The adult vaccine delivery process is becoming a mess

'We're Absolutely Making It Too Hard': The Complexity Of Adult Immunization Delivery Hinders Vaccine Uptake

Alison Buttenheim was floored by a sign she saw in her doctor's office when she went to get the first jab of the two-dose shingles vaccine to protect her against painful flare-ups of varicella zoster.

"Medicare patients cannot receive Tdap or zoster vaccines here. They need to obtain [them] at their pharmacy. If they receive it here, they need to pay out of pocket," the notice read.

Medicare patients could get flu shots, Covid-19 shots, and vaccinations to protect against pneumonia in that office. And they could probably actually get the Tdap vaccination (it protects against tetanus, diphtheria, and pertussis) if they had stepped on a nail or had some other accident that could lead to tetanus infection — in other words, if they needed it as a treatment. No dice, though, if they were doing what all adults are actually supposed to do: Get a tetanus booster every 10 years to maintain protection against the dangerous bacteria, which kills 10% to 20% of people infected.

Buttenheim is a professor of nursing at the University of Pennsylvania who studies vaccine acceptance and hesitancy. She knows that any amount of difficulty in the immunization process can deter people from getting vaccinated. She couldn't believe her eyes.

"Really? It's different for Medicare and non-Medicare — which is common — and it's different by shot?" she said, explaining her incredulity in a recent interview with STAT. (Buttenheim is old enough to qualify for the shingles shot but not old enough to qualify for Medicare. She got the vaccine in her doctor's office without having to pay.)

The sign Buttenheim saw neatly illustrates the complexity of the burgeoning field of adult immunizations. In recent years, the number of vaccinations adults are being asked to get has expanded substantially. As a result, keeping track of which vaccines are recommended — and avoiding paying for them out of pocket — has grown increasingly convoluted.

To stay abreast of what to get and when and where to get it almost requires would-be vaccine recipients to have advanced degrees. Buttenheim has a couple — and yet she recently found herself shelling out $160 for her latest Covid booster. She wanted to get it before attending a conference, but the only place she could nab an appointment — at an independent pharmacy — wasn't in her insurance network.

She thinks she might be able to get the money back if she jumps through some insurance company hoops, but knows from her research that barriers like these deter a lot of people from keeping up to date on immunizations.

"We're absolutely making it too hard," Buttenheim said of the current patchwork system for adult vaccination.

Adult immunization rates are perennially suboptimal. Fewer than half of adults in the U.S. Get a flu shot. Only about 1 in 5 adults got a Covid booster in 2022; even among the highest-risk group, adults 65 and older, only 43% got last fall's Covid shot. The Centers for Disease Control and Prevention estimated that in 2019, only 22% of adults were up to date on all the vaccines they should have received.

Some of that may be due to vaccine hesitancy but more of it is likely due to the sheer difficulty of knowing what to get, when to get it, and how to get insurance coverage for the various shots, said Saad Omer, a vaccine expert who is dean of the Peter O'Donnell Jr. School of Public Health at the University of Texas Southwestern.

Omer said that when he thinks about vaccination policy, he is reminded of his adult nieces. They got Covid boosters last fall, but a couple of months after the shots became available. The delay wasn't due to concerns about vaccines. It was just that vaccination — any vaccination — isn't top of mind for them. And they are not alone, he said.

"Beyond the cacophony of pro-vaccine and anti-vaccine arguments on Twitter, most of the country doesn't actively think about vaccines, period," said Omer.

To get people like Omer's nieces to actively engage in immunization programs, the systems need to be "super easy" to navigate, he said.

But that is not the current reality, as Americans have been finding out this fall as they've struggled to book appointments for Covid shots and battled with insurance companies over coverage of the new RSV vaccine.

Buttenheim agreed, saying that some people are eager to stay up to date on their vaccinations while others won't take any vaccines, no matter what. But the majority of people are somewhere in between — open to the idea, but not so motivated that they'll follow through if they encounter access or cost hurdles. "There's just a really big group where just the littlest amount of uncertainty and friction is going to … bump you to not getting it," she said.

