COVID-19 Data Dispatch

Tag: breakthrough cases

  • COVID source callout: CDC’s breakthrough case data

    The CDC has not updated its breakthrough case data since September. A full two months ago.

    Earlier in 2021, the agency reported a total count of breakthrough infections, hospitalizations, and deaths—then switched to reporting only those breakthrough cases leading to hospitalization or death in May.

    The page that used to house this data now no longer includes total case counts; instead, the CDC redirects users to a couple of other pages:

    The CDC and FDA expanded booster shot eligibility to all adults in part because of increasing COVID-19 cases across the country.  But without comprehensive breakthrough case data, as I’ve said numerous times, it’s hard to pinpoint exactly how well the vaccines are working—and who’s most at risk of a breakthrough case.

    MedPage Today, which published a detailed article on this topic, received a statement from the CDC claiming that the breakthrough case and death data will be updated “in mid-November, to reflect data through October 2.” This long lag is due to the time it takes for the CDC to link case surveillance records to vaccination records, the agency said.

    Almost a year into the U.S.’s COVID-19 vaccination campaign, you’d really think our national public health system would have a better way of monitoring breakthrough cases by now.

    more source spotlights

  • Sources and updates, November 21

    • CDC adds data on 5-11 vaccinations: The main vaccinations page on the CDC’s COVID-19 dashboard now includes vaccination rates for all U.S. residents ages 5 and older, in addition to all the previous categories (12 and older, 18 and older, 65 and older). These rates are available by dose and by state. Plus, the CDC has added an age 5-11 category to its demographic vaccination trends page. Notably, age 5-11 data haven’t been added to the Community Profile Reports yet, but I expect this will happen in the next couple of weeks.
    • Breakthrough case reporting by state: 36 states are reporting breakthrough COVID-19 cases, 34 are reporting breakthrough hospitalizations, and 37 are reporting breakthrough deaths, according to a report from former COVID Tracking Project researchers and the Rockefeller Foundation. The report also discusses the challenges of tracking breakthrough cases and the importance of linking clinical and demographic data to these cases.
    • Long COVID resources from ApresJ20: ApresJ20, a Long COVID association based in France, has compiled this extensive document of over 1,000 scientific papers about the condition. Topics include defining Long COVID, characterizing symptoms, managing patient care, genetic associations, and more. For each paper, the document includes its title, authors, publish date, peer review status, and summary.

    All featured sources
  • Boosters for all adults: Why eligibility expanded, and what it means for you

    Boosters for all adults: Why eligibility expanded, and what it means for you

    As of November 20, almost 35 million Americans have received a booster shot. That number is likely to shoot up in the coming weeks with expanded eligibility. Chart via the CDC.

    On Friday morning, the FDA authorized booster shots of Pfizer’s and Moderna’s COVID-19 vaccines for all adults in the U.S., six months after their first two doses. The CDC’s vaccine advisory committee voted to support this expanded booster eligibility that afternoon, and CDC leadership signed off on it a few hours later.

    Although the Biden administration has supported boosters for all adults since August, this specific federal eligibility expansion was preceded by several state and local leaders. Prior to Friday, the governors of Colorado, New Mexico, California, and other states said that any adult living in their jurisdictions could go get a booster, even if they didn’t fit the current national criteria. New York City leaders made a similar announcement this past Monday.

    Perhaps spurred on by these state decisions, the FDA and CDC moved quite quickly to authorize booster shots for a larger group of Americans. The FDA was originally just considering the move for Pfizer’s vaccine, then added Moderna to the mix just this week (when Moderna sent in a formal application).

    And the CDC’s vaccine advisory committee meeting had somewhat less time for deliberation than this committee typically tends to take. As Helen Branswell wrote in STAT News:

    The meeting was called on such short notice — it was announced Tuesday — that only 13 of the committee’s members were able to attend. When the meeting went longer than scheduled, two members had to leave without voting.

    I discussed expanded booster shot eligibility this week in a FiveThirtyEight Chat with editor Chadwick Matlin and science writer Maggie Koerth. Today at the COVID-19 Data Dispatch, I’d like to expand on the ideas in that chat piece, and attempt to answer a couple of other questions.

    Why expand booster eligibility to all adults?

    The short answer here is 1) more compelling evidence that boosters provide additional protection against coronavirus infection and 2) cases are rising in the U.S., and boosters might help make the surge less severe. Also, so far, very few cases of severe side effects have been reported following booster shots.

    Since the last FDA and CDC booster shot deliberations, more evidence has rolled in showing their efficacy. One notable study, from the Imperial College of London, was published this past Wednesday; the report suggests that people who’ve received two COVID-19 vaccine doses are more than twice as likely to test positive than those who’ve received three doses.

    While the study hasn’t yet been peer-reviewed, it’s part of a long-running surveillance project in the U.K. that examines COVID-19 prevalence in the entire population—including all age groups and comparing those who received Pfizer and AstraZeneca vaccines. “What they found is very, very strong data showing that as soon as 7 days after a third COVID-19 vaccine dose, the risk of infection is cut in half when you look at the entire population,” wrote Dr. Jorge Caballero in a Twitter thread summarizing the study. 

    https://twitter.com/DataDrivenMD/status/1461167298102784001

    At the same time, cases are going up in the U.S.—appearing to indicate a new winter surge. It’s no coincidence that Colorado and New Mexico, two of the states that were among the first to expand booster eligibility to all adults, are also among the states with the highest COVID-19 case rates.

    When Delta hit Israel this past summer, the country started administering booster shots: first to seniors at the end of July, then for younger and younger age groups until all adults were able to get the shots. Data from the country’s national health agency suggest that these booster shots played a key role in driving down case numbers among both vaccinated and unvaccinated Israelis.

    Personally, I am still a bit skeptical that Israel’s drop in cases was thanks to booster shots alone, as the data don’t necessarily show causation. But for a lot of U.S. leaders, the Israeli data provide a compelling model: it seems like booster shots can potentially drive down a case surge. This fits nicely into the national strategy that the Biden administration has already been preaching for months, which I call “vaccinate out of the pandemic.”

    Here’s how I explained it in the FiveThirtyEight chat piece:

    Listening to the advisory-committee meetings, I noticed that there seems to be this tension between the scientific experts who want to make robust evidence-based decisions — and the sense that, here in the U.S., our overall pandemic strategy is basically “vaccinate our way out of the pandemic.” If we had better masking, distancing, contact tracing, ventilation, rapid tests and everything else, we would not need boosters to stop people’s mild cases. But we’re not doing a great job at any of those other things, so … we kinda need boosters.

    Maggie Koerth also pointed out that booster shots are also politically easier for a lot of leaders than some of the other COVID-19 strategies I mentioned. We already have the shots stockpiled, so it’s just a matter of telling people to go get them—unlike, say, expanding contact tracing, which would take a huge investment in hiring and training people.

