Tag: vaccine results

  • Vaccine cocktails look viable—just in time for hot-vax summer

    Some good global vaccine news this week: it looks like vaccine cocktails may be a promising option.

    A clinical trial based in Spain of around 600 participants (aged 18-59) reported encouraging results regarding mix-and-match vaccines (or “heterologous prime-and-boost,” if you want the jargon) meaning one shot of one vaccine and the second shot of another. In this study, the first dose given was AstraZeneca, and the second was Pfizer. 

    The study found that protective IgG antibodies were 30-40 times higher in the treatment group than the control group (those who had only received the first dose of the AstraZeneca vaccine). Neutralizing antibodies were also seven times higher after the Pfizer dose compared to the control, while usually they double in number after the second AstraZeneca shot. 

    As some people familiar with Covid vaccines may note, these vaccines use two different mechanisms to stimulate the immune system: the AstraZeneca shot uses an adenovirus vector modified with the SARS-CoV-2 spike protein while the Pfizer vaccine uses messenger RNA to coax cells into making the spike protein themselves. This early success demonstrates that vaccines with different mechanisms can be combined to induce a strong immune response.

    In the wake of the AstraZeneca blood clot news, it’s reasonable to expect that some may be hesitant to get the second shot if they have received the first AstraZeneca shot. Some authorities have advised people who have gotten the first dose of AstraZeneca to get an alternative for the second shot. Having an alternative that hasn’t been linked to blood clots might persuade those hesitant to get the second AstraZeneca shot to complete a vaccination regimen, especially if it might stimulate even more of an immune response than the regular AstraZeneca regimen.

    There’s currently another heterologous prime-and-boost trial in place in the United Kingdom with a slightly more complicated experimental setup (the four groups were AstraZeneca for both shots, Pfizer for both shots, Pfizer for the first and AstraZeneca for the second, or vice versa), with all participants over 50. 

    This study hasn’t reported results regarding immune responses yet, but they have reported some preliminary reactogenicity results. On May 12, researchers reported that mild side effects like fever or fatigue were more common in people who had received mixed vaccines. However, there were no severe side effects, and the mild ones subsided after a few days. The Spanish study did not find this, and instead found that mild side effects were about as common as they were with a regular vaccine regimen. 

    The UK study is expected to report immune response data soon, so it’ll be interesting to see if it matches the results found by the Spanish study. We’ll keep you updated when those results come out.

    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.
  • Pfizer for the whole pfamily (now CDC-verified!)

    Pfizer for the whole pfamily (now CDC-verified!)

    In case you missed it amidst the mask discourse: Pfizer was already the “vaccine for cool people,” but this week, it formally became the vaccine for teens. The FDA announced on Monday that it was expanding the Emergency Use Authorization for this vaccine to include children ages 12 to 15, and the CDC followed this up with an official recommendation on Wednesday.

    As Sarah Braner reported when the Pfizer adolescent trial results were released: “In the trial, no participants who received the vaccine contracted symptomatic COVID-19 out of a total of 2,260 participants, marking an efficacy rate of 100%.” So, this formal endorsement was a pretty foregone conclusion, but it’s still good news for the 17 million children ages 12 to 15 in the country.

    Here are a couple more statistics about the 12-15 age group, via the Kaiser Family Foundation:

    • This group accounts for 5% of the U.S. population and 27% of the population under age 16.
    • Nearly half of children in this age group are people of color, including: 25% are Hispanic, 13% are Black, and 5% are Asian.
    • 36% of children in this age group live in a family with incomes below 200% of the Federal Poverty Level.
    Vaccination coverage for the population ages 12 and up, as of May 15. The darker blue a state is, the better its coverage.

    And speaking of adolescent data: on Friday, the CDC diversified its vaccine tracker. In addition to state-by-state views of vaccination coverage for the overall population, adult population, and senior population, the Tracker will now show you vaccination coverage for each state’s population over age 12. Nationwide, 56% of this group has had at least one dose and 44% is fully vaccinated.

