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How To Help Patients Navigate A Newly Complex Vaccine Season
O'Donnell is an infectious diseases physician and a hospital epidemiologist.
In years past, once the calendar moved into September, there were straightforward recommendations across healthcare settings being provided to all adult patients about the benefits of receiving the annual influenza vaccine. Healthcare providers and patients are no longer in such a simple landscape for fall 2023. Along with the already-available influenza vaccines, two recently approved vaccines to prevent respiratory syncytial virus (RSV) are now available for older individuals, and the new updated COVID-19 boosters are expected to arrive toward the middle or end of September.
The Advisory Committee on Immunization Practices (ACIP) has clear guidance on influenza vaccines and those recommendations have not changed -- everyone is recommended to get a flu shot. ACIP has also released formal guidance around RSV vaccinations in adults 60 and older, but has yet to provide recommendations on use of one of the RSV vaccines, Abrysvo, which has also been approved for use in pregnant women to prevent RSV disease in infants. Guidance on who should receive the upcoming COVID-19 boosters, which will target an XBB strain, is not yet available from ACIP or CDC. Additionally, there are questions about timing of each of these vaccines, and whether they can be administered together or should be separated over time.
So, what are healthcare providers to do when trying to determine who will gain the most benefits from these three vaccines to prevent respiratory infections?
Flu Vaccines
Everyone 6 months of age and older should receive an influenza vaccine. Influenza vaccination not only prevents infection, it also significantly decreases the risk of severe disease, need for hospitalization, and death in those who are vaccinated and then get infected with influenza. People who are ages 65 and older should receive the high-dose influenza vaccine preparations. New this year, people with egg allergies can be vaccinated without special additional safety measures needed. They can receive any influenza vaccine (egg-based or non-egg-based) that is otherwise appropriate for their age.
It is not possible to predict when seasonal influenza will arrive, but it typically peaks in December-January. Getting vaccinated in September or October will still provide protection even if the flu season arrives in February or March.
RSV Vaccines
RSV may cause severe lower respiratory tract infections (LRTIs) in older adults and infants. Two RSV vaccines were approved by the FDA in May for the prevention of LRTIs in adults ages 60 and older. In June, the ACIP formally recommended that people ages 60 and above may receive a single dose of an RSV vaccine, using shared clinical decision-making. This means that the decision to proceed with RSV vaccination should be made between the patient and their healthcare provider after a discussion of the patient's underlying health conditions, their risk of severe RSV-associated LRTI, and the potential benefits, risks, and limitations of vaccination. Patients 60 and over with chronic lung diseases, asthma, congestive heart failure, coronary artery disease, diabetes, chronic kidney or liver diseases, and moderate or severe immunosuppression are among those most likely to benefit from RSV vaccination.
For eligible patients who decide they want to receive an RSV vaccine, the time to get vaccinated is now. Note that RSV vaccination should be offered without regard to seasonality to any unvaccinated adult who is in the target population (based on age and chronic conditions). With respect to severe side effects after an RSV vaccination, a small number of patients in the original vaccine trails did experience serious neurologic conditions including Guillain-Barré syndrome. However, these occurred rarely and it was not clear whether the vaccine caused the events. As part of any shared decision-making discussions, patients should be provided the CDC's RSV Vaccine Information Statement found here to help drive the conversation and decisions.
As noted above, one of the two approved RSV vaccines (Abrysvo, manufactured by Pfizer) was also approved in late August for use in women who are 32 to 36 weeks pregnant, as a tool to protect RSV in infants from birth to age 6 months. The vaccine was generally well tolerated with minimal side effects. There was a slightly increased incidence of preterm birth in the group who received the RSV vaccine, although a causal relationship has not been determined. The ACIP has yet to weigh in on guidance for use of the RSV vaccine in pregnancy, though it is under review and expected in the near future. When the time comes, this information should be provided to pregnant women considering RSV vaccination.
