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Use these resources to background yourself on COVID-19 vaccine development

AHCJ Staff

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By Bara Vaida and Tara Haelle

Returning to a society where people can safely gather with friends, family and large crowds will take a combination of a vaccine and treatments to stop the spread of SARS-CoV-2, the coronavirus that causes COVID-19.

The race to find a vaccine has spurred much media attention. As of mid-October, between 50 and 179 promising vaccine candidates were under study, with more than 50 having reached the human clinical trial stage, according to BioRender and the COVID-19 Vaccine Tracker, two open-platform websites tracking the process.

Many of the studies and trials are taking place in the U.S. and are part of the White House’s Operation Warp Speed program. Many more are being conducted outside the country.

During the first presidential debate on Sept. 29, President Trump predicted that a vaccine was “weeks” away from being approved ”• a statement that wasn’t supported by vaccine makers or most scientists. No vaccine maker in the U.S. had yet published results from a late-stage clinical trial as of late October.

The head of Operation Warp Speed said a vaccine might be ready for regulatory consideration within the next two months and that all Americans may have access to a vaccine by mid-2021. Dr. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, expects two vaccine makers to have enough data from clinical trials to apply for regulatory approval in December.

So what is political hype and what is real? Which vaccine candidates should reporters be paying attention to? How can they keep track of them and report findings responsibly to the public?

Here are some resources, expert sources and other tips to help you make sense of the COVID-19 vaccine race and report it responsibly. For additional resources, also check out our regularly updated pandemic tip sheet.

Vaccine Trackers

Many sites are now tracking of COVID-19 vaccines, but Tara’s favorite is the COVID19 Vaccine Tracker, mainly because the information is presented in a user-friendly way that’s as accessible to the general public and general assignment reporters as to science and health journalists

The site was developed by a team of public health, epidemiology, vaccine, infectious disease and biostatistics experts from McGill University in Canada, the University of Minnesota and a few other universities and research institutions. She learned about the site from one of those experts, Nicole Basta, Ph.D., an associate professor of epidemiology, biostatistics, and occupational health at McGill.

Here are other top ones we recommend:

Approval and Recommendations Process

Before a new vaccine can be distributed to the public, it goes through several approval and recommendation stages following clinical trials, as described in these backgrounders from the Centers for Disease Control (CDC) and Food & Drug Administration (FDA). Briefly, these are the steps:

  1. The clinical trials’ sponsor (a company, university or other research group) submits an Investigational New Drug (IND) application to the FDA’s Center for Biologics Evaluation and Research (CBER).
  2. The sponsor conducts clinical trials: Phase 1 trials are small and focused on safety and immunogenicity (how well the vaccine induces an immune response). Phase 2 studies involve hundreds of participants and focus on finding the appropriate dosing while assessing safety. Phase 3 studies enroll tens of thousands of participants to test the vaccine’s efficacy and safety.
  3. After completing phase 3 trials, the sponsor submits a Biologics License Application (BLA) to the FDA.
  4. The FDA conducts a pre-approval inspection of the proposed manufacturing facility. Here are the nitty-gritty details.
  5. After the FDA reviews the license application, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC), composed of independent experts, reviews the scientific data in open public meetings and makes recommendations to the FDA on the vaccine’s safety, efficacy and indications.
  6. FDA develops and approves appropriate product labeling. The agency then licenses the vaccine and production begins under its oversight.
  7. The Advisory Committee on Immunization Practices (ACIP), a committee of independent experts at the CDC, reviews the scientific data in open public meetings to make recommendations on who should receive the vaccine, the number of doses, and the timing (schedule) of doses. The CDC then formally makes those recommendations.
  8. After the vaccine enters public use, post-licensure studies and safety monitoring continues through the Vaccine Adverse Event Reporting System (VAERS), Vaccine Safety Datalink (VSD), the Post-Licensure Rapid Immunization Safety Monitoring (PRISM), and the Clinical Immunization Safety Assessment Project (CISA).

For additional details on the process, watch the AHCJ webcast on understanding the vaccine approval process that Tara moderated in May.

Helpful Resources for Context

Operation Warp Speed

The name of the federal effort announced by President Trump in May to develop, produce, and distribute 300 million doses of a coronavirus vaccine by January 2021. The initiative, led by the Department of Defense (DOD) and the U.S. Department of Health and Human Services (HHS), is one of the largest since the atomic bomb’s development during World War II. The government has poured $10 billion into clinical development and manufacturing of potential vaccine candidates. It also has begun stockpiling hundreds of thousands of doses of as-yet-unproven immunizations in warehouses around the country to be distributed as soon as one of them reaches the safety and effectiveness standards set by U.S. regulators. Warp Speed said it has deals with six major drug companies that are developing COVID-19 vaccines and may seek more deals. See this Sept. 28 Stat story.

Five of the six vaccine candidates are in late-stage clinical trials. Two of them may have enough data to begin the regulatory approval process by December, according to Dr. Anthony Fauci, head of the National Institute of Allergy Infectious Diseases. Regulators probably wouldn’t be able to complete the approval process until January 2021, at the earliest, he said.

During clinical trials and after vaccine licensure, here are some important considerations to investigate:

Clinical Trial Equity

What was the representation of trial participants by historically oppressed or disproportionately burdened populations, such as Native Americans, Blacks, Latinx, children, the elderly or those with underlying health conditions? If there was very little representation, how will public health officials build confidence in these populations that the vaccine is safe? How will they know if it’s safe and effective in those populations? Should anyone in these populations take the vaccine without this data?

Infrastructure for Manufacturing

What facilities are being used to manufacture the vaccine? Are they existing facilities using traditionally used vaccine manufacturing methods or new facilities that had to be built to accommodate new vaccine development technologies? Where are these facilities geographically? What is the economic impact of them locally and more broadly?