    The Vaccinations County View page will show you coverage over age 12 by county, but these data aren’t yet available for easy download in the Community Profile Reports.

    The CDC’s demographic vaccination data, meanwhile, groups adolescents in with (already eligible) 16 to 18-year olds in an under 18 category—so we aren’t yet able to see precisely how many children in this age group are getting vaccinated. This may become a concerning data gap as schools may seek to use 12-15 vaccination rates as an indicator for reopening next fall.

    More vaccine coverage

    • 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.
  • The data behind the CDC’s new mask guidance

    The data behind the CDC’s new mask guidance

    This past Thursday, the CDC announced that, if you are fully vaccinated, the pandemic is basically over for you.

    The announcement surprised everyone—from my parents to COVID-19 scientists—because it appeared to come out of nowhere. Before this week, the CDC’s most recent guidance revisions included an acknowledgment that surface transmission of the coronavirus is very rare and a recommendation that masks might not be necessary outside; both of these conclusions were already well-known in the scientific community. In fact, STAT published an article last week in which Nicholas Florko suggests that the CDC’s COVID-19 messaging has been “overly cautious” and perhaps even “irrelevant for most Americans.”

    So, what led to the announcement on Thursday? The rest of this post will go over the CDC’s evidence for its guidance, taking the epidemiological perspective. Also, as two-thirds of Americans aren’t yet fully vaccinated, I’ll touch on another COVID-19 truism that has garnered some confusion lately: yes, you are significantly safer outside than you are inside.

    CDC graphic on COVID-19 safety, updated with the new mask guidance on Thursday.

    (I need to acknowledge, though, that a. there are certainly outside political and economic forces at play here, and b. the public health perspective on this guidance is far more complicated. For one perspective on the public health side, I recommend this Twitter thread by virologist Angela Rasmussen.)

    Our first category of evidence: the mRNA vaccines work really well. It’s no surprise that the Pfizer and Moderna vaccines are both exceptionally capable of protecting people against the coronavirus, but a couple of recent studies really hammer this home:

    • In this recent study from Israel, the Pfizer vaccine demonstrated 97% effectiveness against symptomatic cases and 86% effectiveness against asymptomatic cases among about 6,700 healthcare workers who were regularly tested for COVID-19.
    • According to this MMWR report from the CDC, the Pfizer and Moderna vaccines were 94% effective in preventing COVID-19 hospitalization for fully vaccinated seniors (over age 65), demonstrating how well the vaccines protect against severe disease. Plus, the vaccines were 64% effective in preventing hospitalization for partially vaccinated seniors.
    • Another MMWR report, released this past Friday, demonstrates that the mRNA vaccines were 94% effective at preventing symptomatic COVID-19 in U.S. healthcare workers. A single shot of Pfizer or Moderna ws 82% effective at preventing symptomatic COVID-19.
    • A study from the Cleveland Clinic, a medical research center based in Cleveland, Ohio, studied COVID-19 cases among its caregivers after vaccines were made available; the Clinic found that a whopping 99.7% of those workers who tested positive for COVID-19 had not been fully vaccinated. Only 0.3% were breakthrough cases. Meanwhile, 99.75% of COVID-19 patients that the Clinic treated during the study’s time frame were not fully vaccinated.
    • According to the CDC’s breakthrough case data, out of about 122 million fully vaccinated Americans, less than 1,400 people have been hospitalized or have died due to COVID-19. That’s 0.001%. (The CDC’s breakthrough reporting focuses on severe outcomes rather than cases, as these cases may be difficult to systematically identify outside of studies.)

    Second evidence category: the vaccines work against variants.