There was a time when adults were mostly just advised to get tetanus and flu shots. No longer. Adults — especially older adults — are urged to get shingles shots and Covid jabs and pneumococcal vaccines, and the new immunizations to protect against respiratory syncytial virus, or RSV.

There has been a proliferation, too, of the number of vaccines recommended for pregnant people, to protect them during pregnancy or their baby after birth. The list now includes influenza, Covid, hepatitis B, Tdap, and RSV vaccines, the latter only if the baby is to be born between October and March.

Pregnant people can and should get these vaccinations from their obstetrician-gynecologists, where they should not be asked to pay out of pocket. OB-GYNs have a narrow window in which to administer the full slate of immunizations — if the pregnant person agrees to accept them all.

"Beyond the cacophony of pro-vaccine and anti-vaccine arguments on Twitter, most of the country doesn't actively think about vaccines, period."

Saad Omer, dean of the Peter O'Donnell Jr. School of Public Health at the University of Texas Southwestern

The delivery picture for non-pregnant adults is more complex still, a reflection of a combination of factors. Many adults don't have a primary care provider, or have a hard time getting in to see their PCP if they do. "It's like, 'Great, we can see you in three months,'" said Rupali Limaye, a behavioral and social scientist who studies vaccine acceptance and hesitancy. "You've missed flu season."

Unless they are ill, many adults interact infrequently with the medical establishment. When they do, they may get care in a variety of places — making it no one person's job to ensure they are up to date with their vaccinations. That's a far cry from what happens with children, who have well-child visits mapped across the timeline of their childhoods that are deliberately synced to when they should be getting one or some of the myriad vaccine doses kids are supposed to receive.

"You know what you're there for. You're there for your vaccines," said Helen "Keipp" Talbot, an infectious diseases expert at Vanderbilt University, said while taking part in a panel discussion during STAT's Future Summit earlier this fall. "We don't have anything like that in the adult world."

Furthermore, for the most part, kids get their vaccines in that single setting, allowing for easy record keeping. Again, not the case with adults.

"Adults get vaccines in like 30 different places — at their employer or a pharmacy that they just go to. And I think the fact that we don't have a system where all of that is captured, it does increase the complexity of knowing who's received what," said Helen Chu, an infectious diseases specialist at the University of Washington.

The use of pharmacies to deliver adult vaccinations is a relatively new phenomenon, the growth of which was turbocharged by the Covid pandemic. It has undeniably created immunization opportunities that didn't exist before. Buttenheim got her flu shot on Aug. 31 — earlier than she had planned to — because she was in a pharmacy and the pharmacist effectively wouldn't take no for an answer.

"I think pharmacies would argue, correctly: 'We're much more likely to see these folks than a physician is. We're a touch point that has a much higher frequency than a physician's office.' So that's great," she said.

But delivering multiple types of vaccines adds a whole new layer of complexity to the jobs of busy pharmacists. Some vaccines shouldn't be given together if it can be avoided, because the response to one could dampen the response to another. (It's been shown that RSV vaccines weaken the response generated by the pertussis component of Tdap, for instance.) In other cases, some vaccines are sufficiently reactogenic — meaning they carry a kick — that getting them in combination could make for an unpleasant day or two following injection.

"Shingrix is a great vaccine. It's really, really effective. And shingles is a pretty morbid illness for older adults, so it's great that it exists. But with an … adjuvant," — a compound that amplifies the impact of the vaccine — "you're not going to give it at the same visit as your GSK RSV [vaccine]," Chu said, because it also contains the same adjuvant.

Because there is no fixed schedule, as there is with childhood vaccines, adults often have to figure this stuff out themselves. The second dose of shingles vaccine should be given no sooner than two months after the first, but no later — in theory — than six months after dose 1. Buttenheim asked her doctor's office to send her an electronic reminder to book an appointment when she was due for her second shingles shot. She was told they didn't do that.

"I'm a behavioral scientist. Give me a cue to action here," she said. Buttenheim ended up getting the second shingles shot a year minus a day after the first dose.

