South Florida Sun-Sentinel (Sunday)

Real-time research

Florida is certain to be studied for how its older population fares with vaccine

- By Cindy Krischer Goodman

Florida has given the vaccine to more seniors than any other state, making it ripe for real-time research on the people most vulnerable to the deadly virus.

Because so few elderly people were included in the vaccine trials, much remains unknown about how the vaccine will affect them. Answers may now come from Florida, where Gov. Ron DeSantis chose to give the vaccine first to nursing home residents and where nearly a million people over 65 have now been vaccinated.

Until now, research about the vaccine’s effect on older people has been minimal and short term. Of the 21,720 people who received the Pfizer-BioNTech vaccine rather than the placebo in its phase 3 trial,

7,971 or 37% were over age 55. Pfizer’s study did not include a breakout for those 65 and older. In the Moderna phase 3 trial, of the

15,181 volunteers given the vaccine rather than the placebo, 3,763 or 25 percent were older than 65.

Both trials have been going on less than a year.

Florida is certain to be carefully studied for how its older population fares as the state attempts to vaccinate its entire population of 4.5 million seniors.

Among the key outcomes researcher­s will monitor: What side effects occur in older adults and with what frequency? Will the vaccine offer significan­t protection to those who are frail or have multi

ple chronic illnesses? When seniors make antibodies, how long will their immunity to COVID-19 last?

“I think we will learn more as we vaccinate more seniors,” said Dorinda Segovia, vice president of pharmacy services at Memorial Healthcare System. “Time will tell. So far, everything looks very promising.”

What research already shows

In clinical trials, some difference­s emerged in how COVID vaccines affected older adults: According to an analysis of the Moderna vaccine trial published in the New England Journal of Medicine, the vaccine was 95.6% effective for participan­ts 18 to 65 years, while it was only 86.4% effective for those older than 65 years. Pfizer, on the other hand, reported that its vaccine was effective at 94% in individual­s older than 65 years of age, compared with 95% across all ages.

Also, seniors in both trials reported milder and less frequent adverse reactions such as pain at the injection than younger participan­ts.

Researcher­s still do not know if the immune response in vaccinated older individual­s stays robust over time, particular­ly compared with younger adults.

“We can’t say for sure whether the vaccine efficacy is worse or better in seniors,” said Dr. Glenn Morris, director of the Emerging Pathogen Institute at the University of Florida. “We don’t have the data. That is the downside of having done the trials this quickly. The approach Florida has taken is reasonable but I do think we need to continue to collect the data and in a timely fashion and adjust our strategy if needed.”

Throughout the pandemic, the coronaviru­s’ grip on the state’s elderly has been tragically clear: 83% of those who have died of the virus were over 65 years old. This has led seniors in the state to swamp phone lines and websites to score appointmen­ts for vaccinatio­n.

Keep vaccine expectatio­ns in check

Benjamin Neuman, a professor of biology and chief virologist at Texas A&M University, said older people should be encouraged by the vaccine but will need to be realistic about expectatio­ns for long-term protection. Neuman said seniors tend to lose antibodies faster than younger people and should expect to receive immunity for only about six months after receiving the second dose of either the Moderna or Pfizer vaccines.

“It may go longer but I think that’s all you can expect from the data we have now,” he said. Moderna has said immunity should last a year for recipients, but the manufactur­er does not have long-term results yet from clinical trial participan­ts.

Dr. Roy Soiza, a researcher

with University of Aberdeen and author of “Efficacy and safety of COVID-19 vaccines in older people,” told the Sun Sentinel that although major vaccine manufactur­ers made an effort to recruit people over 65 in clinical trials, they failed to include the highest risk groups — such as older people sick enough to be in long-term

care.

“Of special concern is the possibilit­y that those with advanced frailty and failing immune systems may not respond as well to the vaccine,” Soiza said.

Soiza said vaccine side effects in the trials have been mild among those 65 and older, but “there is an evidence gap in the frailest

seniors,” he said. “Having a sore arm for a couple of days may be the difference between a senior being independen­tly mobile or not, and immobility is a killer in this age group.”

Vaccine reactions

Anyone who receives the vaccine gets observed for

15 to 30 minutes at the site. People who develop reactions after that are expected to self-report through a Centers for Disease Control Prevention smartphone app or its website, or through their primary care doctor. The CDC also has a monitoring system for long-term care facilities.

“No one in the entire study was hospitaliz­ed or died as a result of the vaccine,” notes Neuman, the Texas A & M biologist and vaccine expert. “There is not really a downside for seniors to be vaccinated. We don’t’ know how big the benefit is but there is not a downside. This isn’t going hurt and it could at least help a little. It will probably help a lot.”

At Memorial Regional, Melida Akiti, vice president of ambulatory and community services, vaccinated more than 4,000 seniors at her East Hollywood location over the last week. “I even vaccinated a 101-yearold woman,” she said. “I do a lot of hand holding.”

Akiti said she encourages seniors to get the vaccine, regardless of how much research has been done. “We don’t know side effects because it was just a shortterm study, but we know the outcome of COVID. We know COVID does kill the elderly and we know this vaccine is hope.”

Dr. David Moen, president of Prospero Health Partners, which specialize­s in caring for elderly people with chronic health conditions in Florida and nine other states, said he too encourages seniors to get the vaccine.

“We help our patients understand, especially those with chronic illnesses, that this is the best way to protect themselves and halt the spread,” he said. “I would anticipate six months to a year is the low side of how long antibodies will last. We don’t know enough to promise anything to a senior, but we do know it’s safer to be vaccinated than not.”

 ?? SUSAN STOCKER/SOUTH FLORIDA SUN SENTINEL ?? Jenna Lawhead, a Walgreens pharmacist, administer­s the Pfizer COVID-19 vaccine to Dixie Buehrer, 91, a John Knox Village resident, on Tuesday in Pompano Beach.
SUSAN STOCKER/SOUTH FLORIDA SUN SENTINEL Jenna Lawhead, a Walgreens pharmacist, administer­s the Pfizer COVID-19 vaccine to Dixie Buehrer, 91, a John Knox Village resident, on Tuesday in Pompano Beach.
 ?? SUSAN STOCKER/SOUTH FLORIDA SUN SENTINEL PHOTOS ?? John Knox Village residents line up to receive their first dose of the Pfizer COVID-19 vaccine on Tuesday in Pompano Beach.
SUSAN STOCKER/SOUTH FLORIDA SUN SENTINEL PHOTOS John Knox Village residents line up to receive their first dose of the Pfizer COVID-19 vaccine on Tuesday in Pompano Beach.
 ??  ?? Nelson Dayton, 91, a John Knox Village resident, receives his first dose of the Pfizer COVID-19 vaccine from Walgreens pharmacist Rachel Brodskiy.
Nelson Dayton, 91, a John Knox Village resident, receives his first dose of the Pfizer COVID-19 vaccine from Walgreens pharmacist Rachel Brodskiy.

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