The CDC expects that our next round of COVID-19 booster shots will be available in early fall, likely late September or early October. But this limited information has been distributed not through formal reports or press releases—rather, through the new CDC director’s media appearances.
These booster shots will be targeted to Omicron XBB.1.5, one of the most recently-circulating subvariants. It’ll be an important immunity upgrade, especially for seniors and other higher-risk people, as the last round of updated vaccines came almost a year ago. Plus, these new boosters are basically the federal government’s one initiative to combat COVID-19 as we head into another inevitable fall and winter of respiratory illness.
Considering the shots’ importance, we have surprisingly little information about when they’ll be available or how they will be distributed. During one media appearance (on NPR’s All Things Considered in early August), CDC Director Dr. Mandy Cohen said that the boosters would be available “probably in the early October time frame.” Then, a week later (on former federal official Andy Slavitt’s podcast), she said boosters would come “by the third or fourth week of September.”
In both interviews, Cohen shared few details beyond this vague timeline. I would love to see more details from the federal government about their plans—for producing the shots, and also for distributing them in our post-federal emergency landscape. It also seems unclear how the CDC and other agencies will promote the boosters, considering how most officials are now pretending COVID-19 is no longer a concern. (Case in point: Cohen’s many mask-less appearances since she started as CDC director.)
This past Thursday, the FDA’s advisory committee on vaccines and similar biological products met to discuss COVID-19 boosters for this fall. They voted in favor of updating the vaccines based on Omicron XBB, a variant lineage that has dominated both in the U.S. and globally this year.
The fall boosters will be monovalent, meaning they’ll only include the XBB strain—unlike our most recent boosters, which were bivalent (including BA.4/BA.5 and the original, Wuhan strain). The FDA has recommended this switch because research suggests monovalent vaccines may be more effective, and because the original coronavirus strain is no longer circulating; we’re mostly seeing XBB right now.
The FDA has not yet decided which exact variant will be used for this fall’s boosters. While experts generally agree that it should be an XBB lineage, the FDA will make a final call on this closer to the fall respiratory virus season. XBB.1.5, XBB.1.9, and XBB.1.16 are all major contenders right now.
This fall’s vaccination campaign is likely to prioritize at-risk populations, including seniors and those with medical conditions that damage their immune systems, similar to the bivalent booster shot rollouts. Ongoing vaccine effectiveness research suggests that these groups benefit most from the protection of an additional booster shot, though people not in these groups obviously benefit as well.
The CDC will make final decisions about which groups will most need the fall boosters, as well as whether some groups may be eligible for more than one of the shots. Children may also become eligible for new boosters; that’ll be up to the CDC as well.
In choosing XBB for the fall boosters, the FDA is standardizing with recommendations from the World Health Organization and European Union, which have also suggested that XBB be the target for the next boosters. Last year, the WHO recommended BA.1, while the U.S. used BA.4/BA.5. Standardizing will be helpful for ongoing data collection, since…
Data problems persist: I’ve written a lot about the U.S.’s disadvantages in tracking vaccine effectiveness, particularly compared to other countries with more standardized health systems. This problem has persisted through all rounds of boosters, including the shots planned for this fall; in fact, it’s even harder now for U.S. agencies to monitor how well the vacines work, as the federal public health emergency’s end led to fewer data collection authorities for the CDC. (Safety monitoring systems will continue, though.)
It’s also worth noting that the boosters this fall will be the first major COVID-19 vaccine rollout following the end of the federal public health emergency. While the Biden administration has devoted some funding for getting vaccines to uninsured Americans, most people will now be getting vaccinated through their health insurance.
This is certain to make the process more complicated and more challenging for many. I’ve already seen stories of people who are eligible for a second bivalent booster having a hard time getting that shot. (See this recent Death Panel episode, for example.) The federal government is doing very little to improve this situation in time for the fall boosters to arrive—and no matter how well XBB vaccines work in theory, they’ll do little in practice if nobody can actually get them.
