not used title

not used title

As the world continues to feel the impact of the COVID-19 pandemic, the biopharmaceutical industry is continuing working around the clock to research, develop and manufacture vaccines to prevent infection. To date, substantial progress has been made in vaccinating Americans with COVID-19 vaccines that have been granted emergency use authorization (EUA) by the U.S. Food and Drug Administration (FDA).

Behind this progress are advances in technology and a deep understanding of both the basic biology and genetics of the virus and the nature of the immune response which has allowed us to rapidly respond to the current pandemic. While what has been accomplished to date has been a tremendous achievement, biopharmaceutical companies are not done fighting back against COVID-19. Across the industry, companies are urgently conducting additional preclinical and clinical research to address emerging variants and exploring additional treatments for those infected with the virus.

Further, it’s impossible to overstate the significance of collaborations. The unprecedented level of strategic collaborative efforts that have taken place across the biopharmaceutical ecosystem have been central to efforts to ensure efficient development, manufacture and distribution of critical COVID-19 vaccines and treatments while keeping the safety and well-being of patients as our top priority.

For COVID-19 vaccines, let’s take a closer look at how companies and the public sector are continuing to work together to help ensure patients’ health and well-being are protected:

• Robust clinical research standards: COVID-19 studies are subject to the same requirements, including safety monitoring, as all drug clinical trials. Researchers closely monitor data throughout the clinical trial and the FDA reviews these data as part of its assessment of the benefit/risk profile of the vaccine.
  
  
• Safety monitoring of COVID-19 vaccines continues after FDA emergency use authorization and approval: Once a vaccine candidate is authorized for emergency use or receives approval from the FDA, biopharmaceutical companies and the Agency continue monitoring product safety through surveillance and assessment of reported or observed adverse events. They also continue comprehensive manufacturing controls to help ensure ongoing product quality. Additionally, the Centers for Disease Control and Prevention’s (CDC) Immunization Safety Office “uses many strategies to assess vaccine safety, [including the Vaccine Adverse Event Reporting System] to identify health problems possibly related to vaccines, and to conduct studies that help determine whether a health problem is caused by a specific vaccine. CDC also works with other federal government agencies and other stakeholders to determine the appropriate public health response to vaccine safety concerns and to communicate the benefits and risks of vaccines.”
  
  
• Medical and public health experts provide outside scientific guidance: The Advisory Committee on Immunization Practices meets regularly to provide recommendations on vaccination use based on the latest scientific data. Further, the FDA has taken steps to ensure a robust vaccine candidate review process including by engaging the Vaccines & Related Biological Products Advisory Committee to discuss issues such as the development and potential authorizations of vaccines to prevent COVID-19 prior to any EUA.
  
  
• Genomic surveillance efforts: Public health officials and biopharmaceutical companies closely track variants using genomic surveillance to identify and decode changes in the COVID-19 virus’ genes and learn more about how these variants may impact vaccine efficacy. Biopharmaceutical companies are continuing to evaluate efficacy and investigate options that target the common viral strain as well as new variants.

It is important to remember that while an EUA is different than the FDA approval of a vaccine, safety standards for all COVID-19 vaccines are robust and no corners have been cut along the way. The FDA has issued guidance specifically on EUAs for COVID-19 vaccines that brings greater scientific transparency to the review process. America’s biopharmaceutical companies are supportive of the FDA’s efforts to date to facilitate the development of vaccines and have pledged ‘to make the safety and well-being of vaccinated individuals the top priority in development’ of these first vaccines. For more information about COVID-19 vaccine development, visit https://phrma.org/coronavirus

Richard Moscicki M D

Dr. Moscicki served as executive vice president, Science and Regulatory Advocacy and chief medical officer at PhRMA from 2017-summer of 2022. He joined the organization after serving as the Deputy Center Director for Science Operations for the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) since 2013. While at FDA, Dr. Moscicki brought executive direction of Center operations and leadership in overseeing the development, implementation, and direction of CDER’s programs. Previous positions include serving as Chief Medical Officer at Genzyme Corporation from 1992 to 2011, where he was responsible for worldwide global regulatory and pharmacovigilance matters, as well as all aspects of clinical research and medical affairs for the company. He served as the senior vice president and head of Clinical Development at Sanofi-Genzyme from 2011-2013.

