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Strong communications from caregivers on safety and logistics will set recipients up for success
Now that phased administration of a COVID-19 vaccine has begun, general practice physicians are fielding questions and requests for guidance from patients. While we await wide distribution of the Pfizer BioNTech vaccine and a second vaccine by Moderna, healthcare professionals have an opportunity to broaden public understanding and help instill the confidence necessary for patients to feel safe in order to ensure the success of the vaccination program.
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Michelle Medina, MD, is the Associate Chief of Clinical Operations within Cleveland Clinic Community Care. In her practice, she speaks with patients who approach her from a wide range of perspectives and questions about the vaccines.
“There are the patients who want to get it as soon as they can, they just want to be out of this situation. And then there are patients on the other side, who say ‘I don’t care what you say, I don’t think I’m going to get it, I’m too skeptical,’” Dr. Medina says.
Her approach is to meet them where they are, whether that means clarifying the nuts and bolts of the vaccination process, debunking myths or addressing fears about safety. This process is likely to ease as the vaccine rolls out and people see that few suffer severe side effects, Dr. Medina says.
“Hopefully we’ll also start to see some easing of the recent increase in cases,” she says. “That may start to get people thinking differently.”
Right now, healthcare professionals should be ready to begin an education process that will evolve as the program expands and as FDA review of additional vaccines continues. Here are Dr. Medina’s responses to some of the most common questions health care professionals are likely to face.
For most healthy people, the answer is likely to be in spring.
Currently, the federal government, through state governments, has identified first phase recipients as healthcare workers, essential workers and those who are at most risk of developing severe COVID-19 or at risk of dying from COVID-19, such as residents of nursing homes and long-term care facilities, seniors, and adults with chronic medical conditions. Between 50 million and 100 million doses will be necessary to vaccinate that group, Dr. Medina says. Pfizer expects to deliver about 50 million doses globally by the end of 2020; Moderna has estimated it will deliver 20 million doses nationally.
In addition to the Pfizer BioNTech and the Moderna mRNA-1273 two-dose vaccines, AstraZeneca and Johnson & Johnson hope to gain FDA Emergency Use Authorization of their single-dose vaccines later this winter.
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There is no waiting list at the moment. Limited supplies of the vaccines will be administered to the first recipients through their workplaces or delivered to congregate-living centers. As supplies increase and different vaccine products become approved, more patients may be vaccinated through medical offices; eventually retail pharmacies and community health centers may be able offer vaccines, as they do with annual influenza vaccines. It’s conceivable that there may never be a need for a waiting list if there are enough vaccines, Dr. Medina says.
Individuals in prioritized groups will receive the intramuscular injection, be given information about possible side effects, and will be asked to wait for 15 minutes of observation as a precaution in case of immediate allergic response. They will be reminded to schedule their second dose. Even after receiving the vaccine, everyone should continue to follow pandemic protocols: wearing masks, washing their hands frequently and thoroughly, maintaining physical and social distance, and avoiding large indoor gatherings.
Even today, a portion of the population remains skeptical about well-established vaccines for a variety of reasons. With COVID-19 vaccines being brand new, more wariness is expected. Dr. Medina tells patients that new isn’t necessarily bad.
“New can be anxiety provoking, but in this situation, new can be very miraculous,” she says. “Consider this: Scientists across the world, drug manufacturers and government agencies set aside almost everything else they do in order to focus on this and do it as quickly as possible. That’s not a small undertaking.”
Physicians may stem fears by explaining how speed and rigor worked in tandem for the development and clinical trials of the new drugs.
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“The speed of this is a concern to people,” Dr. Medina says. “And it’s true: A process that used to take years has now taken eight months. But there are a number of things that made it possible in only eight months. First of all, very early, we already knew the genetic makeup of the virus because it’s a cousin of viruses that we’ve seen before—SARS-CoV (SARS) and MERS-CoV (MERS). We already knew which protein in the virus is the bad agent that leads to infection.”
Patients should be reminded that no steps were skipped during drug trials. Unprecedented cooperation among scientists worldwide enabled trials to proceed quickly.
“You literally had all hands on deck,” she says. “Whereas before you might run a trial in one country, then run another in another country or state after, because this is such a worldwide concern, they ran them all at once with a lot of communication going back and forth. They enrolled a lot of people in such quick order to be able to have enough participants in the trial.”
Dr. Medina also points out that many people were vaccinated as part of the clinical trial process. Pfizer has enrolled more than 43,000 people worldwide in its phase 3 clinical trial, which began in July.
The Pfizer and Moderna vaccines both require second doses to achieve vaccine effectiveness of about 95%.
“The way that vaccines work, you’re likely to get some protection after one dose, but it’s the second dose that really boosts that immunity and makes your cells remember with some permanence what you went through,” Dr. Medina says.
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She expects there may be few barriers that would prevent patients from following up for the second shot. First, while some recipients experience mild side effects, they tend to occur after the second dose rather than the first. They appear to be less bothersome than the side effects of another popular two-dose vaccine, Shringrix. Second, she said, there will be layers of reminders in place once the first dose has been administered.
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