Updated COVID-19 Vaccines
The updated COVID-19 vaccines are expected in late September. They will target the XBB.1.5 strain of Omicron, which has circulated widely throughout the U.S. For much of 2023. These vaccines have not yet been evaluated by the FDA, and CDC and ACIP have not yet provided guidance. However, it is widely expected that once approved, the updated COVID-19 vaccines will be recommended for all adults 65 and older, for adults of any age with chronic medical conditions that make the risk of severe COVID more likely, for anyone with moderate or severe immunocompromising conditions, and for those who are pregnant.
The big questions will be focused on other populations such as healthy adults 50-65, adults under age 50 with chronic conditions, and teens and older children. Shared decision-making will probably be recommended for these groups. Patients who have had a recent COVID-19 infection should wait at least 3 months before getting a fall 2023-updated COVID vaccine. The same goes for patients who received a dose of the current bivalent vaccines any time since July 2023. Patients with severe immunocompromising conditions should discuss timing with their healthcare providers.
With COVID-19 rates on the rise nationally, there have been renewed questions about boosting those who are eligible now. Given that the updated COVID-19 vaccines are expected this month, most experts are advising patients to wait for the updated vaccine.
In terms of timing for getting vaccinated with the upcoming updated COVID-19 vaccines, individuals not in the higher risk groups may also want to consider when they want the highest level of protection, since we know that protective immunity begins to wane after about 2 to 3 months. For example, if someone is planning to spend the winter holidays traveling or with extended families in large indoor gatherings, then they may want to time their updated COVID-19 vaccine for late October or early November.
Timing and Co-Administration of Respiratory Virus Vaccines
Patients can receive an influenza vaccine simultaneously with either the RSV vaccine or the updated COVID-19 vaccines. Whenever multiple vaccines are administered at the same time, the injection sites should be spaced appropriately from one another, or in opposite arms. There are no data around co-administration of the RSV vaccines and COVID-19 vaccines. Most experts are recommending a 2-week period between receiving an RSV vaccine and the updated COVID-19 vaccine, but there are no data to guide these decisions, and patients should be encouraged to do what works best for them and their schedules. Some patients may be unable to make three separate trips to their provider's office or local pharmacy for the injections, and we don't want that to be a barrier to getting immunized. Although the landscape around fall vaccines is more complex this year, the overarching message healthcare providers should be sharing with their patients is how important these immunizations are to staying healthy during winter respiratory virus season.
Judith A. O'Donnell, MD, is chief of infectious diseases, director of infection prevention, and hospital epidemiologist at Penn Presbyterian Medical Center. She is also professor of clinical medicine at the University of Pennsylvania Perelman School of Medicine in Philadelphia.
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Monovalent Vaccine Outperforms Bivalent In Fighting New Omicron Variants
In a recent study posted to the medRxiv preprint* server, researchers in the United States evaluated the immunogenicity and safety of messenger ribonucleic acid (mRNA) vaccines based on severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Omicron XBB.1.5.
SARS-CoV-2 Omicron XBB sub-variants exhibit the potential to evade vaccine- or infection-induced immunity. As such, the United States (US) Food and Drug Administration (FDA) has recommended switching to vaccines based on SARS-CoV-2 XBB.1.5 from Fall 2023. MRNA-1273.815 is a monovalent vaccine encoding the SARS-CoV-2 Omicron XBB.1.5/XBB.1.9.1 spike protein. On the other hand, mRNA-1273.231 is a bivalent vaccine encoding BA.4/5 and XBB.1.5/XBB.1.9.1 spike proteins.
Study: Safety and Immunogenicity of XBB.1.5-Containing mRNA Vaccines. Image Credit: Dmitry Kovalchuk / Shutterstock
*Important notice: medRxiv publishes preliminary scientific reports that are not peer-reviewed and, therefore, should not be regarded as conclusive, guide clinical practice/health-related behavior, or treated as established information.
