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Earlier, when news broke about a 28-year-old doctor on the front line of COVID-19 in Brazil who died after receiving an experimental vaccine, doubts arose about the safety of one of the most promising coronavirus vaccine candidates. But then the story changed. Although the vaccine manufacturer did not confirm this, the doctor appeared to have been in the control group and had received a dose of an established meningitis vaccine. The danger came from exposure to the coronavirus itself.
That tragedy underscores the continuing risk of COVID-19 for health care professionals, who have been designated by U.S. advisory committees as part of Phase 1A, the first to receive doses of any approved vaccine. The Centers for Disease Control and Prevention (CDC) recently reported that 6% of adults admitted to hospital with COVID from March to May were health care workers. The report was based on surveillance data from 13 states. The mean age of the patients was 49 years. The agency has set a “ready date” for vaccination on November 15 for jurisdictions such as state health departments, although a vaccine is unlikely to be authorized by then.
As hospitals rush to prepare, their watchword is flexibility. They still don’t know how many initial doses they will receive, of which vaccine or in what time frame. They have a sophisticated infrastructure to deliver flu vaccines every fall, but that picture falls short of likely scenarios of limited supply, additional reporting requirements, two-dose regimens, and varying conservation needs.
Dr. Anna Legreid Dopp
“Healthcare organizations have consistently taken up the challenge. I strongly believe in their potential to do so,” says Anna Legreid Dopp, PharmD, senior director of quality improvement and guidelines for the American Society of Health-System Pharmacists. Medscape Medical News.
Healthcare professionals will not face a vaccine mandate
Even after months of caring for COVID patients, most doctors remain vulnerable to infections, at work and in their communities. This was what occupational health physician Kevin Smith, MD, realized when his health system, ProMedica, based in Toledo, Ohio, offered antibody tests to all of its 50,000 employees. About 2% of the 6933 tests provided were positive, he says.
Dr Kevin Smith
Yet many doctors, nurses, and other healthcare professionals share public skepticism about the safety and efficacy of a vaccine that receives rapid US Food and Drug Administration (FDA) approval for emergency use. According to a Medscape survey, about half of nurses (47%) and nearly 1 in 3 doctors (30%) say they do not want to receive the vaccine when it is first available or are unsure about the vaccination.
As vaccination of health workers will lay the groundwork for public acceptance of the vaccine, hospital epidemiologists are concerned. “We know there will be some hesitation in healthcare personnel, just as there will be in the wider public,” says Marci Drees, MD, infection prevention manager and hospital epidemiologist for the Christiana Care Health System in Newark, Delaware, and liaison from Society for Healthcare Epidemiology of America to the CDC Advisory Committee on Immunization Practices. “I don’t think we can expect anyone to get vaccinated if we’re not willing to vaccinate ourselves.”
Healthcare professionals are generally required to receive a variety of vaccines, including measles, mumps and rubella (MMR) and whooping cough shots. Every year, nearly half of US healthcare workers receive a flu shot as part of a workplace mandate. But COVID-19 will be different. The FDA requires anyone who receives products with an Emergency Use Authorization (EUA) to receive information on the risks and benefits and have the option to refuse. Hospitals on the other hand will rely on education as they offer a new vaccine (or more than one) that will be at least 50% effective.
ProMedica does not require employees to be vaccinated against the flu, but employees who refuse must obtain a note from a doctor stating that they have talked about the risks and benefits of the vaccine. A similar approach can be used with a COVID-19 vaccine, where employees may be required to learn about the vaccine before they refuse, Smith says. “I think some people will say they don’t want to get it,” he added.
Like colleagues across the country, Smith is identifying healthcare professionals who are involved in the direct care of COVID-19 patients and are at the highest risk of exposure. Even within the top tier, those performing the riskiest tasks, such as respiratory therapists who provide aerosol and droplet-releasing respiratory treatments, will be marked as a priority group, he says. Healthcare workers who spend most of their time around COVID patients, such as nurses in a COVID unit, are also likely to receive their first doses, he says.
Swirl, Don’t Shake, the Vaccine
Hospitals are experts in stepping up vaccination campaigns. For example, last year, Vanderbilt University Medical Center, in Nashville, Tennessee, vaccinated nearly 16,000 employees against the flu in their 1-day “Flulapalooza” event. The medical center even earned a Guinness World Record in 2011 at the first Flulapalooza for giving the most vaccinations ever within 8 hours.
The 10th anniversary of the event was canceled this year due to COVID restrictions. Instead, nurses, pharmacists and other doctors took steps to vaccinate their colleagues against the flu. Now, plans for COVID-19 vaccination are moving forward amidst uncertainty.
Dr. Lori Rolando
Instead of organizing a mass event, “the delivery mechanisms will need to be more focused and focused,” says Lori Rolando, MD, MPH, director of the Vanderbilt Occupational Health Clinic. In the CDC’s most recent “playbook” version of its vaccination schedule, the agency recommends giving the vaccines in an area that allows people to stay 6 feet away and wait 15 minutes after receiving the injection. to make sure they don’t pass out, a potential risk common to nearly all vaccines.
This is the easy part. Planning becomes more complex, given the uncertainty about which vaccines will receive approval and which one will receive a hospital.
If Pfizer / BioNTech vaccine receives EUA in 2020, 10 to 20 million doses could be available in November and 20 to 30 million doses in December. Ultra-cold containers used to ship vaccines should be filled with dry ice within 24 hours of receipt and every 5 days thereafter. Hospitals will need temperature probes to monitor storage in containers. The five-dose ampoules can be refrigerated prior to administration, but only for 5 days. The product must be diluted and then used within 6 hours.
The Moderna vaccine will initially be somewhat less abundant. About 10 million doses are expected in November and 15 million doses by the end of December. The 10-dose vials are stored in a freezer. Once placed in the refrigerator for defrosting, they must be used within 7 days and, once removed from the refrigerator, must be used within 12 hours. The pharmacist or another vaccinator must be spinning, but not shaking! – the vial before administering a dose, according to the CDC playbook.
As more information about vaccines emerges, the instructions may change and Smith is ready to change scenarios. “These are all draft plans. We will change as we go along,” he says.
The Pfizer vaccine requires a second dose at 21 days and the Moderna vaccine targets the second dose at 28 days. In addition to using information systems to monitor vaccinations and any adverse effects, hospitals will provide employees with a card indicating which vaccine they received, the date it was given, and the date they need to return. (At this point, the time frame for the second dose does not appear to be flexible.)
Regardless of the vaccine, one message remains the same: COVID precautions must continue. This means wearing the mask, social distancing and washing hands – practices that must also be followed by health professionals who test positive for naturally acquired antibodies.
“I don’t think anyone expects the COVID vaccine to be 100% effective in preventing COVID,” says Rolando. “So all the other tools in our toolbox will have to be used too.”
Michele Cohen Marill is an Atlanta-based freelance journalist. He has written for Wired, STAT, Health Affairs and other publications. She can be contacted at [email protected].
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