Adults are eligible for the shingles vaccine once they hit the age of 50, and for the pneumococcal vaccine when they reach the age of 65. But where kids have doctor visits before school entry — when final doses of some vaccines are given — adults don't typically have medical appointments timed to specified ages. "We just don't have those kinds of built-in cues and default milestones that we do for the childhood schedule," Buttenheim said.

Then there's the issue of seasonal versus non-seasonal vaccines. Some adult vaccines are one-offs — a single shot like the pneumococcal vaccine or, in the case of shingles, two doses. But other vaccines are given annually, in a particular time frame — flu and Covid shots, for instance, in the lead up to cold-and-flu season. The RSV vaccines for seniors are so new it's not yet known how frequently they will need to be administered, or what the impact on overall protection would be of administering Covid plus flu plus RSV in one session.

How do you coordinate all these shots? Do you have to wait a certain interval after having one type of vaccine before you can have another? Can you get other vaccines in the gap between the first shingles shot and the second?

This is complicated stuff — even for people well versed in vaccines. "I can interpret the info, but it doesn't live inside my head. I have to go and search for it," Buttenheim said.

A lot of people may struggle to find, let alone interpret, the necessary information.

"I think for most people, it is too much. It is too much mental bandwidth to figure this out," said Limaye, who is an associate professor in the Johns Hopkins Bloomberg School of Public Health. "I think the majority of our issues here in the U.S. — I think, yes, we do have hesitancy, absolutely — but I think a lot of them just have to do with access and availability. That's it."

Then there are issues around payment.

The payment piece should be simple because U.S. Health insurers are required to pay for vaccines that have been recommended by the Advisory Committee on Immunization Practices, which guides the CDC on vaccine use. The vaccines we're talking about here have all been recommended by the ACIP. But when a vaccine is newly added to the recommended list, insurers have up to a year to start to cover the cost. Some take their time, as a number of people who tried to get an RSV shot this fall found out to their dismay.

Even insurers that add a new vaccine quickly may have restrictions on where the people they cover can get immunized. Limaye's insurance pays for her vaccines if she gets them at a Hopkins pharmacy or at a Walgreens. If she books an appointment at a CVS, however, she'd end up having to pay for her shot.

There's a simple fix for this, Omer said. The Vaccines.Gov website that people can search to find appointments for Covid or flu shots could be programmed to ask users for health insurance details, and incorporate that information into the search results they are shown. Even better would be if the site linked individuals to their vaccine records to help remind them of the immunizations they are missing. "That would be the version 4.0," he said. "There seems to be some limitation of our imagination, even within the existing resources. It's not easy, but it's not nearly impossible."

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For older adults who are on Medicare, there is a counterintuitive situation in which some vaccines are covered by one part of Medicare while others are covered by another. Medicare still covers the cost, but this divvying up of vaccines into Part B versus Part D coverage restricts which health professionals can get paid to administer particular vaccines — hence the sign that flummoxed Buttenheim in her doctor's office.

Part B covers influenza, pneumococcal, hepatitis B, and Covid-19 vaccines. They can be administered by a physician or a pharmacist, at no cost to the recipient. Other vaccines recommended for adults by the ACIP are covered by Part D. That includes the shingles shot, Tdap, RSV vaccines for adults 60 and older, and a range of other shots. Insurers must cover the cost of these vaccines too. But physicians have a difficult time claiming compensation for administering them, so often prefer not to stock them, leaving this work to pharmacies.

Not simple, but not super hard, right? But wait, there's more.

As mentioned earlier, Tdap is sometimes a Part B vaccine — if it's being given in response to a tetanus exposure risk — and sometimes a Part D vaccine. "It's 100% insane," Limaye said.

And while the RSV vaccine is a Part D vaccine — to be given by pharmacists — some states require people to first get a prescription from a doctor to give to the pharmacist, an irritating two-step procedure that adds friction to a process that does not benefit from anything that might act as a deterrent. Other states, like New York, have taken regulatory steps to allow pharmacists to give RSV vaccines without a prescription.

