Hospitals ready to launch the first COVID-19 vaccines for clinicians

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At first, when word spread of a 28-year-old doctor on the frontlines of COVID-19 in Brazil who died after receiving an experimental vaccine spread, doubts arose over the safety of one of the vaccine candidates. most promising against the coronavirus. But then the story changed. Although the vaccine manufacturer has not confirmed it, the doctor appeared to have been in the control group and received a dose of an established meningitis vaccine. The danger came from exposure to the coronavirus itself.

This tragedy underscores the continued risk of COVID-19 to healthcare workers, who were appointed 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 hospitalized with COVID from March to May were healthcare workers. The report was based on surveillance data from 13 states. The average age of the patients was 49 years. The agency has set a vaccination “readiness date” of November 15 for jurisdictions, such as state health departments, although a vaccine is unlikely to be licensed until then.

As hospitals struggle to prepare, their watchword is flexibility. They do not yet know how many initial doses they will receive, of which vaccine, or by when. They have a sophisticated infrastructure to deliver influenza vaccines each fall, but this framework does not fit the likely scenarios of limited supply, additional reporting requirements, two-dose schedules, and different storage needs.

“Healthcare organizations have consistently taken up the challenge. I believe wholeheartedly in their potential to make it happen, ”says Anna Legreid Dopp, PharmD, senior director of quality improvement and guidelines for the American Society of Health-System Pharmacists. Medscape Medical News.

Healthcare workers will not be faced with a vaccination mandate

Even after months of caring for COVID patients, most clinicians remain vulnerable to infection – at work and in their communities. That’s what occupational physician Kevin Smith, MD, achieved when his Toledo, Ohio-based healthcare system, ProMedica, offered antibody testing to all of its 50,000 employees. About 2% of the 6,933 tests administered came back positive, he says.

Yet many doctors, nurses, and other healthcare workers share public skepticism about the safety and effectiveness of a vaccine that is quickly receiving US Food and Drug Administration (FDA) approval. United for emergency use. According to a Medscape survey, about half of nurses (47%) and almost one in 3 doctors (30%) say they do not want to be vaccinated as soon as it becomes available or are not sure of the vaccination.

Since the vaccination of healthcare workers will pave the way for public acceptance of the vaccine, hospital epidemiologists are concerned. “We know there will be some hesitation among the healthcare workforce, just as there will be in the general public,” says Marci Drees, MD, infection prevention manager and hospital epidemiologist for Christiana Care Health System in Newark, Delaware, and the Society for Healthcare Epidemiology of America Liaison on the CDC Advisory Committee on Immunization Practices. “I don’t think we can expect anyone to be vaccinated if we are not willing to vaccinate ourselves.”

Healthcare workers typically need to receive a range of vaccines, including measles, mumps and rubella (MMR) and pertussis vaccines. Each year, nearly half of U.S. healthcare workers receive a flu shot as part of a work assignment. But COVID-19 will be different. The FDA requires that anyone receiving products under an Emergency Use Authorization (EUA) be provided with information about the risks and benefits and be given the opportunity to decline. Rather, hospitals will rely on education because they offer a new vaccine (or more than one) that will have a minimum effectiveness of 50%.

ProMedica does not require employees to be vaccinated against the flu, but employees who refuse must get a doctor’s note stating that they have discussed the risks and benefits of the vaccine. A similar approach can be used with a COVID-19 vaccine, in which employees may be required to educate themselves about the vaccine before refusing, Smith says. “I think some people will say they don’t want to get it,” he added.

Like his colleagues across the country, Smith identifies healthcare workers who are involved in the direct care of patients with COVID-19 and are most at risk of exposure. Even at the highest level, those who perform the riskiest tasks, such as respiratory therapists who provide respiratory treatments that spill aerosols and droplets, will be labeled as a priority group, he says. Healthcare workers who spend the most time near COVID patients, such as nurses in a COVID unit, are also likely to receive the first doses, he says.

Whirlwind, don’t shake, the vaccine

Hospitals are able to intensify vaccination campaigns. For example, last year, Vanderbilt University Medical Center in Nashville, Tennessee vaccinated nearly 16,000 employees against influenza during their one-day “Flulapalooza” event. The medical center even won a Guinness World Record in 2011 during the first Flulapalooza for giving the most vaccines ever in 8 hours.

The 10th anniversary of the event has been canceled this year due to COVID restrictions. Instead, nurses, pharmacists and other clinicians have stepped up to get their colleagues vaccinated against the flu. Now, COVID-19 vaccination plans are moving forward with uncertainty.

Instead of holding a mass event, “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 version of its immunization program playbook, the agency recommends administering vaccines in an area that allows people to stay 6 feet from each other and wait. 15 minutes after receiving the vaccine to make sure they don’t. low, a potential risk common to almost all vaccines.

This is the easy part. Planning becomes more complex, given the uncertainty of which vaccines will be approved and which a hospital will receive.

If the Pfizer / BioNTech vaccine receives EUA in 2020, around 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 vials can be refrigerated prior to administration, but only for 5 days. The product should be diluted, then it should be used within 6 hours.

The Moderna vaccine will be a little less abundant at first. 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 they are placed in a refrigerator to thaw, they should be used within 7 days, and once they are taken out of the refrigerator, they should be used within 12 hours. The pharmacist or other vaccinator should swirl – but not shake! – the vial before the administration of a dose, according to the CDC booklet.

As more information emerges about vaccines, instructions may change and Smith is ready to change the scenario. “These are all draft plans. We will change them as we go, ”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 track vaccinations and any adverse reactions, hospitals will issue employees with a card indicating the vaccine they received, the date it was given and the date it was due. come back. (At this point, the timing of the second dose does not seem flexible.)

Regardless of the vaccine, one message remains the same: COVID precautions must continue. This means wearing a mask, social distancing, and hand washing – practices that should also be followed by healthcare workers who test positive for naturally acquired antibodies.

“I don’t think anyone expects the COVID vaccine to be 100% effective in preventing COVID,” Rolando says. “So all the other tools in our toolkit should be used as well.”

Michele Cohen Marill is a freelance journalist based in Atlanta. She has written for Wired, STAT, Health Affairs and other publications. She can be reached at [email protected].

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