KFF Medicaid Unwinding tracker: The Kaiser Family Foundation just published a new tracker detailing Medicaid enrollment by state. Enrollment rose to record levels during the pandemic, as a federal measure tied to the public health emergency forbid states from taking people off the insurance program. Now, states are going through the slow process of evaluating people’s eligibility and taking some off the program, in a process called “unwinding.” The KFF tracker is following this process, presenting both Medicaid enrollment data by state and information on each state’s timeline for evaluation.
Biden administration ends vaccine mandates: In time with the federal public health emergency’s end, the Biden administration has announced that it will lift its COVID-19 vaccine rules for federal workers and contractors. International travelers to the U.S. also will no longer need to provide proof of their vaccination status, and the administration is working to end requirements for other groups of workers and travelers. This change is, essentially, another signal of the administration giving up on mass vaccination campaigns; after all, most of the people who got their shots under these rules haven’t received an Omicron booster.
Vaccine protection wanes over time: A new review paper from researchers in Trento, Italy, published this week in JAMA, shows the importance of booster shots for maintaining protection from COVID-19. The researchers compiled and analyzed findings from 40 studies that evaluated vaccine effectiveness. Overall, they found, the protection that both primary series and booster shots provide against an Omicron infection drops significantly by six months and nine months after vaccination. Remember: Americans over 65 and/or immunocompromised, you’re now eligible for another bivalent/Omicron-specific booster.
Disparities in COVID-19 deaths persist: Two new studies this week examine COVID-19 deaths by race and ethnicity. The first study, from the CDC’s National Center for Health Statistics, examined deaths of all causes during the pandemic, finding that Black and Native Ameircans had higher death rates than other racial/ethnic groups. COVID-19 was the fourth highest cause of death in 2022, after heart disease, cancer, and unintentional injury. The second study, from Andrew Stokes and collaborators, examined COVID-19 deaths during the U.S.’s first Omicron wave compared to earlier surges, finding that disparities decreased—but only because white deaths went up during the second year of the pandemic.
Characterizing Long COVID neurological symptoms: Another new study from this week: researchers at the NIH performed detailed examinations of 12 Long COVID patients to better understand their neurological symptoms. The researchers used an approach called “deep phenotyping,” which involves a variety of tests that aren’t typically used in clinical settings. They found that the patients had a number of abnormalities in their immune systems and autonomic nervous systems compared to healthy controls, pointing to different potential drivers of symptoms.
FDA approves RSV vaccine: Finally, a bit of non-COVID good news: for the first time, the FDA has approved a vaccine for RSV, the seasonal respiratory virus that can cause severe symptoms in older adults and young children. This vaccine, made by GSK, was approved for adults ages 60 and up and will likely get distributed during the next cold/flu season. Scientists have been working on RSV vaccines for decades, making this a major milestone for reducing the disease’s impact. Helen Branswell at STAT has more details.
External review of the CDC: The People’s CDC, a group of public health experts, scientists, and educators dedicated to advocating for increased COVID-19 precautions, released a new report reviewing the federal CDC’s actins during the pandemic. The report incorporates feedback from a survey of almost 500 experts and from over 200 reports. Overall, the People’s CDC “found that the CDC has prioritized individual choice and short-term business interests over sharing accurate scientific evidence with the public and protecting population health.” (Disclaimer: I was one of the experts surveyed for this report!)
Use of COVIDTests.gov: This new paper, published in the CDC’s Morbidity and Mortality Weekly Report (MMWR), reports on how Americans used COVIDTests.gov, the USPS/HHS effort to distribute free at-home tests. Since the site’s launch in January 2022, about one in three U.S. households received a test kit from this program, the research team found. They also found that this program may have helped improve equity in COVID-19 test access, as Black and white Americans utilized the free tests at similar rates. Of course, the program has been discontinued as of this spring.