In the present study, researchers presented interim immunogenicity and safety data of the mRNA-1273.231 and mRNA-1273.815 vaccines from an ongoing phase 2/3 trial. The vaccine was intramuscularly administered as the fifth dose to recipients of the two-dose primary vaccination series, booster of the original coronavirus disease 2019 (COVID-19) vaccine, and bivalent booster. Individuals were excluded if they had a history of COVID-19 within three months before screening.
The researchers randomized individuals to receive a single monovalent or bivalent booster dose. Formal statistical testing for comparing immunogenicity between groups was not performed. The exploratory endpoint, surveillance of COVID-19 events, did not apply to this 15-day interim analysis. The study's primary objectives were the reactogenicity, immunogenicity, and safety of the mRNA-1273.231 and mRNA-1273.815 vaccines.
Immunogenicity was evaluated based on neutralizing antibodies (nAbs) against vaccine variants. Safety assessments included unsolicited adverse events (AEs) within 28 days and solicited systemic and local AEs within seven days. The team also evaluated serious or medically-attended AEs, special interest AEs, and those resulting in discontinuation from participation. The team used lentiviral pseudovirus neutralization tests to assess immunogenicity 15 days post-administration.
In addition, a research-grade vesicular-stomatitis virus-based pseudovirus neutralizing test was separately performed for ancestral SARS-CoV-2, FL.1.5.1, EG.5.1, XBB.2.3.2, XBB.1.16, XBB.1.5, and BA.4/5 variants, in a sub-sample of 20 randomly selected recipients of mRNA-1273.815. The team reported geometric mean titers (GMTs) and geometric mean fold-rises (GMFRs) from baseline (pre-booster) levels.
FindingsThe researchers randomized 51 and 50 adults to receive mRNA-1273.231 and mRNA-1273.815 vaccines, respectively, in April 2023. Participants generally had similar baseline characteristics. The median time from the last dose was 8.1 and 8.2 months for mRNA-1273.231 and mRNA-1273.815 recipients, respectively.
Both vaccines increased nAb responses against ancestral SARS-CoV-2, BA.4/5, BQ.1.1, XBB.1.5, and XBB.1.16 variants at day 15 relative to pre-booster levels. GMTs and GMFRs were higher against ancestral SARS-CoV-2, XBB.1.5, and XBB.1.16 with the monovalent vaccine than with the bivalent dose but were comparable against BQ.1.1 and BA.4/5 for both vaccines.
The monovalent vaccine induced similar responses against FL.1.5.1, EG.5.1, XBB.2.3.2, XBB.1.5, and XBB.1.16 in the sub-sample tested using the research-grade neutralizing assay. The median follow-up was 20 days for both groups. The unsolicited AEs and solicited systemic and local AEs were similar to previously reported AEs for the mRNA-1273 vaccine or the bivalent BA.4/5-containing mRNA vaccine. Fatal or severe AEs were not observed.
ConclusionsIn summary, the tolerability of mRNA-1273.231 and mRNA-1273.815 vaccines was similar to previous vaccines. Both vaccines induced potent nAb responses against sub-variants of the XBB-sublineage. The monovalent dose induced higher nAb titers than the bivalent vaccine. In general, responses were higher against variants of the XBB lineage.
The monovalent vaccine was also effective against the more recent Fornax (FL.1.5.1) and Eris (EG.5.1) variants, which harbor an additional substitution and may evade prior immunity. Overall, the findings reassure the potential of XBB.1.5-based vaccines to protect from emerging variants and support updating to an XBB.1.5-containing monovalent vaccine in 2023-24.
*Important notice: medRxiv publishes preliminary scientific reports that are not peer-reviewed and, therefore, should not be regarded as conclusive, guide clinical practice/health-related behavior, or treated as established information.
The Fall Virus Season Is Approaching. Which Vaccines Should You Get?
A new COVID variant is circulating. Flu season is about to begin. Respiratory syncytial virus (known as RSV) is becoming a greater cause of hospitalizations.
But this fall, something is different. The country has new vaccines for COVID, influenza and RSV, the three fall respiratory viruses that hospitalize and kill hundreds of thousands annually.