Richard Moscicki M D

Bayh-Dole: The fuel for America’s innovation engine

September 2, 2026

ICYMI: Biopharmaceutical companies in America hit new investment milestone

August 14, 2026

Why smart vaccine policy matters

August 3, 2026

New study: HPV vaccination helps prevent cervical cancer deaths

July 21, 2026

World Sickle Cell Day: Recognizing the promise of gene therapy

June 19, 2026

America's cancer research progress is real and worth protecting

May 28, 2026

Ahead of ASCO: Cancer innovation is promising, but policy choices matter

May 26, 2026

New research reinforces the importance of hepatitis B vaccination at birth

May 21, 2026

World Immunization Week: Putting preventable diseases in the past

April 24, 2026

ICYMI: Measles resurgence could cost U.S. nearly $8 billion over five years

April 15, 2026

How AI is transforming the drug innovation lifecycle

March 19, 2026

Why shifting childhood vaccines to “shared clinical decision-making” puts kids at risk

February 23, 2026

Changes to America’s childhood vaccine schedule fail to protect our nation's kids

January 13, 2026

New study: Measles setbacks harm health and America’s economy

October 28, 2025

Why the hepatitis B vaccine matters

October 21, 2025

Vaccines and autism: Decades of scientific evidence find no link

September 22, 2025

Why the vaccine injury program matters

August 18, 2025

Recognizing the importance of vaccination for American health and security

August 4, 2025

Answering common questions on mRNA technology

July 17, 2025

What to know about vaccine ingredients: Aluminum and thimerosal

June 24, 2025

Americans are paying a 26% freerider tax on medicines because other countries don’t pay their fair share

June 17, 2025

PhRMA Foundation celebrates 60 years of investing in future scientific leaders

June 11, 2025

New report: Post-approval innovation delivers substantial patient benefits

June 2, 2025

World Immunization Week: Highlighting the importance of vaccines for public health

April 28, 2025

ICYMI: PhRMA submits comments to White House on artificial intelligence

March 17, 2025

What you need to know: Measles and the MMR vaccine

March 10, 2025

4 things to know on Rare Disease Day

February 28, 2025

Improved treatments continue to lead to declining cancer mortality rates in the U.S.

February 25, 2025

Biopharmaceutical innovation for a healthier America: PhRMA releases new innovation report

February 21, 2025

New policy agenda charts solutions for a healthier America

February 20, 2025

A successful PhRMA Forum highlights our commitment to a healthier America

February 20, 2025

Guest Perspective: Prioritize Innovative Care

February 11, 2025

Preventing and fighting disease: A look at the biopharmaceutical progress made for patients in 2024

February 3, 2025

A new administration poses new opportunities for patient access

December 17, 2024

Recognizing the value of disease prevention with Dr. Len Friedland from GSK

December 12, 2024

Congratulations to our 2024 Working for Cures Employee Champions

December 11, 2024

Post-approval R&D is critical for fighting cancer. The IRA makes it more difficult.

November 13, 2024

Leveraging the power of vaccines to prevent antimicrobial resistance

October 31, 2024

From the emergency department to the CDC Advisory Committee: Key takeaways from ACIP’s recent meeting

October 30, 2024

The Patient Perspective: Vaccines

October 23, 2024

New Report: Tackling chronic conditions with preventive treatment

September 30, 2024

Addressing the mounting threat of antimicrobial resistance

September 23, 2024

40 Years of Hatch-Waxman: What is the Hatch-Waxman Act?

September 19, 2024

New research: American biopharmaceutical investment in R&D drives transformational innovation

September 16, 2024

How to protect your children’s health this school year

August 22, 2024

Industry-backed STEM programs have supported 111 million students and nearly 183,000 teachers

