COVID-19 Data Dispatch

Tag: vaccine results

  • New COVID-19 vaccines are now available: 10 key facts and statistics about these shots

    New COVID-19 vaccines are now available: 10 key facts and statistics about these shots

    Data from a CDC presentation suggest that people of all ages, including children, receive a benefit from updated COVID-19 vaccines.

    We now have two new COVID-19 vaccines available for this year’s respiratory virus season, one from Pfizer and one from Moderna, which are expected to perform well against current variants. The FDA approved both vaccines this week, and the CDC recommended them for almost all Americans.  A third option, from Novavax, may become available in the coming weeks as well.

    The federal government aims to present this fall’s shots as the next iteration in routine, annual COVID-19 vaccines—similar to the routine we’re all used to for flu shots. In fact, I’ve seen some news suggesting that the federal health agencies don’t want us to call these shots “boosters,” instead calling them “updated” shots or annual shots.

    But this fall’s vaccine rollout is likely to be anything but routine, as it’s the first rollout following the end of the federal COVID-19 public health emergencies. The government is no longer purchasing shots and distributing them for free; now, insurance companies will have to cover the shots.

    As a result, many Americans—especially those without health insurance—will have a harder time accessing these vaccines than they have for previous shots. Plus, the federal emergency’s end will make it harder for us to track how the vaccines are performing, as the coronavirus continues to evolve into new variants.

    With all of these complications in mind, here are ten key facts and statistics that you should know about this fall’s COVID-19 vaccines.

    Pfizer and Moderna’s shots have been approved and recommended for all Americans, ages six months and older.

    Despite some debates among scientists about whether younger people really need updated COVID-19 shots, the FDA has approved these vaccines—and the CDC has recommended them— for all age groups. This is important because CDC recommendations are often the basis for insurance coverage, as experts explained at a webinar hosted by the National Press Foundation on Tuesday.

    The shots exclusively target XBB.1.5, a coronavirus lineage that is common in the U.S. and globally right now.

    According to the CDC’s genomic surveillance program, almost all cases in the U.S. in recent weeks have been caused by XBB.1.5 or related variants from the XBB lineage. Variants like EG.5 and FL.1.5.1 are also XBB descendants, which have been given nicknames to make it a bit easier for scientists to keep track of them.

    It’s also important to note that, unlike last year’s boosters, this fall’s shots are monovalent vaccines—meaning they only target XBB.1.5. The shots no longer target the original strain of SARS-CoV-2 that first circulated in 2020. Scientists generally approve of this choice, as the virus has mutated so much since that time.

    Moderna’s booster led to a 17-fold increase in antibodies against XBB.1.5 and XBB.1.6.

    The vaccine companies presented data to the CDC’s vaccine advisory committee on Tuesday. Moderna’s presentation included results from a study testing its new vaccine against several different variants, using blood samples from people who received the booster.

    About one month after vaccination with Moderna’s booster, the participants had about 17.5 times more neutralizing antibodies against XBB.1.5, 16.7 times more against XBB.1.6, 14 times more against EG.5.1, and 10 times more against BA.2.86. Pfizer also presented data, suggesting that their vaccine should similarly perform well against current variants.

    The new vaccines should lead to similar side effects as we’re used to from past mRNA shots.

    Based on data that the vaccine companies presented to the CDC’s committee, this fall’s Pfizer and Moderna vaccines should lead to similar side effects—headache, fatigue, muscle pain, etc.—as many of us have expected from past rounds of COVID-19 shots. The companies, along with the CDC and FDA, will continue to monitor these vaccines for any safety issues that may emerge as people start to get them.

    Young, unvaccinated children are at higher risk for COVID-19.

    One of the CDC presentations focused on how this fall’s vaccines may benefit young children. Last fall and winter, hospitalization rates were higher for COVID-19 than for the seasonal flu across all young age groups, from infants (under six months) to 12-17 years old. The vast majority of the children hospialized were not vaccinated or hadn’t received last year’s booster.

