COVID-19 Data Dispatch

Tag: vaccine results

  • Next-generation COVID-19 vaccines: what you should know

    Next-generation COVID-19 vaccines: what you should know

    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.

    More on vaccines

  • Sources and updates, February 26

    • Deaths in U.S. prisons: Throughout the pandemic, the UCLA COVID Behind Bars Data Project has been a leading source for data on COVID-19 cases and deaths in carceral settings. As COVID-specific data on prisons and jails have become more sporadic, the project recently turned its attention to overall mortality data in these settings. Last week, the UCLA team released a new dataset sharing all-cause deaths in prisons through 2020, which combines data from public reports and records requests. The full dataset is available on GitHub, and a summary of this project’s findings on all-cause mortality was published in the New York Times last weekend.
    • BIOFIRE syndromic trends data: BIOFIRE Diagnostics is a biotech company focused on diagnostic testing, offering tests for a variety of viruses, bacteria, and other pathogens. The company publishes anonymized test results from its labs on its Syndromic Trends dashboard; this dashboard is a helpful way to get an overview of test positivity for COVID-19 compared to other common diseases. (H/t Force of Infection.)
    • R&D roadmap for COVID-19 vaccines: The University of Minnesota’s Center for Infectious Disease Research and Policy has published a new report outlining the research and development steps needed for the world to produce coronavirus vaccines that are “broadly protective,” not tied to a specific variant. It includes recommendations for research on virology, immunology, and vaccine technologies, along with information on using animal models and guidance on vaccine policy. Related: the CDC’s Advisory Community on Immunization Practices met this week to discuss COVID-19 and other vaccines.
    • CDC reports on travel surveillance: Two new studies about COVID-19 among international travelers to the U.S. were published in this week’s CDC Morbidity and Mortality Weekly Report. Both studies describe results from the agency’s Travel Surveillance program, which is a collaboration with biotech company Ginkgo Bioworks and testing company XpresCheck. One report compares traveler test results from before and after the U.S. ended its pre-departure testing requirement for international flights, finding that travelers were much more likely to have COVID-19 after the requirement was lifted. The second report provides results from a pilot program testing airplane wastewater at JFK Airport; this report found that the vast majority of plane samples tested were positive for SARS-CoV-2, and researchers identified a variety of Omicron variants. More work is needed to really get airplane wastewater testing going in the U.S., but it’s good to see early results showing this program’s feasibility.
    • Early data from XBB.1.5 in NYC: Another notable study in CDC MMWR this week provided analysis from New York City’s health department on Omicron XBB.1.5. The subvariant was first identified in the city in October 2022 (though it may have evolved somewhere else), and quickly spread through the region; it accounted for 81% of sequenced COVID-19 test samples by early January. The NYC health department linked sequencing data with patient outcomes data, finding that people infected with XBB.1.5 were not significantly more likely to be hospitalized or to die from COVID-19 compared to those infected with other variants. In other words, XBB.1.5 appears to not cause more severe disease, based on this report.
    • Predicting COVID-19 cases based on wastewater results: One more newsworthy study to share this week: researchers at Hokkaido University developed a mathematical model to predict COVID-19 cases based on coronavirus concentration levels in Sapporo, Japan. I’m always on the lookout for studies like this, as wastewater data become increasingly important to track true infection numbers. (Here’s a prior example, from the University of Florida.) Of course, it’s worth noting that the Hokkaido researchers had consistent wastewater and case data from spring 2020 through 2022 to use for their model; for wastewater researchers working in the U.S. now, that consistency is often harder to achieve.

    All featured sources

  • Sources and updates, February 19

    Just a couple of updates today!