    In addition, the eligibility expansion solves communication and logistics challenges: now, every adult in the U.S. can just go get a booster shot, once enough time has passed from their first two doses. Almost 90% of vaccinated Americans were eligible already, but a lot of people were confused about whether they fit the criteria; the situation became much simpler after Friday.

    Should you get a booster shot?

    If you’re over 65 or you have a health condition that makes you particularly vulnerable to severe COVID-19 symptoms, answering this question is easy: YES. Go get a booster shot, as soon as you’re able to do so.

    If you live or work in a setting that puts you at risk of contracting the coronavirus—or if you live or work in a setting with other people who are more vulnerable than you—then you also have a pretty solid argument towards getting a booster shot.

    Even if you’re very unlikely to have a severe case of COVID-19 thanks to your initial vaccination, a mild case could still disrupt your work, your household, and others in your community. A teacher with breakthrough COVID-19 might cause their classroom to shut down for a week, for example, while a parent with breakthrough COVID-19 may interrupt their kids’ lives if those kids are too young to be vaccinated themselves.

    For those who don’t fall into these categories (like me!), the situation is a bit more complicated. But after following all of the news this week, I’ve decided that it does make sense for me to get my booster shot.

    Here’s why: much as I wish that national leadership and my own local leaders in NYC were investing in other measures to control COVID-19 cases, I don’t foresee widespread mask mandates, rapid tests, contact tracing, or any other safety overhauls anytime soon. Instead, my public health leaders are asking me (and those around me) to get booster shots in order to potentially lower case rates. So, I’ll do my part to contribute to that “vaccinate out of the pandemic” strategy, though I don’t necessarily agree with it.

    It’s also important to note here that vaccinating the people who are still unvaccinated is much more important for lowering overall case counts—and for keeping people out of the hospital—than boosters. That includes kids in the 5 to 11 age group. As Maggie Koerth said in our chat:

    If you’re under 65 and you’re not immune compromised, it almost certainly matters more to get your kiddos vaxxed the first time than to get yourself a booster. That’s my parent-centric takeaway from all this reading.

    And, of course, to end the pandemic on a global scale, we need to get first and second doses to everyone in the world. Right now, booster shots are hindering global vaccination: according to the WHO, there are about six times more boosters administered daily in wealthy nations right now than there are first and second doses administered in low-income nations.

    The U.S. has already chosen to stockpile millions of doses for boosters, so refusing a booster shot on an individual level doesn’t have any impact on the global situation. But there are other options for people who want to take action about vaccine inequality: for example, you can contact your congressional representatives about the issue.

    What happens after a lot of Americans get booster shots?

    Someone asked me this question on Twitter earlier this week. Do booster shots lead to other loosening COVID-19 restrictions, or something else?

    It’s difficult to answer that right now, because the U.S. is still close to the beginning of our booster shot rollout. Within a couple of months—and millions more doses—we’ll have some data on whether booster shots here lead to a drop in cases, like what we saw in Israel. At the same time, many European countries are similarly offering booster shots to wide swaths of their populations; we can also watch what happens in those nations.

    The U.S. is still likely to face a case surge this holiday season, I think, simply due to cold weather combined with travel and gatherings. But perhaps booster shots will mean that hospitalizations don’t rise as much as cases do, or that a higher share of the cases are mild. We’ll have to see.

    Looking beyond this winter, we could see three shots become standard for COVID-19 vaccines. (Several other vaccines, such as HPV, are three-shot series.) We could also see annual boosters for COVID-19, similar to flu shots. More study of the booster shots’ effectiveness and of long-term COVID-19 immunity in general will help scientists figure this out.

    Finally, I couldn’t end this post without pointing out the continued data gaps here. The U.S. is still not tracking breakthrough cases in any kind of comprehensive manner, and a lot of information is missing on who’s getting booster shots—the CDC and most states are not reporting demographic data on booster recipients.

    To quote Dr. Katelyn Jetelina from her recap of Friday’s CDC advisory committee meeting:

    And this is it. This [three small studies] is all the data the CDC presented today. Which is insane— the United States does not have a real-time, comprehensive picture of our vaccines, nor the number of breakthrough cases, nor who’s more likely to have a breakthrough case or not. I cannot emphasize enough of how detrimental this is to our public health response. Bad data produces (potentially) bad policy. We are flying blind.

    More vaccine reporting

  • Public health data in the US is “incredibly fragmented”: Zoe McLaren on booster shots and more

    Public health data in the US is “incredibly fragmented”: Zoe McLaren on booster shots and more

    This week, I had a new story published at the data journalism site FiveThirtyEight. The story explores the U.S.’s failure to comprehensively track breakthrough cases, and how that failure has led officials to look towards data from other countries with better tracking systems (eg. Israel and the U.K.) as they make decisions about booster shots.

    In the piece, I argue that a lack of data on which Americans are most at risk of breakthrough cases—and therefore most in need of booster shots—has contributed to the confusion surrounding these additional doses. Frequent COVID-19 Data Dispatch readers might recognize that argument from this CDD post, published at the end of September.

    Of course, an article for FiveThirtyEight is able to go further than a blog post. For this article, I expanded upon my own understanding of the U.S.’s public health data disadvantages by talking to experts from different parts of the COVID-19 data ecosystem.

    At the CDD today, I’d like to share one of those interviews. I spoke to Zoe McLaren, a health economist at the University of Maryland Baltimore County, about how the U.S. public health data system compares to other countries, as well as how data (or the lack of data) contribute to health policies. If you have been confused about your booster shot eligibility, I highly recommend giving the whole interview a read. The interview has been lightly edited and condensed for clarity.

    Betsy Ladyzhets: I’m writing about this question of vaccine effectiveness data and breakthrough case data in the U.S., and how our data systems and sort-of by extension public health systems compare to other countries. So, I wanted to start by asking you, what is your view of the state of this data topic in the U.S.? Do you think we can answer key questions? Or what information might we be missing?

    Zoe McLaren: It’s the age-old problem of data sources. A lot of cases are not going to be reported at all. And then even the ones that are reported may not be connected to demographic data, for example, or even whether the people are vaccinated or not. Whereas other countries like Israel, and the U.K., your positive COVID test goes into your electronic health record that also has all the other information. 

    And Medicare patients, they have that whole [records] system. There will be information [in the system] about whether they got vaccinated, as well as whether they have a positive test. So that data will be in there. But for other people, it may or may not be in an electronic health record. And then of course, there’s multiple different electronic health record systems that can’t be integrated easily. So you don’t get the full picture.

    But it’s all about sample selection. Not everyone [who actually has COVID] is ending up in the data, which messes up both your numerator and denominator when you’re looking at rates.

    BL: Could you say more about how our system in the U.S. is different from places like Israel and the U.K., where they have that kind of national health record system?

