December 18, 2020
The pandemic is far from over, but there is hope for a better 2021 as thousands of doses of the Pfizer-BioNTech COVID-19 vaccine were delivered to hospitals and healthcare systems across the United States this week.
In this week’s newsletter, I want to highlight and thank some of the PIDS members who played key roles in making that possible. At the top of the list is Dr. Bill Gruber, Senior Vice President of Pfizer Vaccine Clinical Research and Development. At Pfizer, he is responsible for global clinical development of vaccines and spearheaded the COVID-19 vaccine effort. Last week, he and his team published results of an ongoing multinational, placebo-controlled, observer-blinded, pivotal efficacy trial of an investigational COVID-19 vaccine.
Dr. Gruber emphasized the work of all those who contributed to the clinical trial, particularly those who volunteered as trial subjects. “Although phase 1 data offered some potential promise of a safe and effective vaccine, people on the front lines of risk volunteered in the tens of thousands to receive a vaccine delivered by an at the time unproven mRNA LNP platform. They are the real heroes in all of this. I was pleased to have an opportunity to contribute to this effort.”
The vaccine developed by Pfizer BioNTech is the first in the United States to be available under the Food and Drug Administration’s (FDA) Emergency Use Authorization (EUA). Before this could happen, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) reviewed available data about the safety and efficacy of vaccines and made a recommendation to the FDA.
PIDS members who serve on VRBPAC are listed below, and we have asked a few of them to comment on their recommendations to the FDA. Ultimately, VRBPAC voted 17-4 with one abstention in favor of the EUA. Note that members involved as investigators in the vaccine trial did not vote. You can watch a recording of the VBPAC meeting here.
Hayley Gans, MD
Professor of Pediatrics
Stanford University Medical Center
“This is a remarkable time in scientific history: the journey from an unknown organism to a potential vaccine in 9 months demonstrates the extraordinary feat facing the scientific community and the ability to accomplish not only disease management but prevention in this short unprecedented time frame. Sadly, along the way many individuals have suffered greatly from SARS-CoV-2, not only from a medical standpoint with significant morbidity and mortality, but also from the enormous economic toll.
As a member of the FDA Vaccine Related Biologic Products Advisory Committee (VRBPAC), I have the honor and responsibility to assess new vaccines and help to advise their place in disease mitigation. The committee members take this role very seriously, and I know that our community understands the components of the decision-making process when considering exposing healthy individuals to antigens that may pose some adverse events. History and science support vaccines as one of the safest and most effective infectious disease prevention strategies, second to clean water. Vaccines allow susceptible individuals to avoid disease following wild type infection which uniformly carries a higher chance of adverse outcomes compared with vaccine antigens.
Additionally, it cannot be underscored how vaccines also address health care inequity which is not handled well elsewhere. The VRBPAC members must balance vaccine efficacy with safety in the context of wild type disease. It is through this lens that the committee is tasked with evaluating the new SARS-CoV-2 vaccines. The task includes entertaining the first ever emergency use authorization for a vaccine, considering a vaccine approach not yet licensed for use, evaluating safety data from phase 3 trails after a predetermined, yet shorter time period than historically used for licensure, and understanding efficacy in multiple high risk populations as well as the general population.
After careful consideration and scientific deliberation, it became apparent how miraculous this moment truly was. The committee approved, me included, a highly efficacious and safe vaccine that can provide the tool we need to get to safe herd immunity and impact the end to the pandemic. The evidence is overwhelming in favor of approving vaccination. The studies represent some of the largest vaccine trials to be put forth for licensure, and show remarkable efficacy for a respiratory virus, with little serious events. Should these vaccines continue to be studied, absolutely. Will we have the continued opportunity to evaluate the vaccines going forward, definitely, especially as the number of doses globally will quickly be in the millions.
With the current systems in place that are used for all vaccines to monitor the safety for rare events after millions of doses, we can continuously assess for adverse events. Will there be events following vaccination, definitely, this is known and expected, but will these be less than wild-type disease, most certainly yes. I feel very privileged to be part of history, and so proud of the scientific and infectious diseases communities for allowing the purity of science to prevail and decrease human suffering.”
Archana Chatterjee, MD, PhD
Dean, Chicago Medical School
Vice President for Medical Affairs
Rosalind Franklin University of Medicine and Science
“I am fully in support of the Emergency Use Authorization for the Pfizer/BioNTech vaccine for adults 18 years and older, along with any measures that are going to help us get this deadly pandemic under control. This is a serious public health issue that requires data and science at the forefront. However, we currently have 16- and 17-year-olds who, as minors, are not able to make their own decisions on whether or not to take part in a vaccination program, and we have limited safety and efficacy data on how the vaccine affects the pediatric population. Since most of them will not be eligible to receive the vaccine in the near future, I believe we have time to gather and analyze additional data in this and younger age groups.”
