Clinical Context
As most of the world hopes for an end to the coronavirus disease 2019 (COVID-19) pandemic, trust in a vaccine provides a glimmer of hope. Limited quantities of 2 anti-COVID-19 vaccines are available in the United States, mandating prioritizing populations for vaccination. Healthcare workers (HCW) are key on the list, as they are on COVID-19 care front lines and are at high risk for exposure and transmission.
The Centers for Disease Control and Prevention (CDC) issued guidance for HCW vaccination with these vaccines,[1] which have been found safe and effective in clinical trials and were completed with unprecedented speed.
Synopsis and Perspective
The COVID-19 vaccination debut celebrated teamwork. Hospitals awaiting their allotment collaborated to share limited supply. Priority lists for first vaccinations included environmental services workers and critical care physicians.
"HCW have pulled together throughout this pandemic," said Melanie Swift, MD, COVID-19 Vaccine Allocation and Distribution Work Group cochair, Mayo Clinic, Rochester, Minnesota. "We've gone through the darkest of years relying so heavily on each other. Now we're pulling together to get out of it."
A rollout of this magnitude has hitches. Stanford Medicine apologized December 19 after its medical residents protested a distribution plan omitting most residents and fellows, many of whom treat patients with COVID-19.[2]
HCW have already experienced > 354,524 COVID-19 cases and 1216 deaths,[3] thus causing the CDC to state: "[C]ontinued protection of them at work, at home, and in the community remains a national priority," requiring vaccinating approximately 21 million.[1]
Don't Waste a Dose
Storage requirements for the Pfizer-BioNTech vaccine highlight the importance of not wasting any doses. Once vials are removed from ultracold storage and refrigerated, they must be used in ≤ 5 days.[4[ Thawed 5-dose vials must be brought to room temperature before dilution and can remain there for ≤ 2 hours. Once diluted, they must be used within 6 hours.
Social distancing of employees awaiting COVID-19 vaccination prevents emulating large-scale influenza immunization.
"We have applied some principles to make sure that as we roll it out, we prioritize people who are at greatest risk of ongoing exposure and who are really critical to maintaining the [COVID-19] response and other essential health services," said Swift.
If doses remain once highest-priority HCW are vaccinated, supervisors in high-risk areas can refer other HCW. As each 5-dose vial actually provides 6 doses, 474 vials allow vaccination of 2844 top-priority HCW.
"It's going to expand each week... as we get more and more vaccine," Swift said.
Sharing Vials With Small, Rural Hospitals
Minnesota uses a hub-and-spoke system to give small rural hospitals access to Pfizer-BioNTech's vaccine, even though they lack ultracold storage and cannot use a minimum order of 975 doses. Large hospitals, acting as hubs, share orders.
"We are all working together. It doesn't matter what system you're from," said Eric Weller, Minnesota regional healthcare preparedness coordinator, South Central Healthcare Coalition. "We're... using [some] lessons we learned during H1N1, but during H1N1, you could have lines of people."
Coordinating appointments is more important than ever.
"One [strategy] is to get people in groups of five [using one vial] and don't waste it," Weller said.
For the Moderna vaccine, the minimum order is 100 doses, and the 10-dose vials can be refrigerated for ≤ 30 days.[5]
Both vaccines may produce mild flu-like symptoms, including fatigue, headache, or muscle pain, particularly after the second dose. Vaccination plans should consider this, because HCW might miss workdays.
"We're not going to vaccinate a whole department at one time. It will be staggered," said Kevin Smith, MD, medical director, occupational medicine program, ProMedica, Toledo, Ohio.
Smith advocates use of v-safeSM [6], a CDC app tracking adverse vaccine effects. He noted that transient achiness is better than COVID-19 symptoms, as some recovered employees still have fatigue or lost sense of taste and smell.
Hope for Ending the Pandemic
Public health officials have worried about vaccine hesitancy, even among HCW, yet Smith’s employees want to know when they can be vaccinated.
"I think everyone feels relief," he said. "We're at the beginning of the end.
"No doubt there are still people who are hesitant, but I'm feeling a shift," Swift said, citing building momentum of HCW wanting vaccination, setting an example for patients.
For Colleen Kelley, MD, infectious disease physician and principal investigator for a Moderna clinical trial site at Emory University, Atlanta, Georgia, the past month has been emotional: "very bleak and dark for a time, and then... efficacy results... greater than anyone imagined."