    ZM: When the government is providing health insurance, then all of your records and the [medical] payments that happen, there’s a record of them… And then, because it’s a national system, it’s already harmonized, and everyone’s in the same system. So it’s really easy to pull a dataset out of that and analyze it.

    Whereas in the US, everything is incredibly fragmented. The data, and the systems and everything is very fragmented. The electronic health systems don’t merge together easily at all. And so you get a very fragmented view of what’s going on in the country.

    BL: Right, that makes sense. Yesterday, I was talking to a researcher at the New York State Health Department who did a study where they matched up the New York State vaccination records with testing records and hospitalization records, and were able to do an analysis of vaccine effectiveness. And he said, basically, the more specific, you tried to go with an analysis, the harder it is to match up the records correctly, and that kind of thing.

    ZM: Exactly. It’s easy to match on things like age, sex, race, since everybody has them. But then, the different data fields are gonna have different formats and be much harder to merge together.

    BL: So what can we do to improve this? I know Medicare for All is one option— 

    ZM: Medicare for All, end of story, end of article. It would solve so many problems.

    It’s tricky, though, because there isn’t a simple fix. All of these health systems have their own electronic health records, and integrating them is really costly and hard to do, and who is going to pay for that? There’s also additional privacy concerns about integrating things, in terms of protecting privacy and confidentiality. So, that’s really tricky.

    The way that we get around that, in general, is to have reporting requirements. Like with COVID tests, [providers are] required to report to the CDC or the HHS… Still, that’s also costly and time consuming. But that is kind-of the best thing that we can do right now, is have the different [public health] entities produce reports on a regular basis and send that to a centralized location. And the reports are supposed to be produced in a way that they are harmonized, they’re easy to put together from all the different systems.

    The problem with the different systems not integrating is, it requires everyone to basically fill out the equivalent of a form and send it in—listing individual patient information, or at the state level, individual county information. An example of that is the COVID data. All of the COVID data gets reported up to the national level [by state and county health departments]… 

    But the reporting often gives you the numerators, when you need to figure out the denominators. Because you would want to know, for example, we want to know what proportion of breakthrough cases end up hospitalized. But if only the hospitalized people end up in the data, and a lot of breakthrough cases go either undetected or never tested, or they do an at-home test and there’s no record of that positive case in the system, then your denominator is—there’s a problem with your denominator. That’s a problem with sample selection, you get people that are self-selecting into the numerator [by testing positive], but also self-selecting into the denominator [by getting a test to begin with].

    BL: Yeah, that makes sense. I know you said it would be pretty complicated to basically force different public health departments—to standardize them so that they’re all reporting in the same way. Is there more that researchers in the US could be doing in the short-term to either improve data collection or use what we have to answer questions like, what occupations might confer higher risk of a breakthrough case? 

    ZM: This is a coordination problem. Because in general, we all have an incentive to contribute to having a better understanding of breakthrough cases. But the trick is that, unless the national government or the CDC takes the role of saying what the [data] format’s gonna look like…

    Part of the problem is that there’s an effort involved [in collecting these data] and people don’t want to put in the effort. But if they do want to put in the effort, then you still have a coordination problem, because who gonna to be deciding what format we’re using?

    BL: Or like, what the data definitions are.

    ZM: Exactly. Like, do you report the month and the day of the vaccination dose, or just the month of the dose? Things like that where it doesn’t seem like a big deal, but it does matter for research purposes. If you look, for example, at the Census, or any of the national surveys, like the Current Population Survey or the National Labor Force Survey where we get unemployment numbers, there are big committees that figure out which questions we’re asking and how we ask them. So, if the CDC just says, like, “This is the dataset we’re building,” then everyone [local agencies] will be like, “Okay, we’re gonna send our reports in that way.” 

    Part of [the challenge] is that it takes effort to produce the data, and part of it is somebody needs to coordinate. And usually that would be something the CDC would do, saying, “This is the data that needs to be reported to us,” and everybody reports to them. But they could be doing more, they could be asking for more detailed information—for example, data based on vaccination status, because that information will be important for understanding the progression of the pandemic.

    BL: Yeah. I volunteered for the COVID Tracking Project for a while, and one of the most tedious things that we had to do there was figuring out different definitions for like, what states were considering a case or a test, or whatever else. So that definitely makes sense to me.

    ZM: Exactly. And the COVID Tracking Project filled a gap. Nobody was doing that [collecting data from the states], so the COVID Tracking Project did that… But it’s tricky, because a lot of the stuff that seems like splitting hairs [on definitions] really does make a difference when you’re doing your analysis.

    BL: I also wanted to ask you about what the implications are of this lack of standardized data in the U.S., and the lack of information that we have—largely around vaccinations, but I think there are other areas as well where we’re missing information. So I’m trying to figure out, for this story, how data gaps might contribute to the confusion that people feel when they watch health agencies make decisions. Like watching all the back and forth on booster shots, or thinking about Long COVID, other things like that.

    ZM: Well, we talk about evidence-based medicine, and we also care about evidence-based policy. And so it means that when the quality of data is poor, the quality of our policy is going to be worse. So it really is in everybody’s best interest to have high-quality data, because that is the bedrock of producing high quality policy.

    BL: Right. So if we don’t know, for example, if people who live and work in certain situations are more likely to have a breakthrough case, then we can’t necessarily tell them—we can’t necessarily say, “These specific occupations should go get booster shots.” And then we just say, “Everyone can go get a booster shot.”

    ZM: It means that we’re flying blind. And the problem of flying blind is twofold. One is that you can end up making poor decisions, the wrong decisions, because you don’t have the data. And then the other problem is that you end up making decisions that, in economics, we call it “inefficient.” I think about [these decisions] as, you end up with “one size fits all.” 

    If we have really high quality data, then we’re able to create different policies for different types of people, and that helps minimize any of the downsides. But the less data we have, the more we have to rely on “one size fits all.” And of course, if “one size fits all,” it’s going to be too much for some people and too little for others. Data would help improve that.

    BL: How do you think that this kind of “one size fits all” contributes to how individual people might be confused or might not be sure how to kind of interpret the policies for their own situations?

    ZM: I think in a “one size fits all,” people get very frustrated because they see in their own lives, both the uncertainty and how that can be stressful—and also the waste. The situations where they fall under one policy, but they have enough information to know that that policy doesn’t necessarily apply to them. It does undermine confidence in policymaking. People get frustrated with “one size fits all,” because it seems wasteful.

    Though sometimes the “one size fits all” is still optimal, it’s better than the alternative. For example, the recommendation of “one size fits all” wearing masks tends to trump the “one size fits all” of not wearing masks. But there’s waste. There are situations where we end up wearing masks where they wouldn’t necessarily be needed. And vice versa.