Impact of racial discrimination on vaccination: Speaking of health equity: another report published in MMWR this week shares a correlation between discrimination and vaccination status. Researchers at the CDC and their collaborators analyzed data from the CDC’s National Immunization Survey, including about 1.2 million survey results from April 2021 through November 2022. Among the respondents, people who reported experiencing racial or ethnic discrimination in a healthcare setting were less likely to be vaccinated for COVID-19. The findings confirm many health experts’ equity concerns from early in the vaccine rollout.
Declining childhood vaccinations worldwide: Vaccine equity is a concern on the global scale, too. A new report from UNICEF shows that 67 million children worldwide missed at least one vaccination between 2019 and 2021, as healthcare systems were strained. The report also presents new data on global confidence in childhood vaccines: in some countries, this confidence has dropped by up to 44 percentage points. Vaccine confidence only improved in three countries (China, India, and Mexico). “The threat of vaccine hesitancy may be growing,” UNICEF warns.
Healthcare workers present while sick: One more paper that caught my attention this week: researchers at the Veterans Affairs healthcare system in Boston tracked a cohort of about 4,000 healthcare workers between December 2020 and September 2021. In addition to PCR testing, the workers conducted daily COVID-19 symptom reviews, and received guidance to stay home or leave work if they didn’t feel well. But the researchers found that many workers didn’t actually stay home: among 255 workers who had symptomatic COVID-19 during the study period, almost half reported that they were present, at work, at the time they received a positive test result. The paper indicates why it’s important to keep masks in healthcare settings, even when community cases are lower.
This week, the FDA made some adjustments to the U.S.’s COVID-19 vaccine guidance in order to standardize all new mRNA shots to bivalent (or Omicron-specific) vaccines, and to allow adults at higher risk to receive additional boosters. The CDC’s vaccine advisory committee and Director Rochelle Walensky both endorsed these changes.
Adults are now considered “up to date” on their COVID-19 vaccines if they have received at least one dose of a bivalent/Omicron-specific vaccine. These are the vaccines manufactured by Pfizer and Moderna that became available last fall.
Any unvaccinated adult should receive one dose of a bivalent vaccine, rather than the former primary series (which was based on the original coronavirus strain). The prior vaccines will essentially go out of use in the U.S.
Seniors (65 or older) and immunocompromised adults may receive an additional bivalent vaccine dose, starting at four months after their prior dose. Recent research has demonstrated that protection from these shots wanes over a couple of months, so there’s a good case for seeking out a new booster if you fall into one of these high-risk categories.
Immunocompromised adults may receive more bivalent doses going forward, in consultation with their doctors. This guidance intends to provide more protection to people who are severely immunocompromised, such as those undergoing cancer treatment.
A new version of the bivalent booster will likely be available in the fall, designed to protect against more recent coronavirus variants. We don’t know much about this yet, but prior FDA and CDC meetings have suggested it will roll out on a similar schedule to the annual flu shot.
These recommendations mostly apply to adults. While the FDA and CDC are also working on simplifying their guidance for children (to similarly prioritize vaccines aligned to current variants), that’s still a more complicated situation right now. See the YLE post for more details.
Another open question, at the moment, is what non-mRNA vaccines may be available, for people who may be allergic to those vaccines or who had severe reactions to earlier doses. Novavax is reportedly working on a bivalent/Omicron-specific option, which people might be able to get this fall. The Johnson & Johnson vaccine is no longer widely used at all.
It makes sense for the FDA and CDC to shift towards bivalent vaccines. Numerous studies have demonstrated that these vaccines perform better against Omicron variants, and this move simplifies the immunization process for everyone involved (doctors, pharmacies, patients, etc.).
However, this shift reveals how poorly the bivalent booster rollout has gone in the U.S. so far. Only 17% of the population has received one, compared to 81% who’s received at least one dose overall, according to the CDC. Even among seniors, only 42% have received a bivalent booster. It would be a massive task for the country to move towards “up-to-date” coverage among all adults.
And the federal government doesn’t appear to be pushing for this in any meaningful way. I’ve already seen several reports on social media of people trying to get an additional booster, and failing—whether because of an insurance issue or because pharmacies have simply stopped offering the shots. This process will only get more challenging when the federal public health emergency ends next month. While the Biden administration has announced funding to cover vaccines for uninsured Americans, that’s just one hurdle among a growing number.
