Vaccines & Biodefense

In the U.S., the recommended immunization series prevents approximately 33,000 deaths each year. Advancements in biotechnology have made it possible to produce vaccines that cannot transmit a virus or bacterium. This method has helped create more than 20 new vaccines against infectious agents, improved existing vaccines, and increased the amount of vaccine that can be produced.

Coronavirus
Biotech Response to COVID-19

As the threat of the novel coronavirus continues to grow globally, innovative biopharmaceutical companies are ramping up efforts to study the virus and develop vaccines and cures to protect individuals from contracting the virus.

Blog Posts
Bacteria
January 26, 2022
A new first-of-its-kind study published in The Lancet examines the impact of antimicrobial resistance (AMR) around the world. AMR occurs when different types of pathogens grow resistant to existing antibiotics and other…
AMR
November 23, 2021
We are on the precipice of a looming crisis. Antimicrobial resistance (AMR) is the evolution of deadly pathogens like bacteria and fungi to resist all current antimicrobial medicines. In this episode, we talk about how…
Health-AMR-Action-Image
November 18, 2021
The next global pandemic may already be in the works. Antimicrobial resistance (AMR)—when bacteria, viruses, fungi, and parasites no longer respond to medicines, making infections harder to treat—is a global crisis…
Press Releases
November 19, 2021
Dr. Michelle McMurry-Heath, president and CEO of the Biotechnology Innovation Organization (BIO), released the following statement after the House of Representatives passed the Build Back Better Act: “The legislation that passed the House today will upend a successful Medicare system and weaken…
May 18, 2021
"The White House’s decision to send Covid-19 vaccines to countries in need is an important step to ensuring people around the globe have access to lifesaving shots and ending this global pandemic. “As part of BIO’s recently-proposed Global “SHARE” program, we’ve made clear the urgent need to…
April 20, 2021
Dr. Michelle McMurry-Heath, president and CEO of the Biotechnology Innovation Organization (BIO), yesterday sent a letter to U.S. Trade Representative (USTR) Ambassador Katherine Tai sharing BIO perspectives regarding the proposed WTO “TRIPS waiver” for COVID related products. The letter, written…
Letters, Comments & Testimony
January 3, 2022
On Wednesday, December 29th, BIO submitted comments to the Food and Drug Administration’s recent draft guidance for industry entitled, Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act. Existing regulations require each…
December 13, 2021
On Monday, December 13th, BIO submitted comments to the Food and Drug Administration’s recent draft guidance for industry entitled, Q13 Continuous Manufacturing of Drug Substances and Drug Products. The draft guidance was prepared under the auspices of the International Council for Harmonisation …
August 9, 2021
On Thursday, June 10th, 2021, the U.S. Food and Drug Administration (FDA) published a draft guidance, Core Patient-Reported Clinical Outcomes in Cancer Clinical Trials, providing recommendations to sponsors on the collection of a core set of patient-reported clinical outcomes in cancer clinical…
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