    BL: Yeah. That makes me think of friends I have who are eligible to get booster shots because of medical conditions, but they’re sort-of thinking, “I wish the shots could go to another country where they need vaccinations more.” And that’s not something individuals have any control over, but it’s frustrating.

    ZM: Part of it is, with the booster shots, is the guidelines that say people who have higher occupational exposure to risk [are eligible] without specifying exactly who that is. That is one way that we allow some leeway. So it’s not a “one size fits all” where nobody gets it, because there’s actually people who qualify under higher occupational exposure. But we also don’t want to have a “one size fits all” where we tell everyone they need it, because we do want to be sending doses abroad as well.

    So that’s a situation where we know that a “one size fits all” is not perfect. And so we create a, like, “use your judgement, talk to your doctor” kind-of thing that tries to help people self-select into the right groups… There are likely a lot of people who do have higher exposure and should be getting it, but don’t think the benefit applies to them.

    Editor’s note: According to one analysis, about 89% of U.S. adults will qualify for a booster shot after enough time has passed from their primary vaccine series. And, according to the October COVID-19 Vaccine Monitor report, four in ten vaccinated adults were unsure whether they qualified.

    BL: I also wanted to ask, you mentioned rapid tests—those don’t necessarily get reported. Are there other other things that you think pose data gaps in the U.S. public health system?

    ZM: With rapid tests, the actual tests are not getting reported. But the important thing is, people are getting tested. I mean, the reason we want good data quality is to reduce cases, and we wouldn’t want to limit access to rapid tests in order to collect data, because it’s much easier to prevent the cases by allowing people to get tested in their homes.

    But yeah, just the fact that there’s no centralized database for analysis [is a gap]. I mean, if you look at the U.K., and Israel, they have these great studies, because they’re able to just download, like, the entire population into a dataset. And it has all the information they need, like demographic factors. The fact that the U.S. has made so much of its national policy based on Israeli data, this shows how far behind we are with having our own data to answer these questions.

    BL: Yeah. I know, it’s something like half or a third of cases in the U.S., the CDC doesn’t have race and ethnicity information for [editor’s note: it’s 35%], and other stuff like that. It’s wild.

    ZM: Yeah… And one of the things about reporting is that every additional piece of data you want is very costly. And so you have to be very judicious about [collecting new values].

    BL: Well, those were all my questions. Is there anything I didn’t ask you that you think would be important for me to know for this story?

    ZM: Just that data is helpful for planning now, and helpful for the future. If we can improve our data systems now—it’s part of being prepared for the next pandemic.

    More vaccine reporting

  • Sources and updates, October 31

    A lot of COVID-19 data sources caught my eye this week!

    • More booster data from the CDC: This week, the CDC added both booster shot trends by day and booster shots by primary series type to its COVID Data Tracker. For booster shot trends, click “People Receiving a Booster Dose” on the Trends page, and for primary series data, scroll down to “Covid-19 Booster Dose Type by Primary Series Type” on the Vaccination Totals page. So far, it looks like a lot of Johnson & Johnson recipients are opting for mRNA boosters.
    • KFF’s latest Vaccine Monitor update: The Kaiser Family Foundation has released the latest edition of its monthly vaccine poll, the COVID-19 Vaccine Monitor. This month’s edition focuses on vaccinations for children ages 5 to 11, in line with the recent discussions around shots for this age group, but it also includes other polling on general vaccination demographics, boosters, mandates, and more.
    • Under-testing in U.S. prisons and jails: A new report from the UCLA Law COVID Behind Bars Data Project explores how insufficient COVID-19 testing of incarcerated people in the U.S. contributes to skewed case rates. Even in the states that have tested their incarcerated populations the most, this report shows, that testing is still far less frequent than testing for other congregate living facilities, like nursing homes.
    • Impact of School Opening on SARS-CoV-2 Transmission: A group of scientists (including school data expert Emily Oster) recently published a new paper in Nature examining how school reopening models—remote, hybrid, or in-person—contribute to community transmission. In most parts of the country, reopening model did not have a significant impact on transmission, they found; the South was an exception. The authors shared the data underlying their paper, with some information from Burbio and the CDC removed due to requirements from those organizations.
    • Reporting recipe for breakthrough case data: Dillon Bergin, my colleague at the Documenting COVID-19 project, wrote this reporting recipe, which guides local newsrooms through acquiring data on and covering breakthrough cases in their areas. The recipe accompanies a recent story that Dillon wrote, in collaboration with the Las Vegas Review-Journal, on breakthrough cases by occupation in Las Vegas. (Unsurprisingly, healthcare workers and casino workers were likely to have breakthrough cases, the Las Vegas data show.)
    • Polling on small businesses and vaccine mandates: Here’s another vaccine survey released this week, this one from the U.S. Chamber of Commerce. The agency asked small businesses about their positions on vaccine mandates, as well as hiring challenges and other issues. 64% of small business owners support “businesses in their area requiring vaccines for their employees,” the survey found.

    All featured sources
  • Unpacking Delta AY.4.2: Are we prepared for the next variant?

    Unpacking Delta AY.4.2: Are we prepared for the next variant?

    AY.4.2, an offshoot of the Delta variant, now comprises about 10% of new COVID-19 cases in the U.K. Chart via U.K. COVID–19 Genomic Surveillance.

    Recently, a new offshoot of the Delta variant has been gaining ground in the U.K. It’s called AY.4.2, and it appears to be slightly more transmissible than Delta itself. While experts say this variant doesn’t differ enough from Delta to pose a serious concern, I think it’s worth exploring what we know about it so far—and what this means for the future of coronavirus mutation.

    How was AY.4.2 identified?

    The U.K. national health agency first found AY.4.2 in July 2021, and has watched it slowly spread through the country since then. The agency formally designated this variant as a Variant Under Investigation (VUI) on October 22; at this point, about 15,000 cases had been identified across the country.

    It’s worth noting here that the U.K.’s genomic surveillance system is incredibly comprehensive—considered to be the best in the world. The country sequences over 20,000 coronavirus samples a week; it’s consistently sequenced a large share of its COVID-19 cases since the beginning of 2021. And, since the country’s public health system integrates COVID-19 testing records with hospitalization records, primary care records, and other data, U.K. researchers are able to analyze other aspects of a variant’s performance, such as its ability to cause breakthrough cases or more severe disease.

    As STAT News’ Andrew Joseph explains in a recent story about this variant:

    It’s perhaps not a surprise that the U.K. noticed AY.4.2 so quickly. The country has an incredible sequencing system in place to monitor genetic changes in the virus, and researchers there have been among the global leaders in characterizing different mutations and forms of the virus. It’s possible that other Delta sublineages have similar growth rates to AY.4.2, but they’re in parts of the world where it will take longer for scientists to detect.

    How does AY.4.2 differ from OG Delta?

