EXECUTIVE SUMMARY

The coronavirus vaccine rollout faces challenges from logistical supply issues and vaccine hesitancy among healthcare staff and the general public.

  • Barriers to effective rollout to all healthcare staff included the requirements to transport and store the Pfizer/BioNTech vaccine at temperatures between -76°F and -112°F.
  • Hospitals and other providers appeared hesitant to mandate vaccination, even if they already had flu shot mandates.
  • Reproductive health providers also need their employees to continue wearing masks and practicing social distancing.

The COVID-19 vaccine received mixed reviews in its early rollout. Public health officials and healthcare providers praised the research leading to the safe, effective vaccines, while antivaccine groups expressed skepticism and disdain.

From a reproductive health provider perspective, the big question is how to handle the rollout and overcome challenges on both the supply and demand sides.

The vaccine supply questions continued into 2021. In late December 2020, the United States government reached agreements with Pfizer/BioNTech and Moderna to obtain 400 million doses of their COVID-19 vaccines by July 31. This would provide vaccination to 200 million Americans, as both vaccines require two doses.1

But there were early obstacles to a smooth vaccine rollout, including the requirement to transport and store the Pfizer/BioNTech vaccine at temperatures between -76° F and -112° F. Some health systems have freezers capable of storing the vaccine, but ambulatory sites likely do not.

Also, Pfizer planned to ship coolers to keep the vaccine cold for about week, says Robert Salata, MD, professor of medicine, chair of the department of medicine, and a physician-in-chief of University Hospitals Cleveland Medical Center. Salata participated in Phase II and Phase III of the Pfizer vaccine trial.

“Once the vaccine is taken out of a container, it takes 30 minutes to thaw. After that, it’s like any other vaccine,” Salata explains. “These are multidose vials with five doses in each vial. After administering the vaccine, we kept people around for 30 to 60 minutes to make sure there were no immediate side effects.”

In the first two weeks of the Pfizer and Moderna vaccine rollouts, severe allergic reactions were reported among eight people out of more than 270,000 who first received the vaccine. Typically, anaphylactic reactions occur in one out 1 million doses of any vaccine.2

Another logistical challenge is tracking those who received the first dose of vaccine and when they need to receive the second dose (21 days for Pfizer, 28 days for Moderna), Salata notes.

The first doses went to hospitals and nursing homes, but ambulatory healthcare settings and pharmacies also are preparing for the vaccine. “Places like CVS are getting geared up to have the vaccine available, but I don’t know how fast that is coming,” Salata says.

“Pfizer cannot ship [hundreds of] millions of doses immediately,” says Tinglong Dai, PhD, associate professor of operations management and business analytics at Johns Hopkins University Carey Business School in Baltimore. Dai also is core faculty at Hopkins Business of Health Initiative.

“By February, we should see 100 million doses, and by March, we should have more vaccines available — maybe have 100 million people vaccinated,” Dai says.

Weather also is a supply obstacle. Heavy storms could impede vaccine transportation and pause vaccination efforts.

Even with the logistical issues, it is likely that demand obstacles will be as big of a problem as supply obstacles. “The issue is that by the time vaccines have arrived, there is no guarantee that all staff members will be taking them,” Dai says.

To Mandate or Not to Mandate

As frontline healthcare workers began receiving the vaccine in mid-December 2020, it appeared that many hospitals were not requiring staff to take the vaccine, even if they mandate flu shots for all employees. This raised the question about what ambulatory healthcare sites should do.

“The reason hospitals are not mandating the vaccine is because around 40% of individuals in the United States don’t want to be primarily vaccinated,” says David F. Archer, MD, professor of OB/GYN at the Jones Institute for Reproductive Medicine at Eastern Virginia Medical School in Norfolk. Archer also is an editorial advisory board member for Contraceptive Technology Update. “Some of that is related to the type of information we’ve seen in the media about how rapidly it has moved forward.”

Many people are unsure whether they can trust the vaccine, and forcing every employee to become vaccinated further erodes trust. It is better to allow staff to have a say in the decision, Archer says.

“Most individuals on the frontline, if they have faith in the FDA, and believe in clinical trials, they’ll be vaccinated,” he adds.