"Go get those vaccines and it will make a dramatic difference in your getting sick this winter," Dr. Ashish Jha, former White House COVID response coordinator told NPR. "We are going to be dealing with respiratory viruses forever but we are getting better at building treatments and vaccines. No one loves getting shots but these shots are literally saving lives."
Here's a guide to fall vaccines, how to time them right, and where they are available.
Seasonal influenza (flu)Doctors recommend an annual flu shot before the start of the season. In Florida, the 2022–23 flu season began in early October and went through May 20.
What's new this year: Each year the influenza vaccine is reformulated, but it doesn't always match perfectly with the circulating virus. Katelyn Jetelina, founder of Your Local Epidemiologist, a viral newsletter, says she is optimistic that this year's is a good match because the vaccine composition matches flu strains that recently circulated in Australia, which tends to be a predictor of what happens in the United States.
Who should get it: Everyone ages 6 months and older is eligible for the basic flu vaccine.
Bianca Perez, nurse practitioner at CVS Minute Clinic in Miramar, prepares a flu vaccine for a patient on Wednesday. (Carline Jean/South Florida Sun Sentinel) For those over 65, there is a high-dose influenza vaccine specially formulated to provide added protection to older adults. (AARP estimates that 70% to 85% of flu-related deaths and 50% to 70% of flu-related hospitalizations occur in people 65 and older.)
Bianca Perez at CVS Minute Clinic in Miramar said she also administers a specially formulated flu shot for people 50 to 64. "We have all three types at the Minute Clinic but it depends on insurance. Some don't cover this one."
The American Academy of Pediatrics urges all children over 6 months to get vaccinated and wants to see at least 70% immunized. Last year only about 55% were vaccinated.
"We know for children under age 5, influenza is unpredictable, it can be very serious, it leads a lot of children into the hospital and unfortunately we see tragic pediatric flu deaths every year," said Dr. Jennifer Ashton, a medical expert for Good Morning America. "We are encouraging those young children to get vaccinated starting now until the end of October."
When is the optimal timing: Pharmacies and doctors' offices in Florida already have the flu shot in stock. However, you don't want to get your shot too early and see your immunity wane before flu activity peaks. For most people, early October is the best time to get vaccinated so you have protection before the season fully kicks in, yet can keep your immunity until it ends, experts say. When timing your shot, consider it takes about two weeks after being vaccinated before you develop peak level of antibodies.
What else to know: You can get a flu shot at the same time as a COVID booster. Some Florida pharmacies offer coupons when you get vaccinated. CVS pharmacies and clinics are offering $5 off a $20 store purchase with a flu shot. At the CVS pharmacies in Target you can use your coupon at any Target store.
"I am hoping this year we will have an uptick in people who get a flu vaccine," Perez said. "We even had flu in Florida in the middle of summer which was rare. We had a very sick summer, and if that's any precursor of what's to come in the fall, it's going to be a sick winter as well."
COVID-19 vaccineWhat's new this year: The fall COVID-19 booster will have an updated formula targeting the newer omicron variant, XBB.1.5. Moderna, Pfizer, and Novavax all plan to have boosters on the market this fall. The exact timing hasn't been released but CDC director Mandy Cohen has said the booster should be available for most people by the third or fourth week of September.
While vaccine makers have been manufacturing updated vaccines that target XBB to ensure enough doses are ready by the fall and winter season, several new variants emerged. One of those new variants, BA.2.86, also known as "Pirola," appears more likely to infect people who have been vaccinated or have had previous infections. So how much protection will the booster give you? The manufacturers say early findings indicate that because the newer variants are still part of the Omicron family, the vaccines made to target XBB should still be effective against them, and the booster should offer some protection against BA.2.86
Who should get it: The CDC will determine who is eligible after the FDA fully approves the vaccine. The FDA can only fully approve it once the manufacturers submit data showing the vaccines are safe.