    • It’s important to note here that, when I say “vaccines work,” it’s not an all or nothing situation. A vaccine might protect you against severe COVID-19 disease or death (the primary goal), but not against an asymptomatic case that allows you to transmit the virus to someone else.
    • All the COVID-19 vaccines currently on the market protect us against severe COVID-19 disease and death—whether you’re infected with an older version of the coronavirus or with a variant. 
    • For a couple of the variants, that protection might not be quite as secure. Studies on B.1.351 (the variant first identified in South Africa), P.1 (identified in Brazil), and B.1.617 (identified in India) have all demonstrated lower vaccine effectiveness. But again, lower effectiveness here still means protection for the majority of people who get vaccinated.
    • And one big advantage of mRNA vaccine technology is, the Pfizer and Moderna vaccines may easily be adjusted to protect against particularly concerning variants. Moderna recently reported promising data for two booster shots designed to protect specifically against B.1.351 and P.1.
    • If you’d like a more detailed rundown of the vaccine v. variants battle, check out this article by STAT’s Andrew Joseph.

    Third evidence category: U.S. cases are way down.

    • As I noted in today’s National Numbers post: cases have dropped by 50% in the last month. And beyond that, cases have dropped from a peak of 250,000 new cases per day in January to under 40,000 new cases per day now.
    • During this time frame, most states did not impose lockdowns or other restrictions on the level of what we saw in spring 2020. So, these drops can primarily be attributed to the vaccines.
    • We still do not have much evidence showing how well the vaccines protect against asymptomatic transmission and infection, but the evidence we have so far is promising, as Apoorva Mandavilli explains in the New York Times. (One major study investigating this question in college students is currently underway.)
    • Still, the massive case drops—occurring even as B.1.1.7 and other more contagious variants spread through the country—indicate that the vaccines must be doing some work to stall coronavirus spread from one person to another. This supports the CDC’s argument that vaccinated Americans can take off their masks in public without worrying about spreading a latent coronavirus to someone else.

    Fourth evidence category: outdoor transmission is incredibly low.

    • Earlier this week, the New York Times’ David Leonhardt provided a compelling argument for why, though the CDC said “less than 10%” of COVID-19 transmission occurs outside, the true number is actually much lower. In fact, fewer than 1% (and possibly even fewer than 0.1%) of COVID-19 cases happen due to someone getting infected outside.
    • As I’ve previously reported, there is not a single recorded superspreading event that took place solely outside. This includes the large Black Lives Matter protests last summer. (A few superspreading events have both outdoor and indoor components.)
    • A new study from researchers at Drexel University specifically examined COVID-19 transmission in parks, and found no correlation between the number of people using a park and the number of COVID-19 cases in the surrounding ZIP code. The research suggests that you should feel safe at your local park, even if it seems a bit more crowded and less mask-adherent than it did a few months ago. I spoke to Franco Montalto and Bita Alizadehtazi, two authors on this study, who emphasized that “it’s important to get outside,” take advantage of the green infrastructure in your neighborhood, and feel safe while doing so.

    This evidence brings us to what The Atlantic’s Drew Thompson calls the “Two Commandments of COVID-19”:

    1. COVID-19 is an indoor aerosol disease.

    2. Vaccination protects you; more vaccinations protect everyone.

    Speaking just for myself: I am fully vaccinated, but I fully intend to keep wearing a mask in stores, on the subway, and even outside when I’m in a large crowd of people. This is partially because my state still has a mask mandate in place, but also because there are still a lot of people in my community who aren’t yet vaccinated—and I don’t want to pose a risk to them, no matter how small that risk may be. (In Brooklyn, where I live, 41% of the population has had at least one dose and 33% are fully vaccinated, according to city data.)

    Suffice it to say, the CDC makes recommendations about COVID-19 safety. It doesn’t issue requirements. I made a personal masking decision for myself, based on the community where I live; I hope this article helped you understand the science behind the guidance change so that you can do the same. And if you have questions—my inbox is always open.

