COVID-19 Data Dispatch

Tag: vaccine results

  • Answering your COVID-19 questions

    Answering your COVID-19 questions

    The Delta surge is waning. Will this be the last big surge in the U.S., or will we see more? This question and more, answered below; chart from the CDC.

    Last week, I asked readers to fill out a survey designed to help me reflect on the COVID-19 Data Dispatch’s future. Though the Delta surge—and the pandemic as a whole—is far from over, I’m considering how this publication may evolve in a “post-COVID” era. Specifically, I’m thinking about how to continue serving readers and other journalists as we prepare for future public health crises.

    Thank you to everyone who’s filled out the survey so far! I really appreciate all of your feedback. If you haven’t filled it out yet, you can do so here. 

    Besides some broader questions about the CDD’s format and topics we may explore in the future, the survey asked readers to submit questions that they have about COVID-19 in the U.S. right now. In the absence of other major headlines this week, I’m devoting this week’s issue to answering a few of those questions.

    Should I get a booster shot? If so, should it be a different one from the first vaccine I got? When will my kids (5-11) likely be eligible?

    I am not a doctor, and I’m definitely not qualified to give medical advice. So, the main thing I will say here is: identify a doctor that you trust, and talk to them about booster shots. I understand that a lot of Americans don’t have a primary care provider or other ways to easily access medical advice, though, so I will offer some more thoughts here.

    As I wrote last week, we do not have a lot of data on who’s most vulnerable to breakthrough COVID-19 cases. We do know that seniors are more vulnerable—this is one point where most experts agree. We know that adults with the same health conditions that make them more likely to have a severe COVID-19 case without a vaccine (autoimmune conditions, diabetes, kidney disease, etc.) are also more vulnerable to breakthrough cases, though we don’t have as much data here. And we know that vaccinated adults working in higher-risk locations like hospitals, nursing homes, and prisons are more likely to encounter the coronavirus, even if they may not necessarily be more likely to have a severe breakthrough case.

    The FDA and CDC’s booster shot guidance is intentionally broad, allowing many Americans to receive a booster even if it is not necessarily needed. So, consider: what benefits would a booster shot bring you? Are you a senior or someone with a health condition that makes you more likely to have a severe COVID-19 case? Do you want to protect the people you work or live with from potentially encountering the coronavirus?

    If you answered “yes” to one of those questions, a booster shot may make sense for you. And, while you may be angry about global vaccine inequity, one individual refusal of a booster shot would not have a significant impact on the situation. Rather, many vaccine doses in the U.S. may go to waste if not used for boosters. But again: talk to your doctor, if you’re able to, about this decision.

    Currently, Pfizer booster shots are available for people who previously got vaccinated with Pfizer. The FDA’s vaccine advisory committee is meeting soon to discuss Moderna and Johnson & Johnson boosters: they’ll discuss Moderna on October 14 and J&J on October 15. Vaccine approval in the U.S. depends upon data submission from vaccine manufacturers—and vaccine manufacturers have not been studying mix-and-match booster regimens—so coming approvals will likely require Americans to get a booster of the same vaccine that they received initially. We will likely see more discussion of mix-and-match vaccinations in the future, though, as more outside studies are completed.

    As for when your kids will likely be eligible: FDA’s advisory committee is meeting to discuss Pfizer shots for kids ages 5 through 11 on October 26. If that meeting—and a subsequent CDC meeting—goes well, kids may be able to get vaccinated within a week of that meeting. (Potentially even on Halloween!)

    Why don’t people get vaccinated and how can we make them?

    I got a couple of questions along these lines, asking about vaccination motivations. To answer, I’m turning to KFF’s COVID-19 Vaccine Monitor, a source of survey data on vaccination that I (and many other journalists) have relied on since early 2021.

    KFF released the latest round of data from its vaccine monitor this week. Here are a few key takeaways:

    • The racial gap in vaccinations appears to be closing. KFF found that 71% of white adults have been vaccinated, compared to 70% of Black adults and 73% of Hispanic adults. Data from the CDC and Bloomberg (compiling data from states) similarly show this gap closing, though some parts of the country are more equitably vaccinated than others.
    • A massive partisan gap in vaccinations remains. According to KFF, 90% of Democrats are vaccinated compared to just 58% of Republicans. This demonstrates the pervasiveness of anti-vaccine misinformation and political rhetoric among conservatives.
    • Rural and younger uninsured Americans also have low vaccination rates (62% and 54%, respectively). Both rural and uninsured people have been neglected by the U.S. healthcare system and face access barriers; for more on this topic, I recommend this Undark article by Timothy Delizza.
    • Delta was a big vaccination motivator. KFF specifically asked people who had gotten their shots after June 1 why they chose to get vaccinated. The most popular reasons were, in order: the increase in cases due to Delta (39%), concern about reports of local hospitals and ICUs filling with COVID-19 patients (38%), and knowing someone who got seriously ill or died from COVID-19 (36%).
    • Mandates and social pressures were also vaccination motivators. 35% of KFF’s recently vaccinated survey respondents said that a big reason for their choice was a desire to participate in activities that require vaccination, like going to the gym, a big event, or traveling. 19% cited an employer requirement and 19% cited social pressure from family and friends.

    The second part of this question, “how can we make them?”, reflects a dangerous attitude that has permeated vaccine conversations in recent months. Yes, it’s understandable to be frustrated with the Americans who have refused vaccination. But we can’t “make” the unvaccinated do anything, and such a forceful attitude may put off people who still have questions about the vaccines or who have faced discrimination in the healthcare system. To increase vaccinations among people who are still hesitant, it’s important to remain open-minded, not condescending. For more: read Ed Yong’s interview with Dr. Rhea Boyd.

    That said, we’re now getting a sense of which strategies can increase vaccination: employer mandates, vaccination requirements for public life, and personal experience with the coronavirus. As the Delta surge wanes, it will take more vaccination requirements and careful, open-minded conversations to continue motivating people to get their shots.

