Food and Drug Administration (FDA) panel recommended the Pfizer coronavirus vaccine be approved for Emergency Use Authorization Thursday night, putting it a step closer to full approval and delivery to Americans within days.
The federal government and the State of New Jersey have said the first doses will first be given to health care workers and nursing home residents. It could make a big difference in the lives of those who have faced isolation from their loved ones and increased risk of infection as the virus spreads.
Exactly how it will play out in New Jersey nursing homes, where more than 7,000 residents have died from COVID-19, is beginning to take shape. The state has released some details of the plan, as have some nursing homes, industry groups and the pharmacies that will administer the vaccines.
Vaccines will be made available at long-term care facilities through a federal partnership with CVS and Walgreens, covering some 75,000 residents and 90,000 employees, officials said.
The Department of Health said it is “awaiting confirmation from Operation Warp Speed about long-term care facilities that will participate in the Federal Pharmacy Partnership.”
CVS said it would be ready to administer COVID-19 vaccines in long-term care facilities in New Jersey and across the country.
“It’s important to remember that we run seasonal flu clinics in thousands of these locations every year, which means our health care professionals – pharmacists, pharmacy technicians and nurse practitioners – are very familiar with this population,” said CVS spokesman Joseph Goode.
According to a CVS guide given to long-term care facilities, a facility would register patients online with CVS in preparation for the distribution date. The facility would then make appointments for patients and make sure consent forms and insurance information is collected.
Goode said all 10,000 CVS Pharmacy locations have refrigeration and freezing capabilities for five of the six vaccine candidates, including Moderna’s.
“Pfizer has an ultra-cold requirement, which the company has also addressed – special shippers that utilize dry ice will be used to transport vaccines,” he said. “After five days at our pharmacies the dry ice can be replenished, and again five days later. After 15 days the vaccines can be refrigerated for another five, meaning we can store them in our pharmacies for up to 20 days.”
On the day of vaccine administration, the company’s vaccine teams will go pick up the necessary doses from the storage locations, using dry ice, on their way to long-term care facilities, Goode said.
A similar process would take place on a future date for the second dose of the vaccine, and there will be a third date for anyone who was missed.
That’s how it will play out at Juniper Communities, which operates nursing homes in Chatham and Williamstown.
CVS expects to be able to vaccinate Juniper’s 150 residents and approximately 150 employees as soon as Dec. 21, depending on vaccine approval timing, said Lynne Katzmann, Juniper’s founder and CEO.
Juniper will have three dates for the vaccine clinics. At the first, residents and workers would get the first dose. The second clinic would be 21 days later for the second dose, and the third would be 21 days after that to vaccinate any new residents or employees.
Katzmann said employees will get the shots first.
“Our feeling is our residents live with us. They can isolate but the staff cannot. The staff poses the largest risk to the residents so we have to vaccine them first,” Katzmann said, noting they hope all residents and employees can get the first shot on the first day.
She said anyone who regularly comes into the community, including workers such as home office teams, physical therapists and private duty aides, will also get the vaccines.
Residents who live in the skilled nursing communities will have the vaccines brought to their rooms, while others will come to a common room — a 10-foot by 10-foot room with two chairs and a table — where they will create a clinic for the vaccines, she said.
Walgreens said it has also partnered with long-term care facilities to be a vaccine provider, but it didn’t share any specific details of how the distribution would work.
AN EDUCATION CAMPAIGN
It’s unclear what would happen if a nursing home resident doesn’t want to take the vaccine. A recent poll by Pew Research found four out of 10 people said they definitely or probably would not get a vaccine, though half of that group said they’d consider it after more information becomes available.
Nursing homes and other long-term care facilities are working to educate residents, families and staff about the vaccines and their side effects, hoping to eliminate any reluctance to take the vaccine.
Stuart Shapiro, the interim CEO of the Health Care Association of New Jersey, a long-term care industry group, said he believes any skepticism about the vaccine is more among the general public and not among nursing home residents and staff.
“My belief is that nursing home staff are well informed and I fully expect the majority of them will want to take the shot to protect themselves and their patients,” he said.
Shapiro wouldn’t address what would happen if an employee or resident refused to take the vaccine or whether unvaccinated nursing home residents would face restrictions to protect the general population.
“The issue hasn’t even been looked at because the goal is to have the vaccine voluntarily taken by staff and residents,” he said, noting “at this time they have a right to say no.”
Andrew Aronson, director of the Nursing Home Advocates of New Jersey, said facilities are actively working to educate residents and their families about “the many benefits” of being vaccinated.
“We hope that after consideration, most residents will be inoculated and will soon be able to resume the visitation and activities they have missed,” he said.
CareOne, which runs 33 facilities in the state, said that it’s waiting for “guidelines to be issued from state officials on how to implement this complex endeavor.”
While vaccination is voluntary, facilities may choose to place restrictions on the activities of an unvaccinated resident to protect their health, said Donna Leusner, spokeswoman for the Department of Health.
That’s not surprising, experts said. The virus crashed through nursing homes at such a devastating rate that facilities will want to prevent new waves of infection.
If a resident refuses to take the vaccine, it could be a basis for the facility to discharge the resident, said Harold Grodberg, a Bayonne-based certified elder law attorney.
“A person can be discharged from the nursing home if they are an imminent threat of harm to themselves or another,” Grodberg said. “I think the nursing facility, to limit their liability, would have no choice but to seek the discharge of a patient refusing to take the COVID vaccine.”
Juniper’s Katzmann said they have been educating residents and their families about the vaccine, and so far, no resident has refused to take it.
She said the residents are part of a generation that went through vaccinations for polio and small pox. “They are not fearful of vaccines. The choices are pretty clear for adults with chronic conditions.” she said.
“If a resident decides they don’t want to take the vaccine, they would have to isolate until there was herd immunity in the community,” Katzmann said. “They would have to follow more rigorous infection protocols and continue with testing.”
Juniper has also decided to make the vaccination a condition of employment unless the employee has a medical or legal reason not to be vaccinated, she said.
“We believe we are responsible for one another and we think it will provide safety to our residents and to our other team members,” she said. “We are still going to be using infection prevention protocols in a big way but we will be able to engage within the community. For the for seniors who are fighting social isolation, that’s a big deal.”
SIDE EFFECT CONCERNS?
While the United Kingdom on Tuesday said people with “significant history of allergic reactions” should not take the Pfizer vaccine after two people had an “anaphylactoid reaction” a day after receiving the shot, health experts said concerns about how older adults with weaker immune systems and other conditions will react to the vaccines are unfounded.
The studies for both the Pfizer and Moderna vaccines included people over age 70, and they were shown to be “very effective, even in the older age group,” said Shobha Swaminathan, associate professor and principal investigator for the Moderna vaccine trial at Rutgers New Jersey Medical School.
“There were no serious side effects that were reported thus far with these vaccines,” she said.
Craig Palosky, director of communications for the Kaiser Family Foundation, called vaccine safety data “very reassuring.”
“Some fairly minor side effects were reported, such as soreness, fatigue, and headaches, especially after the second dose,” Palosky said. “If anything, these side effects were reported less frequent and were less severe in those over 55 compared to those 55 and under.”
Swaminathan, who also serves as medical director of the infectious disease practice at University Hospital, said no one will be forced to take a vaccine that they do not want.
“Based on the outstanding efficacy results of these vaccines, given the known increased risk of death associated with COVID-19 in nursing homes, if my parent were a nursing home resident, I would give it to them,” she said.
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NJ Advance Media Statehouse reporter Susan K. Livio contributed to this report.
Karin Price Mueller may be reached at KPriceMueller@NJAdvanceMedia.com.