    For some CDC advisory committee members, these data were convincing in suggesting that this fall’s vaccine should be recommended for children, experts told STAT News. Vaccines updated to match current variants have a clear benefit for all age groups.

    Long COVID remains a significant risk for Americans across age groups.

    Another CDC presentation discussed Long COVID, as one of the potential adverse outcomes of a COVID-19 case. The CDC shared new data from a national survey conducted in 2022, which suggests that 9% of Americans ages 35 to 49 have experienced Long COVID symptoms (defined as symptoms lasting at least three months after a COVID-19 case). Adults ages 50-64 and 18-34 also reported high levels of Long COVID, at 7.4% and 6.8% ever experiencing symptoms, respectively.

    Many studies have shown that vaccination lowers risk of Long COVID, though it does not by any means eliminate this risk. While it’s good to see the CDC incorporating Long COVID into its vaccine risk/benefit discussions, much more research is needed to better understand how to prevent this debilitating condition.

    A Novavax vaccine is still in the pipeline.

    Novavax also presented data to the CDC’s advisors this week, suggesting that its vaccine (also based on XBB.1.5) should perform similarly to the Pfizer and Moderna options. But unlike the Pfizer and Moderna vaccines, Novavax’s has yet to receive FDA approval. The company has said it’s still planning to distribute its vaccine this fall, but it’s unclear when the FDA may authorize it. 

    Some people are eager to receive the Novavax vaccine this fall, rather than Pfizer or Moderna’s, because this vaccine uses a different mechanism to boost the immune system. It may also lead to fewer side effects than the mRNA vaccine, making it a potentially good option for people who’ve had particularly strong reactions. (I know a couple of readers have sent me questions about this, and aim to do a deep-dive on Novavax in a future issue.)

    Only 17% of Americans received last fall’s bivalent booster.

    The booster uptake last year was low, according to the CDC. Even among seniors, only 43% received the booster. Can we do better this year?

    A POLITICO/Morning Consult poll found that about 60% of respondents said they “probably or definitely” would get this year’s vaccine. (The poll included about 2,000 registered voters from across the U.S.) But it’s likely that access issues could get in the way for many people, as getting this COVID-19 vaccine will be much more challenging than it’s been in past rollouts.

    HHS program should provide free vaccines for 25-30 million adults.

    The Department of Health and Human Services has officially launched its “Bridge to Access” program, designed to provide free COVID-19 shots to uninsured Americans. Through this program, the HHS is essentially buying a small number of shots and distributing them to pharmacies, federally supported health centers, and other providers. You should be able to view these providers at vaccines.gov, according to the HHS. But I’ll be curious to see how well that actually works.

    This year’s vaccine rollout will be much harder to track.

    In the past, I’ve written about how the U.S. has failed to monitor breakthrough cases, or COVID-19 infections that occur after someone is vaccinated (and the hospitalizations, deaths, and long-term symptoms that may result). This year, not only are we failing to track breakthrough cases—the U.S. no longer has any national case data at all. We also no longer have vaccination data, as the CDC is not collecting this information from state and local health systems.

    So, how will we know how this year’s vaccine rollout goes? It’ll likely be a lot of guesswork, extrapolating from a few state/local health departments, polling data, and other smaller-scale research to estimate how many people are getting vaccinated nationally. This challenge is just another example of the damage that the federal government has done in the last year by dismantling many of its COVID-19 data systems.

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  • Answering reader questions: Incubation period, vaccines coming this fall, nasal sprays

    I received a couple of reader questions in recent weeks that I’d like to answer here, in the hopes that my responses will be more broadly helpful. As a reminder, if you ever have a COVID-19 question that you’d like to ask, you can email me at betsy@coviddatadispatch.com, or send it anonymously through this Google form.

    COVID-19’s incubation period

    One reader asked:

    I’d love to learn more about COVID’s incubation period. I have read that it’s 2 to 14 days … but the median time seems to be on the low end (and could be as low as 24 hours?) How likely is it that it’s more like 14 days? I’d love to better understand this so that I know how to better handle exposures… Should I avoid someone who has had an exposure for two full weeks?