    What are some things I might say to convince people of Delta’s severity and the need to not relax on masking, distancing, etc?

    To answer this, I’ll refer you to the article I wrote about Delta on August 1, as the findings that I discuss there have been backed up by further research.

    Personally, there are two statistics that I use to express Delta’s dangers to people:

    • Delta causes a viral load 1,000 times higher than the original coronavirus strain. This number comes from a study in Guangzhou, China, posted as a preprint in late July. While viral load does not correspond precisely to infectiousness (there are other viral and immune system factors at play), I find that this “1,000 times higher” statistic is a good way to convey just how contagious Delta is, compared to past variants.
    • An interaction of one second is enough time for Delta to spread from one person to another. Remember the 15-minute rule? In spring 2020, being indoors with someone, unmasked, for 15 minutes or more was considered “close contact.” Delta’s increased transmissibility means that an interaction of one second is now enough to be a “close contact.” The risk is lower if you’re vaccinated, but still—Delta is capable of spreading very quickly in enclosed spaces.

    You may also find it helpful to discuss rising numbers of breakthrough cases in the U.S. While vaccinated people continue to be incredibly well protected against severe disease and death caused by Delta, the vaccines are not as protective against coronavirus infection and transmission. (They are protective to some degree, though! Notably, coronavirus infections in vaccinated people tend to be significantly shorter than they are in the unvaccinated, since immune systems can quickly respond to the threat.)

    It’s true that rising breakthrough case numbers are, in a way, expected—as more people get vaccinated, breakthrough cases will naturally become more common, because the virus has fewer and fewer unvaccinated people to infect. But considering the risks of spreading the coronavirus to others, plus the risks of Long COVID from a breakthrough case… I personally don’t want a breakthrough case, and so I continue masking up and following other safety protocols.

    What monitoring do we have in place for COVID “longhaulers” and their symptoms/health implications?

    This is a great question, and one I wish I could answer in more detail. Unlike COVID-19 cases, hospitalizations, and other major metrics, we do not have a comprehensive national monitoring system to tell us how many people are facing long-term symptoms from a coronavirus infection, much less how they’re faring. I consider this one of the country’s biggest COVID-19 data gaps, leaving us relatively unprepared to help the thousands, if not millions, of people left newly disabled by the pandemic.

    In February, the National Institutes of Health (NIH) announced a major research initiative to study Long COVID. Congress has provided over $1 billion in funding for the research. This initiative will likely be our best source for Long COVID information in the future, but it’s still in early stages right now. Just two weeks ago, the NIH awarded a large share of its funding to New York University’s Langone Medical Center; NYU is now setting up long-term studies and distributing funding to other research institutions.

    As I wrote in the September 19 issue, the NIH’s RECOVER website currently reports that between 10% and 30% of people infected with the coronavirus will go on to develop Long COVID; hopefully research at NYU and elsewhere will lead to some more precise numbers.

    While we wait for the NIH research to progress, I personally find the Patient-Led Research Collaborative (PLRC) to be a great source for Long COVID research and data. The PLRC consists of Long COVID patients who research their own condition; it was founded out of Body Politic’s Long COVID support group. This group produced one of the most comprehensive papers on Long COVID to date, based on an international survey including thousands of patients, and has more research currently ongoing.

    If you have the means to support Long COVID patients—many of whom are unable to work and facing homelessness—please see the responses to this tweet by PLRC researcher Hannah Davis:

    Why is the CDC not doing comprehensive high volumes of sequencing on all breakthrough cases at the very least?

    I wish I knew! As I wrote last week (and in several other past issues), the lack of comprehensive breakthrough case data in the U.S. has contributed to a lack of clarity on booster shots, as well as a lack of preparedness for the next variants that may become threats after Delta. The CDC’s inability to track and sequence all breakthrough cases—not just the severe ones—is dangerous.

    That said, it is very difficult to track breakthrough cases in a country like the U.S. Consider: the U.S. does not have a comprehensive, national electronic records system for patients admitted to hospitals, much less those who receive COVID-19 tests and other care at outpatient clinics. This lack of comprehensive records makes it difficult to match people who’ve been vaccinated with those who have received a positive COVID-19 test. Thousands, if not millions of Americans are now relying on rapid tests for their personal COVID-19 information—and most rapid tests don’t get entered into the public health records system at all. 

    Plus, local public health departments are chronically underfunded, understaffed, and burned out after almost two years of working in a pandemic; they have little bandwidth to track breakthrough cases. Many Americans refuse to participate in contact tracing, which hinders the public health system’s ability to collect key information about their cases. And there are other logistical challenges around genomic sequencing; despite new investments in this area, many parts of the country don’t have sequencing capacity, or the information infrastructure needed to send sequencing results to the CDC.

    So, if the CDC were tracking non-severe breakthrough cases, they’d likely miss a lot of the cases. But that doesn’t mean they shouldn’t be trying, in my opinion.

    How safe is it to visit my family for the holidays?

    This is another place where I don’t feel qualified to give advice, but I can offer some thoughts. If I were you, I would think about the different ways in which holiday travel might pose risk to me and to the people at the other end of my trip. I would consider:

    • Quarantining beforehand. Do your occupation and living circumstances allow you to quarantine for a week, or at least limit your exposure to settings where you might be at risk of catching the coronavirus, before you travel? Can you get a test before traveling?
    • Types of travel. Can you make the trip in a car or on public transportation, or do you need to fly? If you need to fly, can you select an airline that has stricter COVID-19 safety requirements? (United recently reported that over 96% of its employees are now vaccinated, for example.) Can you wear a high-quality mask for the flight?
    • Quarantining and/or testing upon arrival. Can you spend a couple of days in quarantine once you get to your destination? Would you have access to testing (with results in under 24 hours) upon your arrival, or would you be able to bring rapid tests with you?
    • Who you’re spending time with. Among the family you’d be visiting, is everyone vaccinated (besides young children)? If anyone is not vaccinated, could your potential travel be a motivator to help convince them to get vaccinated? Does the group include seniors or people with health conditions that put them at high risk for COVID-19, and if so, can they get booster shots?
    • Activities that you do at your destination. Would you be able to have large gatherings outside, or in a well-ventilated space? What else can you do to reduce the risk of these activities?

