{"id":17569,"date":"2021-03-01T03:32:38","date_gmt":"2021-03-01T03:32:38","guid":{"rendered":"https:\/\/nclnet.org\/?p=17569"},"modified":"2021-03-29T13:36:56","modified_gmt":"2021-03-29T13:36:56","slug":"testimony_janssen_biotech","status":"publish","type":"post","link":"https:\/\/nclnet.org\/testimony_janssen_biotech\/","title":{"rendered":"NCL testimony before FDA on Janssen Biotech COVID-19 vaccine"},"content":{"rendered":"

Media contact: National Consumers League \u2013 Carol McKay, carolm@nclnet.org<\/a>, (412) 945-3242<\/a>\u00a0or Taun Sterling, tauns@nclnet.org<\/a>, (202)\u00a0207-2832<\/a><\/p>\n

February 26, 2021<\/p>\n

NCL’s Associate Director of Health Policy Nissa Shaffi testified before the FDA’s Vaccines and Related Biological Products Advisory Committee at the Center for Biologics Evaluation and Research. Read her testimony.<\/em><\/p>\n

Hana El Sahly, M.D., Chair
\nVaccines and Related Biological Products Advisory Committee
\nCenter for Biologics Evaluation and Research
\nFood and Drug Administration
\n10903 New Hampshire Ave, Silver Spring, MD 20993<\/p>\n

RE: <\/strong>Docket No.\u00a0FDA-2021-N-0173<\/strong>;<\/strong>\u00a0for Vaccines and Related Biological Products Advisory Committee<\/p>\n

Good Afternoon. I am Nissa Shaffi, present today on behalf of the National Consumers League. I have no conflicts of interest to disclose. Our organization extends its gratitude to the Vaccines and Related Biological Products Advisory Committee, for the opportunity to amplify consumer voices regarding the Janssen Biotech COVID-19 vaccine.<\/p>\n

For over 120 years, NCL has championed efforts to increase vaccine education, safety, and access for consumers. As consumer advocates, we thank the Food and Drug Administration for their commitment to fostering public trust throughout the development and approval of a vaccine for COVID-19. We have been encouraged by the transparency and opportunities for engagement afforded to the public during this process.<\/p>\n

Emergency Use Authorization (EUA)<\/strong><\/p>\n

Consumers are relying on the FDA more than ever for guidance pertaining to treatments for COVID-19, and preserving their confidence in the Agency is of vital importance at this time. Emergency Use Authorization, while not intended to replace randomized clinical trials, has been a critical component to the nation\u2019s pandemic strategy. NCL appreciates the FDA\u2019s recognition of clinical trials as vital to demonstrating the safety and efficacy of a treatment.<\/p>\n

Safety and Effectiveness<\/strong><\/p>\n

We are encouraged by reports indicating that the Janssen Biotech vaccine has proven to be effective against hospitalizations and deaths from COVID-19. The added benefit of another vaccine is to decrease virus mutation. Presently, three, far more contagious, variants of COVID-19 spread and could hamper efforts to quell the virus. We are reassured that the Janssen vaccine has demonstrated efficacy against certain variants. As new data is collected, we call on the FDA to perform post-market surveillance to monitor ongoing efficacy.<\/p>\n

Health Equity<\/strong><\/p>\n

Vaccine hesitancy and social determinants of health remain critical obstacles in the vaccine rollout process. The Janssen Biotech single-shot vaccine has the potential to increase access for hard-to-reach communities, bringing us closer to herd immunity. This week, we marked a grim milestone, as half a million Americans have now perished from this relentless virus. Amidst this loss, the continued development of vaccines for COVID-19 has provided the nation with much-needed hope and respite.<\/p>\n

As the Committee deliberates on the Janssen Biotech COVID-19 vaccine, we request the Agency to also consider the benefit its release would have for historically disadvantaged communities, for which this vaccine would be logistically more accessible than the prior two vaccines.<\/p>\n

Thank you to the Committee for your consideration of our views. Through our consumer education work, NCL will continue to support FDA in its efforts to develop a safe, effective, and expedited pathway towards a vaccine for COVID-19.<\/p>\n

Sincerely,<\/p>\n

Nissa Shaffi
\nAssociate Director of Health Policy
\nNational Consumers League<\/p>\n

\u00a0<\/strong><\/p>\n

###<\/p>\n

About the National Consumers League (NCL)<\/strong><\/p>\n

The National Consumers League, founded in 1899, is America\u2019s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.
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