(Further adding to confusion about the RSV vaccines for seniors is the fact that the ACIP issued what is known as a "shared decision-making" recommendation for them. Anyone 60 and older can get one of the shots, but should have a discussion with a health professional about their individual risk and the potential side effects of the vaccine. This will dampen uptake of the vaccine, Chu predicted.

"I think a lot of people perceive that as a hedge," she said. "I think it makes you think that the CDC is saying, 'Well, you should get this vaccine, but you need to talk to your doctor about all the risks and the benefits and all these rare side effects that we saw, and all of these other things.' And really, primary care physicians do not have time for this.")

To Limaye, the solution is obvious: Iron out the insurance reimbursement kinks.

"Honestly, if we really care about the health of the American people, all pharmacies should be able to offer all adult vaccines. Bottom line," she said, adding there should be no in-network/out-of-network deals between insurers and pharmacy chains.

"I think there has to be this recognition of meeting people where they are. Most people go to a pharmacy for something. Fewer people go to a doctor's office regularly. So that's why I would argue … the easiest and most widespread impactful solution is to have all adult vaccines available at a pharmacy."

Even if the issues around insurance reimbursement could be clarified, that wouldn't solve the problem of under-vaccinated adults, however. That's because a big chunk of American adults, an estimated 25 million, are not covered by private insurance, Medicaid, or Medicare.

For children in similar straits, there's a program called Vaccines for Children, which pays for vaccinations for kids who wouldn't otherwise be vaccinated. The CDC program covers a little over half of the country's children.

But there is no corresponding program for adults. President Biden's 2024 budget proposes to create a Vaccines for Adults program. (Some people in public health prefer the moniker Vaccines for All, with the goal of melding the two programs.) But presidents' budgets are wish lists; the prospects that a Republican-led House would greenlight spending expansion to cover more vaccinations seems unlikely in the current climate.

Not having such a program undermines the country's capacity to respond to health threats, Demetre Daskalakis, acting director of the CDC's National Center for Immunization and Respiratory Diseases, said during a recent panel discussion, pointing to the 2022 response to the mpox outbreak to illustrate his point.

In an attempt to quell the fast-growing outbreak, mpox vaccine was provided to at-risk individuals, at no cost, regardless of their insurance status. But some medical providers who see at-risk patients couldn't bill to claim compensation for their work, limiting the pool of people involved in vaccinating individuals and slowing the process of protecting the people at risk.

"The lack of compensation for uninsured meant that many providers couldn't implement mpox vaccination in their settings. A program like VFA would help address that," Daskalakis said in an email.

"In an ideal world, we would have simplified payment of vaccines, delivery of vaccines, and a Vaccines for Adults program," said Omer, who suggested that at the end of the day better uptake of vaccines would likely be cost-saving, because of the serious illnesses that vaccines can avert.

Canadian Seniors Can Get 4 Key Vaccines This Fall: What To Know About COVID, RSV, Flu & Pneumococcal Shots

As COVID-19 cases surge in Canada, the federal and provincial governments have been reminding Canadians — especially those older and most vulnerable — to get their vaccine shots this fall.

These include not only monovalent, mRNA-based shots for COVID-19, but also a flu shot and a pneumococcal vaccine shot to protect against a bacterial infection in seniors 65 years and older.

For the first time, older adults will also have access to the respiratory syncytial virus (RSV) vaccine.

"We know some people are already getting these vaccines, but we're just going to see greater access in the days and weeks ahead," said Dr. Isaac Bogoch, an infectious diseases specialist at Toronto General Hospital.

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In Canada, Infection Prevention and Control Canada claimed "influenza and pneumonia are ranked among the top 10 leading causes of death. It is estimated that influenza causes approximately 12,200 hospitalizations and 3,500 deaths."

COVID-19 is also affecting older Canadians the most, with Statistics Canada saying since the start of the pandemic, older Canadians have experienced "a disproportionate share of both excess deaths and COVID‑19-caused deaths."

From March 2020 to early March 2021, StatCan said "about one third of the excess mortality and just over half of the deaths caused by COVID‑19" in Canada occurred in people older than 84.

As of October 2023, the number of COVID-19 related hospitalizations and admissions to ICU remain highest among the oldest age groups, according to the COVID-19 epidemiology update website.