    AY.4.2 is transmissible enough that it is slowly pushing out the original Delta in some parts of the U.K. In late June, it comprised 0.1% of new U.K. COVID-19 cases; in late August, it was at 3.5%; and now it’s at 11.3%, as of the most recent data (the week ending October 24).

    “It’s a slow burner,” wrote U.K. epidemiologist Meaghan Kill in a Twitter thread last week. “But Delta is already *so* transmissible, it’s notable that AY.4.2 is increasing in that context.”

    Kill and other scientists estimate that AY.4.2 is between 10% and 15% more transmissible than Delta. That’s a small enough difference that scientists are not panicking about this variant, in the same way that epidemiologists sounded the alarm when Delta itself was first identified in India earlier in 2021. (For context: Delta is 60% to 80% more transmissible than the Alpha variant.)

    Still, AY.4.2 is worth watching as a signal of Delta’s continued ability to mutate and spread more readily. As Joseph points out in his STAT article, some experts hypothesized that Delta might be so contagious, the coronavirus basically could not mutate further in that direction. AY.4.2 suggests that we haven’t hit that upper limit yet.

    Is AY.4.2 more likely to cause breakthrough cases?

    This is one piece of good news that came out in the U.K. health agency’s most recent variant report, released this past Friday: AY.4.2 is not more likely to cause a breakthrough case than the original Delta variant. (Not thus far, anyway.) This is true for both symptomatic and asymptomatic infections, as well as different ages and vaccine types.

    The AY.4.2 data in this U.K. report are based on a relatively small sample size—about 13,000 people infected with AY.4.2, compared to over 350,000 people infected with the original Delta variant. Still, it’s good news that the variant appears to simply be more transmissible, not more able to break through vaccine-induced immunity or cause severe disease.

    “More likely (I believe) is a slightly increased biological transmissibility,” Meaghan Kill wrote in a Twitter thread about this news. “Growth rate & secondary attack rates are refreshed with new data and findings remain the same as last week.” She predicts that AY.4.2 may be able to replace the original Delta by summer 2022.

    How much is AY.4.2 spreading in the U.S.?

    AY.4.2 has been identified in over 30 countries, including the U.S. But here, OG Delta continues to dominate; this variant has been causing over 99% of new cases in the U.S. for well over a month, with a couple of other Delta sub-lineages (AY.1 and AY.2) briefly popping up without getting competitive. AY.4.2 is not yet accounted for on the CDC’s variant tracker, but other estimates indicate that it’s causing under 1% of new cases in the U.S.

    “We have on occasion identified the sublineage here in the United States, but not with recent increased frequency or clustering to date,” CDC Director Dr. Rochelle Walensky said at a recent COVID-19 briefing, according to STAT.

    Are we prepared for a surge of AY.4.2—or another coronavirus variant?

    The U.S. does not have a great track record for dealing with COVID-19 surges—whether that’s New York City in spring 2020 or Delta hotspots in the South this past summer. We’re doing more genomic sequencing than we were at the start of 2021, which helps with identifying potentially-concerning variants, but sequencing still tends to be clustered in particular areas with high research budgets (NYC, Seattle, etc.). And even when our sequencing system picks up signals of a new variant, we do not have a clear playbook—or easily-utilized resources—to act on the warning.  

    To illustrate this point, I’d like to share a major project of mine that was published this past week: an investigation of the Delta surge in Southwest Missouri this summer. This project was a collaboration between the Documenting COVID-19 project at the Brown Institute for Media Innovation and MuckRock (where I’ve been working part-time for a few weeks now), and the Missouri Independent, a nonprofit news outlet that covers Missouri state government, politics, and policy.

    Missouri Independent reporter Tessa Weinberg and I went through hundreds of emails, internal reports, and other documents obtained through public records requests. We found that, even though Missouri had ample warnings about Delta—wastewater surveillance picked up the variant in May, and hospitals noticed increasing breakthrough cases in June—the Springfield area was completely overwhelmed by the virus. Infighting and mistrust between state and local officials also hindered the region’s response to the Delta surge.

    Our major findings (copied from the article) include:

    Springfield hospital and health department leaders urged the state to take advantage of additional genomic sequencing assistance to address unanswered questions about the variant’s spread. The state declined, forcing Springfield officials to seek additional data on their own.

    After days of preparation for an overflow hospital for COVID patients requested by Springfield officials, local leaders decided to forego the plan after the window of need had passed — setting off dueling narratives over the reason why in public while state officials seethed in private.

    When local officials pleaded for more support in addressing the Delta surge, state officials questioned the value of directing more resources to the area and even wondered whether the overflow hospital request was fueled by motivations to “pay for an expansion of their private hospital.”

    You can read the full story here (at the Missouri Independent) or here (on MuckRock’s website). Find the documents that we used here.

    And read my Twitter thread with more highlights here:

    More variant reporting

  • Booster shots: What we’ve learned—and what we still don’t know

    Booster shots: What we’ve learned—and what we still don’t know

    This week, the FDA’s vaccine advisory committee had a two-day meeting to discuss booster shots for Moderna’s and Johnson & Johnson’s COVID-19 vaccines. From the outside, these meetings may have appeared fairly straightforward: the committee voted unanimously to recommend booster shots for both vaccines.

    But in fact, the discussions on both days were wide-reaching and full of questions, touching on the many continued gaps in our knowledge about the need for additional vaccine doses. The FDA committee continues to make decisions based on rather limited data, as do other top U.S. officials. Case in point: on Thursday, the committee was asked to consider data from Israel’s booster shot campaign—which is utilizing Pfizer vaccines—as evidence for Moderna boosters in the U.S.

    In the Moderna vote on Thursday afternoon, committee member Dr. Patrick Moore, a virologist at the University of Pittsburgh, said that he voted “on gut feeling rather than really truly serious data.” The comment exemplified how much we still don’t know regarding the need for boosters, thanks in large part to the CDC’s failure to comprehensively track breakthrough cases in the U.S.

    Still, there are a few major facts that we have learned since the FDA and CDC discussions on Pfizer boosters that took place a couple of weeks ago. Here’s my summary of what we’ve learned—and what we still don’t know.

    What we’ve learned since the Pfizer discussion:

    Israel’s booster rollout continues to align with falling case numbers. On Thursday, representatives from the Israeli national health agency presented data on their booster shot rollout—which, again, is using Pfizer vaccines. The vast majority of seniors in Israel have now received a third dose, and over 50% of other age groups have as well. According to the Israeli scientists, this booster rollout both decreased the risk of severe COVID-19 disease for older adults and helped to curb the country’s Delta-induced case wave, causing even unvaccinated adults to have a decreased risk of COVID-19.

    In Israel, severe cases among both vaccinated and unvaccinated adults decreased after the country provided third Pfizer doses to its residents. Screenshot taken from Thursday’s VRBPAC meeting.