    Like other activities, travel can be relatively safe or fairly dangerous depending on the precautions that you’re able to take, and depending on COVID-19 case rates where you live and at your destination. And, like other activities, your choice to travel or not travel depends a lot on your personal risk tolerance. Nothing is zero-risk right now; each person has a threshold that determines what level of COVID-19 risk they are and are not comfortable taking. Through some self-reflection, you can determine if travel is above or below your risk threshold.

    Why are policies so different now than they were at this time last year?

    Public health tends to go through cycles of “panic” and “neglect.” Ed Yong’s latest feature goes into the history of this phenomenon:

    Almost 20 years ago, the historians of medicine Elizabeth Fee and Theodore Brown lamented that the U.S. had “failed to sustain progress in any coherent manner” in its capacity to handle infectious diseases. With every new pathogen—cholera in the 1830s, HIV in the 1980s—Americans rediscover the weaknesses in the country’s health system, briefly attempt to address the problem, and then “let our interest lapse when the immediate crisis seems to be over,” Fee and Brown wrote. The result is a Sisyphean cycle of panic and neglect that is now spinning in its third century. Progress is always undone; promise, always unfulfilled. Fee died in 2018, two years before SARS-CoV-2 arose. But in documenting America’s past, she foresaw its pandemic present—and its likely future.

    During the COVID-19 pandemic, the U.S. took a nosedive into the “neglect” cycle before we were even finished with the “panic” cycle. Congress has already slashed its funding for future pandemic preparedness, while state and local governments across the country restrict the powers of public health officials. As a result, we’re seeing an “everyone for themselves” attitude at a time when we should be seeing new mask mandates, restrictions on public activities, and other safety measures.

    Basically, America decided the pandemic was over and acted accordingly—and if you get COVID-19 now, it’s “your fault for not being vaccinated.” This phenomenon has been especially pronounced in rural areas, which struggled a lot (but saw few cases) during spring 2020 lockdowns and are extremely hesitant to do anything approaching a “lockdown” again.

    We need an attitude shift—and more investment in public health—to actually end this pandemic and prepare for the next health crisis. Yong’s feature goes into this in more detail; definitely give that a read if you haven’t yet.

    When is this going to be over?!?

    Unfortunately, this is very hard to predict—even for the expert epidemiologists and computational biologists who make the models. Check out the CDC’s compilation of COVID-19 case models: most of them agree that cases will keep going down in the coming weeks, but they’re kind of all over the place.

    Last week, I summarized two stories—from The Atlantic and STAT News—that discuss the coming winter, and kind of get at this question. It’s possible that cases keep declining from their present numbers, and that the Delta surge we just faced is the last major surge in the U.S. It’s also possible that a new variant arises out of Delta and sends us into yet another new surge. If that happens, more people will be protected by vaccination and prior infection, but healthcare systems could come under strain once again.

    As long as the coronavirus continues spreading somewhere in the world, it will continue to pose risk to everyone—able to cause new outbreaks and mutate into new variants. This will continue until the vast majority of the world is vaccinated. And then, at some point, the coronavirus will probably become endemic, meaning it persists in the population at some kind of “acceptable” threshold. Just like the flu.

    Dr. Ellie Murray, epidemiologist at Boston University’s School of Public Health, explained how a pandemic becomes endemic in a recent Twitter thread:

    Dr. Murray points out that, even when a disease reaches endemic status, tons of scientists and public health workers will still continue to monitor it. This is the case for the flu—think about all of the effort that goes into a given year’s flu shot!—and it will likely be the case for COVID-19.

    In short, public health leaders need to figure out what level of COVID-19 transmission is “acceptable” and how we will continue to monitor it. This needs to happen at both U.S. and global levels. And, thanks to our vaccine-rich status, it’ll likely happen in the U.S. long before it happens globally.

    Again, if you haven’t filled out the survey yet, you can do so here. I may answer more questions next week!

  • 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

  • Boosters for the vulnerable: FAQs following the FDA advisory meeting

    Boosters for the vulnerable: FAQs following the FDA advisory meeting

    This past Friday, the Food and Drug Administration (FDA)’s vaccine advisory committee voted to recommend booster shots of the Pfizer-BioNTech vaccine for all Americans over age 65 and those who are particularly vulnerable to the virus, due to their health conditions and/or work environments. This was a notable recommendation because it went against the FDA’s ask: booster shots for everyone over the age of 16.

    Let’s walk through the data behind this decision.

    How is the current two-dose vaccine regimen faring against severe COVID-19 disease?

    Before we get into any numbers, it’s important to remember the initial goal of the COVID-19 vaccines: protect people against severe disease, hospitalization, and death, basically reducing the coronavirus’ power to cause deadly harm.

    On this front, all of the vaccines are performing well. Numerous papers cited during the advisory meeting, as well as the U.S.’s breakthrough case data, suggest that vaccination protects against severe COVID-19 disease for the vast majority of recipients. Among over 178 million people who had been fully vaccinated in the U.S. by mid-September, just 3,000 have died following a positive COVID-19 test. Those 3,000 deaths account for just about 1% of all COVID-19 deaths in the U.S. since January 2021.

    The numbers get a bit more complex, however, when you look at older adults and other vulnerable populations. Those who were more vulnerable to a severe COVID-19 case in the first place are also more vulnerable to having a severe breakthrough case, if they encounter the virus after vaccination. One chart, presented at the FDA meeting, provides a picture of this trend. From late January to mid-July, 2021, the hospitalization rate among younger adults (ages 18-49) was 23 times higher for the unvaccinated than for the vaccinated. For seniors (over age 65), however, the rate was 13 times higher for the unvaccinated.

    Seniors are more likely to experience a severe breakthrough case than younger adults, CDC data suggest.

    How is that current regimen faring against coronavirus infection?

