Vaccines deployed against triple viral threat from COVID-19, RSV, flu

Newly formulated COVID-19 vaccines won final approval from federal regulators Tuesday, giving Americans a triple shot of vaccines to protect against respiratory viruses this fall.

The director of the U.S. Centers for Disease Control and Prevention signed off on recommendations from an independent vaccine committee and the U.S. Food and Drug Administration to approve the updated mRNA vaccines against COVID-19, made by Moderna and Pfizer-BioNTech, for Americans ages 6 months and older.

Doses of the newly updated shots should arrive in Michigan pharmacies and doctors' offices in the coming days. The vaccines target a single strain of the virus, the XBB.1.5 lineage of the omicron variant. The new shots are expected to protect most people from serious illness, hospitalization and death from several strains now circulating.

"We expect the updated COVID-19 vaccine to be available through the Vaccines for Children and Bridge program starting early next week," said Chelsea Wuth, a spokesperson for the state health department. "Private providers may be able to receive some vaccine earlier than the public programs."

The approval comes as spread of coronavirus begins to swell once again in Michigan and health leaders expect to see influenza and RSV (Respiratory Syncytial Virus) cases rise with cooling temperatures as people return to indoor spaces in the months ahead.

It's yet again sparking concerns of a so-called "tripledemic," which could overwhelm hospitals this fall and winter.

"We have said that every year," since the start of the coronavirus pandemic in 2020, said Dr. Matthew Sims, director of infectious diseases research at Corewell Health, adding that it's hard to predict what will happen in the months ahead.

More: School is back, and so is COVID. Here's how Detroit area districts are addressing illness

Where does Michigan stand now with COVID-19 spread?

It's clear already that coronavirus cases are climbing in Michigan. The virus has been detected at higher levels in wastewater. And although the numbers are still quite low compared with previous pandemic peaks, in one month's time — from Aug. 11 to Sept. 11 — the number of people hospitalized with COVID-19 has more than doubled, from 175 to 396, according to state health department data.

Sims said he's seen more cases among patients at Corewell Health East, which includes all eight southeastern Michigan hospitals that were in the former Beaumont Health system. In a single week, between Aug. 31 and Sept. 7, the percentage of hospitalized patients with COVID-19 rose 30% at the hospitals, Sims said. And the test positivity rate climbed to 12.4% as of Sept. 7, which is a 50% increase from two weeks earlier.

Now is the time, Sims said, to get the COVID-19 booster, along with the flu shot. For anyone who is pregnant or age 60 or older, he also recommends the new RSV vaccine.

"Get the vaccines," Sims said. "Vaccines are probably among of the greatest medical discoveries of all time. ... People forget what it was like before the days of vaccines; they have forgotten what serious childhood illness was like."

Here's what you need to know about all the respiratory vaccines available this fall, who should get them and when.

Who is eligible for the new COVID-19 booster?

The CDC recommends all Americans ages 6 months and older get the new coronavirus vaccine.

How effective is the new COVID-19 vaccine likely to be?

"It looks like it's going to protect very well," Sims said.

The newly updated COVID-19 vaccine, which has been called a booster but actually is an entirely reformulated mRNA vaccine, is expected to offer protection against severe illness and death against most of the coronavirus strains now circulating, including the EG.5 subvariant of Omicron.

EG.5 made up at least 20% of all known cases in Michigan as of Sept. 2, according to health department data.

The new vaccine also is expected to offer protection from the newer BA.2.86 sublineage of omicron, which has made headlines because of the more than 30 mutations on its spike protein, Sims said.

"It looks like it generates good neutralizing antibodies to all the strains that are out there right now, even this BA.2.86, which has got 30 mutations right in the area that you worry about."

For now, at least, Sims said infections with the BA.2.86 strain remain rare.

More: First US case of new COVID-19 variant identified in Michigan lab

"It just so happens that the first known case of it in the U.S. was in Michigan," he said. "It's been circulating for a while at very low levels. And when a variant is spreading at very low levels, it probably means it doesn't spread as easily as some of the other ones out there."