August 1, 2024

Three things to know about the United Nations’ new HIV/AIDS report

July 31, 2024

New Report: Vaccines continue to drive improved health outcomes

July 16, 2024

The future of oncology R&D lies in policymakers’ hands

July 8, 2024

Showcasing the promise of biopharma at ASCO 2024

June 28, 2024

Alzheimer's & Brain Awareness Month: A conversation with Biogen

June 27, 2024

Alzheimer's & Brain Awareness Month: A conversation with Eisai

June 24, 2024

Alzheimer's & Brain Awareness Month: A conversation with Eli Lilly and Company

June 20, 2024

ICYMI: Misaligned policies undermine patient access

June 6, 2024

Women’s Health Month: A conversation with Astellas

May 31, 2024

ICYMI: Innovation transforms lives but misguided federal policies threaten patient outcomes

May 30, 2024

Mental Health Awareness Month: Supporting loved ones and improving mental health in America

May 28, 2024

Women’s Health Month: A conversation with Sage

May 23, 2024

The use of real-world data in drug development

May 13, 2024

New analysis: Accelerated approval pathway is changing lives in underserved communities

April 30, 2024

World Vaccine Congress: Building on vaccine success

April 1, 2024

The impact of innovative medicines: A caregiver's perspective

March 26, 2024

ICYMI: More evidence of the IRA’s harmful consequences on post-approval research and development

March 25, 2024

What new cures would mean to families

March 7, 2024

Watch: A conversation with Dr. Mike Ybarra on Rare Disease Day

February 29, 2024

American Heart Month: A nurse’s perspective

February 27, 2024

Proposed march-in framework would chill American innovation

February 7, 2024

Three things to know about antibody drug conjugates

February 2, 2024

Powering the next generation of therapies: A conversation with Astellas US President Mark Reisenauer

January 30, 2024

New poll: Americans agree that expanding the TRIPS waiver will harm U.S. global manufacturing and innovation leadership

January 29, 2024

What they are saying: Experts agree that proposed march-in framework would jeopardize innovation

January 25, 2024

Novel treatments and vaccines approved for U.S. patients in 2023 reach five-year high

January 23, 2024

When it comes to the future of innovation, the ball is in policymakers’ court

January 22, 2024

The White House continues to attack American innovation

December 15, 2023

Taking stock of obesity and its costly effects

December 8, 2023

Congratulations to our 2023 Working for Cures Employee Champions

December 6, 2023

Watch: Putting patients front and center for World AIDS Day

November 30, 2023

Misuse of march-in could stifle innovation

November 27, 2023

WHO Pandemic Agreement offers opportunities and risks for American innovators

November 20, 2023

The IRA’s pill penalty threatens the future of oncology R&D

November 16, 2023

Don't close the door on rare disease research

November 13, 2023

New Report: 1,600 cancer treatments and vaccines in clinical development

November 9, 2023

Word of the Month: The Bayh-Dole Act

November 8, 2023

ICYMI: 3 takeaways on the IRA’s unintended consequences from America’s Physician Groups’ 2023 annual fall conference

November 6, 2023

R&D leaders to Biden Administration: Your policies are undermining the Cancer Moonshot

October 18, 2023

What you should know about protecting your health this fall

October 16, 2023

Three things economists are saying about the Inflation Reduction Act

October 11, 2023

Celebrating Hispanic Heritage Month at PhRMA

October 11, 2023

Word of the Month: AMR

September 27, 2023

What you need to know: COVID-19 public health emergency is over, but ideological attacks on IP remain

September 12, 2023

New PhRMA site demonstrates how a technology-driven health care system brings benefits to patients

September 11, 2023

Watch: New video series spotlights advances in biopharmaceutical science

August 24, 2023

Decentralized clinical trials and the future of drug development

August 9, 2023

WTAS on reasonable pricing and public-private partnerships

August 8, 2023

Key considerations as Congress works towards PAHPA reauthorization

July 12, 2023

New report shows high-impact R&D happens after cancer medicines are first approved

July 10, 2023

A conversation with Dr. Mike Ybarra on the current state of COVID-19

June 27, 2023

New report shows how the Inflation Reduction Act stifles innovation for small molecule medicines

June 22, 2023

Biopharmaceutical science powered by PRIDE

June 16, 2023

ASCO 2023: Protecting our progress in the fight against cancer

June 15, 2023

Reject efforts to undermine America’s R&D ecosystem

June 15, 2023

Highlights from ASCO 2023

June 8, 2023

Mental Health Awareness Month: Fighting the growing mental health crisis and supporting innovation