    This is a tricky question for two reasons. First, the incubation period—or the time between exposure to COVID-19 and starting to show symptoms of infection—does indeed vary a lot. One review of studies on this topic, posted as a preprint in May, found a range from two to seven days, though it can be even longer. The CDC recommends precautions for up to ten days after exposure.

    Second, the incubation period has changed as the coronavirus has mutated. The virus is constantly evolving to keep infecting us even as people build up immunity; shortening the incubation period is one of its strategies. Omicron has a notably shorter period than past variants; Katherine Wu at The Atlantic wrote an article about this in December 2021 that I think is still informative.

    The preprint I cited above found that Omicron had an average incubation period of 3.6 days, shorter than other variants. I think it’s reasonable to assume that this period has continued to get shorter as Omicron has evolved into the many lineages we’re dealing with now. But the pace of research on this topic has slowed somewhat (with less contact-tracing data available for scientists to work with), so it’s hard to say for certain.

    So, with these complexities in mind, how should one handle exposures? My personal strategy for this (noting that I’m not a doctor or qualified to give medical advice, just sharing my own experience) is to rely on a combination of timing, testing, and symptom monitoring. For the first couple of days after exposure, you wouldn’t be likely to have a positive test result even if you are infected, as it takes time for enough virus to build up in the body for tests to catch it. So, for those days, I’d just avoid people as much as possible.

    After three to four days, PCR tests would start to be effective, and after five to six days, rapid tests would be. So at that point, I’d start testing: using a mix of PCR and rapid tests over the course of several days, up to two weeks after exposure. Studies have shown that the more tests you do, the more likely you are to catch an infection (and this applies to both PCRs and rapids). Daily is the best strategy, but less frequent regimens can still be useful if your access to tests is limited. At the same time, I’d keep track of any new symptoms, as that can be a sign of infection even if all tests are negative.

    I’d personally be comfortable hanging out with someone who has had an exposure but consistent negative test results and no symptoms. But others who are less risk-tolerant than I am might avoid any contact for two weeks. The type of contact matters, too: a short, outdoor meeting or one with masks on is safer than a prolonged indoor, no-mask meeting.

    Vaccine effectiveness

    Another reader asked:

    Is there any information on the effectiveness of the latest vaccines, including vaccines that combine Covid and RSV, and are there similarities between these viruses (related?)

    As we head into respiratory virus season in the U.S., there will be, for the first time, vaccines available for all three major diseases: COVID-19, the flu, and RSV. I’ll talk about effectiveness for each one separately, because they are all separate vaccines for separate viruses. There’s no combined COVID-RSV vaccine on the market.

    COVID-19: We know the fall boosters will target XBB.1.5, a variant that has dominated COVID-19 spread in the U.S. recently. There isn’t much data available on these vaccines yet, because the companies developing them (Pfizer, Moderna, Novavax) have yet to present about their boosters to the FDA and CDC, as is the typical process. The CDC’s vaccine advisory committee is meeting this coming Tuesday to talk fall vaccines, though, so it’s likely we will see some data from that meeting.

    Also worth noting: some early laboratory studies suggest that vaccines based on XBB.1.5 will provide good protection against BA.2.86, despite concerns about differences between these variants. (More on this later in today’s issue.)

    Flu: Every year, scientists and health officials work together to update flu vaccines based on the influenza strains that are circulating around the world. Effectiveness can vary from year to year, depending on how well the shots match circulating strains.

    This week, we got a promising update about the 2023 flu vaccines: CDC scientists and colleagues studied how well these shots worked in the Southern Hemisphere, which has its flu season before the Northern Hemisphere. The vaccine reduced patients’ risk of flu-related hospitalization by 52%, based on data from several South American countries that participate in flu surveillance. This is pretty good by flu vaccine standards; see more context about the study in this article from TIME.

    RSV: There are two new RSV vaccines that will be available this fall, both authorized by the FDA and CDC in recent months. These vaccines—one produced by Pfizer, one by GSK—both did well in clinical trials, reducing participants’ risks of severe RSV symptoms by about 90% (for the first year after infection, with effectiveness declining over time).

