{"id":15784,"date":"2020-12-11T15:58:45","date_gmt":"2020-12-11T15:58:45","guid":{"rendered":"https:\/\/nclnet.org\/?p=15784"},"modified":"2021-03-09T08:42:02","modified_gmt":"2021-03-09T08:42:02","slug":"fda-testimony-covid-vaccine","status":"publish","type":"post","link":"https:\/\/nclnet.org\/fda-testimony-covid-vaccine\/","title":{"rendered":"NCL testified before FDA committee meeting on Pfizer-BioNTech COVID-19 vaccine"},"content":{"rendered":"

For immediate release: December 11, 2020<\/p>\n

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

Washington, DC \u2013 The National Consumers League (NCL) testified before the Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) this week regarding the Pfizer-BioNTech COVID-19 Vaccine.<\/p>\n

\u201cAs the nation\u2019s oldest consumer advocacy organization, NCL has been encouraged by the honesty, transparency, and access afforded to the public during this critical time.\u201d NCL commended the Food and Drug Administration, Centers for Disease Control and Prevention, and other public health entities for their commitment to fostering public trust throughout the COVID-19 vaccine development and approval process and thanked the committee for the opportunity to speak.<\/p>\n

In its testimony, NCL noted that there has never been a more critical time for consumers to have confidence in the FDA.<\/p>\n

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

The FDA has undergone scrutiny from the scientific community for prematurely issuing EUAs for COVID-19 therapeutics. NCL is aware that developing a vaccine for COVID-19 is a time-sensitive priority and appreciates that the FDA recognizes that an EUA is not intended to replace long-term randomized clinical trials data associated with full FDA approval. We are encouraged by data reporting a consistent vaccine efficacy rate of 95 percent across age, gender, race, and ethnicity demographics and look forward to seeing more guidance around the vaccine, as the trial continues to collect safety and efficacy data.<\/p>\n

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

NCL noted the public\u2019s growing trust in the FDA\u2019s rigorous\u00a0vaccine approval process and called on the\u00a0agency to perform\u00a0ongoing\u00a0post-market surveillance. Such surveillance\u00a0performed in the United Kingdom found that the vaccine may be unsafe for individuals with severe allergies. Consumers will rely on\u00a0ongoing guidance from\u00a0public health agencies\u00a0regarding\u00a0any\u00a0potential adverse\u00a0events from\u00a0the vaccine and expect that the FDA will be aware of these concerns.<\/p>\n

Innovative Vaccine Delivery Systems:<\/strong><\/p>\n

Additionally,\u00a0ensuring innovative vaccine delivery methods, such as including\u00a0oral or nasal\u00a0options, could address geographical access\u00a0issues, diverse health needs, and increase uptake overall.<\/p>\n

Diversity in Clinical Trials:<\/strong><\/p>\n

We applaud Pfizer\u2019s efforts to ensure diversity in their COVID-19 vaccine clinical trials. NCL requests that the FDA continue to prioritize vaccine clinical trial data that reflects diversity, as people of color will need to have confidence in the vaccine\u2019s efficacy. This will affect the overall uptake of the vaccine.<\/p>\n

The development of a COVID-19 vaccine in such a short time frame is a huge scientific feat, made possible through\u00a0robust\u00a0collaboration between private and public entities.\u00a0NCL will continue to support\u00a0the\u00a0FDA and CDC in efforts to\u00a0release a COVID-19 vaccine safely and expeditiously.<\/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<\/a>.<\/p>\n<\/div><\/section>\n","protected":false},"excerpt":{"rendered":"

NCL is deeply disappointed at the Department of Transportation\u2019s decision late Friday to finalize its Rule on Defining Unfair or Deceptive Practices.<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"_price":"","_stock":"","_tribe_ticket_header":"","_tribe_default_ticket_provider":"","_tribe_ticket_capacity":"0","_ticket_start_date":"","_ticket_end_date":"","_tribe_ticket_show_description":"","_tribe_ticket_show_not_going":false,"_tribe_ticket_use_global_stock":"","_tribe_ticket_global_stock_level":"","_global_stock_mode":"","_global_stock_cap":"","_tribe_rsvp_for_event":"","_tribe_ticket_going_count":"","_tribe_ticket_not_going_count":"","_tribe_tickets_list":"[]","_tribe_ticket_has_attendee_info_fields":false},"categories":[14,287,290,416,16,292,284],"tags":[],"acf":[],"_links":{"self":[{"href":"https:\/\/nclnet.org\/wp-json\/wp\/v2\/posts\/15784"}],"collection":[{"href":"https:\/\/nclnet.org\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/nclnet.org\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/nclnet.org\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/nclnet.org\/wp-json\/wp\/v2\/comments?post=15784"}],"version-history":[{"count":5,"href":"https:\/\/nclnet.org\/wp-json\/wp\/v2\/posts\/15784\/revisions"}],"predecessor-version":[{"id":17820,"href":"https:\/\/nclnet.org\/wp-json\/wp\/v2\/posts\/15784\/revisions\/17820"}],"wp:attachment":[{"href":"https:\/\/nclnet.org\/wp-json\/wp\/v2\/media?parent=15784"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nclnet.org\/wp-json\/wp\/v2\/categories?post=15784"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nclnet.org\/wp-json\/wp\/v2\/tags?post=15784"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}