Low uptake of the Omicron-specific boosters does not inspire confidence in the government’s ability to distribute next-gen vaccines. Data from the CDC.
This week, the White House announced that it’s setting up a $5 billion program to support next-generation COVID-19 vaccines and treatments. The program, called Project Next Gen, is essentially a follow-up to Operation Warp Speed (which launched our current COVID-19 vaccines in 2020).
Project Next Gen is a big step toward actually ending the pandemic, not just pretending it’s over. The federal government can support large-scale clinical trials and speed up regulatory approval in a way that no research group or company could. Still, the U.S.’s prior vaccine campaigns don’t inspire confidence that this project will lead to widespread adoption of new shots when they become available.
What are the “next-gen” vaccines under development?
Next-gen COVID-19 vaccines generally fall into two categories: nasal vaccines that would provide better protection against infection, and pan-coronavirus vaccines that would provide better protection against new variants.
Nasal vaccines basically deliver immunity with a spray into the nose, rather than a shot in the arm. This type of vaccine already exists for other common viruses, like the flu. They’re easier to receive for people wary of needles, but they also have a big advantage for the immune system: these vaccines boost immunity in the nose, mouth, and upper respiratory tract, which are the main places where the coronavirus typically infects people. With a nasal vaccine’s help, the immune system is better poised to fight off the virus at infection, rather than fighting off severe symptoms after someone is already infected.
Pan-coronavirus vaccines, meanwhile, address the variant challenge. Our current COVID-19 vaccines are designed around the virus’ spike protein, a component on the outside of the virus that helps it break into human cells. But the spike protein is the primary area where the coronavirus mutates; the spike proteins of XBB.1.5.1 or XBB.1.16 are very different from that of the original virus. New pan-virus vaccine candidates are designed around different aspects of the virus that don’t mutate as much, and therefore would remain more protective against new variants.
For more details on why these vaccine options are important and which candidates are now in the pipeline, I recommend reading this Substack post by Eric Topol, the prominent COVID-19 commentator and director of the Scripps Translational Research Institute. Topol has been calling on the Biden administration to support next-generation vaccines for a long time; he’s written extensively on this subject.
Why is a federal program important to advance these vaccines?
Operation Warp Speed was a monumental achievement, probably the most successful aspect of the U.S.’s response to COVID-19. The federal government provided significant funding to pharmaceutical companies, while also assisting with clinical trial development and facilitating collaboration between companies and the FDA. And the first mRNA vaccines were delivered within one year of the pandemic starting.
Project Next Gen will provide a similar boost to the companies working on next-gen vaccines. It’s not going to operate at the same scale as Operation Warp Speed; it received $5 billion in funding, compared to Warp Speed’s $18 billion. Still, that’s a huge chunk of money for companies, and other types of federal support that will be crucial for quickly starting up large clinical trials.
The White House is currently assessing pharmaceutical companies that it may partner with on this initiative, according to reporting by the Washington Post. There’s no clear timeline for Project Next Gen yet, as the government will need to work with specific companies and the FDA to plan trials, but it’ll certainly be much faster than these vaccines would get to people otherwise.
What are the challenges facing Project Next Gen?
While this initiative is great news, its implementation will face a lot of challenges—especially after the new vaccines become available. The federal government’s rhetoric around COVID-19, combined with our now-mostly-dismantled infrastructure for responding to the disease, will present major barriers to getting people vaccinated.
For example, it’s obviously very ironic that the Project Next Gen announcement came in the same week as Biden signed a bill ending one of the federal COVID-19 emergencies. And the timing isn’t just coincidental: the White House and HHS are actually using the emergency’s end to fund this project, moving in money that was previously devoted to COVID-19 testing and other preventative measures.
The administration is basically telling people: “COVID-19 is over, but uh, we might need you to get a new vaccine or two next year so that you don’t die from it.” It’s hard to blame people for not getting the second part of the message.