    • Test positivity will become less reliable after PHE ends: CBS News COVID-19 reporter Alexander Tin flagged last week that, after the federal public health emergency for COVID-19 ends this spring, private labs that process PCR tests will no longer be required to report their results to state health departments. States will still report any results they get to the CDC, but federal officials expect that this data will become much less reliable, according to a background press briefing from the Department of Health and Human Services (HHS). Case data are already unreliable; soon, we won’t even have consistent test positivity data to tell us how unreliable they are. This may be one of several data sources that get worse after the end of the PHE.
    • HHS is supporting improved healthcare data sharing: The inability to connect different health records systems (or lack of interoperability, to use the technical term) has been a big problem during the pandemic, as researchers and health officials often couldn’t answer questions that require multiple health datasets. HHS has taken some steps to improve this situation, while also making it easier for individual patients to access their personal records. Most recently, HHS announced that it’s chosen six companies and organizations to develop data-sharing platforms, according to POLITICO. It’ll take some time for these organizations to start actually sharing data, but I’m glad to see any movement on this important issue.
    • Yes, vaccination is still the best way to get protected from COVID-19: A new study from the Institute for Health Metrics and Evaluation, published in the Lancet this week, has been making the rounds on social media recently. Anti-vax pundits are claiming the study shows that immunity from a prior coronavirus infection is more effective than immunity from vaccination at preventing future severe COVID-19. While the study does show that a prior infection can be helpful, the authors found a significant drop in the value of this type of protection after Omicron variants started circulating in late 2021. And, as some commentators have pointed out, infections can always lead to severe symptoms and Long COVID—the risks from vaccination are much lower. Basically, this XKCD comic remains accurate.

  • Sources and updates, February 12

    • CDC committee recommends adding COVID-19 to childhood vaccine schedule: The CDC’s Advisory Committee on Immunization Practices (ACIP), which makes guidance on vaccination policies, issued a report this week recommending that COVID-19 vaccines be added to the standard childhood immunization regimen. Under the new guidelines, most children ages six months and older should receive two doses of a Moderna or Pfizer vaccine, followed by a bivalent/Omicron-specific booster shot. Immunocompromised children are eligible for additional doses.
    • KFF’s latest COVID-19 Vaccine Monitor focuses on winter surge: The Kaiser Family Foundation recently released the January 2023 update of its Vaccine Monitor project, which tracks U.S. sentiment around COVID-19 vaccines (and other pandemic topics) over time. In the latest round of surveys, KFF researchers found that about 38% of U.S. adults reported that “their households experienced either COVID-19, the flu, or RSV over the past month or so.” About 46% of adults reported that the news of these viruses made them more likely to take safety precautions. The report also includes data on bivalent booster shot uptake, behavior among immunocompromised people, and more.
    • New variants have yet to emerge from China, study suggests: A new paper from researchers at the Beijing Center for Disease Prevention and Control, published in The Lancet this week, found that COVID-19 cases in China during November and December 2022 were primarily driven by the Omicron subvariants BA.5.2 and BF.7. Both of these lineages entered China from other countries, rather than evolving during the country’s surge following the end of its “zero COVID” policies. The new paper is good news for global health experts who’ve been worried about new variants emerging from China, though outside reviewers have cautioned that it’s only one small snapshot of cases in the country, according to reporting by POLITICO EU. 
    • Wastewater surveillance has a global health equity problem: Another study that caught my attention this week was a paper from the COVIDPoops19 team at the University of California Merced, summarizing findings from their global wastewater dashboard. The team reviewed wastewater surveillance projects at over 200 universities, 1,400 sites, and 55 countries, and found that monitoring primarily occurred in high-income countries. The researchers also examined open access to data, finding that high-income countries were better at sharing information with researchers and with the public. For wastewater-based epidemiology to reach its full potential, “show us the data,” the team writes in their paper’s abstract.
    • Microbiome research shows promise for understanding ME/CFS: In one more piece of research news: two recent studies suggest that the gut microbiome could play a role in causing myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), a debilitating chronic disease that often occurs after viral infection. In research projects funded by the National Institutes of Health, scientists found specific changes to gut bacteria that were associated with ME/CFS patients. These changes could potentially be used as biomarkers to diagnose ME/CFS and as starting points for treatment. The new research also has potential implications for Long COVID, as many Long COVID patients meet the diagnostic criteria for ME/CFS.