Shortages in Materials

What materials are needed for the specific vaccine that was approved, and do enough exist? A shortage of glass vials has already aroused concerns. Will the vaccine involve single dose or multi-dose vials? What preservative will be used in multi-dose vials? Are there adequate supplies of needles? Syringes? Rubber stoppers?

Infrastructure for Distribution

Ethics of Determining First Recipients

Vaccine hesitancy

Vaccine hesitancy isn’t likely to be an immediate concern given the other challenges to COVID-19 vaccine development, manufacturing, distribution, and prioritization. Still, it will almost certainly eventually become a concern. Further early concerns may involve healthcare workers and populations with a history of being exploited by the medical industry, such as Black Americans. However, it’s important to recognize that vaccination of any kind works on norms. It’s possible to inadvertently undermine those norms by overhyping concerns about vaccine hesitancy before a vaccine is available.

Other helpful sources

AHCJ Tara Haelle’s list of COVID-19 vaccine resources

AHCJ: Vaccine development glossary

AHCJ: Types of vaccines

Medium Elemental: Top 50 experts to trust in a pandemic

Experts

  • Amesh Adalja, M.D., (@AmeshAA), senior scholar at the Johns Hopkins University Center for Health Security, Adalja is an infectious disease expert and effective science communicator specializing in pandemic policy. Contact: aadalja1@jhu.edu.
  • Maria Elena Botazzi, Ph.D., FASTMH, (@mebottazzi), associate dean, National School of Tropical Medicine and professor of pediatrics and molecular virology and microbiology, Baylor College of Medicine and Texas Children’s Hospital. Botazzi has been working on a COVID-19 vaccine as co-director of the Texas Children’s Hospital Center for Vaccine Development. Contact: 832-824-0510 or bottazzi@bcm.edu.
  • Kizzmekia Corbett, Ph.D., (@KizzyPhD), research fellow and team lead for coronavirus research in the Viral Pathogenesis Laboratory of the Vaccine Research Center, National Institute of Allergy and Infectious Diseases (NIAID). Corbett is the scientific lead of the coronavirus team in the Viral Pathogenesis Laboratory of the NIAID Vaccine Research Center (VRC). For media inquiries on the NIAID vaccine, contact Jennifer Routh at 301-402-1663
  • Natalie Dean, Ph.D. (@nataliexdean), assistant professor of biostatistics, University of Florida. Dean is a biostatistician specializing in infectious disease epidemiology. Her research focuses on designing clinical trials to evaluate vaccine efficacy, Contact: 352-294-1945 or nataliedean@ufl.edu.
  • Carlos del Rio, M.D. (@CarlosdelRio7), distinguished professor of medicine and executive associate dean for Emory at Grady at Emory University School of Medicine. Del Rio is an infectious disease expert and leader and is passionate about diversity in science, particularly COVID-19 vaccine trials. Contact: cdelrio@emory.edu.
  • Jeremy Faust, M.D., M.S., (@jeremyfaust), an emergency physician at Brigham and Women’s Hospital, Emergency Division of Health Policy and Public Health, and an instructor at Harvard Medical School. Faust is editor-in-chief of Brief-19, a daily roundup of COVID-19 research and policy on Twitter and the web. Contact: 617-732-5636 or 617-732-5640.
  • Scott Gottlieb, M.D., (@ScottGottliebMD), resident fellow at the American Enterprise Institute and a former FDA commissioner. The former Trump administration official is a prolific expert on Twitter and the media, especially on issues at the intersection of health and industry (think vaccines, diagnostics, and antibody testing). For media inquiries, contact Brendan Rascius at Brendan.Rascius@aei.org.
  • Peter Hotez, M.D., Ph.D., (@PeterHotez), professor and dean for the National School of Tropical Medicine at Baylor College of Medicine and co-director of the Texas Children’s Center for Vaccine Development. If you’re looking for science-backed information on the COVID-19 vaccine, Hotez is a must-follow. Contact: 713-798-1199 or hotez@bcm.edu.
  • Marc Lipsitch, D.Phil., (@mlipsitch), professor of epidemiology, Harvard University. Lipsitch is an epidemiologist specializing in infectious diseases. His research focuses on the transmission, evolution and control of bacteria and viruses, emphasizing the study of immunity, vaccines, and antibiotics. Contact: 617-432-4559 or mlipsitc@hsph.harvard.edu.
  • Vineet Menachery, Ph.D., (@TheMenacheryLab), assistant professor in the Department of Microbiology and Immunology, University of Texas Medical Branch. As the leader of one of the few labs in the country studying coronaviruses before the start of the pandemic, Menachery had a head start figuring out how the novel coronavirus SARS-CoV-2 worked. Contact: 409-266-6934 or vimenach@utmb.edu.
  • Michael Mina, M.D., Ph.D., (@michaelmina_lab), assistant professor in the Department of Epidemiology and the Department of Immunology and Infectious Diseases at Harvard University and associate medical director of molecular virology diagnostics at Brigham and Women’s Hospital/Harvard Medical School. Mina is a pandemic triple threat with expertise in epidemiology, immunology, and clinical pathology, specifically molecular virology diagnostics. Contact: mmina@hsph.harvard.edu.
  • Angela Rasmussen, Ph.D., (@angie_rasmussen), associate research scientist, Center of Infection and Immunity at the Columbia University School of Public Health. Rasmussen is a virologist researching the interaction between viruses and human cells. She is frequently interviewed on the fundamentals of vaccines. Contact: alr2105@cumc.columbia.edu.

Other journalist tipsheets:

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