We’re already seeing this with the Omicron boosters: only 17% of the U.S. population has received one, according to CDC data. Lack of awareness about those vaccines and the many barriers that now exist to get the shots contributed to that low number. Even if Project Next Gen delivers the most effective COVID-19 vaccines possible, a lot more investment would be necessary to actually get them to people.
Second Omicron boosters for high-risk adults: The FDA and CDC are planning to authorize a second round of bivalent, Omicron-specific vaccines for high-risk adults, the Washington Post reported this week. This decision will apply to Americans over age 65 and those who have compromised immune systems, with these groups becoming eligible four months after their initial bivalent boosters. It’s unclear exactly when the decision will become official; the FDA and CDC will make authorizations sometime “in the next few weeks,” according to WaPo.
HHS announces (underwhelming) Long COVID progress: This week marks one year since Biden issued a presidential memo kicking off a “whole-of-government response” to Long COVID. The Department of Health and Human Services (HHS) commemorated the occasion with a fact sheet sharing the federal government’s progress so far. Unfortunately, that progress has been fairly minor, mostly consisting of reports and guidance that largely summarize existing government programs or build on existing systems (such as Veterans Affairs hospitals). Many of the Long COVID programs that Biden previously proposed have not received funding from Congress; meanwhile, the National Institutes of Health’s RECOVER initiative, the one program that has been funded, has faced a lot of criticism.
RECOVER PIs recommend action on treatment: Speaking of RECOVER: this week, a group of scientists leading research hubs within the national study called for federal funding that would support treatment. The principal investigators (PIs) of these hubs have developed expertise in Long COVID through recruiting and studying patients, leading them to identify gaps in available medical care for long-haulers. To respond, the PIs recommend that Congress allocate $37.5 million to support Long COVID medical care at the RECOVER research sites. Their proposed budget includes patient outreach, telehealth support, educating healthcare workers on Long COVID, and more.
Ventilation improvements in K-12 schools: The CDC released a new study this week in its Morbidity and Mortality Weekly Report, sharing results of a survey (conducted last fall) including about 8,400 school districts representing 62% of public school students in the U.S. Research company MCH Strategic Data asked the districts about how they’d improved ventilation in their school buildings, along with other COVID-19 safety measures. About half of the districts reported “maintaining continuous airflow in classrooms,” one-third reported HVAC improvements, 28% reported using HEPA filters, and 8% reported using UV disinfectants. The results indicate that many districts have a long way to go in upgrading their indoor air quality.
Flu vs. COVID-19 mortality risk: Ziyad Al-Aly and his colleagues at the VA healthcare system in St. Louis have published another paper analyzing COVID-19 through the VA’s electronic health records. This study, published in JAMA Network, describes the mortality risk of COVID-19 compared to seasonal flu for patients hospitalized during the 2022-2023 winter season. The researchers evaluated about 9,000 COVID-19 patients and 2,400 flu patients, finding that risk of death for COVID-19 patients in the 30 days following hospitalization was about 1.6 times as high as the risk of death for flu patients. Despite great advances in vaccines and treatments, COVID-19 remains more dangerous than other seasonal viruses, the study suggests.
Biobot launches mpox dashboard: This week, leading wastewater surveillance company Biobot Analytics launched a new dashboard displaying its mpox (formerly monkeypox) monitoring. Biobot tests for mpox at hundreds of sewage sites across the U.S., largely through its partnership with the CDC, and will continue this monitoring through at least summer 2023. The new dashboard shows mpox detections nationally over time and monitoring sites by state; it also includes some information on how mpox surveillance differs from COVID-19 surveillance.
The FDA recommends that the U.S. shifts to annual COVID-19 vaccines, with a variety of data sources feeding into decision-making. Screenshot from the VRBPAC meeting on January 26, 2023.
On Thursday, the FDA’s Vaccines and Related Biological Products Advisory Committee (or VRBPAC) met to discuss the future of COVID-19 vaccines. While the committee readily agreed that our current, Omicron-specific shots are working well and should be used more broadly, it had a hard time answering other questions about future vaccine regimens—largely due to a lack of good data.