The issue family planning providers and other healthcare facilities are seeing is a fundamental dilemma in the face of a global pandemic of a very transmissible and dangerous virus, coupled with the arrival of new vaccines that work in ways unfamiliar to the general public.

But should directors require or merely request that staff be vaccinated? What should they do if some employees refuse or ask to wait a few months? “I will certainly recommend to my staff that they become vaccinated,” Archer says.

“The first reaction is to mandate it and not give anyone a choice. That gets us closer to 70% to 80% immunity for the entire population,” says Ken Resnicow, PhD, Irwin M. Rosenstock collegiate professor of health behavior and health education at the University of Michigan.

But if COVID-19 vaccination is mandated, it could backfire by making people who are vaccine hesitant feel they are being controlled. “We have about 30% who are hesitant, and about half of them are a hard ‘no,’ a refusal to be vaccinated at this point,” Resnicow says.

The good news is that surveys show a decline in vaccine hesitancy, from 37% in September 2020 to about 29% in December 2020, he adds.

“We still have to do something about that 30%, or we’ll have a hard time with the goal of vaccinating 80% of people,” Resnicow says. (See story in this issue on obtaining vaccination buy-in.)

From a health facility director’s perspective, it is desirable to vaccinate every staff member. For instance, family planning centers generally serve younger, healthier populations that are at less risk from serious illness due to COVID-19. If a clinic’s entire staff received all necessary doses of a vaccine, it could be easier for the clinic to reopen to an optimal level of in-person visits. Some staff could return to the building instead of continuing their work remotely.

Until the pandemic ends, meaning zero cases over many weeks or months, facilities need to continue requiring masks and extra attention to hand hygiene, surface disinfection, and some level of keeping patients and their guests masked and separated. They might continue to screen patients by phone, and take other measures to prevent outbreaks.

“We should continue to urge people to mask and maintain social distancing,” Archer says.

Preventing pandemic fatigue will be a big challenge in 2021. Family planning providers can emphasize the point that no one knows when the COVID-19 pandemic will end.

“We didn’t even know about this disease until late 2019. It’s a novel disease, and we have a novel vaccine,” Dai says.

Data on Immunity Needed

While the vaccine is effective at preventing COVID-19 symptoms, there is less information about whether the vaccine stops the SARS-CoV-2 virus from replicating and spreading.

“In the clinical trials, researchers looked at people who developed the symptoms and then got tested for COVID-19,” Dai explains. “What we don’t know is whether there are any clinical trial participants who developed COVID-19, but didn’t show symptoms and weren’t tested.”

Also, there are no data on how long vaccine immunity lasts. “From [data on the] people who were given the vaccine in Phase I, their protection seems to be lasting at least three months,” Salata explains. “We’ll be studying these people for 26 months and making sure we’re measuring several things, including capturing COVID cases, looking at antibody persistence, and assessing other responses in immunity.”

Until researchers obtain longer-term vaccine results, healthcare providers will need to ask staff and patients to continue following infection prevention practices.

“No one can claim the vaccine will last for one year or more than one year because we don’t have the data,” Dai says. “I believe it will be long-lasting enough to end the pandemic. If we could vaccinate 75% of the population by May or June, then our lives will be back to normal by the fall.”

But this is an unknown. Healthcare providers and leaders should not make this promise, as several obstacles could slow down the pandemic’s end, including the logistics of the federal government distributing the vaccine to everyone by summer.

Even people who have had COVID-19 will be asked to take the vaccine, says Eli Rosenberg, PhD, associate professor in the department of epidemiology and biostatistics at the University at Albany School of Public Health, SUNY – The State University of New York.

“There’s no data out yet on how prior infection and vaccine will interact,” Rosenberg says. “Most current thinking is that all people with prior infection should be vaccinated, even those who had severe illness.”

REFERENCES

  1. Pfizer. Pfizer and BioNTech to supply the U.S. with 100 million additional doses of COVID-19 vaccine. Dec. 23, 2020. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-supply-us-100-million-additional-doses
  2. de Vrieze J. Suspicions grow that nanoparticles in Pfizer’s COVID-19 vaccine trigger rare allergic reactions. Science. Dec. 21, 2020. https://www.sciencemag.org/news/2020/12/suspicions-grow-nanoparticles-pfizer-s-covid-19-vaccine-trigger-rare-allergic-reactions