    More vaccine coverage

    • 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.
  • Featured sources, May 2

    • AHCJ resource on COVID-19 vaccine results: The Association for Health Care Journalists has added a section to its Medical Studies repository for studies on how well COVID-19 vaccines protect against infection. Tara Haelle, AHCJ’s medical core topic leader, compiled the studies; “The list is not necessarily exhaustive, but it includes the studies I was able to track down so far,” she writes in a blog post about this update.
    • Colleges requiring COVID-19 vaccinations (Chronicle): A growing number of colleges and universities are aiming to protect their students, professors, and staff by requiring COVID-19 vaccinations for those coming to campus next fall. The Chronicle of Higher Education has identified 190 such institutions as of April 30, and is continually updating its list. (Note: You need to sign up with a free account to view the page.)
    • Post-COVID Care Centers: Post-COVID Care Centers, or PCCCs, are clinics where long COVID patients can receive treatment. They’re staffed by a growing group of multidisciplinary doctors and medical researchers seeking to understand this prolonged condition. The long COVID advocacy network Survivor Corps has compiled this database of PCCCs by state; 17 out of 50 states don’t yet have any such centers. (H/t Chelsea Cirruzzo, who has a great Twitter thread covering the recent House Energy & Commerce health committee hearing on long COVID.)
    • Excess deaths in the U.S. (Kieran Healy): Kieran Healy, sociology professor at Duke University, recently updated his chart gallery on excess deaths in the U.S. during 2020, using CDC data. All states saw significantly higher death rates in 2020 compared to 2015-2019 (except for North Carolina, which has incomplete data due to reporting delays). New York City has the highest death rate by far at over 30%.

  • J&J is back on the menu

    After 10 days, the pause on the J&J vaccine has been lifted. According to CDC Director Rochelle Walensky, there have been about 1.9 cases of severe blood clotting per million people who had received the J&J vaccine. It has been re-authorized for use in people aged 18 and older, now with an addendum to the label and fact sheet warning of the risk of blood clots: 

    It’s important to note that at time of writing (April 24) only some states have already resumed its use. (These are Arizona, Colorado, Connecticut, Louisiana, Maine, Massachusetts, Michigan, Missouri, Nevada, New York, Tennessee, Texas, Indiana, and Virginia.) However, this is coinciding with a larger trend of states ordering fewer vaccine doses.

    The J&J vaccine’s return is probably good news for the rest of the world as well. Combined with the AstraZeneca vaccine, the J&J vaccine was supposed to be one of the big players in the global fight against COVID-19. But the U.S. pause raised concerns for vaccine diplomacy and the global rollout—J&J had also paused its European distribution, South Africa announced they were putting J&J distribution on a temporary hiatus, and Australia said it wouldn’t purchase any J&J doses. Resuming distribution in the U.S., which can act as a bellwether for which vaccines are seen as desirable abroad, might allay concerns about safety abroad.

    More vaccine coverage

    • 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.
  • How to talk about breakthrough cases

    How to talk about breakthrough cases

    This week, The Hill posted an article with a rather misleading headline: “CDC finds less than 1 percent of fully vaccinated people got COVID-19.” If you actually click into the piece, you’ll find that the precise number is less than 0.008%. Less than 0.0005% have been hospitalized and less than 0.0001% have died.

    This headline reflects a common issue with vaccine reporting that I’ve seen in the past few weeks. A lot of journalists, especially those who aren’t familiar with the science/health beat, may be inclined to publish news of breakthrough cases as surprising or monumental. In fact, these cases—referring to a COVID-19 infection that occurs after someone has been fully vaccinated—are entirely normal, yet incredibly rare.

    No vaccine is perfect. Even the Pfizer and Moderna vaccines, which both demonstrated 95% efficacy in their late-stage clinical trials and over 90% effectiveness in the real world, are not perfect. Scientists still expect a few COVID-19 infections to slip through the immune system defenses built up by these vaccines and cause illness in a small number of patients.

    And it really is a small number: 129 million Americans have received at least one dose of a COVID-19 vaccine as of yesterday, per the CDC, and 82 million have been fully vaccinated. The agency has only documented 5,800 breakthrough cases. Less than 0.008% of those people who have been fully vaccinated. That’s the equivalent of one-quarter of a seat in Queens’ Citi Field baseball stadium (which seats about 42,000).