Now, the lack of good U.S. data on vaccine effectiveness is not a new problem. I personally have been writing about thissince fall 2021, to the point that I feel like a broken record for bringing it up again. To summarize: the U.S. has a fractured health system in which every state tracks vaccinations differently, with a lot of local public health departments and private companies in the mix, too. As a result, it’s challenging for researchers to determine exactly who is getting COVID-19 after vaccination and how the virus is impacting them.
This lack of detailed vaccine effectiveness data was a problem in fall 2021, when federal officials decided on an initial round of booster shots. And it’s still a problem in winter 2023, as the same officials attempt to plot out a future in which COVID-19 is another disease that we deal with on an annual basis.
But this week’s VRBPAC meeting revealed some other areas of data that are also lacking as we try to answer questions about future vaccines. Here’s my summary of five primary data gaps that came up at the meeting, and some suggestions for potential solutions.
Detailed vaccine effectiveness data
The biggest data gap, of course, is our lack of answers to the question: Who is getting sick with COVID-19 after vaccination? And related questions: How sick did they get? Which variants did they get sick with? What preexisting conditions or comorbidities did they have?
Our lack of standardized medical data in the U.S. makes it tough to answer these questions at the population level. Analyzing variants is particularly tricky, given that variant surveillance in the U.S. tends to be entirely anonymized—with no connections between the genomic sequencing of random PCR tests and the health outcomes (or vaccination statuses) of those patients. And analyzing preexisting conditions can be crucial as officials try to decide which groups of people need extra boosters, but these conditions often are not collected in standard databases or linked to COVID-19 records.
As a result, U.S. officials tend to rely on other countries with more comprehensive, standardized data systems for information on how well the vaccines work. We also have to rely on the pharmaceutical companies producing these vaccines, which often don’t openly share their data—they tend to present clinical trial results in press releases, over peer-reviewed studies. Companies also tend to do trials that align better with their own financial interests, rather than looking at the full scope of vaccine effectiveness.
Even in this week’s VRBPAC meeting, scientists from Moderna presented results from a clinical trial—conducted in the U.K.—that tested the company’s bivalent boosters against the original (non-Omicron) boosters.
Better tracking of variants
The primary reason why our COVID-19 vaccines require updates in the first place is the coronavirus’ continued evolution. Every new lineage of Omicron that rises to prevalence is either a bit better at spreading quickly, a bit better at evading immunity from prior infection or vaccination, or both. To successfully tweak our vaccines in the future, scientists will need to know which variants are out there and how dangerous they are.
Right now, variant tracking largely relies on PCR testing, as researchers randomly select some swab samples to sequence. But with fewer and fewer people getting PCR tests, the sample pool is dwindling. As a result, to stay ahead of new variants, the U.S. needs to diversify its surveillance options. That will likely include more variant sequencing from wastewater (as a population-level COVID-19 sample), more sequencing at hospitals and healthcare centers, and more travel surveillance focused on international variant patterns.
Variant surveillance will also need to inform how suited U.S.-developed COVID-19 vaccines are for the rest of the world. Right now, the pharmaceutical companies that have produced the most effective vaccines (i.e. Pfizer and Moderna) are American—so American regulators are essentially dictating vaccine policy for the world, even though their priority is the U.S. FDA official Jerry Weir said as much at the meeting. U.S. hegemony over COVID-19 vaccines will continue to be a complex, fraught topic going forward.
Tracking different types of immunity
At the VRBPAC meeting, Moderna, Pfizer, and Novavax all presented data on how well their vaccines work against currently-dominant coronavirus variants. While they included some clinical data (case rates, hospitalization rates), the presentations mostly focused on one metric: antibody titers. To calculate if a vaccine works against a certain variant, the easiest strategy is measuring the antibodies produced after a vaccinated blood sample is exposed to that variant.
