If all goes as planned, the county hospital will receive its first COVID-19 vaccines next week.
State health officials are confident the Pfizer BioNTech vaccine will be approved, distributed to hospitals and ready to administer by then, they said Wednesday during the state’s weekly news conference.
A Food and Drug Administration subcommittee is expected to make a decision on the Pfizer vaccine today. The FDA released a 52-page report about the vaccine that shows study results are more positive than previously reported by the vaccine maker. The vaccine, the report says, causes only mild side effects and a 95% efficacy rate, meaning only 5% of those who got a dose of the vaccine during the trial later got the virus.
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The Pfizer vaccine has already been approved for use in the United Kingdom and Canada. The first Pfizer shots given outside of the vaccine trial were administered to British healthcare workers and elderly residents on Tuesday.
Health care workers and residents of long-term care facilities will be the first in the state to receive the long-awaited shot. Both the state and Centers for Disease Control and Prevention agreed these populations should be first in line, respectively, given their high risk for exposure and high risk for poor outcomes if infected.
Designated health systems around the state will be responsible for vaccinating those groups of people in the initial phase of distribution. Locally, Johnson Memorial Health, in collaboration with the Johnson County Health Department, will distribute the vaccines.
Johnson Memorial expects to receive 975 doses of the Pfizer vaccine Dec. 18, said Michelle Amos, infection preventionist at the hospital. The first round will cover all 800 Johnson Memorial Health employees, plus a number of other health care workers in Johnson County and some long-term care facility residents, she said.
The next week, the hospital expects to receive up to 2,925 doses to vaccinate any remaining health care workers and long-term care facility residents, and start to vaccinate first responders and others who are at high risk of exposure, Amos said. The second shipment is expected to contain doses of both the Pfizer vaccine and another vaccine — from Moderna — that is also up for FDA approval in the coming weeks.
The state as a whole will receive 55,000 vaccines that will be distributed to five regional hospitals initially, said Lindsay Weaver, the state’s chief medical officer. Johnson Memorial is one of 50 county health systems that will help distribute the vaccine.
With mere days to go before a likely vaccine arrives, local health care leaders are still waiting for some sort of direction on distribution. Hospitals are asked to get the vaccine to those who need it most as determined by the state, she said.
Right now the challenge for the hospitals is working to wrangle enough staff to give vaccines while they are also challenged with a nursing staff shortage, Amos said.
To try and simplify the process, the hospital is collaborating with the county health department to register people for vaccines using the same platform it uses to schedule COVID-19 tests, said Betsy Swearingen, health department director. That system, Zotec, will also be used to send reminders to get the second dose of the vaccine, she said.
Over time, the vaccines will gradually be sent to other vaccination centers such as doctor’s offices and pharmacies as the supply becomes more plentiful and available to the general population. When that will happen remains unclear, and will depend heavily on how many people in those first groups actually want the vaccine as well as the local supply, Amos said.
The state expects to get new shipments of vaccines weekly and send out more and more doses until all Hoosiers who want a vaccine receive one, Weaver said.
Dr. Kristina Box, state health commissioner, estimated the state is still at least six months out from returning to normal, but said that will depend on how many Hoosiers choose to get the vaccine and how many doses are available.
The lack of concrete information makes it hard to plan. But local officials are hopeful their years of experience giving other vaccines will make the process run smoothly, Swearingen said.
For example, during the 2009 swine flu pandemic, the county health department organized hundreds of vaccine clinics. The department dusted off its playbook for that vaccine roll-out, and plans to tweak it to accommodate the severity and uniqueness of the coronavirus pandemic, Swearingen said.
Both the health department and hospital have the infrastructure to handle the vaccines, such as ultra-cold freezers to safely store the Pfizer vaccine, which must be kept a cool -76 degrees Fahrenheit.
The state is not making the vaccine mandatory for any Hoosier, but state leaders have said other entities such as health systems or businesses may do so if they choose.
Johnson Memorial will not require its employees to be vaccinated, but Dr. David Dunkle, the health system’s president and CEO, is strongly recommending all employees get one.
Both Dunkle and Amos said they feel comfortable getting the vaccine and believe it is safe enough, despite the hurried development and approval process.
“I don’t think the FDA would approve it if they didn’t think it was safe for the public,” Amos said. “It is like with any vaccination or medication. There is always a risk of complications, but the benefits of getting it outweigh the risks.”
Once the vaccine is approved, they know their biggest battle will be convincing the public it is safe to take, Dunkle said. Though the fast pace may cause some fear among the public, vaccinating as many people as possible is the fastest way to return to normal.
“I’m very encouraged because of the success rate it has shown in trials … Seeing it is over 90% (effective) is encouraging,” Dunkle said. “It is the first ray of light since the coronavirus started. This is truly a hope that we will be able to put this pandemic behind us at some point.”
Amos has heard a number of people say, ‘you get it first’ or ‘not me,’ but she encourages the public to think not just about their own health, but of the greater community’s wellbeing when considering whether to get the vaccine.
“Don’t be scared to get it,” Amos said. “We need to think about the next generation coming up. We have to look at the bigger picture. Don’t just think of yourself … We have to get this under control just like we have with all of the other communicable diseases over the years.”
Weaver on Wednesday tried to reassure Hoosiers, encouraging them to look up the FDA report for themselves to determine how safe the vaccine is.
She said there is no risk of getting the virus from the vaccine, because the Pfizer vaccine was made with mRNA instead of a live virus, which all previous vaccines have used. The mRNA protein in the vaccine is designed to teach the body’s cells how to respond to the spike (S) protein, showing the body how to react if it is exposed to the live virus.
Gov. Eric Holcomb called the vaccine and its quick approval a “modern medical miracle,” and encouraged Hoosiers to get one when they are eligible.
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Who can get the vaccine?
The Pfizer vaccine was demonstrated to have uniform effectiveness in individuals age 16 and up regardless of race or weight.
The first doses in Indiana will be available to health care workers and long-term care facility residents.
How effective is the vaccine?
The vaccine was tested in 44,000 study participants in a double-blind study. Of those getting the vaccine, only eight were infected with COVID-19 during the study period, and 162 were infected in the placebo group.
What side effects does the vaccine have?
The most common solicited adverse reactions were injection site reactions (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%) and fever (14.2%). These reactions typically dissipate within one or two days of vaccination.
Have there been any severe reactions to the vaccination?
Severe adverse reactions occurred in 0.0% to 4.6% of participants, with fewer severe reactions occurring among those older than 55.
How many doses do I need?
The Pfizer vaccine requires two doses 21 days apart to have the maximum efficacy of 95%. Recent data shows the vaccine is still very effective after one dose, but two are highly recommended.
Does the vaccine prevent transmission of COVID-19?
The study does not draw the conclusion that the vaccine on its own will stop the spread of the virus, so those vaccinated should still wear masks for now. There is not yet enough research to determine whether the vaccine can stop the asymptomatic spread in individuals who get the vaccine but are still infected with the virus.
Source: Food and Drug Administration report. View it for yourself here: fda.gov/media/144245/download
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