COVID vaccines may arrive at record speeds, but dose delivery is complex

Science is Incredible progress towards the COVID-19 vaccineBut as approval approaches – potentially as early as December – Concerns have shifted to the complexity of distribution.

Overall, hope was the theme of this month’s USA TODAY vaccine panel. Five months later, the panel’s countdown clock to the widely available vaccine was skipped for another hour at 8 am.

Companies and observers generally expect At least one COVID-19 (new coronavirus infection) (# If there is no character limit, add parentheses when it first appears Candidate vaccines will soon be approved by regulators. Doctor Francis Collins, Director of the National Institutes of Health, When he joined the choir on Tuesday He told NPR that he was “carefully optimistic.” At least one of the candidates will be determined to be safe and effective by the end of the year.

But the reality is How difficult it is to get an approved vaccine in the arms of everyone who wants it – twice.

“The first vaccine supply and distribution and vaccination programs will not meet the general demand for immediate and widespread access to safe and effective vaccines,” he said. Doctor Kelly Moore, Deputy Director of Immunization Education of the Immunization Behavior Coalition.

Healthcare professionals and first responders are likely to prioritize approved vaccines, followed by older people at high risk.

Even those limited groups said they make up 150 million Americans Doctor Paul Offit, a vaccine expert at the Philadelphia Children’s Hospital. Unless three vaccines are approved at the same time, it is unlikely that sufficient doses will be available immediately.

The two major vaccine candidates need to be provided in different ways, making it difficult to get the right vaccine to the right person. Both require two doses, but Pfizer-BioNTech vaccinations are given every 21 days and Moderna’s second dose is given every 28 days.

Moderna vaccines should be stored frozen. Pfizer needs to be kept even cooler, at minus 78 degrees Fahrenheit, the temperature of dry ice. This means that different shipping and storage protocols are required.

Another variable is whether the vaccine is equally effective in groups such as the elderly.Ongoing studies may show that one vaccine is more effective than another in a high-risk population, Add more complexity..

“It will be difficult to get the right vaccine to the right person’s arm at the right time,” said Ofit. Then do it again with the second dose.

Progress

Over the last 5 months, USA TODAY has become more than 12 professionals All aspects of Vaccine development to measure Include progress About COVID-19 vaccine..

We asked panel members to develop the vaccine on a 12-hour basis. This time zone is the moment when the world notices a virus called SARS-CoV-2 in early January, and noon is that time. Vaccines will be widely available.

To In late June, panelists set aside at 4 am. One-third of the road – an amazing amount of progress given the short time frame.

Along In July, panel quotes sneaked up forward Until 5 am The start of large-scale clinical trials has strengthened optimism, alleviated by concerns that “many things have to go well.”

August And September Each watched the clock advance an hour. There were no major setbacks and the distribution plan began to be in place.n Finally vaccine.

This month, the panelists ran the clock yet An additional hour closer to a widely available vaccineAlthough there was a wider spread than usual among 15 people.. Some say it’s still early morning. Others have said we are approaching our goal.

The midpoint of expert time in October was 8:00 am, nearly three-quarters of that.

First generation vs. next generation

All six candidate vaccines backed by U.S. taxpayers have been developed quickly This spring.They received government funding For development, manufacturing, or both, they can be made faster than traditional vaccines, which took at least four years to develop, often much longer.

All companies are contractually required to produce at least 100 million doses of vaccine in return for funding. Not all of these doses are available on the first day the vaccine is approved by the US Food and Drug Administration.

Prasant Yadav, a senior fellow and medical supply chain expert at the Center for Global Development, said: ..

If none of the front runners pan out, things won’t be clearer, he said.

Two leaders, Pfizer and Moderna, are using a messenger RNA platform that has never been used for approved vaccines, said Duke University Law School professor and health law expert Arthirai. Stated.

Even better vaccines may come, even if they have more than one effect – For example It requires only one dose or has proven to be more effective for the elderly and more vulnerable people. Once the vaccine is available, it can be difficult to convince tens of thousands of people to volunteer for the 2.0 or 3.0 version of the test.

It will be difficult to find volunteers in the United States who may be infected with COVID-19, as infections are expected to decrease as vaccines become available. The trial includes 30,000 people, and at least 150 people need to get sick to statistically prove that the vaccine is effective. Fewer infections mean that it will take longer to reach that number.