    You can read more about Israel’s booster campaign in this paper, published in the New England Journal of Medicine in early October. It’s worth noting, however, that Delta is known to spur both case increases and decreases in cycles that can be somewhat unpredictable—and may not be exactly linked to vaccination. So, I personally take the Israeli claims that boosters stopped their case wave with a grain of salt.

    Decreased vaccine effectiveness against infection may be tied more to Delta and behavioral factors than “waning antibodies.” This week, the New York State Department of Health (DOH) announced results from a large study of vaccine effectiveness which is, from what I’ve seen, the first of its kind in the U.S. The New York DOH used state databases on COVID-19 vaccinations, tests, and hospitalizations to examine vaccine effectiveness against both infection and hospitalization in summer 2021, when Delta spread rapidly through the state.

    They found that vaccine effectiveness against infection did decline over the summer. But the declines occurred similarly for all age groups, vaccine types, and vaccine timing (i.e. which month the New Yorkers in the study received their vaccines)—suggesting that the decline in effectiveness was not tied to waning immune system protection. Rather, the effectiveness decline correlated well with Delta’s rise in the state. It also correlated with reduced safety behaviors, like the lifting of New York’s indoor mask mandate and the reopening of various businesses.

    Vaccine effectiveness against hospitalization declined for older adults, but remained at very high levels for New Yorkers under age 65, the study found. Here’s what lead author Dr. Eli Rosenberg said in a statement:

    The findings of our study support the need for boosters in older people in particular, and we encourage them to seek out a booster shot from their health care provider, pharmacy or mass vaccination site. We saw limited evidence of decline in effectiveness against severe disease for people ages 18 to 64 years old. While we did observe early declines in effectiveness against infections for this age group, this appears to have leveled off when the Delta variant became the predominant strain in New York. Together, this suggests that ongoing waning protection may be less of a current concern for adults younger than 65 years.

    I was surprised that this study didn’t come up in the FDA advisory committee meetings this week, and will be curious to see if it’s cited in future booster shot discussions. The study does align, however, with the committee’s decision against recommending booster shots for all adults over age 18 who received Moderna vaccines.

    Johnson & Johnson vaccine recipients appear to need boosters more than mRNA vaccine recipients. On Friday, presentations from both J&J representatives and FDA scientists made a clear case for giving J&J vaccine recipients a second dose of this adenovirus vaccine. In one 30,000-patient study, patients who received a second J&J shot two months after their first shot saw their vaccine efficacy (against symptomatic infection) rise from 74% to 94%.

    Interestingly, unlike the Pfizer and Moderna vaccines, a J&J shot’s ability to protect against coronavirus infection appears relatively stable over time. However, a booster shot can make this vaccine more effective—especially against variants. Despite arguments from J&J representatives that their vaccine’s second dose should come six months after the first dose, the FDA advisory committee voted to recommend second J&J shots just two months after the first dose, for all adults over age 18.

    It’s worth noting that this vaccine regimen might effectively change J&J’s product from a one-shot vaccine to a two-shot vaccine. STAT’s Helen Branswell and Matthew Herper go into the situation more in their liveblog.

    Mixing and matching vaccines is a strong strategy for boosting immunity, especially if one of the vaccines involved uses mRNA technology. This week, the National Institutes of Health (NIH) released a highly anticipated study (posted as a preprint) on mix-and-match vaccine regimens. The NIH researchers essentially tested every possible booster combination among the three vaccines that have been authorized in the U.S. Before and after vaccination, the researchers took blood samples and tested for antibodies that would protect against the coronavirus.

    In short, the NIH study found that all three vaccines—Pfizer, Moderna, and J&J—will provide a clear antibody boost to people who have received any other vaccine. But the mRNA vaccines (Pfizer and Moderna) provide bigger benefits, both in the form of higher baseline antibody levels (after two shots) and a higher boost. The best combination was a J&J vaccine initially, followed by a Moderna booster, Dr. Katelyn Jetelina notes in a Your Local Epidemiologist summary of the study.

    Every vaccine provided a “boost” of protective antibodies to recipients of every other vaccine. Figure from the NIH preprint. mrna-1273 refers to the Moderna vaccine, Ad26.COV2.S refers to the J&J vaccine, and BNT162b2 refers to the Pfizer vaccine.

    The booster regimens also appeared to be safe, with limited side effects. But this was a relatively small study, including about 450 people. In their discussion on Friday afternoon, the FDA advisory committee members said that they would be very likely to authorize mix-and-match vaccine regimens after seeing more safety data.

    Moderna and J&J boosters appear to be safe, with similar side effects to second shots. Safety data from Moderna’s and J&J’s clinical trials of their booster shots, along with data from the NIH mix-and-match study, indicate that the additional doses cause similar side effects to first and second doses. After a booster, most recipients had a sore arm, fatigue, and other relatively minor side effects.

    And here’s what we still don’t know:

    Which medical conditions, occupations, and other settings confer higher breakthrough case risk? I wrote about this issue in detail in September. The U.S. continues to have little-to-no data on breakthrough case risk by specific population group, whether that’s groups of people with a specific medical condition or occupation. This data gap persists, even though U.S. researchers have some avenues for breakthrough risk analysis at their disposal (see: this post from last week).

    This lack of data came up in FDA advisory committee discussions on Thursday. An FDA representative was unable to cite any evidence that people in specific occupational settings are at a higher risk for breakthrough cases.

    Are there any rare vaccine side effects that may occur after breakthrough doses? When I covered the FDA advisory committee meeting on Pfizer boosters, I noted that Pfizer’s clinical trial of these shots included just 306 participants—providing the committee members with very limited data on rare adverse events, like myocarditis. Well, Moderna’s clinical trial of its booster shots was even smaller: just 171 people. J&J had a larger clinical trial, including over 9,000 people.

    These trials and the NIH mix-and-match study indicated that booster shots cause similar side effects to first and second shots, as I noted above. But few clinical trials are large enough to catch very rare (yet more serious) side effects like myocarditis and blood clots. (In J&J’s case, blood clots occur roughly twice for every million doses administered.) Federal officials will carefully watch for any side effects that show up when the U.S.’s booster rollout begins for Moderna and J&J.

    How do antibody levels correlate to protection against COVID-19, and what other aspects of the immune system are involved? The NIH mix-and-match study focused on measuring antibody levels in vaccine recipients’ blood, as did other booster shot trials. While it may sound impressive to say, for example, “J&J recipients had a 76-fold increase in neutralizing antibodies after receiving a Moderna booster,” we don’t actually know how this corresponds to protection against COVID-19 infection, severe disease, and death.

    Some experts—including a couple of those on the FDA advisory committee—have said that discussions focusing on antibodies distract from other types of immunity, like the memory cells that retain information about a virus long after antibody levels have fallen. More research is needed to tie various immune system measurements to real-world protection against the coronavirus.