    Both vaccines were authorized specifically for older adults, and Pfizer’s was also authorized for pregnant people as a protective measure for their newborns. We’ll get more data about these vaccines as the respiratory virus season progresses, but for now, experts are recommending that eligible adults do get the shots. This article from Yale Medicine goes into more details.

    Nasal sprays as COVID-19 protection

    Another reader asked:

    I’m thinking of researching what foods and supplement are anti-viral anti-COVID. I’m wondering if anyone has done any research on that?

    I haven’t seen too much research on about foods and supplements, since dietary options are usually not considered medical products for study. Generally, having a healthy diet can be considered helpful for reducing risk from many health conditions, but it’s not something to rely on as a precaution in the same way as you might rely on masking or cleaning air.

    Another thing you might try, though, would be nasal sprays to boost the immune system. I have yet to try these myself, but have seen them recommended on COVID-19 Safety Twitter and by cautious friends. The basic idea of these nasal sprays is to kill viruses in one’s upper respiratory tract, essentially blocking any coronavirus that might be present from spreading further. People take these sprays as a preventative measure before potential exposures.

    A couple of references on nasal sprays:

    https://twitter.com/Clean_Air_Club_/status/1685790242681331713

  • Sources and updates, August 20

    • New toolkit for estimating COVID-19 risk from wastewater: Researchers at Mathematica published a new, open-source toolkit for interpreting wastewater data. It includes an algorithm that scientists and health officials can use to identify when a new surge might be starting based on wastewater results, as well as a risk estimator tool that combines wastewater data with healthcare metrics. The researchers developed this toolkit using data from North Carolina during the Delta and Omicron surges; their paper in PNAS last month describes it further, as does a blog post by the Rockefeller Foundation (which funded the project). This tool doesn’t provide real-time updates, as it only includes wastewater data through December 2022, but it offers a helpful model for using this source to inform public health policies.
    • Vaccine delays for uninsured Americans: The CDC estimates that new COVID-19 boosters will become available in late September or early October, as I wrote last week. But Americans without health insurance may have to wait longer to get the shots or pay a hefty price tag, according to recent reporting from POLITICO. A federal government program with national pharmacy chains, which will provide the shots for free to uninsured people, is not slated to start until mid-October. Instead, uninsured people will need to pay out-of-pocket or find one of a small number of federal health centers to get vaccinated; this is likely to discourage vaccinations, POLITICO reports. And the number of uninsured people is only growing thanks to Medicaid redeterminations.
    • Budget cuts at the CDC could mean layoffs: A recent op-ed in STAT News, written by two researchers familiar with the CDC’s organizational structure, warns that budget cuts at the agency could lead to a significant reduction in public health workers. The CDC’s budget was cut as part of the federal government’s debt ceiling negotiations last month, the authors explain. It faces a cut of about 10%, or $1.5 million a year, which could lead to significant layoffs. The reduced jobs are particularly likely to impact staff at the state and local levels, the op-ed’s authors argue, rather than at the CDC’d headquarters in Atlanta. “Reductions there will cut public health services and will have their greatest impact on the most vulnerable populations,” they write.
    • Vaccine effectiveness for young children: Speaking of the CDC: the agency published a study this week in its Morbidity and Mortality Weekly Report describing COVID-19 vaccine effectiveness for the youngest children who are eligible (i.e. under five years old). Researchers at the CDC and partners at healthcare centers across the country tracked COVID-related emergency department and urgent care visits among young children, from July 2022 through July 2023. Effectiveness for the primary series was low: Moderna’s two-dose series scored just 29% effective at preventing ED and urgent care visits, while Pfizer’s three-dose series was 43% effective. Children who received a bivalent (Omicron-specific) follow-up dose were much more protected, however: this regimen was 80% effective. Bivalent boosers should be a priority for young kids along with adults, the study suggests.
    • Immune system changes following COVID-19: Another notable study from this week, from scientists at Weill Cornell Medicine and other institutions, describes how severe COVID-19 cases may damage patients’ immune systems. The researchers analyzed how specific genes were expressed in immune system cells taken from people who had severe cases of COVID-19. They found expression changes as long as a year after patients’ initial infections, and connected those changes to inflammation, organ damage, and other long-term issues. These genetic changes may point to one cause for Long COVID symptoms, though the study is somewhat limited by its focus on patients who had severe symptoms early on (as most people with Long COVID have initially milder cases).
    • Smell and taste loss following COVID-19: While smell loss has long been considered a classic COVID-19 symptom, a new study shows that taste loss is also common, even among people who don’t lose their sense of smell. Researchers at the Monell Chemical Senses Center (a nonprofit center in Philadelphia) studied these symptoms through an online survey, which included about 10,000 participants between June 2020 and March 2021. COVID-positive participants were more likely to report smell issues, taste issues, and both together, compared to people who didn’t get sick, the researchers found. Their survey methodology—which included asking people to self-assess their senses by smelling common household objects—could be used for further large-scale studies of these symptoms, the researchers write.