    This is where we see a bigger drop in efficacy. Multiple studies point to the Pfizer and Moderna vaccines becoming less capable of protecting recipients against infection, over time; in other words, if you got your two shots in April 2021, you’re more likely to get a positive test result now, in September, than you were in May. (Though your case will likely be mild or asymptomatic!)

    While the vaccines are still highly effective against severe disease, their effectiveness against coronavirus infection appears to be waning.

    We can also see this in breakthrough case numbers when we look at all infections, as opposed to only those cases that lead to severe disease or death. This type of analysis is difficult to do in the U.S., as the CDC is only systematically tracking those severe cases, but we can see patterns in the data from local jurisdictions that are reporting their breakthrough cases more comprehensively.

    For example, let’s look at Washington, DC, which reports breakthrough cases in extensive detail:

    Washington, D.C. is seeing many more breakthrough cases now than it was earlier in 2021.

    During the week of March 8, DC reported 14 breakthrough cases. The district reported about 800 cases overall that week, meaning that breakthroughs accounted for 2% of all cases. 

    During the week of August 23, however, the district reported almost 500 breakthrough cases. In that week, the district reported about 1,400 cases overall—meaning that breakthrough cases have jumped from 2% of all weekly DC cases to 35% of all weekly DC cases.

    DC also reports a breakdown of breakthrough cases according to the time it’s been since residents were fully vaccinated. This reveals that most breakthroughs occur at least two months after an individual completed their dose series, with the highest number of breakthroughs in people who’d been vaccinated three to four months ago. We can assume that similar patterns are occurring elsewhere in the country.

    It’s also worth noting that we don’t have a great sense of how well the vaccines protect against Long COVID—though data thus far suggest that post-vaccination Long COVID cases are much rarer than non-breakthrough cases.

    Why are the vaccines appearing to lose their effectiveness?

    This was a big point of discussion for the FDA advisory committee. Are the Pfizer and Moderna vaccines appearing to lose their ability to protect us against coronavirus infection because Delta has a special ability to evade the vaccines or because the vaccines become less effective over time?

    One early-morning presenter at the FDA meeting, medical statistician Jonathan Sterne from the University of Bristol, dove into this issue. His presentation focused on confounders, a statistical term for an outside force that influences the question a researcher is trying to study. In the case of vaccine effectiveness, Sterne said, there are a lot of confounders; these include vaccine recipients’ ages, how long ago they were vaccinated, and when they were vaccinated (i.e. in which phase of the pandemic?).

    Sterne’s presentation focused on the confounders that make it difficult to estimate vaccine effectiveness.

    Sterne and other British researchers have taken advantage of the U.K.’s extensive electronic health records to analyze how well the vaccines are working, attempting to take these confounders into consideration. Overall, he said, it’s very challenging to get trustworthy effectiveness numbers—though the U.K. has approved boosters for residents over age 50, so it’s clear that the country’s public health agency does see some need for the additional shots.

    Sterne’s presentation, as did a presentation from Israeli public health officials, also underscored the need for the U.S. to collect more standardized data on breakthrough cases, among other things.

    Why did the FDA advisory committee vote against booster shots for everyone, ages 16 and over?

    When this advisory committee votes on a question regarding vaccines or another biological product, the committee is specifically asked to consider whether the benefits of the product outweigh the risks. In this case, do the benefits of widespread boosters outweigh the risks of potential side effects from those additional doses?

    When it comes to those risks of potential side effects, the committee had strikingly little data to evaluate. Pfizer did conduct a clinical trial of booster shots, but it only included 306 participants—an incredibly small number, when compared to the massive trials of the vaccine’s original two-dose regimen. The trial didn’t include any participants under age 18 or over age 55, which some advisory committee members found problematic, as they were being asked to consider approval for all Americans over age 16.

    Israel—which has now administered booster shots to over 2.8 million residents—provided some data on side effects, but their utility is limited. The country started giving boosters to older adults before moving to younger adults, limiting Israeli health officials’ ability to identify potential risk for myocarditis or other severe side effects that might be more common in the younger population.

    Israel has only identified 19 serious vaccine side effects from its booster shot rollout thus far, but the majority of the country’s young adults have yet to be vaccinated.

    While data from Israel do suggest that booster shots can bring down infection numbers in an overall population, the FDA advisory committee did not find that a sufficient argument to recommend boosters for all Americans. Not at this time, anyway.

    Why did the committee vote to support boosters for seniors and other vulnerable populations?

    The risks of booster shots may not be clear for younger adults, but the risks of a breakthrough COVID-19 case are clear for older adults and others with health conditions that make them more vulnerable to severe COVID-19 case. The committee’s vote to recommend boosters for vulnerable groups aligns with a growing scientific consensus: that the U.S. should protect seniors, nursing home residents, and others who are at higher risk for serious COVID-19 cases.

    What happens next?

    It’s important to underscore here that this booster shot recommendation came from a committee that advises the FDA, not from the FDA itself. The agency typically follows its committee’s recommendations, but it doesn’t have to. We can expect the FDA’s decision—approval of booster shots for vulnerable groups, for everyone over age 16, or something else—within a couple of days.

    Next week, on Wednesday and Thursday, a CDC advisory committee is set to meet to further discuss booster shots. If both the FDA and CDC approve boosters, health departments across the country are prepared to begin administering them to eligible Americans; this will likely include seniors and other vulnerable adults who previously got two shots of the Pfizer vaccine. 

    What about everyone who got the Moderna or Johnson & Johnson vaccines?

    Again, this decision focused on the Pfizer vaccine, so Moderna and J&J recipients will need to wait for more data and more deliberation. Moderna has formally applied to the FDA for authorization of its booster shot, so we may see a similar series of meetings about that vaccine in the coming weeks.

    J&J vaccine recipients will likely experience a longer wait as researchers collect data on the effectiveness of this one-shot vaccine. CNET has a good explainer of the situation.