    What needs to happen at the FDA for mix-and-match vaccination to be authorized? One challenge now facing the FDA is, the federal agency has clear evidence that mix-and-match vaccine regimens are effective—but it does not have a traditional regulatory pathway to follow in authorizing these regimens. Typically, a company applies for FDA authorization of its specific product. And right now, no vaccine company wants to apply for authorization of a regimen that would involve people getting a different product from the one that brings this company profit.

    So, how will the FDA move forward? There are a couple of options, like the CDC approving mix-and-match boosters directly. See this article for more info.

    Finally: I can’t end this post without acknowledging that, as we discuss booster shots in the U.S., millions of people in low-income countries have yet to even receive their first doses. Many countries in Africa have under 1% of their populations vaccinated, according to the Bloomberg tracker. While the Biden administration has pledged to donate doses abroad, boosters take up airtime in expert discussions and in the media—including in this publication. Boosters distract from discussions of what it will take to vaccinate the world, which is our true way out of the pandemic.

    More vaccine reporting

  • New study demonstrates potential for measuring breakthrough risk

    New study demonstrates potential for measuring breakthrough risk

    Adults with substance use disorders have an increased risk of breakthrough cases, according to a new study published this week in the journal World Psychiatry. Though the chances of a COVID-19 case after vaccination were very low in this group, these patients’ odds of a breakthrough case were about twice as high as the odds for adults without substance use disorders, researchers from the National Institutes of Health (NIH) found.

    This study is the first I’ve seen to delineate breakthrough case risk in a specific, vulnerable population—besides studies demonstrating higher risk for older adults. As I wrote two weeks ago, a lack of specific data on breakthrough cases has contributed to confusion and debate surrounding who should be eligible for a booster shot in the U.S.

    So, how did these NIH researchers determine the risk for people with substance abuse? They used anonymous, electronic health records from 63 healthcare organizations across the U.S., compiled in the TriNetX Analytics platform. The study included health records from about 30,000 patients with substance use disorders, compared with 550,000 patients without these disorders. From this large pool of anonymous data, the researchers were able to determine breakthrough case risk among different patient demographics, different substance use disorders, and more.

    I got a chance to talk to Dr. Nora Volkow, director of the NIH’s National Institute on Drug Abuse and one of the study’s lead authors, about this methodology, as I covered the paper for DailyMail.com. I asked her if she expected to see similar studies examining breakthrough case risk for other health risks and occupations.

    “Absolutely,” Dr. Volkow said. She told me she’s already seen other papers comparing the risk of a breakthrough with Delta compared to other variants, and that more research looking at specific patient groups may be ongoing. Still, using electronic health records has its drawbacks.

    “We are basically basing [the analysis] on the electronic health records,” she said. “But it could be useful to complement this with studies that actually are genotyping, getting information about, what was the virus that is responsible?” In other words: health records from hospitals and clinics typically are not matched with genetic sequencing information, making it difficult to link specific variants with breakthrough case risk.

    As for why patients struggling with substance abuse have a higher risk of breakthrough COVID-19: Dr. Volkow said this is largely due to socioeconomic factors, such as lack of access to healthcare, low income, and homelessness. Drugs and alcohol are also capable of weakening patients’ immune systems, though; marijuana in particular can hinder immune system regulation.

    More vaccination data

  • The data problem underlying booster shot confusion

    The data problem underlying booster shot confusion

    This is all the breakthrough case data that the CDC gives us. Screenshot taken on September 26.

    This past Thursday, an advisory committee to the CDC recommended that booster doses of the Pfizer vaccine be authorized for seniors and individuals with high-risk health conditions. The committee’s recommendation, notably, did not include individuals who worked in high-risk settings, such as healthcare workers—whom the FDA had included in its own Emergency Use Authorization, following an FDA advisory committee meeting last week.

    Then, very early on Friday morning, CDC Director Rochelle Walensky announced that she was overruling the advisory committee—but agreeing with the FDA. Americans who work in high-risk settings can get booster shots. (At least, they can get booster shots if they previously received two doses of Pfizer’s vaccine.)

    This week’s developments have been just the latest in a rather confusing booster shot timeline:

    Why has this process been so confusing? Why don’t the experts agree on whether booster shots are necessary, or on who should get these extra shots? Part of the problem, of course, is that the Biden administration announced booster shots were coming in August, before the scientific agencies had a chance to review all the relevant evidence.

    But from my (data journalist’s) perspective, the booster shot confusion largely stems from a lack of data on breakthrough cases.

    Let’s go back in time—back four months, or about four years in pandemic time. In May, the CDC announced a major change in its tracking of breakthrough cases. The agency had previously investigated and published data on all breakthrough cases, including those that were mild. But starting in May, the CDC was only investigating and publishing data on those severe breakthrough cases, i.e. those which led to hospitalization or death.

    At the time, I called this a lazy choice that would hinder the U.S.’s ability to track how well the vaccines are working. I continued to criticize this move, when researchers and journalists attempted to do the CDC’s job—but were unable to provide data as comprehensive as what the CDC might make available. 

    Think about what might have been possible if the CDC had continued tracking all breakthrough cases, or had even stepped up its investigation of these cases through increased testing and genomic sequencing. Imagine if we had data showing breakthrough cases by age group, by high-risk health condition, or by occupational setting—all broken out by their severity. What if we could compare the risk of someone with diabetes getting a breakthrough case, to the risk of someone who works in an elementary school?

    If we had this kind of data, the FDA and CDC advisory committees would have information that they could use to determine the potential benefits of booster shots for specific subsets of the U.S. population. Instead, these committees had to make guesses. Their guesses didn’t come out of nowhere; they had scientific studies to review, data from Pfizer, and information from Israel and the U.K., two countries with better public health data systems than the U.S. But still, these guesses were much less informed than they might have been if the CDC had tracked breakthrough cases and outbreaks in a more comprehensive manner.

    From that perspective, I can’t really fault the CDC and the FDA for casting their guesses with a fairly wide net—including the majority of Americans who received Pfizer shots in their authorization. There’s also a logistical component here; the U.S. has a lot of doses that are currently going unused (thanks to vaccine hesitancy), and may be wasted if they aren’t used as boosters.

    But it is worth emphasizing how a lack of data on breakthrough cases has driven a booster shot decision based on fear of who might be at risk, rather than on hard evidence about who is actually at risk. Other than seniors; the risk for that group is fairly clear.

    The booster shot decision casts a wide net. But at the same time, it creates a narrow band of booster eligibility: only people who got two doses of Pfizer earlier in 2021 are now eligible for a Pfizer booster. Recipients of the Moderna and Johnson & Johnson vaccines are still left in the dark, even though some of those people may need a booster more than many people who are now eligible for additional Pfizer shots. (Compare, say, a 25-year-old teacher who got Pfizer to a 80-year-old, living in a nursing home, with multiple health conditions who got Moderna.)

