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This week, the CDC sent a message to states advising them to prepare to distribute a potential COVID-19 vaccine in the fall. Getty Images
  • The CDC is asking states to prepare to distribute a COVID-19 vaccine by as early as late October.
  • This announcement has some experts concerned that the vaccine will be rushed to market without first clearing key measures for safety and effectiveness.
  • Healthcare professionals, essential workers, national security employees, and other high-risk groups, including those over 65, would be among the first to receive the vaccine.
  • Experts warn that large-scale trials are needed to ensure that vaccines are safe and don’t cause unintended or dangerous side effects.

The Centers for Disease Control and Prevention (CDC) has asked public health officials in all states to be prepared to start distributing a COVID-19 vaccine as soon as late October or early November, reports the New York Times.

This push comes even before large-scale clinical trials of candidate vaccines are finished. Data from these studies are needed to show whether the vaccines are safe and effective.

Distributing a vaccine to millions of Americans in a short time is a vast undertaking that will require the coordination of many public health and other agencies, so an early start on planning will likely be needed.

But some health experts are worried that the Trump administration may be pushing for a vaccine to be made available by Election Day on November 3 in order to give the administration a “win” for its handling of the pandemic.

Thomas A. LaVeist, PhD, dean of the School of Public Health at Tulane University, says he is concerned about the possibility that the administration might cut corners to fast-track a COVID-19 vaccine.

“Vaccine development requires painstaking work. Typically, a vaccine will take more than a decade to be developed and deployed,” he said. “So putting an artificial deadline on the production of a vaccine is extremely dangerous.”

The Times reports that three documents sent by the CDC to public health officials lay out requirements for how two vaccines would be shipped, mixed, stored, and administered to the public.

The vaccines are unnamed, but the description of how they will be stored and given matches what is known about the candidate vaccines being developed by Pfizer and Moderna, according to the Times.

The CDC documents also indicate that healthcare professionals, other essential workers, and national security employees would be among the first to receive the vaccine.

Also prioritized are others at higher risk of contracting the coronavirus and severe illness from COVID-19 — including people 65 years and older, racial and ethnic minorities, rural communities, and people who are incarcerated, homeless, or living in shelters.

Moncef Slaoui, the chief adviser for the White House vaccine program, said in an interview with NPR that the CDC asking public health agencies to start preparing early for the distribution of a COVID-19 vaccine was “the right thing to do.”

However, he says there is a “very, very low chance” that the phase 3 vaccine trials that are currently running would have data available before the end of October.

Eight COVID-19 candidate vaccines are in phase 3 clinical trials, according to the World Health Organization, including the ones developed by Pfizer, Moderna, and Oxford University.

Smaller clinical trials — what’s known as phase 1 and phase 2 studies — have shown that these candidate vaccines are generally safe in healthy people and can generate an immune response.

But larger studies are still needed.

“The purpose of phase 3 is to test the safety and effectiveness of vaccines in large, more diverse populations,” said Dr. Ami Parekh, chief medical officer at Grand Rounds. “It is an important step to ensure the benefits of the vaccine outweigh the potential side effects.”

These trials enroll tens of thousands, with people randomly assigned to receive either a candidate vaccine or an inactive placebo.

Given the urgency of the COVID-19 pandemic — with over 186,000 American deaths — groups developing COVID-19 vaccines were able to rapidly recruit volunteers for the phase 3 trials.

But the next part of the trial can’t be rushed. Researchers have to wait for people in both groups to be exposed to the coronavirus — and then look at the data to see if the vaccine protected people from the coronavirus.

“How long will it take for enough people to be exposed to the virus to see if you have a higher rate of infection among people who were in the placebo group?” said LaVeist, adding that this slower part of the research makes a Nov. 1 deadline for a vaccine unlikely.

Large-scale trials are also needed to ensure that vaccines are safe. Smaller studies can catch some negative side effects — like pain and redness at the site of injection — but more rare adverse effects may only show up after tens of thousands of people have received the vaccine.

Dr. Shruti Gohil, associate medical director of epidemiology and infection prevention at UCI Health, says the rigorous clinical trial process used to test vaccines was developed over decades.

“This [process] must be adhered to when developing any new vaccine,” she said. “It is more important than ever for this first-ever new mRNA vaccine strategy for COVID-19.”

Both Pfizer and Moderna have developed vaccines that deliver mRNA — an intermediary between DNA and a protein — to the cells in the body.

Once in the cells, the mRNA is converted to a protein that is part of the coronavirus. This doesn’t cause disease, but primes the immune system to recognize and attack the virus.

This type of vaccine has never been approved before — for any disease.

Gohil says it is far more important to get a COVID-19 vaccine right than to aim for a certain deadline.

“A vaccine that is not useful or worse yet, not proven to be safe, risks far more injury to the public than no vaccine at all,” she said.

“These harms extend beyond the current coronavirus pandemic,” she added. “A poorly vetted vaccine could end up causing greater harm to vaccine acceptance by the public for other well-vetted and extremely effective vaccines.”

A large number of Americans are already hesitant about a COVID-19 vaccine. A Gallup poll last month found that 35 percent would not get the vaccine, even if it were free and approved by the Food and Drug Administration.

Brooke McKeever, PhD, associate dean of research and an associate professor of communications at the University of South Carolina, is concerned that rushing the COVID-19 vaccine might make more people hesitant about getting vaccinated.

“Cutting corners at this point could undermine public trust,” she said. “If the data are complete, clear, and compelling, that is one thing, but we need to make sure the vaccine is safe and effective before it is made available to the public.”

LaVeist says the Trump administration has already damaged public trust in vaccines, starting with calling its COVID-19 vaccine program Operation Warp Speed.

“This is terrible messaging from a health communication standpoint,” he said, “because that emphasizes the speed at which this is being done, which gives people less confidence that it is being done correctly.”

McKeever says that targeted messaging to different audiences about a COVID-19 vaccine once it is approved could help increase public trust. But only if the government doesn’t cut corners in order to release the vaccine sooner.

“Emphasizing that the vaccine is safe and effective will resonate with some audiences,” she said. “Being able to say the vaccine went through all the necessary trials is an important part of that message.”

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