Children’s Minnesota has released the following statement on behalf of nearly 100 infectious disease experts from Minnesota and Wisconsin, expressing their views on COVID-19 vaccination:
We, the undersigned, are infectious disease clinicians and researchers from Minnesota and Wisconsin writing to share our perspective on COVID-19 vaccination. As health care professionals, investigators and experts in numerous aspects of infectious disease and public health, we have been fully involved in responding to the COVID-19 pandemic. The pandemic has disrupted many aspects of our lives and has had a profound impact on our communities. Many people have suffered significant physical, mental, economic, and psychosocial hardships. However, we are encouraged by the hard work that vaccine scientists are conducting to develop effective and safe COVID-19 vaccines, and the impact these could have on subduing the pandemic.
Many vaccines are in development and some are in clinical trials. While it is in everyone’s interest for vaccines to be available as soon as possible, COVID-19 vaccines will need to meet existing high standards for safety and effectiveness based on the availability of sufficient data before licensure or emergency use authorization (EUA). We need to be patient and ensure that the appropriate processes occur.
We are heartened by the recent unprecedented pledge made by nine pharmaceutical companies developing COVID-19 vaccines to only submit candidate vaccines for approval once this safety and efficacy has been demonstrated, and by the transparency of companies publicly reporting possible safety concerns and halting their trial to fully investigate. This is an expected part of vaccine research to ensure safety and is a hopeful sign that proper measures are being taken.
As with all vaccines, it is our expectation that recommendations for COVID-19 vaccine approval and use will come from existing, expert scientific bodies established at the Food and Drug Administration and the Centers for Disease Control and Prevention. These should include their external expert advisory committees that routinely review data on vaccine safety and efficacy. Because of this system, the United States has one of the safest and most rigorous processes for vaccine approval in the world, and we have a strong post-licensure/release surveillance system in place to watch for adverse effects.
We support the following in the review and distribution of COVID-vaccines:
- A vaccine approval process that is transparent and made public.
- The vaccines are shown to be safe, with a plan for follow-up included in studies to detect adverse events after participants have completed the vaccine series and during longer term follow-up.
- Sufficient data from Phase 3 studies that show the vaccine is effective against COVID-19 infection and/or disease.
- A robust plan after the COVID-19 vaccines start being distributed to monitor for vaccine effectiveness and safety, as is standard for all vaccines following approval.
- Reassurance that COVID-19 vaccines will undergo additional study in diverse segments of the population (diversity in race, ethnicity, age, persons with medical conditions, pregnant women, and children) to further establish safety and efficacy in all members of our communities.
- A distribution plan that is equitable so that access to potentially limited supply of vaccine is fair geographically and to diverse populations.
- Clear storage, handling and administration guidelines for clinicians that are practical and can be implemented across the board.
- Last, but by no means least, a clearly developed public communication campaign prior to the roll out of COVID-19 vaccine(s) to explain the safety and effectiveness of the vaccine(s). This will be essential to promote vaccine confidence and uptake.
We are ready to support the distribution of proven safe and effective COVID-19 vaccines to patients as soon as they are available for use. There is much to gain with effective vaccines if implemented properly. However, the success of any vaccination campaign will be dependent on public and provider confidence in the scientific methods and regulatory approval mechanisms. This will require transparency and clear communication about what is included in the review process and specific information about safety and efficacy.
To best fight SARS-CoV-2, we need safe and effective vaccines in conjunction with our effective prevention strategies such as mask wearing, physical distancing and hand washing. We look forward to the time that these properly vetted vaccines are available for us, our families, our patients and our communities.
The views expressed in this letter are our personal opinions and do not necessarily represent those of our employers or affiliated institutions.
Sincerely,
Mohamad Abbas, MD
Omobosola Akinsete, MD MPH
Sadia Ali, MD
Jonathan D. Alpern, MD
David Andes, MD
Andrew D. Badley, MD
Leslie A. Baken, MD
Cristina Baker, MD MPH
Jason Baker, MD MS FIDSA
Kiran K. Belani, MD
Edward Belongia, MD
Kimberly Boeser, PharmD MPH BCIDP
Jessica Boettcher, DO
Ravit Boger, MD
Peter F. Bornstein, MD MBA
Thomas G. Boyce, MD MPH
Brian P. Buggy, MD
Farah Cassis-Ghavami, MD
James H. Conway, MD FAAP
Christopher J. Crnich, MD PhD
Zach DeLanoit, PharmD
Aaron Devries, MD MPH FIDSA
Mankpondehou Etienne Djevi, MD
Jim Donahue, DVM MPH PhD
Dimitri Drekonja, MD MS FACP FIDSA
Caitlin Eccles-Radtke, MD
Gregory A. Filice, MD
Thomas Friedrich, PhD
Anne E.P. Frosch, MD MPH
Alison Galdys, MD
Ashley Gyura, DNP CPNP-PC
Matthew C. Hall, MD
William R. Hartman, MD PhD
Peter L. Havens, MS MD
Elizabeth B. Hirsch, PharmD
Anna Huppler, MD
Charles Huskins, MD MSC
Robert M. Jacobson MD FAAP
Anupama Kalaskar, MD
Michael Kessler, MD
Bruce Klein, MD
Michael Klevay, MD
Susan Kline, MD MPH
Gary Kravitz, MD
Christina Koutsari, Pharm D PhD
Michael L. Landrum, MD FACP FIDSA
Janet Larson, MD
Nicholas Lehnertz, MD MPH
Emily R. Levy, MD FAAP
Alan R. Lifson, MD MPH
Sarah Lim, MBBCh
Ruth Lynfield, MD
Dennis G. Maki, MD
Stacene Maroushek, MD PhD MPH
Meghann K. Martin, RN DNP APNP-BC
Joseph A. McBride, MD
Huong McLean, PhD MPH
Lucio Minces, MD
Elizabeth Ann Misch, MD
Michelle Mitchell, MD
Ashley Newberry, MD
Laura E. Norton, MD MS
Dave O’Connor, PhD
Meredith Oliver, PharmD
Becca Peglow, MD
Edwin Pereira, MD
Tamara C. Pozos, MD PhD
Rajesh M. Prabhu, MD
Nipunie Rajapakse, MD MPH
Richard Reich, MD
Patrick Remington, MD MPH
Elizabeth Ristagno, MD MSc FAAP
Stacey Rizza, MD FIDSA
Frank Rhame, MD FIDSA
Priya Sampathkumar, MD
Mark Sannes, MD
Emily Schaaf, MD
Mark R. Schleiss, MD
Kathryn M. Schmit, MD
Ronald Schut, MD
Jonathan Sellman, MD MPH
Ajay K. Sethi, PhD MHS
Megan Shaughnessy, MD
Daniel Shirley, MD MS
Dawd S. Siraj, MD MPH&TM FIDSA
James M. Sosman, MD FACP AAHIVS
Keith Stelter, MD
Patsy Stinchfield, MS CPNP CIC
Rob Striker, MD PhD
Nila Suntharam, MD
Brian Temple, MD MS FACP
Beth K. Thielen, MD PhD
Andrew Thompson, MD
Katherine M. Torres, DO
Harmony Tyner, MD MPH
Ryan Westergaard, MD PhD MPH
Wirtz, MD
Shewaangizaw Worku, MD PhD
Anthony Zeimet, DO
Dina Elrashidy