While this is the easiest strategy, it’s far from the only way to examine how well a vaccine works. Members of the VRBPAC committee frequently asked the pharmaceutical companies for those other metrics: T cells, B cells, and more ways of measuring the immune system’s response to COVID-19. But the companies had little response to these questions. Even FDA and NIH officials at the meeting admitted that they still didn’t have a good understanding of how, exactly, our current vaccines impact our immune systems, beyond generating antibodies.
To better evaluate future vaccines, scientists will need to get better at measuring other aspects of our immune responses. That includes future mRNA vaccines as well as next-generation vaccines in the works right now, such as nasal vaccines (recently authorized in China and India) and vaccines designed to protect against all variants (currently in development at Duke University and other institutions).
I also think it’s worth noting that, as Katelyn Jetelina writes in her coverage of the VRBPAC meeting at Your Local Epidemiologist, the FDA could require pharmaceutical companies to study the immune system more holistically when they submit further vaccine updates for authorization. “The FDA could require sponsors to do detailed investigations, e.g. assessing lymph nodes, bone marrow, and breakthroughs,” she writes. “This would help us understand immunity better, so we can make better recommendations. It’s not clear why they aren’t pushing for this.”
Improving vaccine safety tracking
Two years after the first COVID-19 vaccines were authorized, we now know that the vaccines are overwhelmingly safe and effective. Most people have mild side effects following their shots, like sore arms and fatigue, but the benefits of getting vaccinated far outweigh the risks. However, some discussion at the VRBPAC meeting indicated that federal agencies could do a better job of tracking rare (yet important) serious side effects.
For example, a safety presentation from the Kaiser Permanente Vaccine Study Center suggested that there might be a small increase in stroke risk for older adults who get vaccinated. The risk has only appeared in one vaccine safety database so far and appears to be minimal, per the FDA, but it’s still worth closer examination.
In addition, as Helen Branswell and Matthew Herper discuss in the STAT News liveblog, the VRBPAC meeting didn’t present much new data about vaccine safety risks for children, such as myocarditis among boys and young men. Plus, we have limited data so far on whether vaccination may contribute to autoimmune conditions or Long COVID-like symptoms, a problem that has shown up in some studies and anecdotal reports.
If public health officials are going to continue encouraging Americans to get COVID-19 shots once a year (or more), they will need to thoroughly address concerns about these potential side effects. This is particularly true for young children, a group that’s been vaccinated at fairly low numbers so far.
Navigating COVID-19’s interactions with other vaccines
At the VRBPAC meeting, FDA officials suggested a potential future in which most Americans get one COVID-19 vaccine per year, on a similar timeline to the annual flu shot. Variant strains might be selected in the spring or summer, with vaccines developed and produced in time for a fall vaccination campaign. Some at-risk groups (older adults, people with compromised immune systems, etc.) might get two doses each year.
To make this possible, the VRBPAC committee members suggested that we’ll need to track how COVID-19 vaccines intersect with other vaccines. For example, if an older adult receives their flu shot and COVID-19 shot in the same doctor’s visit, does that dampen how well one or the other vaccine works? Does it increase the risks of severe side effects? We don’t know, at this point.
Another major area of future study will be how COVID-19 vaccines may fit into regular, childhood immunization schedules for young kids. Similarly to the COVID-19 plus flu question, scientists will need to track any potential interactions between COVID-19 shots and other regular shots—along with answering questions about how many shots are needed, timing between shots, and more.
One day, I’m sure, we will have a regular COVID-19 vaccination schedule in the U.S. that runs parallel to our flu vaccination schedule. But it will take time, discussions, and a lot more data to get there.
2022 America’s Health Rankings released: This week, the United Health Foundation released its 2022 edition of America’s Health Rankings, a comprehensive report providing data for more than 80 different health metrics at national and state levels. The 2022 report includes new metrics tailored to show COVID-related disparities; for example, Black and Hispanic Americans had higher rates of losing friends and family members to COVID-19 compared to other groups. I’ve used data from past iterations of this report in stories before, and I’m looking forward to digging into the 2022 edition.