  • Sources and updates, August 13

    • CDC identifies continued Long COVID risk: A new study from the CDC this week, published in the agency’s Morbidity and Mortality Weekly Report, summarizes data from the CDC and Census Household Pulse Survey examining Long COVID prevalence in the U.S. According to the survey, Long COVID prevalence declined slightly from summer 2022 to early 2023, but has remained consistent this year at about 6% of all U.S. adults. The survey also found that about one in four adults with Long COVID consistently report “significant activity limitations” from the condition, meaning they are less able to work and participate in other aspects of daily life. Treating Long COVID and supporting long-haulers should be priorities for the healthcare system, the study’s authors write.
    • Mitochondrial dysfunction in Long COVID: Another new paper, published this week in Science Translational Medicine, demonstrates the role that mitochondria may play in Long COVID. Researchers at the Children’s Hospital of Philadelphia studied tissue samples from autopsies and animals infected with COVID-19, finding that the coronavirus led to malfunctioning mitochondria in several key organ systems. These malfunctions may contribute to Long COVID symptoms such as fatigue and brain fog, and could be a target for future treatments. Elizabeth Cooney at STAT News covered the study in more detail.
    • Benefits of vaccination during pregnancy: One more notable new study: researchers at the National Institute of Allergy and Infectious Diseases (or NIAID, part of the NIH) tracked the impacts of COVID-19 vaccination for pregnant people. The study included 240 vaccinated participants who contributed blood samples, between July 2021 through January 2022. Both the parents and their newborns developed antibodies against the coronvirus following infection, the researchers found. While previous papers have demonstrated the value of vaccination for new parents, this study is one of the largest so far to show that protection is conferred to newborns.
    • Wastewater surveillance webinar from the People’s CDC: If you’ve been following wastewater data to keep up with COVID-19 trends but have had questions about how this form of surveillance works, you may find it helpful to watch this recorded webinar from health advocacy organization the People’s CDC. In the video, Marc Johnson, a professor at the University of Missouri and director of the state’s wastewater surveillance program, talks through how wastewater is tested for the coronavirus (and variants), how to interpret wastewater data, cryptic lineages, and more. Understanding this novel data source is increasingly important now, as traditional healthcare data on COVID-19 are less reliable.
    • New federal heat surveillance dashboard: Finally, in other public health news, the federal government has launched a new dashboard to track heat-related health issues. The dashboard compiles data from Emergency Medical Services reports across the country, representing responses to 911 calls for any health reason related to heat stress. (You can see the list of potential health events in the dashboard’s documentation.) Currently, many southern states are experiencing high levels of heat-related health problems, according to the dashboard. Many of the same states are also experiencing COVID-19 upticks right now—trends that may be related, as more people gather inside during hot weather.