Unless a variant emerges that causes much more severe disease or completely evades protection from the newly formulated vaccine, the U.S. Food and Drug Administration reported Monday that it anticipates COVID-19 shots will need to be updated annually, like the seasonal flu vaccine.

What are the risks of the new COVID-19 vaccine?

The newly updated COVID-19 mRNA vaccines are expected to cause similar side effects as previous versions, the U.S. Food and Drug Administration reported.

In adults, side effects can include allergic reactions; injection site pain, redness and swelling; tiredness; headache; muscle and joint pain, chills, fever; nausea, diarrhea and vomiting; decreased appetite, swollen lymph nodes; arm pain; dizziness; and irritability.

Additionally, there is a very small risk of myocarditis, which is inflammation of the heart muscle that can affect its ability to pump properly; and pericarditis, inflammation of the lining of the heart. That's more likely to occur among teen boys and young men, said Dr. Laith Al Ejeilat, a pediatrician and senior staff physician with the Henry Ford Medical Group.

In children, other side effects can include: irritability; poor feeding; fatigue; vomiting and/or stomach pain; and cool, pale skin and allergic reaction.

How concerned should I be about myocarditis after vaccination?

Although myocarditis and pericarditis are acknowledged risks after taking mRNA COVID vaccines, Al Ejeilat said an infection with coronavirus is more likely to cause those heart conditions than the shot.

"By getting the vaccine, you are choosing to reduce your risk," he said. "Myocarditis is currently estimated to occur one in 50,000 people in their teens and 20s after the second dose of COVID vaccines."

Among those who contract COVID-19, the rate of myocarditis is estimated to be as high as 10 out of 50,000, according to a study published in the Canadian Journal of Cardiology.

"We would never, ever use a vaccine that hurts more than it helps," Al Ejeilat said. "That is not the point of a vaccine. The point of a vaccine is to reduce harm."

For most, the vaccines can cause some mild discomfort — a sore arm and a fever for a day or two — but it's worth it, Al Ejeilat said.

Inaccurate and false information about vaccines online and on social media have driven too many away from a public health tool that saves lives, he said.

"Be very careful what you believe and what you hear from social media," Al Ejeilat said. "The internet is so wide that you can find information that supports any opinion. If you want to think that elephants are pink, you can find pictures of pink elephants.

"The internet is a very messy place to learn about health. I hope that people establish a trusting relationship with a qualified professional who has gone through the certification and the trainings ... so the patient can learn accurate information for their health from their doctor."

Will I have to pay for my COVID-19 vaccine?

When the coronavirus public health emergency expired in May, so did the guarantee of free COVID-19 vaccines.

Because the updated vaccine has been recommended for all Americans ages 6 months and older, insurance companies are expected to fully cover it. For people who have Medicare, Medicaid or other public insurance plans, the shots also will be covered.

Those who don't have health insurance, however, may have a harder time securing free doses of COVID-19 vaccines. The Biden administration is working to finalize a $1.1 billion bridge program that would provide the shots at no cost to people who are uninsured through community health centers, medical offices and pharmacies. The status of that program was unclear Tuesday.

How long after an infection should I wait to take the new COVID vaccine?

If you've recently had a COVID-19 infection, Sims said it's reasonable to believe you're relatively well protected for about three months.

But, he said, getting a dose sooner could offer even better protection from the virus.

"They say there's an advantage to getting in earlier," Sims said of CDC leaders, "but it's understandable to wait a little while, too."

Al Ejeilat suggested starting fall respiratory immunizations now — especially for young children who need more than one dose to be fully immunized.

"I recommended starting between mid-September and late October," he said. "It's very important to note that if a child has never received the flu vaccine before, they need to receive two doses four weeks apart for their body to recognize the lesson. They should absolutely get it by late September so that they can get their second dose in late October and be ready to fight it off when it peaks in November and December."

Should I go back to wearing a mask?

It's a personal choice, but Sims said he's still wearing a mask when he is in crowded places and around patients as well.

"Look, I appreciate everybody's personal desires," he said. "They don't want to masks. I get it. I don't really want to wear a mask, either. But I recognize the need for it in the right circumstances.