With a number of vaccines now available for seniors to help bring these numbers down, here's what you need to know.

What vaccines are available for seniors in Canada?

As of September, updated Pfizer and Moderna vaccine shots, which target the Omicron XBB.1.5 variant, have been approved.

The updated Novavax, which is a non-mRNA vaccine, is also expected to be approved, but Health Canada hasn't provided details on when.

In the meantime, one dose of Pneu-P-23 vaccine is recommended for adults who are 65 years of age and older to protect them against a severe pneumococcal infection.

The infection is caused by a bacteria, which can cause "life-threatening infections such as meningitis (an infection of the lining that covers the brain), septicemia (an infection of the blood) and pneumonia (an infection of the lungs)," as stated by the ImmunizeBC website.

The newest shot to be made available this season is an RSV vaccine, which has been authorized for use in Canada for the prevention of lower respiratory tract disease caused by RSV in adults 60 years of age and older.

Flu shots are also available across Canada.

All of these vaccines, except Novavax, have started rolling out in provinces like Quebec, Ontario and British Columbia as of Oct. 10.

An expert says that while people can get their COVID and flu shots at the same time, they should wait two weeks before getting the RSV vaccine. (Getty)

Can you get the COVID, flu and RSV vaccines at the same time?

Bogoch said COVID-19 and flu shots can be given at the same time "if people choose to have it at the same time for convenience."

When it comes to the RSV vaccine, however, Bogoch said older Canadians will have to wait two weeks after getting their COVID and flu shots.

"Just to make sure there's no side effects that may be associated with it," he explained.

Are these vaccines free?

Bogoch said flu and COVID-19 vaccines come at no cost to Canadians, but the RSV vaccines won't be free for everyone.

While the RSV vaccine for adults aged 60 and over is not publicly funded, adults aged 60 years and older who are in long-term care homes, elder care lodges and some retirement home residents do qualify for a free RSV vaccine, according to Ontario government.

It's the same for older Canadians living in other provinces.

For those who don't qualify, Canadians can still buy the one-dose vaccine with a prescription from a family doctor or other primary care provider, which can cost upwards to $300 as reported by CBC and Global News.

The pneumococcal vaccine is available free of charge to Canadians aged 65 and older and is part of provinces' routine immunization programs.

Why should seniors consider getting these shots?

Flu and COVID-19 vaccines come at no cost to Canadians. (Getty)

Bogoch explained vaccines can reduce the risk or severity of infection, especially for older Canadians who are at greater risk for severe influenza, COVID and RSV infection.

"There's overwhelming data, not just from Canada, but globally to demonstrate that hospital settings are sadly overrepresented in deaths as a result of these infections," said Bogoch.

"These vaccines can significantly reduce the risk of severe manifestations of infection. So they may not stop these viruses in their tracks, but they can really slow down the rate of severe illness and prevent many people from becoming hospitalized," he added.

Reducing barriers to vaccine access is crucial: Expert

Bogoch said it's great that there's vaccines available, but it's important to reduce the barriers to vaccination and look into how to facilitate higher vaccine rates among seniors.

"Certain communities, typically lower income communities and racialized communities, have lower vaccine uptake," said Bogoch.

As a result, he said there needs to be programs that engage with these kinds of communities to lower barriers and to make it easier for people to get access to them.

For example, Bogoch said Toronto has a program that offers vaccines to home-bound seniors.

"You'd think someone who is home-bound isn't really at risk for these infections, but they don't necessarily live alone," said Bogoch.

He said other people might bring a COVID or an RSV infection into the home, so without a program that offers home-bound seniors an easier access to vaccine shots, it might be very challenging for them to get it otherwise.

The government of Canada recommended adults should discuss the type and number of vaccines they need with a health provider.

"Your health care provider may ask questions about your medical history, including: what vaccines you had in the past, if you're pregnant or planning to become pregnant (or) if you have health conditions," the government stated.