    Also: If you’d like to read a more detailed breakdown of everything that happened at Friday’s advisory committee meeting, I highly recommend the STAT News liveblog by Helen Branswell and Matthew Herper, which I drew upon heavily in writing this post.

    More vaccines 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?
      Following the end of the federal public health emergency in May, the CDC has lost its authority to collect vaccination data from all state and local health agencies that keep immunization records. As a result, the CDC is no longer providing comprehensive vaccination numbers on its COVID-19 dashboards. But we still have some information about this year’s vaccination campaign, thanks to continued CDC efforts as well as reporting by other health agencies and research organizations.
    • 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.
  • Breakthrough case reporting: Once again, outside researchers do the CDC’s job

    Breakthrough case reporting: Once again, outside researchers do the CDC’s job

    In May, the CDC switched from tracking and reporting all cases that occur in vaccinated Americans to reporting only those that cause hospitalizations or deaths. At the time, I criticized this move as a lazy choice that left the U.S. without critical information as Delta and other variants spread through the country.

    Now, Delta is causing the vast majority of cases—and the CDC still isn’t reporting on non-severe breakthroughs. As a result, entities outside the federal government are once again compiling data from states in order to fill in gaps left by the national public health agency.

    On Friday, both Bloomberg and NBC published breakthrough case analyses. Bloomberg reported 112,000 total breakthrough cases from 35 states, as of the end of July. This is a tiny fraction of the vaccinated population—over 164 million Americans—but it is far higher than the national breakthrough case number reported by the CDC in May, pre-reporting switch.

    Bloomberg’s report includes plenty of expert critiques of the CDC’s May decision, suggesting that the lack of data led to many local public health officials flying blind as Delta spread.

    With better understanding of how delta spreads, different public health measures or warnings could have been put in place for vaccinated people, said Rachael Piltch-Loeb, a Harvard Chan School of Public Health researcher on public health emergency responses.

    According to NBC, America’s breakthrough case total is even higher: at least 125,000 cases from 38 states. Nine states, including Pennsylvania and Missouri, failed to provide NBC with any breakthrough case information, while 11 did not provide death and hospitalization numbers. Still, these cases have clearly increased substantially in the past two months, NBC reports:

    In Utah on June 2, 2021, just 27 or 8 percent of the 312 new cases in the state were breakthrough cases. As of July 26 there were 519 new cases and almost 20 percent or 94 were breakthroughs, according to state data.

    Now, it’s important to emphasize that breakthrough cases are still very rare and very mild, compared with non-breakthrough COVID-19. The 125,000 cases reported by NBC comprise less than 0.08% of the 164 million Americans who’ve been fully vaccinated. And the CDC reports just 6,600 severe breakthrough cases (leading to hospitalization and/or death) as of July 26.

    Any news article, headline, or tweet about breakthroughs should make that denominator explicitly clear—something that one NBC reporter failed to do when sharing his outlet’s story on Friday.

    https://twitter.com/derekwillis/status/1421210128632762368

    Also on Friday, the Kaiser Family Foundation (KFF) published detailed annotations on state breakthrough case reporting. 24 states and D.C. have provided public data on this topic, according to KFF; some are reporting data regularly, while others have included the information in limited press releases and other reports.

    If your state is one of the 26 states not providing any public breakthrough case data at all, I’d recommend reaching out to the state public health agency and asking why not. Yes, it’s challenging to identify these cases when vaccinated people tend to have mild symptoms and might not think to get a test. And yes, the vast majority of people who have a breakthrough case will likely be fine in a couple of weeks. But the information is vital as Delta continues to wreak havoc across the country.

    More vaccine reporting

    • 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?
      Following the end of the federal public health emergency in May, the CDC has lost its authority to collect vaccination data from all state and local health agencies that keep immunization records. As a result, the CDC is no longer providing comprehensive vaccination numbers on its COVID-19 dashboards. But we still have some information about this year’s vaccination campaign, thanks to continued CDC efforts as well as reporting by other health agencies and research organizations.
    • 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.
  • Unpacking Delta numbers from this week’s headlines

    Unpacking Delta numbers from this week’s headlines

    It should be no surprise, at this point in the summer, that Delta (B.1.617.2) is bad news. From the moment it was identified in India, this variant has been linked to rapid transmission and rapid case increases, even in areas where the vaccination rates are high.

    This week, however, the CDC’s changed mask guidance—combined with new reports on breakthrough cases associated with Delta—has triggered widespread conversation about precisely how much damage this variant can do. “I’ve not seen this level of anxiety from everyone since the beginning of the pandemic,” Dr. Katelyn Jetelina wrote in her newsletter Friday.

    In the CDD today, I’m unpacking six key statements that you’ve likely seen in recent headlines, including where the statistics came from and what they mean for you.

    1. Delta causes a viral load 1,000 times higher than the original coronavirus strain.

    This number comes from a recent study in Guangzhou, China that was published as a preprint earlier in July. The researchers looked at viral load, a measurement of how much virus DNA is present in patients’ test samples; a higher viral load generally means the patient can infect more people, though it’s not a one-to-one relationship (more on that below).

    Based on measurements from 62 people infected with Delta, the researchers concluded that Delta patients have about 1,000 times more virus in their bodies compared to patients infected with the original coronavirus strain in early 2020. This paper has not yet been peer-reviewed, but outside experts have cited it as evidence behind Delta’s super-spreading ability.

    For more explanation on how Delta differs from past coronavirus strains, check out this KHN story by Liz Szabo.

    2. Delta causes similar viral loads in vaccinated and unvaccinated people who get infected.

    This finding comes from a highly anticipated CDC report published Friday in the agency’s Morbidity and Mortality Weekly Report (MMWR). CDC researchers measured viral loads—remember, a reflection of how much virus DNA is in a patient’s body—in vaccinated and unvaccinated people who got infected during an outbreak in Provincetown, Massachusetts. They found that the two groups had similar measurements, on average. Test samples in this outbreak were also sequenced; 90% of cases in the outbreak were definitively caused by Delta.

