.2 (Delta) Variant – National Healthcare Safety Network, March 1-August 1, 2021, August 18, 2021 (Early Release), https://www.cdc.gov/mmwr/volumes/70/wr/mm7034e3.htm.
[4] U.S. Centers for Disease Control and Prevention, Morbidity and Mortality Weekly Report, New COVID-19 Cases and Hospitalizations Among Adults, by Vaccination Status – New York, May 3-July 25, 2021, August 18, 2021, https://www.cdc.gov/mmwr/volumes/70/wr/mm7034e1.htm.
[5] U.S. Food and Drug Administration, Coronavirus (COVID-19) Update: FDA Authorizes Additional Vaccine Dose for Certain Immunocompromised Individuals, August 12, 2021, https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-additional-vaccine-dose-certain-immunocompromised.
[6] Bloomberg, Israel to Offer 3rd Covid Dose to Those With Weak Immune Systems, by Alisa Odenheimer, July 12, 2021, https://www.bloomberg.com/news/articles/2021-07-12/israel-approves-3rd-vaccine-dose-for-immunocompromised-tv-says. See also Wall Street Journal, Israel Begins Pfizer Booster Shots for At-Risk Adults as Delta Cases Rise, by Dov Leiber, July 12, 2021, https://www.wsj.com/articles/israel-begins-pfizer-booster-shots-for-at-risk-adults-as-delta-cases-rise-11626110100?mod=article_inline.
[7] NPR, Israel Is Offering Its Older Citizens A 3rd COVID-19 Shot As Infections Rise, July 29, 2021, https://www.npr.org/sections/coronavirus-live-updates/2021/07/29/1022334531/israel-covid-booster-shot-vaccine-coronavirus.
[8] Pfizer, Second Quarter 2021 Earnings Teleconference, page 25, https://s21.q4cdn.com/317678438/files/doc_financials/2021/q2/Q2-2021-Earnings-Charts-FINAL.pdf.
[9] Foreign Policy, The Science Says Everyone Needs a COVID-19 Booster Shot—and Soon, by Laurie Garrett, July 30, 2021, https://foreignpolicy.com/2021/07/30/booster-shot-coronavirus-covid-science/.
[10] Barron’s, Countries Are Preparing to Offer Booster Shots. What It Means for Vaccine Makers, by Callum Keown, August 2, 2021, https://www.barrons.com/articles/countries-are-preparing-to-offer-booster-shots-what-it-means-for-vaccine-makers-51627920318.
[11] United Kingdom Department of Health & Social Care, Independent Report: VCVI Interim Advice: Potential COVID-19 Booster Vaccine Programme Winter 2021 to 2022, June 30, 2021, https://www.gov.uk/government/publications/jcvi-interim-advice-on-a-potential-coronavirus-covid-19-booster-vaccine-programme-for-winter-2021-to-2022/jcvi-interim-advice-potential-covid-19-booster-vaccine-programme-winter-2021-to-2022.
[12] Hungary Today, Hungary Starts Third “Booster” Vaccination Campaign Amid Serious Debate, July 30, 2021, https://hungarytoday.hu/hungary-third-booster-vaccination-campaign-debate/.
[13] U.S. Centers for Disease Control and Prevention, Advisory Committee on Immunization Practices Committee, Considerations for Booster Doses of COVID-19 vaccines, August 13, 2021, slides 15-17, https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-08-13/05-COVID-Oliver-508.pdf
[14] U.S. Centers for Disease Control and Prevention, Advisory Committee on Immunization Practices, https://www.cdc.gov/vaccines/acip/index.html?source=email..