    All featured sources
  • The future of COVID-19 vaccines needs more data

    The future of COVID-19 vaccines needs more data

    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 this since 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.

    More vaccination data

  • Sources and updates, January 15

    • New Long COVID review from PLRC and Scripps: Leading Long COVID researchers from the Patient-Led Research Collaborative and the Scripps Research Translational Institute collaborated on a review paper published this week in Nature, summarizing major findings from the literature so far. The paper includes summaries of major symptoms (ranging from cardiac damage to cognitive impairment), correlations between Long COVID and other chronic diseases (ME/CFS, POTS, etc.), treatment options for specific symptoms and/or biological mechanisms, and much more. I haven’t had a chance to read the paper in full yet, but I anticipate that it will be a valuable resource for future research.
    • Vaccines still reduce risk of transmission: Another recent paper in Nature reports on the impact of vaccination among inmates in the California state prison system. Researchers at the University of California San Francisco analyzed COVID-19 surveillance data from 35 prisons during the early months of Omicron (December 2021 to May 2022). They found patients infected with Omicron after vaccination and/or a prior infection had lower risks of transmitting the virus to others. The study suggests that vaccination (and prior infection) is still helpful in reducing COVID-19 spread in addition to reducing severe symptoms, even at this point in the pandemic. (H/t Your Local Epidemiologist.)
    • Coronavirus found in airplane wastewater on international flights: In a small study, researchers at the National Public Health Laboratory of Malaysia tested wastewater samples from 29 flights that arrived at Kuala Lumpur from outside the country. The researchers found that SARS-CoV-2 was present on 28 of the 29 flights—and testing for the remaining flight wasn’t yet complete, according to a local news outlet that covered the study. While this is a relatively small sample, the results suggest that COVID-19 is very prevalent in travel settings. The study also serves as a helpful example for future plane wastewater testing.
    • New report highlights nursing home issues: A recent report from the American Health Care Association shares results from a survey of 524 nursing homes across the U.S. The findings show challenges with staffing and economic challenges; for example, 84% of the nursing homes surveyed reported “moderate to high levels of staffing shortages,” and 67% of the homes surveyed reported concerns that they may need to close their facilities due to staffing problems. (H/t POLITICO Pulse.)
    • End of Ebola outbreak in Uganda: Finally, a bit of (non-COVID-19) good news: this week, health officials in Uganda declared the end of the country’s recent Ebola outbreak. The outbreak started in September 2022, and included a total of 164 cases and 55 deaths. The final patient of this outbreak was released from healthcare on November 30, according to the World Health Organization; Uganda successfully curbed the disease’s spread despite a lack of vaccines and treatments approved against the strain of Ebola that was spreading.