Andi Shane, MD, MPH, MSc
Professor of Pediatrics
Director, Division of Pediatric Infectious Diseases
Emory University School of Medicine
and Children’s Healthcare of Atlanta
“I was and am unable to participate in the discussion or vote on the EUAs for the two mRNA vaccines due to my indirect involvement in the COVID-19 vaccine trials at our institution. However, I am extremely grateful to our colleagues who are and were able to thoughtfully discuss and analyze the data presented at the VRBPAC and ACIP meetings. Their hours and hours of service are greatly appreciated. Continued advocacy for engagement of adolescents and children in clinical trials, as we vaccinate adults, is vital. I long for the moment when we will be able to take celebratory photographs of children being vaccinated.
Paul Spearman, MD
Director, Division of Infectious Diseases
Albert B. Sabin Chair in Pediatric Infectious Diseases
Cincinnati Children’s Hospital Medical Center
Professor of Pediatrics
University of Cincinnati School of Medicine
“While I was not able to vote on this decision at the VRBPAC meeting due to my roles in ongoing COVID19 vaccine trials, I am delighted that the committee recommended the Pfizer/BioNTech vaccine for emergency use authorization. The vaccine efficacy results are amazing, and the safety profile looks very good. It has been deeply satisfying to see the biotech, academia, and government collaborations work together quickly and efficiently to move this vaccine forward. We urgently need this intervention!”
Once the FDA issued the EUA, the Advisory Committee on Immunization Practices (ACIP) decides whether to recommend the vaccine and who should receive it. PIDS members who serve as voting members of ACIP are listed below.
José R. Romero MD, FAAP, FIDSA, FPIDS, FAAA
Secretary of Health/ Director of the Arkansas Department of Health
Professor of Pediatrics, Pediatric Infectious Diseases
University of Arkansas for Medical Sciences
“The ACIP’s vote to recommend the Pfizer-BioNTech COVID-19 vaccine for use in persons 16 years of age and older reflects the voting member’s assessment that, after careful and in-depth review of the available data, the vaccine was safe and efficacious in the population studied. It was acknowledged that the number of study subjects in the 16 and 17 year old age group was low. However, the available safety and efficacy data for those study subjects, as well as for young adults, did not raise concerns that merited excluding that age group from the overall approval.
After reviewing all available data, the ACIP’s earlier interim recommendation to include health care workers as well as residents of long term care facilities in Phase 1a of the national strategy for COVID-19 vaccine allocation was based on an approach and strategy that maximizes benefits from vaccine use, minimizes harm, promotes equity, and addresses health care disparities.”
Grace Lee, MD, MPH
Associate Chief Medical Officer for Practice Innovation
Stanford Children’s Health
Professor of Pediatrics, Stanford University School of Medicine
Chair of the ACIP COVID-19 Vaccine Safety Technical Subgroup
“Given the rapidly escalating burden of COVID-19 disease in the U.S. that is impacting the capacity of our healthcare delivery systems, the critical importance of protecting our healthcare workforce, and the urgent need to prevent further mortality in the medically fragile LTCF population, I voted to approve the Pfizer vaccine. The vaccine is able to prevent 95% of cases of symptomatic COVID-19 disease, with the majority of the adverse events being short-lived (i.e. local and systemic reactions). Getting vaccinated is a much safer way to develop immunity to COVID-19. My hope is that with Phases 1b and 1c, as well as consideration of the Moderna vaccine later this week, that we can continue to enhance our ability to protect the U.S. population equitably and efficiently. I anticipate ACIP will also continuously monitor the balance of benefits and risks of vaccines in the context of the pandemic, in order to ensure access to safe and effective vaccines.”
Pablo Sanchez, MD
Professor of Pediatrics
The Ohio State University College of Medicine
Director of Clinical and Translational Research in Neonatology
Nationwide Children’s Hospital
“I very much agree with the recommendation to vaccinate with the Pfizer-BioNTech COVID-19 vaccine for persons 16 years of age and older under an emergency use authorization. My decision was based on the strong efficacy and safety data presented to ACIP. It is a historic and important beginning as we face the ongoing pandemic with the hope of soon controlling it and preventing the substantial morbidity and mortality that it has brought to so many worldwide. Importantly, there needs to be ongoing evaluation of vaccinees for safety and efficacy, and while I wholeheartedly recommend it for myself and my family, I feel strongly that vaccination needs to be allocated equitably based on risk stratification.”
The following PIDS members serve as Ex Officio Members and Liaison Representatives:
Ex Officio Members
It has been exciting to see so many of our members step up to be among the first vaccinated this week. To view some of their photographs, click here. While prioritization strategies differ by state and to some extent, by hospital, my hope is that each you will have access to vaccine soon.
To those who played a role in making this vaccine—and potentially the end of the pandemic—possible, “thank you” doesn’t seem like enough words to express the gratitude we all feel.
Wishing you all health and happiness in 2021.