Bianca Perez, nurse practitioner at CVS Minute Clinic in Miramar, prepares a flu vaccine for a patient on Wednesday. (Carline Jean/South Florida Sun Sentinel) Last year, though, eligibility was dependent on the manufacturer, and it will likely be the same this year: Moderna: 6 months and older; Pfizer: 6 months and older; Novavax: 18 years and older.
Experts clash over who should get a COVID booster and who doesn't really need to get one. There's wide agreement that older adults should get one as well as people younger than 65 who have chronic conditions.
An FDA official said this week that for people ages 65 and older, an additional shot may be "reasonable" a few months after the first.
Jha, who has returned to Brown University's School of Public Health, said he believes children should get a COVID booster. "Kids still can get sick from COVID. When they get vaccines they are less likely to get sick and miss school," he told NPR. I want them in school … that's why my kids are going to get a COVID and flu vaccine. It just keeps them healthier."
When is the optimal timing: The ideal timing for each person is different depending on when you had your last booster, were infected with COVID, or want to get the most protection. Keep in mind that protection wanes after a few months so it makes sense to time your next shot to last into the winter.
What else to know: This fall season, the federal government is not paying for the vaccines and a program to provide them to uninsured people probably won't launch until mid-October.
Getting the booster in the same arm as your last COVID-19 shot may slightly boost your immune response, according to a study published in the journal eBioMedicine. Also, if you have had COVID recently, you will want to wait 90 days before getting the new COVID booster.
RSV vaccineWhat is new this year: For the first time, an RSV vaccine is available for people 60 and older, and from two manufacturers — GSK and Pfizer. Both effectively protect against severe illness, with up to 89% efficacy. The two vaccines are slightly different in design: The Pfizer vaccine, called Abrysvo, was 89% effective in clinical trials at preventing lower respiratory symptoms while the GSK vaccine, called Arexvy, was 83% effective. Experts believe the vaccine will need to be given every two years.
Who should get it: People ages 60 and older "may" get the vaccine in the U.S. The CDC advises people to consult with their doctor. Someone with underlying health conditions (like heart or lung disease or diabetes) and those living in long-term care facilities should strongly consider the vaccine, CDC guidance says.
When is the optimal timing: RSV vaccines do not wane like flu and COVID-19 vaccines, so getting one now should protect you throughout the entire season and most likely next season, too. The RSV vaccines are available at doctors' offices and some pharmacies, including Walgreens and CVS, this fall.
Special consideration: Pregnant woman may be able to get the RSV vaccine. Because babies tend to get RSV, the FDA has approved giving the Pfizer vaccine to pregnant women so they will pass on antibodies to their babies through the placenta. The vaccine is recommended to be given between 32 to 36 weeks of pregnancy.
What else to know: Medicare Part D covers the RSV vaccine, but some private health insurance plans don't.
Combining vaccinesThere is not a combined vaccine for all three viruses, so if you want to be fully vaccinated, you will need three shots. While it may be more convenient to get three on the same day, the safety risks haven't been studied. So far, what has been proved safe is flu and COVID shots at the same time. Clinical trials for the RSV vaccine found that when it's given at the same time as a flu shot, there were rare instances of severe side effects.
Other vaccinesShingles: This virus causes a painful rash in which the pain can last for months or even years after the rash goes away. Your risk of getting shingles increases as you get older. Adults 50 years and older should get two doses of Shingrix, separated by two to six months.
Pneumococcal vaccine: There are two kinds of pneumococcal vaccines available in the United States with new formulations. The shots are recommended for adults 65 or older and for all babies and children younger than 5 years old. "If you get one this year and a second a year later, you are good for five years," said Perez at CVS Minute Clinic.
Each of the above vaccines can be combined with the flu shot if given in different arms, she said.
Health experts recommend waiting at least seven days between the shingles vaccine and a COVID-19 vaccine, so that if you have any side effects you will know which vaccine they were from.
Sun Sentinel health reporter Cindy Goodman can be reached at cgoodman@sunsentinel.Com.
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