    All featured sources

  • Sources and updates, November 20

    • CDC update on COVID-19 mortality trends: This week, the CDC published a detailed report about how deaths from COVID-19 have changed in 2022. Overall, between 2,000 and 4,500 COVID-19 deaths were reported each week between April and September 2022, the CDC researchers found; this is lower than at earlier points in the pandemic, but still represents a loss of more than 100,000 Americans over the course of a year. Older adults and those who were un- or under-vaccinated had a higher risk of death from COVID-19, the researchers found; racial and ethnic disparities have “decreased, but persisted.”
    • Moderna reports new data on its bivalent booster: Several studies in the last couple of weeks have indicated that the new, Omicron-specific boosters from Pfizer and Moderna are more effective against new variants than the older vaccines. Moderna provided additional data this week, reporting that its new booster led to five times more antibodies that neutralize Omicron BA.4 and BA.5 compared to earlier booster shots. While Moderna’s study hasn’t yet been peer-reviewed, the results are promising in following a trend from past studies, STAT’s Matthew Herper reports.
    • Booster shots could keep kids from missing school: Speaking of the new boosters: a new report from the Commonwealth Fund provides analysis of the boosters’ potential impact on school-aged children, as all kids older than five are eligible for the shots. If 80% of eligible Americans receive their bivalent boosters by the end of 2022, the report suggests, this could save over 46 million days of isolation and over 50,000 hospitalizations for school-aged children, along with other benefits. Even getting kids boosted at the level of flu vaccination in 2020-2021 would prevent millions of days of school from being lost.
    • Test to treat is inaccessible to rural Americans: A new study, published this week in JAMA Network Open, examined equity issues with the Biden administration’s Test to Treat initiative. The initiative was designed to provide locations where Americans could get a COVID-19 test and then, if they received a positive result, quickly receive a free antiviral drug. But many people don’t live near available locations, the researchers found: “approximately 15% of the overall US population, 30% of American Indian or Alaskan Native people, and 59% of the rural population lived more than 60 minutes from the nearest site,” they write.
    • Perception of local COVID-19 levels: A lot of people are acting with incorrect knowledge of their local COVID-19 risk, a new study in the CDC’s Morbidity and Mortality Weekly Report suggests. Researchers from several medical and public health institutions surveyed people who had recently tested positive for COVID-19 in Detroit, Michigan and DuPage County, Illinois, during June and July, 2022. About half of the 5,000 people surveyed said that they thought local COVID-19 transmission was “low or moderate,” even though it was actually at high levels in both places.

    All featured sources

  • Sources and updates, November 6

    • New data on Omicron boosters: This week, we got two major updates on the safety and effectiveness of the bivalent, Omicron-specific booster shots from Pfizer and Moderna. First, a study in the CDC’s Morbidity and Mortality Weekly Report examined safety, finding that side effects of the new boosters similar to the side effects of previous vaccines, according to the agency’s vaccine surveillance systems. For example, about 60% of vaccine recipients experienced pain, swelling, or itching in the arms where they received the shot. And second, Pfizer and BioNTech shared new data about the companies’ bivalent booster, suggesting that the new booster produces four times more neutralizing antibodies against BA.4 and BA.5 compared to the original booster shot. The study focused on older adults (over age 55) but is still helpful evidence that the new boosters are more effective against currently-circulating variants.
    • NIH RECOVER is preparing its first clinical trial: RECOVER, the National Institutes of Health’s flagship study to understand and eventually treat Long COVID, announced this week that it’s preparing clinical trials to test potential treatments. The first of these trials was recently posted to ClinicalTrials.gov (a site for tracking studies that have received federal funding). This trial will focus on testing Paxlovid for Long COVID patients, and RECOVER anticipates it will begin enrolling patients in early 2023. Patients have previously expressed concerns that RECOVER is moving pretty slowly with trials, considering how many Americans are impacted by Long COVID.
    • Patients Rising Now Congressional Scorecard: Speaking of government action on medical issues: Patients Rising Now, an advocacy organization focused on patients with chronic illnesses, recently published its first scorecard for Congressional representatives. The resource grades every Senator and House member in the 117th Congress based on how their voting record aligns with the organization’s priorities. While COVID-19 is not specifically mentioned in the grades, this scorecard could have implications for future pandemic-related votes.
    • COVID-19 vaccination and race/ethnicity inequities: A new paper from researchers at the University of Minnesota and Boston University examined how vaccination impacted COVID-19 mortality patterns in Minnesota. During the Delta and Omicron surges, the researchers found, mortality among middle-aged people of color was higher than mortality among white people in an age group ten years older. The paper shows that COVID-19 remains “a pandemic of the disadvantaged,” author Elizabeth Wrigley-Field wrote on Twitter. (Disclaimer: through my work at MuckRock, I am collaborating with BU researcher Andrew Stokes, one of the paper’s coauthors.)
    • RSV vaccine(s) could be coming soon: Finally, a bit of good news about another respiratory virus: two potential vaccines for RSV are likely to be under FDA review in the coming months. Pfizer recently reported promising results from a clinical trial of a vaccine for pregnant people, who pass antibodies to their children (thus reducing infant RSV risk). And U.S. pharmaceutical company GSK reported results from a trial testing its RSV vaccine for older adults.