    It’s important to be precise when we talk about this CDC report, because viral load is just one specific measurement. While the viral load can reflect how capable someone is of transmitting the coronavirus, the CDC’s data do not definitively tell us that vaccinated and unvaccinated people are equally capable of transmitting Delta.

    Experts commenting on the CDC’s findings have said that other factors, such as length of infection and virus presence in a patient’s nose and mouth, also play into coronavirus transmission.For example, here’s a quote from a Science News story discussing the CDC’s findings:

    The result “just gives you an indication of how much viral RNA is in the sample, it tells you nothing about infectiousness,” says Susan Butler-Wu, a clinical microbiologist at the University of Southern California. These data “are a cause for concern, but this is not a definitive answer on transmissibility” from vaccinated people, she says.

    And here’s a Twitter thread from a vaccine scientist discussing how the CDC has conflated viral load measurements with actual transmission:

    https://twitter.com/sailorrooscout/status/1421111487020609537

    In other words: vaccinated people are not capable of spreading Delta to the same degree as the unvaccinated. The infection and transmission risks for vaccinated people are still much lower. Here’s one reason why…

    3. A breakthrough infection will be over faster than a non-breakthrough infection.

    This finding comes from a study out of Singapore, published yesterday as a preprint. Researchers looked at viral loads over time for patients infected with Delta, comparing numbers for those patients who had and had not been vaccinated. They found that the viral load decreased more quickly in those vaccinated patients who had a breakthrough case, signifying that vaccinated patients both recover more quickly and lose their ability to get someone else infected more quickly.

    In other words, when a vaccinated person has a breakthrough case, their immune system is more prepared to face the coronavirus. That prepped immune system will help the person avoid severe disease, while also getting the virus out of the body more quickly than the immune system would be able to without a vaccine’s help.

    This study is not yet peer-reviewed, but it aligns with other research showing that vaccinated people with breakthrough cases tend to have mild symptoms and spend less time being contagious.

    4. An interaction of one second is enough time for Delta to spread from one person to another.

    In spring 2020, public health leaders agreed on a rule of thumb for COVID-19 risk: if you were indoors with someone, unmasked, for at least 15 minutes, that person qualified as a “close contact” who could give you the coronavirus, or vice versa. Now, with Delta, the equivalent of that 15-minute close contact is one second. I first saw this statistic in a STAT News interview with epidemiologist Dr. Céline Gounder, but it’s been reported in other publications as well.

    Let me emphasize here, though, that this one-second rule applies to indoor transmission. We don’t yet know how much Delta increases the risk of outdoor transmission, which was almost entirely negligible for past variants.

    5. The average person with Delta infects at least twice as many others as the average person with the original coronavirus strain.

    In spring 2020, the average person who got sick with COVID-19 would infect a couple of others, while a select few would cause superspreading events. Now, we’re learning that the average person who gets Delta can infect more. An internal CDC report leaked by the Washington Post says that Delta may infect eight or nine people on average and spreads “as easily as chickenpox.”

    While this comparison is obviously pretty concerning, outside experts have been skeptical of the CDC’s generalization of data from that one Massachusetts outbreak. Plus, the CDC’s estimate of Delta’s capacity for infection is higher than estimates we’ve seen from other sources. Studies out of England suggest that the variant infects five to seven people on average—still high, but not quite chickenpox levels.

    6. Hospitalizations are rising in undervaccinated areas, while well-vaccinated areas are on the alert.

    Florida has been setting COVID-19 records recently. The state now has more people in the hospital with COVID-19 than at any other time during the pandemic, including the winter surge.

    Meanwhile, hospitalizations in Texas are up more than 300% from lows in late June. Austin is running out of ICU beds. Louisiana, Arkansas, and Nevada have all seen more than 10 new COVID-19 patients for every 100,000 residents in the past week. And the healthcare workers treating these patients are burnt out from over a year of pandemic work.

    In well-vaccinated areas, hospitalizations are low for now; even with Delta, the vaccines do a great job of protecting people against severe disease and death. But hospitals in these cities are still on high alert, ready to treat unvaccinated patients and those seniors, immunocompromised patients, and others for whom the vaccines may not be as effective.

    For example, see this thread from University of California San Francisco medical professor Bob Wachter. (San Francisco has the highest vaccination rate of any city in America.)

    TL;DR

    The TL;DR here is: Delta is way more contagious than any variant we’ve seen before. For unvaccinated people, any indoor, unmasked interaction with someone who has Delta—even a very short interaction—is enough for you to get infected. For vaccinated people, the risk of getting and spreading Delta is elevated compared to past coronavirus strains, but it is still far lower than the risk for unvaccinated people.

    So, when the CDC suggests that vaccinated people go back to mask-wearing (if you ever stopped), the agency is saying, wear a mask on behalf of the unvaccinated people around you. Those who are vaccinated are at more risk now than they were in May or June, but vaccination is still the best protection we have against infection, transmission, and—most importantly—severe COVID-19 disease.

    Or, to quote WNYC health and science editor Nsikan Akpan: “The vaccines will keep you from dying. Masks will keep away infections. Otherwise, the COVID odds are against you.”

    More variant reporting

    • The booster shot conversation: What you should know

      The booster shot conversation: What you should know

      Pfizer vaccine, in use at Walter Reed National Military Medical Center. DoD photo by Lisa Ferdinando.

      Recently, a lot of U.S. COVID-19 news has centered around booster shots—additional vaccine doses to boost patients’ immunity against the coronavirus. Questions abound: do we need these shots, when might we need them, how do they impact vaccination campaigns?

      In other countries, booster shots are being deployed as a measure of extra protection for people with weaker immune systems as Delta spreads. In France, extra vaccine doses are available for organ transplant recipients, those on dialysis, and others. Israel is similarly offering third Pfizer doses to Israelis with medical conditions that cause immunodeficiency. And in Thailand, healthcare workers are getting booster shots of the AstraZeneca vaccine after two doses of Sinovac, which has demonstrated lower efficacy than other vaccines.