May 11, 2023

Support for continued progress is critical for pediatric drug development

May 8, 2023

New resource underscores the importance of small molecule medicines

May 4, 2023

Policies need to address the growing threat of antimicrobial resistance

April 28, 2023

World IP Day 2023: Celebrating women leaders in innovation

April 26, 2023

CMS guidance on IRA price setting process doubles down on bad policy

April 14, 2023

A guide to MedPAC’s Part B vote today

April 13, 2023

What they are saying: Experts reinforce that TRIPS waiver expansion is harmful and unnecessary

April 13, 2023

ICYMI: PhRMA President and CEO Stephen J. Ubl discusses patient affordability

April 7, 2023

PhRMA provides comments and testimony to USITC investigation on COVID-19 medicines and the TRIPS Agreement

March 30, 2023

New Report: More than 400 medicines in development for leading chronic conditions affecting older Americans

March 28, 2023

Celebrating the success of the COVID-19 vaccines, and looking to the future

March 27, 2023

IRA Impacts: Cancer treatment research and development

March 23, 2023

PhRMA submits comments to OSTP on enhancing clinical trial diversity

March 21, 2023

What we’ve learned from three years of fighting COVID-19

March 20, 2023

Celebrating 40 years of the Orphan Drug Act on Rare Disease Day

February 28, 2023

PhRMA submits comments to USPTO highlighting important role of patent system in medicine development

February 23, 2023

State policymakers can protect American innovation and help Americans live longer, healthier lives

February 9, 2023

U.S. must address IP and market access barriers abroad to protect American innovation

January 31, 2023

Novel medicines approved in 2022 offer increased treatment options for patients

January 23, 2023

ICYMI: PhRMA kicks off the year at the 2023 J.P. Morgan Health Care Conference

January 19, 2023

WTAS: Inflation Reduction Act already impacting R&D decisions

January 17, 2023

Stories from the lab: Researchers discuss innovative treatments for cancers of the blood

December 1, 2022

Word of the Month: What is TRIPS?

November 29, 2022

Expanding TRIPS waiver would jeopardize biopharmaceutical research and development

November 17, 2022

What you should know about RSV

November 15, 2022

TRIPS waiver expansion risks public health

November 14, 2022

Congratulations to our 2022 Working for Cures Employee Champions

November 10, 2022

New government price setting policy threatens post-approval research

November 10, 2022

Expanding the WTO intellectual property waiver will hurt American jobs

November 9, 2022

ICYMI: PhRMA COO Lori Reilly Esq. speaks with Jacob Van Naarden about the future of cancer research

November 8, 2022

New paper: Addressing the growing crisis of mental health and substance use disorders

November 7, 2022

Protecting treatment advances for breast cancer

October 31, 2022

The law driving technology transfer and fostering innovation

October 24, 2022

Word of the Month: Long COVID

October 19, 2022

Don’t take anti-innovation, activist funded academics at their word

October 18, 2022

Protecting against influenza: A conversation with David Ross, Vice President, Commercial Operations, North America, CSL Seqirus

October 13, 2022

Mental Illness Awareness Week – A time for reflection

October 3, 2022

New Report: Nearly 800 medicines in development to treat chronic conditions

September 29, 2022

Recognizing National Sickle Cell Awareness Month

September 23, 2022

Partnerships are driving global COVID-19 treatment access

September 22, 2022

The dangers of expanding the TRIPS waiver

September 19, 2022

ICYMI: New research builds upon growing body of evidence on value of COVID-19 treatments and vaccines

August 16, 2022

This week’s reading list: All the reasons the Senate-passed drug pricing bill is bad policy

August 10, 2022

Myth vs. Fact: The Senate’s latest price setting proposal

August 5, 2022

An open letter to Congress: Stand with patients and future cures

August 4, 2022

The Senate’s latest price setting proposal will undermine U.S. economic growth

August 3, 2022

New analysis finds deeper impact of drug pricing bill on biopharmaceutical researchers

August 1, 2022

ICYMI: A patient, physician, biotech investor and industry leaders warn about the dangers of government price setting bill