    That Pfizer-only restriction also stems from a data issue. The federal government’s current model for approving vaccines is very specific: first a pharmaceutical company submits its data to the FDA, then the FDA reviews these data, then the FDA makes a decision, then the CDC reviews the data, then the CDC makes a decision.

    By starting with the pharmaceutical company, the decision-making process is restricted to options presented by that company. As a result, we aren’t seeing much data on mixing-and-matching different vaccines, which likely wouldn’t be profitable for vaccine manufacturers. (Even though immunological evidence suggests that this could be a useful strategy, especially for Johnson & Johnson recipients.)

    In short, the FDA and CDC’s booster shot decision is essentially both ahead of evidence on who may benefit most from a booster, but behind evidence for non-Pfizer vaccine recipients. It’s kind-of a mess.

    I also can’t end this post without acknowledging that we need to vaccinate the whole world, not just the U.S. Global vaccination went largely undiscussed at the FDA and CDC meetings, even though it is a top concern for many public health experts outside these agencies.

    At an international summit this week, President Biden announced more U.S. donations to the global vaccine effort. His administration seems convinced that the U.S. can manage both boosters at home and donations abroad. But the White House only has so much political capital to spend. And right now, it’s pretty clearly getting spent on boosters, rather than, say, incentivizing the vaccine manufacturers to share their technology with the Global South.

    I can only imagine this situation getting messier in the months to come.

    More vaccine reporting

  • U.S. moves to approve booster shots despite minimal evidence

    U.S. moves to approve booster shots despite minimal evidence

    Timeline of the scientific results and policy moves leading up to Wednesday’s announcement. Chart via Your Local Epidemiologist.

    This week, the federal government announced that the U.S. intends to provide third vaccine doses to all Americans who received the Pfizer or Moderna vaccines. This booster shot distribution will start in September, with adults becoming eligible once they hit eight months after their second shot.

    While the booster shot regimen still must be approved by the FDA and CDC, federal officials are making it sound like a pretty sure thing—President Biden himself announced the decision at a press conference on Wednesday. However, many epidemiologists, vaccine experts, global health experts, and other scientists have criticized the decision.

    Here are three main criticisms I’ve seen in the past few days.

    First: Scientific evidence is lacking. As the booster shot decision was announced on Wednesday, the CDC published three new studies that appear to show a decline in the Pfizer and Moderna vaccines’ ability to stave off symptomatic COVID-19 infection after several months. One of these reports, from a network of U.S. nursing homes, suggests that efficacy among nursing home residents fell to just 53% by June and July 2021, many months after this vulnerable population was vaccinated. The other two reports show similar declines, though the CDC found that vaccination remains effective against severe disease, hospitalization, and death.

    The federal government—and others arguing in favor of booster shots—have also pointed to data from Israel, which appear to similarly demonstrate that the vaccines lose their effectiveness after several months. In Israel, where almost 80% of residents over age 12 are vaccinated, the majority of those hospitalized with COVID-19 are now fully vaccinated individuals.

    But the act of interpreting these data is more complicated than it first appears. In a blog post at COVID-19 Data Science, biostatistics professor Jeffrey Morris explains that, when the majority of a population is vaccinated, vaccination numbers will go up in this population simply because they are the majority. But the risk remains far higher for the unvaccinated. Plus, Morris explains, stratifying hospitalization numbers by age reveals that older adults are more likely to have a severe COVID-19 case regardless of vaccination status, while younger adults are less likely to be vaccinated (and thus have a non-breakthrough case).

    Simply put, the vaccines do still work well against severe COVID-19—you just need to be precise in calculating effectiveness. And yet, the U.S. government is saying that vaccine efficacy wanes so much, everyone’s going to need a third shot in the fall or early next year. This suggests that the federal government has more data that it is not sharing publicly, which leads us to the second criticism.

    Second: Transparency is also lacking. Typically, when the government makes a decision about approving a new medical product, this decision follows a series of prescribed steps: data submission from the company behind the product, review by FDA scientists, FDA approval, followed by more review by other agencies (such as the CDC or the Centers for Medicare & Medicaid Services) as needed. Review meetings are typically open to the public, with data shared in advance of a decision. In the case of these booster shots, however, the president has announced a specific rollout plan before full scientific review has taken place.

    As STAT’s Helen Branswell explains:

    To many experts, including Baylor, the sequencing of the decisions being made is also out of whack. While U.S. health officials said booster shots could start being offered the week of Sept. 20, the Food and Drug Administration has not even ruled yet on Pfizer’s application for approval of a third shot; it was filed only Monday. Moderna hasn’t yet asked the agency to authorize a third shot at all.

    Plus, remember that the CDC has not publicly shared any comprehensive data on breakthrough cases since the spring, before Delta became dominant.

    The FDA and CDC will certainly still be reviewing the need for booster shots, but the experts cited in Branswell’s piece are skeptical that any decision other than, “Yes, go ahead” will be considered. I, for one, will be very curious to see how the discussions proceed—and what data get cited—at the FDA and CDC committee meetings.  

    Third: We need to vaccinate the world. As I’ve explained in the CDD before, getting vaccines to the low-income nations that have yet to start their rollouts is not just a humanitarian priority. It also protects us, here in the U.S., because the longer the coronavirus circulates, the more opportunities it has to mutate into increasingly-dangerous variants.

    By moving to provide booster shots to everyone—not just the immunocompromised, the elderly, or the otherwise extra-vulnerable—the U.S. is likely delaying shots to other countries, prolonging the pandemic overall.

    As Dr. Michael Ryan, emergencies chief at the World Health Organization, told reporters last week: “We’re planning to hand out extra life jackets to people who already have life jackets, while we’re leaving other people to drown without a single life jacket.”

    More vaccine news

    • Sources and updates, November 12
      Sources and updates for the week of November 12 include new vaccination data, a rapid test receiving FDA approval, treatment guidelines, and more.
    • How is the CDC tracking the latest round of COVID-19 vaccines?
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    • Sources and updates, October 8
      Sources and updates for the week of October 8 include new papers about booster shot uptake, at-home tests, and Long COVID symptoms.
    • COVID source shout-out: Novavax’s booster is now available
      This week, the FDA authorized Novavax’s updated COVID-19 vaccine. Here’s why some people are excited to get Novavax’s vaccine this fall, as opposed to Pfizer’s or Moderna’s.
    • COVID-19 vaccine issues: Stories from COVID-19 Data Dispatch readers across the U.S.
      Last week, I asked you, COVID-19 Data Dispatch readers, to send me your stories of challenges you experienced when trying to get this fall’s COVID-19 vaccines. I received 35 responses from readers across the country, demonstrating issues with insurance coverage, pharmacy logistics, and more.