      Even in the U.S., a small number of immunocompromised patients have received third doses—many of them in clinical trials analyzing how well boosters work. Medical experts tend not to question why boosters may be needed for immunocompromised patients, as their weakened immune systems also make the patients more vulnerable to severe cases of COVID-19.

      The real questions come when we start to consider booster shots for everyone. Pfizer, which has developed a third dose for the general population, recently announced that the company applied for Emergency Use Authorization from the FDA. The company says its currently approved two-shot regimen will cause patients to lose some protection six months after they’ve been vaccinated—and become more vulnerable to Delta—with continued lower immunity over time.

      Officials at the FDA and CDC, however, have said that boosters aren’t yet necessary. The agencies released a joint statement to that effect, and U.S. health officials say they want to see more data—especially from Israel, where Pfizer has been in heavy use. Pfizer’s data on waning efficacy aren’t yet public (released by press release, not scientific paper), which complicates the conversation. Still, some health officials say we will eventually need booster shots, just not right now, according to POLITICO.

      While U.S. public health experts seek more data, our booster shot conversation appears selfish in other parts of the world. While over 3.6 billion doses have been administered globally across 180 countries, high-income countries are getting vaccinated 30 times faster than lower-income countries, according to Bloomberg. More than half of Americans have received at least one shot, compared to under 1% in many African countries.

      Dr. Tedros Adhanom Ghebreyesus, Director-General of the WHO, slammed the U.S. and other wealthy nations at a press briefing last week for even considering booster shots. “The priority now must be to vaccinate those who have received no doses and protection,” he said. “Instead of Moderna and Pfizer prioritizing the supply of vaccines as boosters to countries whose populations have relatively high coverage, we need them to go all out to channel supply to COVAX, the Africa Vaccine Acquisition Task Team and low- and low-middle income countries, which have very low vaccine coverage.”

      For more details and expert takes on the situation, I recommend this article from several ace STAT News reporters.

      More vaccine reporting

      • 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?
        Following the end of the federal public health emergency in May, the CDC has lost its authority to collect vaccination data from all state and local health agencies that keep immunization records. As a result, the CDC is no longer providing comprehensive vaccination numbers on its COVID-19 dashboards. But we still have some information about this year’s vaccination campaign, thanks to continued CDC efforts as well as reporting by other health agencies and research organizations.
      • 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.
    • Novavax vaccine performs well—including against variants

      Novavax vaccine performs well—including against variants

      The COVID-19 news world saw a return of Monday-morning vaccine results this week. Novavax, a small biotech company based in Maryland, announced that its vaccine demonstrated 90% overall efficacy and 100% protection against moderate and severe COVID-19 disease.

      These results come from a trial conducted in the U.S. and Mexico between January and April this year, at a time when the Alpha (or B.1.1.7) variant was becoming dominant here. Among almost 30,000 trial participants, 77 cases were observed: 63 in the placebo group and 14 in the vaccine group, for an efficacy of 90.4%. All of the moderate and severe cases (ten moderate, four severe) were observed in the placebo group.

      Novavax even sequenced samples from 54 out of the 77 cases. The majority of those sequenced cases were variants of concern or variants of interest; Novavax’s vaccine demonstrated 93.2% efficacy against variants of concern/interest and 100% efficacy against non-concerning variants. This finding aligns with other vaccine studies suggesting that the COVID-19 vaccines developed on older versions of the virus still work well against variants, especially at protecting against severe disease and death.

      This new vaccine uses a coronavirus protein—a different method from both Moderna/Pfizer (mRNA vaccines) and AstraZeneca/Johnson & Johnson (adenovirus vaccines). It’s given in two doses, three weeks apart. It had far fewer side effects than other COVID-19 vaccines, with small numbers of participants reporting sore arms and fatigue.

      The Novavax vaccine is also comparatively easier to transport and store than other viruses; it can be stored at refrigerated temperatures. While it’s unlikely to be used in the U.S., it could be critical for vaccine rollouts in other parts of the world.

      More vaccine data

      • 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?
        Following the end of the federal public health emergency in May, the CDC has lost its authority to collect vaccination data from all state and local health agencies that keep immunization records. As a result, the CDC is no longer providing comprehensive vaccination numbers on its COVID-19 dashboards. But we still have some information about this year’s vaccination campaign, thanks to continued CDC efforts as well as reporting by other health agencies and research organizations.
      • 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.

    • Moderna for the middle children

      Good news for kids hoping for jabs in arms (which used to sound like an oxymoron before this spring): Moderna has announced promising results for its trial in adolescent-aged children. In around 4,000 adolescents, the vaccine proved to be 94.1% effective in preventing disease. No cases in the vaccinated group were found two weeks after the second shot, while 4 cases were found in the unvaccinated control group. 

      On Tuesday, May 25, Moderna showed in a clinical trial that its mRNA vaccine is safe and effective in people ages 12 to 17. The company will apply for FDA emergency use authorization in June. This follows the semi-recent authorization of the Pfizer-Biontech vaccine for the same age group, which happened at the end of March. 

      While children tend to have less severe complications from COVID-19 on the whole, serious illness is still quite possible. And even though rates across the country are falling due to more widespread vaccination, it’s still important that kids get vaccinated as herd immunity is not quite in our grasp yet. 

      The availability of another vaccine may help more people in this age group get protected; however, the rest of the world has nowhere near the access to vaccines that U.S. citizens over age 12 do right now. In April, health policy experts estimated that the United States might have an excess of up to 300,000 extra vaccines. 

      That being said, adolescents should still get vaccinated if it is available to them. This problem isn’t the fault of citizens wanting to get protection; it’s about the failures of governments and systems to provide vaccine equity.

      More vaccine reporting

      • 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?
        Following the end of the federal public health emergency in May, the CDC has lost its authority to collect vaccination data from all state and local health agencies that keep immunization records. As a result, the CDC is no longer providing comprehensive vaccination numbers on its COVID-19 dashboards. But we still have some information about this year’s vaccination campaign, thanks to continued CDC efforts as well as reporting by other health agencies and research organizations.
      • 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.
    • Why did the CDC change its breakthrough case reporting?