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Vaxcyte Announces FDA Clearance Of Investigational New Drug Application For VAX-31 For The Prevention Of Invasive Pneumococcal Disease In Adults

-- Company Expects to Initiate VAX-31 Phase 1/2 Study in Healthy Adults This Quarter--

-- Topline Safety, Tolerability and Immunogenicity Results from VAX-31 Phase 1/2 Study Expected in the Second Half of 2024 --

-- VAX-31 is a 31-Valent Pneumococcal Conjugate Vaccine Designed to Provide Coverage for Approximately 95% of Disease Currently Circulating in the U.S. Adult Population --

SAN CARLOS, Calif., Oct. 19, 2023 (GLOBE NEWSWIRE) -- Vaxcyte, Inc. (Nasdaq: PCVX), a vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, announced today that the U.S. Food and Drug Administration (FDA) has cleared the Company's adult Investigational New Drug (IND) application for VAX-31, a 31-valent pneumococcal conjugate vaccine (PCV) candidate designed to prevent invasive pneumococcal disease (IPD). Vaxcyte expects to initiate the VAX-31 Phase 1/2 clinical study in adults in the fourth quarter of this year and announce topline safety, tolerability and immunogenicity results in the second half of 2024.

"The FDA clearance of the VAX-31 IND application represents an important step toward our goal of building a best-in-class PCV franchise, including VAX-31 and VAX-24, the 24-valent PCV for which we achieved positive results in two adult Phase 2 clinical studies," said Grant Pickering, Chief Executive Officer and Co-founder of Vaxcyte. "Given VAX-31, which will be the broadest-spectrum PCV to enter the clinic, leverages the foundation already established with VAX-24, we are very excited about the promise of this vaccine candidate. We expect to advance VAX-31 into the clinic this quarter and announce topline safety, tolerability and immunogenicity results in the second half of 2024."

"The VAX-31 Phase 1/2 study, which will enroll approximately 1,000 adults aged 50 and older, is designed to enable us to understand the clinical potential of VAX-31 to improve upon the standard-of-care for adults by providing a broader-spectrum of protection," said Jim Wassil, Executive Vice President and Chief Operating Officer at Vaxcyte. "With VAX-31, we are leveraging our cell-free platform to develop a PCV candidate with expanded coverage against approximately 95 percent of the serotypes that currently cause IPD in the U.S. Adult population. This is important given IPD contributes to high-case fatality rates, antibacterial resistance and meningitis, all of which are particularly concerning in the older adult population."

About the VAX-31 Phase 1/2 StudyThe VAX-31 Phase 1/2 clinical study is a randomized, observer-blind, active-controlled, dose-finding clinical study designed to evaluate the safety, tolerability and immunogenicity of VAX-31 compared to Prevnar 20® (PCV20) in approximately 1,000 healthy adults aged 50 and above. The Phase 1 portion of the study will evaluate the safety and tolerability of a single injection of VAX-31 at three dose levels (low, middle and high) administered to approximately 64 healthy adults 50 to 64 years of age before the study progresses to Phase 2. Phase 1 participants will also be evaluated for immunogenicity, and the Phase 1 safety, tolerability and immunogenicity data will be pooled with the participants in the Phase 2 portion of the study. The Phase 2 portion of the study will evaluate the safety, tolerability and immunogenicity of a single injection of VAX-31 at the same three dose levels compared to that of PCV20 in approximately 936 healthy adults 50 years of age and older.

About Pneumococcal DiseasePneumococcal disease (PD) is an infection caused by Streptococcus pneumoniae (pneumococcus) bacteria. It can result in IPD, including meningitis and bacteremia, and non-invasive PD, including pneumonia, otitis media and sinusitis. In the United States, approximately 320,000 people get pneumococcal pneumonia each year, which is estimated to result in approximately 150,000 hospitalizations and 5,000 deaths. Pneumococci also cause over 50% of all cases of bacterial meningitis in the United States. Antibiotics are used to treat PD, but some strains of the bacteria have developed resistance to treatments. The morbidity and mortality due to PD are significant, particularly for young children and older adults, underscoring the need for a more broad-spectrum vaccine.