Virtually all USA TODAY panelists said they expect improvements in first-generation vaccines to be difficult.

The decline in the public interest after the approval of the first COVID-19 vaccine can mean that “some of these lagging vaccine trials must be completed.” Doctor Monica Gandhi, a professor of medicine at the University of California, San Francisco and an infectious disease expert.

Bring more than one COVID-19 (new coronavirus infection) (# If there is no character limit, add parentheses when it first appears Dr. Michel McMurray Heats, President and CEO of the Biotechnology Innovation Organization, said that vaccines across the finish line are safe and effective for everyone, regardless of age, race, health or other variables. Important to make it available.

“That’s why it’s so important to have diversity among volunteers in clinical trials, so researchers can track data to see exactly how vaccines work in different populations. You can, “she said. “The more solutions we have, the better we are ready to end this pandemic.”

Distribution and other concerns

Like Ofit Sandra Claus Quinn, senior associate director of the Maryland Health Disparity Center, said she was worried. How state and local health departments deal with complexity It is to vaccinate so many people.

“They are trying to organize their plans through interactions with public health agencies in several counties and states,” she said. “But planning without knowing which vaccine or how many vaccines will succeed is a challenge.”

In the future, there will be major logistics issues. Doctor Gregory Poland, Director of Vaccine Research Group at Mayo Clinic, Editor-in-Chief of Journal Vaccines.

“It’s confusing and probably chaotic,” he said.

Pamela Björkman, a structural biologist at the California Institute of Technology, said her “optimism has diminished.” Holds two of the major vaccine candidates.

The AstraZeneca trial was suspended in September after British volunteers had rare neurological complications. The UK trial was allowed to resume, but the FDA continued to hold the trial in the United States.

This month, the Johnson & Johnson trial was suspended after participants collapsed due to an “unknown illness.”

Clinical trial suspensions are relatively routine and “you don’t necessarily have to worry about vaccine safety,” Björkman said. “But vaccine testing shows that we need to be careful, without skipping safety standards.”

How did you do it

USA TODAY received responses from 15 scientists and researchers asking how far they believe the vaccine development effort has progressed since January 1, when the virus was first internationally recognized. We aggregated those answers and calculated the median, which is the midpoint between them.

This month’s panelists

Pamela Björkman, Structural Biologist, California Institute of Technology

Dr. Monica Gandhi, Infectious Diseases Expert at the University of California, San Francisco

Sam Harabi, Professor, Faculty of Law, University of Missouri.Scholar of O’Neill National and Global Health Law Institute at Georgetown University

Florian Kramer, Virologist at Mount Sinai School of Medicine, New York City

Dr. Michel McMurry-Heath, President and Chief Executive Officer of Biotechnology Innovation Organization

Dr. Kelly Moore, Deputy Director of Vaccination Education, Vaccination Behavior Coalition; Former member of the CDC Advisory Board on Immunization Implementation.Chair of the World Health Organization Vaccination Advisory Board

Plaka Shnagarkati, Vice President of Immunologist and Research, University of South Carolina

Dr. Paul Offit, Director of the Vaccine Education Center and attending physician in the Infectious Diseases Department of the Philadelphia Children’s Hospital.

Peter Pitts, President and co-founder of the Public Interest Medical Center, and former FDA Deputy Commissioner for External Relations.

Dr. Gregory Poland, Mayo Clinic Vaccine Research Group Director, Editor-in-Chief, Vaccines

Sandra Claus Quinn, Senior Associate Director of the Maryland Health Equity Center and Chair of the Department of Family Sciences, Faculty of Public Health, University of Maryland

Liarts, Duke University Law School Law Professor and Health Law Expert

Dr. William Schaffner, Professor of Preventive Medicine, Department of Health Policy, Faculty of Infectious Diseases, Vanderbilt University, Professor of Medicine

Prashant Yadav, Center for Global Development Senior Fellow, Medical Supply Chain Expert

Dr. Ottoyan |, Professor of Medicine, University of California, Los Angeles, David Gefen School of Medicine and Head of Infectious Diseases

Health and patient safety coverage at USA TODAY was partially made possible by grants from the Masimo Foundation for Ethics, Innovation and Competition for Healthcare. The Masimo Foundation does not provide editorial input.