      Why did the CDC change its breakthrough case reporting?

      Earlier this month, the CDC made a pretty significant change in how it tracks breakthrough cases. Instead of reporting all cases, the agency is only investigating and collecting data on those cases that result in hospitalizations or deaths.

      In case you need a refresher: “breakthrough cases” are those infections that occur after a patient is fully vaccinated (including both doses, if applicable, and the two-week waiting period after a final dose). These cases are rare—like, one in ten thousand rare. As I wrote back in April, it’s important to contextualize any reporting on these cases with their incredible rareness so that we hammer home just how effective the vaccines are.

      But just because breakthrough cases are rare doesn’t mean we shouldn’t pay attention to them. In fact, it’s critical to pay attention to these cases in order to monitor precisely how well our vaccines are working—and how new variants may threaten the protections those vaccines provide.

      As The Atlantic’s Katherine J. Wu explains:

      Breakthroughs can offer a unique wellspring of data. Ferreting them out will help researchers confirm the effectiveness of COVID-19 vaccines, detect coronavirus variants that could evade our immune defenses, and estimate when we might need our next round of shots—if we do at all.

      As I’ve discussed in past variant reporting, numerous studies have demonstrated that the vaccines currently in use in the U.S.—especially the Pfizer and Moderna vaccines—work well against all variants. That includes variants of concern, such as B.1.617 (from India), B.1.351 (from South Africa), and P.1 (from Brazil). But the vaccine efficacy rates for some of these variants are lower than that stellar 95% we saw in Pfizer and Moderna’s clinical trials. And some common therapeutic drugs don’t work well for patients infected with variants, too.

      As a result, scientists are concerned that, while the vaccines are working well now, they might not work well forever. Whenever the coronavirus infects a new person, it has the opportunity to evolve. And that continued evolution must be monitored. The first coronavirus variant able to evade our vaccines may emerge in a foreign country with a raging outbreak—but it may also emerge here in the U.S. Closely monitoring all breakthrough cases will help us find that dangerous variant.

      (Of note: A new, potentially-concerning variant was identified just last night in Vietnam; WHO scientist Maria Van Kerkhove described it as an offshoot of the variant from India, B.1.617, with “additional mutation(s).”)

      With that in mind, let’s unpack the CDC’s reporting change. When the vaccine rollout started, the agency was investigating all breakthrough cases that came to its attention—including those in patients with only mild symptoms, or with no symptoms at all. According to an agency study released this past Tuesday, the CDC identified 10,262 such breakthrough cases from 46 U.S. states and territories between January 1 and April 30, 2021.

      Keep in mind: By April 30, about 108 million Americans had been fully vaccinated. Dividing 10,262 by 108 million is where I got that “one in ten thousand” comparison I cited earlier. As I said: very rare.

      Starting on May 1, however, the CDC changed its strategy. Now, it is only tracking breakthrough cases that result in severe illness for patients, leading to hospitalization and/or death. The CDC says that this choice is intended to focus on “the cases of highest clinical and public health significance” rather than tracking down asymptomatic cases.

      In its May 25 report, CDC scientists said that 27% of the breakthrough cases identified before May 1 were asymptomatic. 10% of the infected individuals were hospitalized, though almost a third of those patients were hospitalized for a reason unrelated to COVID-19. Only 160 patients (less than 2% of the breakthrough cases) died.

      We need to take these numbers with a grain of salt, though, because the CDC has likely undercounted the true number of asymptomatic cases. Both clinical trials and studies on vaccine effectiveness in the real world have suggested that those people who get infected with COVID-19 after completing a vaccination regime are more likely to have mild symptoms, or no symptoms at all.

      Plus, the CDC is recommending that vaccinated Americans don’t need to get tested before traveling, if they have come into contact with someone known to have COVID-19, or for many of the other reasons that many of us got tested this past year. (The agency is still recommending that fully vaccinated people get tested if they’re experiencing COVID-19 symptoms, though.)

      As I wrote at Slate Future Tense last month, such guidelines are likely to drive down the number of COVID-19 tests conducted across the U.S. And this trend seems to be happening, so far: PCR tests dropped from their winter surge levels this spring, and are now dropping again. (Antigen and other rapid tests may be getting used more, but we don’t have any comprehensive data on them.)

      With that drop in testing—combined with the overall challenge of identifying asymptomatic COVID-19 cases outside of dedicated studies—it would be pretty damn hard for the CDC to track down all breakthrough cases. The agency’s focus on more serious cases instead may thus be considered a conservation of resources, directing research efforts and care to those Americans who get seriously ill after vaccination.

      But “a conservation of resources” is also a nice way of saying, the CDC made a lazy choice here. The agency has poured money into genomic surveillance over the past few months, sequencing over 20,000 cases a week (compared to a few thousand cases a week before Biden took office). In recent weeks, the Biden administration has announced renewed funding for public health and similar commitments to prioritizing scientific research. If the CDC wants to find and sequence breakthrough cases in order to identify vaccine-busting variants, there should be nothing stopping the agency.

      Or, as epidemiologist Dr. Ali Mokdad told the New York Times: “The C.D.C. is a surveillance agency. How can you do surveillance and pick one number and not look at the whole?”

      Out of those 10,262 cases that the CDC reported this week, only 5% had sequence data available—but the majority of those sequined cases were variants of concern, including B.1.1.7 and P.1. At The Atlantic, Wu reported that epidemiologists in some parts of the country are seeing more breakthrough cases tied to concerning variants, while others are seeing breakthrough case sequences that match the overall infections in the community.

      To me, this high level of unknowns and uncertainties mean that we need more breakthrough case reporting and sequencing, not less. And we need a national public health agency that commits to true surveillance, so that we aren’t flying blind when the coronavirus inevitably evolves beyond our current defenses.

      (P.S. Shout-out to Illinois, the one state that reports its own breakthrough case data.)

      More vaccine reporting

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