"Everyone asks me, 'Should I get it? Are you going to get it?' My answer is 'yes' and 'yes.'" she said. "I am 1000% confident that the benefits of widespread vaccination outweigh the risks of continued [COVID-19] and a continued pandemic."
Highlights
HCW are on the front lines of COVID-19 care, have high exposure, and can transmit to others at higher risk.[7]
When HCW get COVID-19, they are unable to work and provide key patient services, and they may transmit the virus to other HCW and to their patients, many of whom are at risk for severe COVID-19 because of comorbidities.
Early vaccine access is critical for the health and safety of the essential HCW workforce, protecting them, their patients, families, communities, and country.
First priority for COVID-19 vaccine is therefore paid and unpaid HCW in settings including acute/ long-term acute care, inpatient rehabilitation, nursing homes, assisted living, home health, mobile clinics, and outpatient facilities.
HCW include emergency medical services personnel, nurses/nursing assistants, physicians, technicians, therapists, dentists, dental hygienists/assistants, phlebotomists, pharmacists, and students/trainees and contractual, dietary, food services, environmental services, and administrative staff.
HCW risk for COVID-19, severe outcomes, and death depends on race, ethnicity, comorbidities, occupation type, and job setting.
HCW should get the vaccine when available; participate in v-safe; help the CDC monitor for any AEs after vaccination; share their experience with and answer questions from coworkers, friends, and family; and wear a sticker or button to show they were vaccinated.
The FDA issued Emergency Use Authorizations for 2 COVID-19 vaccines: Pfizer-BioNTech BNT162b2: 2 intramuscular doses ≥ 21 days apart, and Moderna messenger RNA (mRNA)-1273: 2 intramuscular doses ≥ 28 days apart.
Testing of both in tens of thousands of adults from diverse backgrounds, ages, and races showed safety and efficacy at preventing COVID-19 but unclear duration of protection.
Both are mRNA vaccines enabling host cells to synthesize a harmless spike protein fragment for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and display it on their surface, stimulating immune response by protective antibodies.
As mRNA vaccines do not contain live SARS-CoV-2, they cannot cause infection or affect or interact with host DNA.
Persons with a history of anaphylaxis or severe allergic reaction to any ingredient in COVID-19 vaccine should not get vaccinated, and persons with severe allergic reaction to other vaccines or injectable therapies should seek medical guidance.
AEs, especially after the second dose, may include injection site reaction, fever, headache, or myalgia.
Clinical trial data (≥ 8 weeks) identified no significant safety concerns; AEs seldom appear > 8 weeks after vaccination.
Fast-tracking COVID-19 vaccines included starting manufacturing during ongoing clinical trials and prioritized FDA/CDC review and authorization.
Still, COVID-19 vaccines adhere to the same safety standards as all vaccines, according to careful FDA review of all clinical trial safety data and close FDA/CDC monitoring of vaccine safety and AEs after vaccine authorization, using new and existing systems (eg, Vaccine Adverse Event Reporting System).
The COVID-19 vaccines help create an antibody immune response without risk for severe illness, reduce risk for infection and transmission, and protect from severe COVID-19.
COVID-19 vaccination is a safer way to build immunity than becoming infected, which has an unknown duration of protection.
Risks for severe COVID-19 illness and mortality far outweigh any benefits of natural immunity.
Although COVID-19 mRNA vaccines are highly effective, they do not replace additional measures to limit transmission: proper mask wearing, avoiding close contact, social distancing, cleaning, disinfecting, and handwashing.
As immune response after vaccination takes several weeks to develop, a person could be infected with SARS-CoV-2 just before or just after vaccination and get sick.
COVID-19 mRNA vaccination does not cause positivity on viral tests but might do so on some antibody tests, suggesting triggering of an immune response and some protection against the virus.
People who contracted SARS-CoV-2 may still benefit from vaccination, as reinfection may occur, and duration of immunity after recovery is unclear.
Clinical Implications
HCW are at highest priority for COVID-19 vaccination, as they are on the front lines of COVID-19 care, have high exposure, and can transmit to others at higher risk.
COVID-19 vaccination is a safer way to build immunity than becoming infected, which has an unknown duration of protection.
Implications for the Health Care Team: People who contracted SARS-CoV-2 may still benefit from vaccination, as reinfection may occur, and duration of immunity after recovery is unclear.
https://www.medscape.org/viewarticle/944696?src=WNL_cmemp_210219_mscpedu_card&impID=3201662&faf=1
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