"When I'm working in hospital, I don't want to worry about any patient I'm seeing or their family or the nurse or whoever giving me COVID. Similarly, I don't want to worry that if I have COVID, I'll spread it around the hospital to the sick patients and everyone I see. So I wear a mask all the time.

"We probably should start wearing masks again as we get closer to respiratory season," Sims said.

Can I get a flu vaccine at the same time as my COVID shot?

Yes. The U.S. Centers for Disease Control and Prevention actually recommends it, saying getting both vaccines at once ensures people are protected and also prevents the inconvenience of having to make repeated visits to a doctor or pharmacy for shots.

However, the CDC acknowledged a study published in July 2022 that showed people who got both an annual flu shot and the COVID-19 mRNA booster at the same time were 8% to 11% more likely to have side effects that included fatigue, headache and muscle ache than those who didn't get both vaccines on the same day.

The reactions, however, were mostly mild and quickly resolved.

What are the new RSV vaccines?

New this year are vaccines called Arexvy, made by GlaxoSmithKline, and Abrysvo, made by Pfizer, that can protect against severe illness and death from RSV.

The highly transmissible virus causes cold-like symptoms in most people, but can be serious, causing pneumonia and bronchiolitis when it infects people ages 60 and older, infants and small children.

Each year in the U.S., anywhere from 60,000 to 160,000 adults ages 65 and older are hospitalized with RSV and 6,000-10,000 die from the virus, according to the CDC. And as many as 80,000 children younger than age 5 with RSV are hospitalized annually; 100–300 die from RSV.

"It's a disease of the very young and the very old — well not even the very old, but the older," Sims said.

The vaccines were approved in May for use in people ages 60 and older, and a single dose was found to reduce the risk of developing lower-respiratory disease in older adults by nearly 83% and slashed the risk of developing severe disease by about 94%.

In August, federal regulators also approved a single dose of Abrysvo for people who are pregnant. The aim is to protect the baby from antibodies it gets from its mother before delivery.

Some underlying medical conditions put people at higher risk of becoming severely ill from RSV. They include people with chronic heart disease, lung disease or immunocompromising conditions.

Should everyone 60 and older get the RSV vaccine, or only those with high-risk conditions?

Everyone 60 and older should get it, Sims said.

Why isn't there a vaccine for babies and young children against RSV?

"We have been really longing for an RSV vaccine," Al Ejeilat said. What's available instead is a monoclonal antibody treatment that can protect infants and small children for up to five months from severe disease and death from RSV — a big leap from the previous RSV preventive treatment, which helped kids for only one month and was more expensive.

The monoclonal antibody treatment, he said, is "like a premade weapon that their bodies can use to fight the RSV virus."

The hope, Al Ejeilat said, is to give the treatment to babies who are younger than 8 months old at the beginning of respiratory virus season and especially vulnerable to severe illness and death from RSV.

"We want to prevent hospitalization," he said. "This medicine can prevent that."

Will Michiganders take the vaccines?

Getting Michigan residents to take the newly available vaccines could be a challenging prospect.

The state's childhood immunization rate for such recommended vaccines like measles, mumps, rubella, polio, chickenpox, tetanus and whooping cough is approaching the lowest level in a decade, according to Michigan Care Improvement Registry data.

And only about 17.5% of the state's total population took the bivalent COVID-19 booster shot when it was recommended last fall, according to the state health department's COVID Dashboard.

Although the goal is to get 4 million Michigan residents to take the flu vaccine this year, about 3 million rolled up their sleeves for a dose in the 2022-2023 season — about 29% of the state's population.

Al Ejeilat likened getting vaccines to wearing a seat belt in a car.

"I have never heard anyone say I've never been in a car accident, so I won't wear a seat belt," he said. "You wear a seat belt because you know of horrifying accidents, because you have passed by accidents on the street. Yes, a seat belt is kind of uncomfortable, but you get used to it. And if you have a fender bender, you might still strain your neck. But you would choose the discomfort and the mild neck strain over going through the windshield in an accident."

Contact Kristen Shamus: kshamus@freepress.com. Subscribe to the Free Press.

This article originally appeared on Detroit Free Press: New COVID-19 booster approved as Americans also face RSV, flu