EXECUTIVE SUMMARY

Healthcare organizations are preparing for the first wave of COVID-19 vaccines.

  • The Pfizer/BioNTech vaccine, which demonstrated 95% efficacy in a clinical trial, has received an FDA emergency use authorization. At least two other vaccine candidates are on the verge of receiving similar authorization.
  • The CDC recommends the first round go to healthcare workers and nursing home residents. It is unclear when ambulatory healthcare workers will be vaccinated.
  • Surgery center leaders should start educating staff about the vaccine candidates and create vaccine policies for employees and patients. Because vaccine demand is high, leaders also should prepare in case their facilities become designated vaccine administration sites.

Most healthcare employers will want to vaccinate their staff against COVID-19, but the task in surgery centers will not be easy.

On the positive side, one part of the access issue is solved: clinical trials produced positive interim results for several of the dozens of vaccine candidates. “It’s an exciting time to be talking about vaccines in general, and to have two vaccines ready for FDA approval is historic,” said Kathleen M. Neuzil, MD, MPH, FIDSA, fellow with the Infectious Diseases Society of America (IDSA). She spoke at IDSA’s virtual COVID-19 vaccine briefing on Dec. 3.

“It couldn’t come any later. We need it now, with the pandemic raging outside our doors,” Neuzil said. “I’ve been involved in Operation Warp Speed from the beginning, and there has been no compromise on safety.”

The Pfizer/BioNTech COVID-19 vaccine was the first to the finish line. When members of the data safety monitoring board (DSMB) met in November, they concluded this vaccine was safe and efficacious, says Robert Salata, MD, principal investigator for the Pfizer/BioNTech vaccine trial and chair of the department of medicine at University Hospitals Cleveland Medical Center.

An analysis revealed the Pfizer/BioNTech vaccine, which uses messenger RNA (mRNA) and targets the virus’ spike protein through the use of new technology, was 95% efficacious.1 The clinical trial authors did not offer comprehensive data on the actual infection rates of SARS-CoV-2 or whether asymptomatic volunteers transmitted the virus to others. But the study demonstrated volunteers in the placebo arm were much more likely to develop COVID-19 than those in the vaccine arm. “This degree of effectiveness is akin to other major effective vaccines like measles, mumps, rubella, and even tetanus,” Salata says. “This is extraordinary, and it’s what we were hoping for.”

The Moderna vaccine, which also uses mRNA, was found in its first interim analysis to be 94.1% efficacious. All 30 severe cases of COVID-19 that were analyzed occurred in the placebo group.2

Both Moderna and Pfizer filed for emergency use authorization (EUA) with the FDA. Pfizer received its EUA on Dec. 11, and Moderna received its EUA on Dec. 18. A third drug, produced by AstraZeneca, showed 70% efficacy.3

Because there are multiple options, healthcare organizations will need to be careful in how they describe vaccines to employees. For instance, it is possible the first healthcare workers to be vaccinated will receive the Pfizer/BioNTech option. But depending on how later rollouts of the vaccine are prioritized, it is possible surgery center staff and others will receive a different vaccine.

The CDC Advisory Committee on Immunization Practices issued an interim recommendation on allocation of initial supplies of the COVID-19 vaccine on Dec. 3. The report authors said healthcare personnel and residents of long-term care facilities should be offered vaccinations first.4 The term “healthcare workers” is broad and ambiguous, and the CDC guidelines are not the law. It will be up to each governor to decide who receives the first available doses, according to Tinglong Dai, PhD, associate professor of operations management and business analytics at Johns Hopkins University.

“The CDC will tell governors, ‘Here are the people you should prioritize,’” he says. “My sense is that, clearly, healthcare workers who are exposed to COVID-19 patients and have a high risk of infection should be the ones who get the first doses of vaccine.”

Other high-priority candidates may include essential workers in the food and transportation industries; teachers, college professors, and staff; and those at higher risk of serious illness because of their age and/or underlying health conditions.

Surgery centers likely will have little say about vaccine distribution in the early period of the rollout. No one knows when ambulatory healthcare settings can vaccinate staff, but surgery center leaders should prepare now. Be aware of the possibility of dealing with multiple options at one time. Make sure vaccines are separated and learn how each type is used. “Some vaccines require two doses, and those two doses of vaccine have to come from the same manufacturer. There are many opportunities for mistakes,” Dai explains.

Another obstacle could be vaccine hesitancy among surgery center staff. A recent national poll revealed only half of Americans are willing to be vaccinated against COVID-19.5 Some of those skeptics could be healthcare workers.

Surgery center administrators should consider designating a committee that provides vaccine education to staff and spearheads distribution. The committee also should consider logistics (e.g., vaccine storage and offsite access).

“If storage is an issue, where does it make sense to store it?” asks Samantha Penta, PhD, assistant professor in the College of Emergency Preparedness, Homeland Security, and Cybersecurity at the University at Albany (NY). “Do you have people go to their doctor to get it, or do you have the vaccine in a place where people can collectively go to be vaccinated? Think about the logistics that go in to drive-in testing centers, and think about how there are similar logistics for the vaccine rollout.”

Surgery centers will need to create a COVID-19 vaccination policy for both staff and patients. A surgery center employee who works directly with patients might need the vaccine. Unvaccinated staffers may be required to wear personal protective equipment even after the pandemic has calmed. Unvaccinated patients might end up on an exclusion list. Staff can create a procedure for finding alternative care arrangements.

Vaccine demand will be high. Thus, there might be a push to recruit primary care offices and surgery centers as vaccine administration sites. “In the initial wave, there are companies like CVS and Walgreens that may be able to administer the vaccine, but the problem is finding enough qualified individuals to administer it,” says Frank Chapman, MBA, chair of the standards development committee for the Accreditation Association for Ambulatory Health Care.

If a surgery center receives vaccine supplies, there will need to be space to receive the delivery and a safe storage area. The Pfizer/BioNTech vaccine requires extremely cold storage. Various sectors of the healthcare industry are ordering these ultra-cold storage freezers, and manufacturers are scrambling to keep up with demand. The entire situation is fluid. Whoever leads a surgery center’s vaccine program should stay on top of new developments and communicate these to staff.

“Have clear information about what you do know and tell people where they can get reliable information,” Penta says.

REFERENCES

  1. Pfizer. Pfizer and BioNTech conclude phase 3 study of COVID-19 vaccine candidate, meeting all primary efficacy endpoints. Nov. 18, 2020.
  2. Moderna. Moderna announces primary efficacy analysis in phase 3 COVE study for its COVID-19 vaccine candidate and filing today with U.S. FDA for emergency use authorization. Nov. 30, 2020.
  3. Knoll MD, Wonodi C. Oxford-AstraZeneca COVID-19 vaccine efficacy. Lancet 2020; Dec 8;S0140-6736(20)32623-4. doi: 10.1016/S0140-6736(20)32623-4. [Online ahead of print.]
  4. Dooling K, McClung N, Chamberland M, et al. The Advisory Committee on Immunization Practices’ interim recommendation for allocating initial supplies of COVID-19 vaccine — United States, 2020. MMWR Morb Mortal Wkly Rep 2020;69:1857-1859.
  5. Neergaard L, Fingerhut H. AP-NORC poll: Only half in US want shots as vaccine nears. The Associated Press. Dec. 9, 2020.