    All featured sources
  • Data considerations for the new Omicron-specific booster shots

    Data considerations for the new Omicron-specific booster shots

    We don’t have data yet on the BA.4/BA.5 vaccines in humans, but studies in mice have been promising. Screenshot from Moderna slides presented to CDC ACIP this week.

    This week, the FDA and CDC authorized new booster shots from both Pfizer and Moderna that are tweaked to specifically target Omicron BA.4 and BA.5. The vaccines will start becoming available at pharmacies and doctors’ offices across the country in the coming days.

    Much of the media coverage of these new boosters has focused on the fact that they’re the first COVID-19 vaccines derived from a newer variant, as opposed to the original Wuhan strain. BA.5 and BA.4.6, a sublineage of BA.4, are causing almost all COVID-19 cases in the country right now; some experts hope that a booster campaign targeted to these versions of the coronavirus will lead to actual decreases in transmission, not just severe disease.

    While this is an important milestone, I’d like to focus on a couple of reasons these shots are notable from a data perspective. First, the Omicron boosters are the first COVID-19 vaccines authorized in the U.S. without data from human trials. During vaccine development, companies typically start with lab studies, then test the vaccine in animal models, then in humans. Because the BA.4/BA.5 shots were designed so recently, Pfizer and Moderna haven’t had time to test them in humans yet.

    From a safety and efficacy perspective, this lack of data isn’t a huge concern because the new vaccines are very close to BA.1 versions that have been tested in humans. As Katelyn Jetelina explained in a Your Local Epidemiologist post about the new vaccines:

    Literally the difference of a few amino acids—like a few letter edits on a Word document. We aren’t changing the number of words in the paper (like dosage of RNA), or the content of the paper, or the platform (like Word to Excel). Because of the minimal change, we are confident that BA.1 bivalent safety data will accurately reflect BA.5 safety.

    Another important piece of context here is that flu vaccines—which are updated each year to reflect currently circulating versions of the virus—are typically not tested in humans before they’re rolled out in annual flu campaigns. So, the new COVID-19 shots are following an existing process; future vaccine adjustments for new variants going forward will likely happen in a similar way.

    Second, the Omicron boosters are the first COVID-19 vaccines authorized in the U.S. before they’ve been tested in other countries. For previous booster campaigns, effectiveness data from countries with better-organized health systems that started using new rounds of shots before we did (such as the U.K. and Israel) have been key for U.S. regulators making authorization decisions. 

    But the BA.4/BA.5 boosters haven’t been rolled out anywhere else yet. Several other countries (the E.U., the U.K., Canada, Switzerland, Australia) have authorized Omicron BA.1 boosters—those that have gone through more clinical testing. The U.S. is the first to try the BA.4/BA.5 option. It will be interesting to see whether there are significant differences in how these countries’ fall booster campaigns mitigate potential surges.

    And third, these boosters are likely to be the last COVID-19 vaccines authorized while they’re still covered by federal funding. Recent announcements from officials like Ashish Jha have suggested that, in 2023, the government will stop buying vaccine supplies in large quantities to distribute for free. Instead, COVID-19 vaccines will start to be privately-purchased, health insurance-mediated products like other vaccines.

    While some local governments and large health institutions will likely still organize free vaccine distributions for future rounds of shots, the lack of federal supplies will be a major shift. It will make COVID-19 vaccination harder to access, especially among people without health insurance—likely leading to even lower uptake. We need to make this last free booster campaign count.

