COVID-19 Resource Center

COVID-19 Resource Center

Source: FDA. FDA takes key action in fight against COVID-19 by issuing emergency use authorization for first COVID-19 vaccine. Accessed December 14, 2020.
Disclosures: Schaffner reports being a principal investigator on a CDC grant related to communicable diseases and being a consultant to VBI vaccines, who do not have a licensed vaccine on the market yet and is not related to COVID-19.
December 14, 2020
7 min read

Experts discuss logistics of COVID-19 vaccine distribution

Source: FDA. FDA takes key action in fight against COVID-19 by issuing emergency use authorization for first COVID-19 vaccine. Accessed December 14, 2020.
Disclosures: Schaffner reports being a principal investigator on a CDC grant related to communicable diseases and being a consultant to VBI vaccines, who do not have a licensed vaccine on the market yet and is not related to COVID-19.
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Now that the COVID-19 vaccine codeveloped by Pfizer and BioNTech has received emergency use authorization from the FDA, experts said physicians need to begin preparing their patients — and themselves — for vaccination.

In a recent survey conducted by the Associated Press-NORC Center for Public Affairs Research, just 47% of 1,117 adults said they plan to get vaccinated, while 26% said they did not plan to get a vaccine and 27% were still unsure.

Quote from Schaffner on COVID-19 vaccine

Of those who do plan on getting vaccinated, according to the poll, 57% said they will wait until other people receive the vaccine first to make sure that it is safe. Meanwhile, of those who said they would not get vaccinated, 75% said they would not change their mind.

“We really want our population, our citizens and our health care workers, to have confidence in both taking the vaccine as well as recommending the vaccine,” C. Buddy Creech, MD, MPH, FPIDS, associate professor of pediatrics and director of the Vanderbilt Vaccine Research Program at the Vanderbilt University School of Medicine, said during an Infectious Diseases Society of America press briefing.

Clarence B. Creech
C. Buddy Creech

How mRNA vaccines work

During the briefing, Kathleen M. Neuzil, MD, MPH, FIDSA, professor of vaccinology and director of the Center for Vaccine Development and Global Health at the University of Maryland School of Medicine, discussed the mechanisms of genetic vaccines, including the messenger RNA (mRNA)-based vaccines codeveloped by Pfizer and BioNTech and Moderna and the NIH, as well as the viral vector-based vaccine codeveloped by AstraZeneca and Oxford University. She said these vaccines use genetic codes for the s-protein, which plays an important role in how the virus infects cells and leads to disease.

Kathy Neuzil
Kathleen M. Neuzil

“These genetic vaccines use some sort of vehicle to deliver that code,” Neuzil, who is also an Infectious Disease News Editorial Board member, said. “For the mRNA vaccines, they use [a] lipid. So, we have a gene code wrapped in the lipid that tells our cells to make an s-protein, and we make an immune response to that.”

Neuzil said that because the Pfizer vaccine is based on mRNA, it needs to be kept in a freezer.

“RNA is actually quite unstable, which is why the Pfizer vaccine has to be put into the freezer right now, and they have not achieved the stability yet for more than 5 days,” she said. “So, these are unstable particles.”

William Schaffner, MD, professor of preventive medicine and infectious diseases at Vanderbilt University Medical Center and Infectious Disease News Editorial Board member, told Healio Primary Care that because the vaccine needs to be stored at such low temperatures — about –94 degrees Fahrenheit — it will likely be distributed to select locations such as large institutions that have the freezer capacity and can train people to handle the vaccine.

As the distribution locations will likely vary across the country, Schaffner recommended that primary care physicians check with their states’ health departments for information on where to go for the vaccine for their patients and themselves, if they are eligible.

Distributing the vaccine

Schaffner noted that due to the handling requirements for the Pfizer vaccine, PCPs will likely not receive it for distribution.

“However, the Moderna vaccine, which we trust will be coming along very soon, does not have these stringent handling requirements ... and it can be managed more like a conventional vaccine,” he said, adding that state health departments have begun reaching out to health care providers, including pharmacies, physician offices and other types of clinics, to ask them to serve as COVID-19 vaccine distribution locations.

Recently, the CDC’s Advisory Committee on Immunization Practices announced that health care workers and residents of long-term care facilities would be the first to receive the vaccine.

“It’s not clear yet, but it should be clear pretty soon which group will be eligible for vaccines once the health care providers and the nursing home residents have been vaccinated,” Schaffner said. “It might be a large group of so-called ‘essential workers,’ or it might be people aged 65 and older and those with chronic illnesses.”