  • Sources and updates, August 6

    • Novavax vaccine safety: This week, the CDC published new data in its Morbidity and Mortality Weekly Report (MMWR) affirming the safety of Novavax’s COVID-19 vaccine. Unlike the Pfizer and Moderna vaccines (which use the virus’ genetic information), the Novavax vaccine works by inserting direct copies of the coronavirus spike protein into the body. It was authorized in summer 2022 as a primary series or booster for people who may be unable or unwilling to receive an mRNA vaccine. The CDC found that, among 70,000 Novavax vaccine doses administered between July 2022 and March 2023, no new safety concerns emerged.
    • Insurance coverage for COVID-19 tests: Insurance companies have covered COVID-19 tests very unevenly since the federal health emergency ended this spring. But that could change, if an advisory panel called the U.S. Preventive Services Task Force recommends that the federal government require insurers to cover COVID-19 testing. The panel is exploring this option, reports Sarah Owermohle at STAT News, though it could face legal challenges.
    • Breath test for COVID-19: A couple of weeks ago, I shared a new tool for detecting SARS-CoV-2 particles in the air, developed by researchers at Washington University in St. Louis. The same team has just published another paper, in ACS Sensors, about a similar tool that can diagnose a coronavirus infection using a patient’s breath. This breath test can detect the virus with as few as two breaths and in under 60 seconds, and is close in accuracy to a PCR test. The research team is working to continue testing this device and potentially manufacture it more broadly, according to a press release.
    • COVID-19 spread among white-tailed deer: A recent paper in Nature Communications describes how SARS-CoV-2 has circulated widely among white-tailed deer across the U.S. The research team (which includes scienitsts at the CDC, U.S. Department of Agriculture, and the University of Missouri) collected about 9,000 respiratory samples from deer in 26 states and Washington D.C. between fall 2021 and spring 2022. Hundreds of the samples were positive for SARS-CoV-2, leading the team to study genetic sequences and study how the virus had evolved in this population. The team’s full data are available online. (H/t Data Is Plural.)

  • Sources & updates, June 25

    • Commonwealth Fund releases 2023 state health scorecard: This week, health research organization the Commonwealth Fund published its 2023 rankings of state health systems. These rankings are an extensive data source for anyone seeking to better understand the decentralized health system in the U.S., and may be particularly useful for local reporters looking for data on how their state compares to others. In the 2023 rankings, the researchers have added new metrics related to care and health outcomes for women, mothers, and infants. This year’s data also highlight preventable deaths from COVID-19 and other causes, and state efforts to take people off of Medicaid following the pandemic emergency’s end.
    • New advisory about Long COVID and mental health: The U.S. Substance Abuse and Mental Health Services Administration (SAMHSA), a federal health agency under the overall Department of Health and Human Services (HHS), published a detailed advisory explaining the mental health implications of Long COVID. This advisory is directed at primary care doctors who may be seeing Long COVID among their patients, as well as others in the medical community who may benefit from the information. SAMHSA highlights that mental health symptoms may result from a coronavirus infection itself as well as from the stress and social isolation that long-haulers experience. For more on this topic, check out this article I wrote last year.
    • Rapid test accuracy can vary widely: A common question that I’ve received from readers in the last few months has been, “How accurate are rapid tests with newer variants?” A new study, published last week in the journal Microbiology Spectrum, offers some insight. The researchers (a team at CalTech) found that rapid tests still work to detect the coronavirus, but their accuracy varies based on viral load and specimen type. Tests that involved swabbing the patient’s throat (along with their nose) were significantly more accurate than nose swabs alone. Tests conducted later in the course of a patients’ infection, when they had higher viral loads, were also more accurate, though some patients never tested positive on rapid tests despite testing positive on PCR. My takeaway here: swabbing your throat and testing multiple times help improve accuracy, but the best option is always to get a PCR if you can.
    • CDC and state agencies track reinfections: Another new study, published this week in the CDC’s Morbidity and Mortality Weekly Report, examines coronavirus reinfections in the era of Omicron. Researchers at the CDC and 18 state and local health departments collaborated to track reinfections from September 2021 through December 2022, finding that these infections went up significantly when Omicron arrived in late 2021. The median time between infections ranged from 269 to 411 days, the researchers found, suggesting that Americans may expect to be sick with COVID-19 once or twice a year while our Omicron baseline persists. 
    • COVID-19 risk and air pollution exposure: One more study I wanted to highlight this week: researchers at Hasselt University in Belgium tracked the air pollution exposures of about 330 COVID-19 patients at hospitals in Belgium. Patients who were exposed to worse air pollution prior to their admission experienced more severe COVID-19 outcomes, including longer hospitalization and admission to the ICU. This paper provides further confirmation that poor air quality and COVID-19 can be compounding health problems for many people.
    • Data problems persist with non-COVID vaccines: The CDC’s vaccine advisory committee met this week to discuss two new RSV vaccine candidates, recently approved by the FDA for seniors. While the CDC committee did vote to recommend these vaccines, I was struck by discussion (in Helen Branswell’s coverage for STAT) that the experts said they did not have sufficient data to make a truly informed decision. I’ve written a lot about data issues for COVID-19 vaccines; the same decentralized health system problems that make it hard to track COVID-19 vaccine effectiveness also apply to products for other diseases.