About VAX-31VAX-31, an investigational 31-valent PCV candidate, is designed to prevent IPD, which is especially serious in infants, young children, older adults, and those with immune deficiencies or certain chronic health conditions. The public health community continues to affirm the need for vaccines that offer broader protection to prevent IPD. Both VAX-31 and VAX-24, Vaxcyte's 24-valent PCV candidate entering late-stage clinical development, are designed to improve upon the standard-of-care PCV vaccines for both children and adults by covering the serotypes that are responsible for a significant portion of IPD currently in circulation and are associated with high case-fatality rates, antibiotic resistance and meningitis. VAX-31 was designed to provide coverage for approximately 95% of the IPD currently circulating in the U.S. Adult population. Vaxcyte aims to efficiently create and deliver high-fidelity, broad-spectrum vaccines by using modern synthetic techniques, including advanced chemistry and the XpressCF™ cell-free protein synthesis platform. With VAX-31 and VAX-24, Vaxcyte is deploying this approach with the intent of adding more pneumococcal strains without compromising the overall immune response.

About VaxcyteVaxcyte is a vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases. The Company is developing broad-spectrum conjugate and novel protein vaccines to prevent or treat bacterial infectious diseases. Vaxcyte's lead candidate, VAX-24, is a 24-valent, broad-spectrum, carrier-sparing PCV being developed for the prevention of IPD and is poised to move into late-stage development. VAX-31, which will be the broadest-spectrum PCV candidate to enter the clinic, is a follow-on candidate to VAX-24 and part of the Company's PCV franchise.

Vaxcyte is re-engineering the way highly complex vaccines are made through modern synthetic techniques, including advanced chemistry and the XpressCF™ cell-free protein synthesis platform, exclusively licensed from Sutro Biopharma, Inc. Unlike conventional cell-based approaches, the Company's system for producing difficult-to-make proteins and antigens is intended to accelerate its ability to efficiently create and deliver high-fidelity vaccines with enhanced immunological benefits. Vaxcyte's pipeline also includes VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease; and VAX-GI, a vaccine program designed to prevent Shigella. Vaxcyte is driven to eradicate or treat invasive bacterial infections, which have serious and costly health consequences when left unchecked. For more information, visit www.Vaxcyte.Com.

Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements related to the potential benefits of VAX-31 and VAX-24, including breadth of coverage and clinical potential, the ability to deliver potentially best-in-class profiles and the improvement upon the standard-of-care; the design, process and timing of anticipated future development of VAX-31 and VAX-24, including the timing of the VAX-31 Phase 1/2 clinical study in adults and announcement of topline safety, tolerability and immunogenicity results; the potential of VAX-31 to serve as a follow-on candidate to VAX-24; and other statements that are not historical fact. The words "anticipate," "believe," "could," "expect," "intend," "may," "on track," "potential," "should," "would" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) convey uncertainty of future events or outcomes and are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are based on Vaxcyte's current expectations and actual results and timing of events could differ materially from those anticipated in such forward-looking statements as a result of risks and uncertainties, including, without limitation, risks related to Vaxcyte's product development programs, including development timelines, success and timing of chemistry, manufacturing and controls and related manufacturing activities, potential delays or inability to obtain and maintain required regulatory approvals for its vaccine candidates, and the risks and uncertainties inherent with preclinical and clinical development processes; the success, cost and timing of all development activities and clinical trials; and sufficiency of cash and other funding to support Vaxcyte's development programs and other operating expenses. These and other risks are described more fully in Vaxcyte's filings with the Securities and Exchange Commission (SEC), including its Quarterly Report on Form 10-Q filed with the SEC on August 8, 2023 or in other documents Vaxcyte subsequently files with or furnishes to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management's assumptions and estimates as of such date, and readers should not rely upon the information in this press release as current or accurate after its publication date. Vaxcyte undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in its expectations. Readers should not rely upon the information in this press release as current or accurate after its publication date.

Contacts:

Janet Graesser, Vice President, Corporate Communications and Investor RelationsVaxcyte, Inc.917-685-8799media@vaxcyte.Com

Jennifer Zibuda, Senior Director, Investor RelationsVaxcyte, Inc.860-729-8902investors@vaxcyte.Com

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