July 29, 2022

The Senate’s latest price setting proposal will undermine: American medical innovation

July 27, 2022

PhRMA member companies’ R&D investments reach record high of $102.3 billion in 2021

July 18, 2022

ICYMI: PhRMA’s Ubl pens op-ed on IP waiver for COVID-19 technologies

July 15, 2022

Increase in drug-resistant superbugs during COVID-19 highlights need for policy reforms to address antimicrobial resistance

July 14, 2022

Word of the Month: Biomarkers and surrogate endpoints

July 11, 2022

COVID-19 vaccines and treatments helped save millions of lives and billions in health care costs

July 7, 2022

ICYMI: Antimicrobial resistance spotlighted as growing public health threat

July 6, 2022

CMS coverage decision restricts access to treatments for Alzheimer’s disease

June 22, 2022

Key takeaways from ASCO's annual meeting

June 10, 2022

Biopharmaceutical researchers to discuss the value of R&D with Congress

June 9, 2022

Recognizing LGBTQ+ Pride in biopharmaceutical science

June 9, 2022

Intellectual Property waiver on COVID-19 innovation is unnecessary and harmful

May 23, 2022

Report: More than 500 medicines in development to treat disorders of the blood

May 18, 2022

ICYMI: PhRMA CEO Stephen J. Ubl spotlights lessons learned during COVID-19

May 13, 2022

Ensuring timely reauthorization of PDUFA and BsUFA

May 11, 2022

ICYMI: PhRMA COO Lori Reilly spotlights efforts to improve health care in 2022 and beyond

May 9, 2022

Spotlighting a growing mental health challenge

May 9, 2022

A conversation with Barry Greene, CEO of Sage Therapeutics

May 4, 2022

ICYMI: New resource catalogs biopharmaceutical industry lessons learned from COVID-19

April 28, 2022

The biopharmaceutical industry leads in helping women achieve new heights, according to IAM’s diversity 100

April 20, 2022

Report: More than 600 medicines in development for diseases affecting women

March 31, 2022

The accelerated approval pathway: Helping patients with serious or life-threatening diseases

March 17, 2022

Biopharmaceutical industry drives economic growth in all 50 states

March 14, 2022

Biopharmaceutical research and development has ushered in a decade of innovation in rare disease

February 28, 2022

4 things to know about biopharmaceutical efforts to fight cancer

February 24, 2022

New Data: COVID-19 vaccine global production capacity projected to exceed 20 billion doses this year

February 24, 2022

What you need to know about newly authorized COVID-19 antiviral treatments

February 22, 2022

Guest post: Joining forces to combat the COVID-19 mental health crisis

February 17, 2022

Guest Blog: COVID-19 vaccines are the key to keeping kids healthy

February 16, 2022

PhRMA submits comments urging CMS to withdraw coverage proposal

February 11, 2022

The importance of timely PDUFA and BsUFA reauthorization

February 3, 2022

Research and development continues long after a medicine is initially approved

February 1, 2022

Protecting U.S. innovation abroad to support economic and pandemic recovery

February 1, 2022

ICYMI: New approvals by the FDA in 2021 offer greater treatment options for patients

January 26, 2022

ICYMI: New report demonstrates growing global impact of antimicrobial resistance

January 24, 2022

New data show continued decline in death rates for cancer patients related to treatment advances

January 20, 2022

New Report: Nearly 800 new medicines in development to treat rare diseases

December 16, 2021

Recap: Our inaugural graduate summit and career expo

December 8, 2021

New report details the promise of the biopharmaceutical pipeline

December 7, 2021

3 things to know about the importance of post-approval research and development

December 6, 2021

Navigating the patient experience in the time of COVID-19

December 6, 2021

World AIDS Day: Remembering those we’ve lost and exploring the continued fight against HIV/AIDS

December 1, 2021

Global COVID-19 vaccination matters now and for the future

November 29, 2021

Guest post: Congress should not put future innovation at risk

November 29, 2021

Preventing the next public health emergency: New evidence demonstrates need to address antimicrobial resistance

November 18, 2021

Understanding breakthrough COVID-19 infections

November 11, 2021