FDA authorizes bivalent boosters for young kids: This week, the FDA revised the emergency use authorizations (EUAs) of both Pfizer’s and Moderna’s updated, Omicron-specific booster shots to include children between six months and five years old. Kids who previously got two shots of Moderna’s vaccine for this age group can receive a bivalent booster two months later, while kids who got two shots of Pfizer’s vaccine can receive a bivalent booster as their third dose. (Remember, Pfizer’s vaccine for this age group includes three doses.) The updated EUAs will help protect young children from Omicron infection, though uptake will likely be low.
CDC updates breakthrough case data: Speaking of the updated boosters: the CDC recently added data on these shots to its analysis of COVID-19 cases and deaths by vaccination status. In September, people who had received a bivalent, Omicron-specific boosters had a 15 times lower risk of dying from COVID-19 compared to unvaccinated people; and in October, bivalent-boosted people had a three times lower risk of testing positive compared to the unvaccinated. The CDC will update these data on a monthly basis.
Director Walensky discusses authority challenges: One bit of coverage from the Milken Future of Health Summit that caught my attention: CDC Director Dr. Rochelle Walensky talked about the agency’s limitations in collecting data from states, reports Rachel Cohrs at STAT News. Walensky specifically highlighted the challenges that the CDC might face in collecting data when the public health emergency for COVID-19 ends, something I’ve previously covered in this publication.
Boston establishes neighborhood-level wastewater testing: Finally, one bit of wastewater surveillance news: the city of Boston is setting up 11 new sites to test wastewater, giving local public health officials more granular information about how COVID-19 is spreading in the region. The new initiative is a partnership with Biobot Analytics, the same wastewater testing company that has long worked with Boston, the CDC, and public health institutions across the country. (Boston was one of the first cities to start doing this testing.) Also, speaking of Biobot: the company just added a nice chart of coronavirus variants in U.S. wastewater over time to its dashboard.
CDC awards $3 billion to improve public health infrastructure: The CDC announced this week that it has awarded state and local public health agencies a total of $3.2 billion to support hiring and training new workers, along with other infrastructure needs. The agency published a breakdown of all the agencies that received awards, although it has not included specific details on what funds will be used for in each place. Local reporters, if your health department received funding, this might be worth looking into!
CDC expands wastewater testing for polio: Another notable CDC announcement this week: the agency is expanding its wastewater surveillance for polio to two new areas, Oakland County, Michigan and Philadelphia. Testing wastewater for polio is more complicated than testing it for the coronavirus, as STAT News’ Helen Branswell explains in this article; as a result, the CDC is expanding this surveillance in a more limited capacity than what it’s doing for other viruses, like monkeypox and the flu.
Majority of COVID-19 deaths are now among vaccinated people: A new report from the Kaiser Family Foundation explains why more than 50% of COVID-19 deaths in the U.S. in recent months were among people who had received at least two vaccine doses. According to KFF, factors driving this trend include the rising share of Americans who are vaccinated, waning protection from initial doses, and low uptake of booster shots—particularly of the Omicron-specific boosters that provide better protection against newer variants. More reason to get the new booster if you haven’t yet!
Paid sick leave correlates with higher vaccination rates: Speaking of vaccination: a new study from researchers at Drexel University and Boston University found that large U.S. cities with city-wide paid sick leave policies had higher vaccination rates than those without such policies. The correlation was particularly evident in neighborhoods with higher social vulnerability, the researchers found. Expanding paid sick leave could help reduce inequities in vaccination coverage, the paper’s authors recommend.
No monoclonal antibody drugs are currently authorized in the U.S.: This week, the FDA announced that bebtelovimab, a monoclonal antibody made by Eli Lilly, is no longer authorized for COVID-19 treatments in the U.S. The drug was designed based on older versions of the Omicron variant and doesn’t perform well against BQ.1 and BQ.1.1, the sublineages that are currently causing the majority of new cases in the U.S. As a result, no monoclonal antibodies are currently authorized, though Paxlovid and other treatments are still available.
COVID-19 Data Dispatch 