Schaffner noted that both the Pfizer vaccine and the Moderna vaccine are two-dose vaccines.

“The first dose, in effect, primes the pump,” he said. “The second is the one that gives you secure 95% protection and will give you some assurance of longer-term protection; we don’t know how long yet, but as with other vaccines, it’s that second dose in the series that assures the protection.”

While both Pfizer and Moderna have released data on the efficacy of their vaccines, some are concerned that the vaccines may not be as effective in certain groups — namely, older adults.

In a recent review, researchers stated that Moderna’s phase 1 results included older adults, but the findings were in 40 healthy adults aged 58 years or older, meaning that the implications for older and more frail adults are unclear. However, they noted that more than a quarter of participants in the phase 3 trial are aged 65 years or older and a similar number have chronic diseases, so their evidence will likely improve when the full results are published. The authors of the review also noted that Pfizer’s vaccine demonstrated 95% efficacy in adults aged 65 years and older, and that 40% of their phase 3 participants fall in the 56 to 84-year age range.

Once the vaccines become available, patients may ask about the cost.

“There’ll be no charge for the vaccines, because as taxpayers, we have already paid for the vaccine,” Schaffner said.

“The thought is that there will be the usual billing practices to conventional, traditional insurers for the administration fees,” he continued. “And so, docs need to be aware of that and get further instructions from their health departments.”

As the vaccine was purchased by the government, PCPs should expect added administrative requirements to keep track of each administered dose, Schaffner said.

“This will be a long-term procedure,” Schaffner said. “We can’t vaccinate everybody in a week and a half.”

If physicians do not sign up to distribute the vaccine at their practice once available, they will likely have the opportunity to do so later, he said.

Because there are two doses of the vaccine, record keeping will be essential to remind patients to come in for the second dose. It will also be essential to ensure that the second dose will be with the same vaccine as the first dose, as “there’s no information on mixing and matching,” Schaffner said.

As more vaccines will likely receive emergency use authorizations from the FDA, he added that “things are likely to get just a little more complicated down the road.”

Adverse events associated with mRNA vaccines

During the IDSA briefing, Creech, an Infectious Diseases in Children Editorial Board member, said the adverse events associated with the COVID-19 mRNA vaccines “are common to other vaccines that we use — things like fever and headache and a feeling of being run down, a feeling of arm soreness or achiness around the site, sometimes redness at the site.”

“Those are things that we expect,” he said. “And we’ve been very reassured that we haven’t seen a number of cases of things that we would not expect, so that gives us confidence.”

Schaffner stressed that as mRNA vaccines have been associated with these adverse events, “it’s very important to let patients know in advance that may happen, so that they’re not frightened or disturbed or really angry about it.”

“If they’re concerned, remind them that this is their immune system starting to work with the vaccine, it’s not COVID-19. They don’t have to worry about that; you can’t get COVID-19 from the vaccine,” he added.

Schaffner also said that physicians need to remind patients to come back for the second dose of the vaccine despite any concerns they may have about adverse events, which “can be a bit worse” after the second dose compared with the first.

“And then, keep reminding patients that a short period of discomfort is a whole lot better than a visit to the ICU,” he said. “It’s easier to get the vaccine than having to get a ventilator.”

Differentiating these symptoms with other conditions could pose a challenge to health care workers, particularly among older nursing home residents and adults with underlying chronic illness.

For instance, health care workers may need to determine whether a patient who is presenting with a fever is experiencing effects from the vaccine or another health issue.

“This, frankly, is going to cause some conundrums,” Schaffner said, adding that the CDC will be providing clinical guidance, but “there won’t be a clear differentiation between the two.”

Therefore, clinicians will need to use their own clinical judgement when assessing vaccine recipients — particularly older adults in long-term care facilities.

If a nursing home resident presents with a fever, “we don’t just stand by and watch that usually,” Schaffner said. Physicians may run some tests to determine whether a fever could be attributed to something else, such as a UTI.

Physicians may also need to consider a history of allergic reactions in those receiving the vaccine. After two health care workers in the United Kingdom experienced symptoms of allergic reaction following receipt of the Pfizer vaccine, the nation’s health authorities advised against giving it to patients with a history of allergic reactions.

To prepare for any adverse events from the second dose of the vaccine, Schaffner recommended that clinicians tell recipients to keep their schedule light the day after the vaccination, as they may not be “up to par.”

Health care providers receiving the vaccine should also heed this advice, he said.

“Doctors don’t tend to think about that; they think they’re strong and they’ll be able to deal with that and still see the same number of patients the next day,” Schaffner said. “I think it would be advisable to schedule a light day after you get the vaccine.”