    Going forward, here are a few questions I’ll be tracking as these boosters get rolled out:

    • How will public health agencies track the effectiveness of these new vaccines? We’ll want to see how the BA.4/BA.5 shots compare to prior boosters at preventing infections, hospitalizations, and deaths. Data on breakthrough cases is already pretty limited in the U.S., so we may have to rely on specific local health departments and health systems that have better infrastructure for this.
    • What additional boosters might be needed in the future? As we examine how well these Omicron-specific boosters work, we will need to keep track of the potential need for more shots. Will immunocompromised people or older adults need second rounds of Omicron shots, for example?
    • What new variants will come on the scene? Also impacting the potential need for further vaccine shots: the arrival of new variants, either continued Omicron mutations or something else entirely. Wastewater surveillance may be particularly helpful for variant tracking as PCR testing continues to be less available.
    • How will the privatization of vaccines impact tracking? If COVID-19 vaccines are no longer purchased and distributed by the federal government after 2022, will this impact the CDC’s ability to track vaccinations? We’re already seeing more vaccine distribution at private pharmacies and doctors’ offices as opposed to publicly-run clinics; I wonder how this trend may continue.

    For more information on the new boosters, check out: 

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  • We need more data for fall booster decisions

    We need more data for fall booster decisions

    At the FDA advisory committee meeting this week, Pfizer presented data from different options of Omicron-specific booster shots.

    This week, the FDA’s vaccine advisory committee met to discuss fall booster shots, in anticipation of another COVID-19 surge next winter. The discussion demonstrated the U.S.’s continued failure to provide the data that are really needed to make these decisions.

    I have written a lot about this topic in the past, so to avoid being too repetitive, I’ll link to a couple of past articles:

    But here’s the TL;DR: due to the fractured nature of America’s public health system, it’s difficult for researchers to connect data on different health metrics. For example, a state might have one database with vaccination records and another database with case records, and the databases might not easily link to answer questions about breakthrough cases.

    Some state health departments have figured out how to make these links, but the process is not uniform. And the breakthrough case data we do have generally aren’t linked to information on variants, or demographic data, or outcomes like Long COVID.

    The more specific the vaccine effectiveness question, the more complicated it becomes to answer. This is a bigger problem now as the FDA considers fall boosters, because the agency needs to determine the best vaccine candidate and identify priority populations for shots—while operating in a politcal climate where vaccine funding is less popular than it was a year ago.

    Here are a few questions that the FDA is trying to answer, drawing from the STAT News meeting recap:

    • Should the fall booster be a monovalent vaccine, meaning it only includes Omicron-specific genetic material? Or should it be bivalent, meaning it includes both Omicron and the original, Wuhan strain? Pfizer and Moderna presented different options; some experts say a bivalent vaccine may provide more long-term protection.
    • Should the booster shot be specific to BA.4 and BA.5? The panel agreed that it should, as these strains are now dominant in the U.S., but there’s a timing trade-off as vaccine companies have yet to do clinical trials (or provide substantial data) for a subvariant-specific vaccine.
    • Should the booster shot be another type of vaccine entirely? In addition to Pfizer and Moderna, the FDA panel also heard from Novavax. This company has developed a protein-based vaccine that hasn’t yet received FDA authorization, but panelists were impressed by its potential for long-term protection.
    • How well do the vaccines provide non-antibody-based protection? As in past advisory committee meetings, the vaccine companies primarily presented data based on antibodies generated from their shots. Experts wanted to see more data about T cells and other aspects of immunity which are harder to measure, but may be more important in the long term.
    • Who would most benefit from another booster? If the federal government isn’t able to buy enough shots for everyone, priortization will need to happen. Will Omicron-specific boosters be most useful for seniors, or for people with certain health conditions? These groups will likely get priority again, though we could still be collecting more data on how the vaccines fare for them.

    Of course, despite the dearth of data and cautions from some members of the FDA advisory committee, the U.S. government seems to be going full-speed ahead with fall boosters. The Biden administration has placed a $3.2 billion order from Pfizer for 105 million doses of whichever Omicron-specific vaccine the FDA chooses to authorize.

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