  • Updated COVID-19 vaccines are coming this fall

    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.

    Here are a few key points from the meeting, citing from Your Local Epidemiologist and the Associated Press’ coverage:

    • 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.

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  • Sources and updates, May 28

    • New Long COVID papers from the Patient-Led Research Collaborative: Speaking of new Long COVID research: the Patient-Led Research Collaborative, a group of long-haulers who do and support research on their condition, has recently published two new papers. The first, published in Nature and based on a patient survey, discusses Long COVID’s intersection with common psychiatric conditions such as depression and anxiety. The second, published in Fronteirs in Rehabilitation Science, is a review paper going over the reproductive health impacts of Long COVID. Long COVID frequently causes disruptions to the menstrual cycle, gonad function, fertility, and other areas of reproductive health, yet these symptoms are understudied.
    • FDA fully approves Paxlovid: The FDA has provided full approval to Pfizer for its antiviral COVID-19 pill, Paxlovid. Millions of Americans have received Paxlovid since it earned Emergency Use Authorization in late 2021, and many studies have shown that it’s effective in reducing the risk of severe COVID-19 symptoms. With the federal public health emergency’s end, the FDA has encouraged pharmaceutical companies to apply for full approval for their COVID-19 products so that they can permanently remain on the market; Paxlovid is a high-profile example of that trend.
    • Bivalent COVID-19 vaccines protect, but wane: The CDC published another study this week evaluating the bivalent (or Omicron-specific) COVID-19 booster shots. These vaccines clearly provide additional protection against severe COVID-19 symptoms, the study finds, but this immune system boost goes away after several months. In the study, vaccine effectiveness against hospitalization declined from 62% in early weeks post-vaccination, to 24% at three to six months post-vaccination. The study shows that additional boosters and/or newer vaccines are needed for vulnerable adults.
    • Value of regular testing for controlling outbreaks: Another notable new study: researchers at the University of Wyoming compared how well different mitigation strategies work for preventing the spread of COVID-19 and other diseases, using a model informed by both epidemiological and economic factors. They found that frequent testing—paired with isolation for people who tested positive—was more effective at reducing disease spread than physical distancing measures, like closing businesses or having employees work from home. The paper suggests that testing can help reduce illness while keeping businesses open.
    • Funding for a WHO disease surveillance initiative: The Rockefeller Foundation and World Health Organization recently announced a new partnership, with the foundation providing $5 million to support the WHO’s Hub for Pandemic and Epidemic Intelligence. This Hub was established in 2021, with goals including fostering global collaboration on disease surveillance, providing better (and more complete) data, and improving tools for public health decisions. Rockefeller’s support will help with scaling up genomic surveillance, real-time data collection, and more.

    All featured sources

  • Sources and updates, May 7

    • 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.

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  • FDA and CDC simplify COVID-19 vaccine guidance

    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.

    Here are the main updates you should know. For more details, I recommend reading Helen Branswell’s reporting in STAT News and/or Katelyn Jetelina’s coverage in Your Local Epidemiologist.

    • 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.

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