    So, if you’re a journalist reporting on this issue—whether it’s nationally or in your community—it’s important to stress that denominator. 82 million fully vaccinated, 5,800 breakthrough cases. Emphasizing the difference in magnitude between these numbers can show readers that, while they should still maintain some caution after getting vaccinated, the vaccines are overwhelmingly safe and effective.

    Small as the breakthrough case numbers are, though, it is important that we still talk about them. A new article by ProPublica’s Caroline Chen discusses how a failure to collect data on breakthrough cases is making it harder for COVID-19 researchers to understand what causes them. Specifically: we should be sequencing the genomes of the coronavirus strains that caused these cases, and by and large, we aren’t.

    Chen describes how many state health departments aren’t getting breakthrough case samples to sequence, whether that’s due to testing labs failing to store the test samples or cases being identified through rapid tests, which do not have established pipelines. Plus, in some cases, we aren’t even recording whether the patients went to the hospital or died—key data points in the U.S.’s continued vaccine monitoring.

    I definitely recommend you read the full piece, but here’s a section that will give you the big idea:

    In many instances, patients’ samples are not sequenced to find out if a variant might have been involved; some labs are throwing out test samples before an analysis can be done; hospitals and clinics aren’t always collecting new samples to analyze them. That means that for so many people, nobody will ever know if a variant was involved, leaving public health officials without data to be able to examine the extent to which variants are contributing to breakthrough cases.

    “It’s alarming that we can’t sequence more of the virus than we’re able to now — that’s something we need to resolve,” said Brian Castrucci, chief executive officer at the de Beaumont Foundation, a health philanthropy. “The more we know, the better we can react. We want to know the information so that we can make the right policy and health decisions.”

    While the CDC has an info page on breakthrough cases, no data on these cases are available on the agency’s COVID-19 dashboard. Reporters need to walk a delicate line on this issue: pursue the data, but report it in a careful, conscientious way that appropriately puts the tiny breakthrough case numbers in context.

    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.
  • Did you know that you, a plebeian, can search through VAERS?

    Did you know that you, a plebeian, can search through VAERS?

    You’ve probably heard about the Johnson & Johnson debacle by now. (Here’s an explainer on NYT’s The Daily and another one with more scientific background from Roxanne Khamsi at The Atlantic if you’re still confused.)

    If you attended or read about the April 14 emergency ACIP (Advisory Committee on Immunization Practices) meeting discussing the pause, you probably heard “VAERS” a lot. VAERS stands for “Vaccine Adverse Event Reporting System.” It’s used as a “national early warning system to detect possible safety problems in U.S.-licensed vaccines,” it’s been around for much longer than the COVID-19 vaccines or even COVID-19, and it’s how regulators are examining the data about possible complications related to the Johnson & Johnson COVID-19 vaccine. And as the cherry on top, the data is open to the public through the WONDER search engine. So what’s there?

    The search procedure is VERY customizable, and there’s even a video teaching you how to do it. You can narrow your search by symptoms, vaccine type, vaccine products, date that the event was reported, and more. For my cursory search, I, like a lot of people, was curious about the results for the Johnson & Johnson COVID-19 vaccine, so I just narrowed my search to “COVID-19 Vaccine Janssen.” 

    Here are my results, sorted by most common symptoms:

    These are the most common results, but the list keeps going after that with rarer side effects as you go down. It quickly became clear that this is not a perfect system, with some slightly nonsensical reports and strange distinctions. I was certainly left wondering how “SARS-COV-2 test negative” ended up as an adverse effect. (Seems like that’s what you want? Either way, there were 59 of these reported. Good for those 59 people—or that one person with a very sore nose.)

    Also notable were “Feeling abnormal” (213 reports), “Irritability” (10 reports) and my personal favorite, “No adverse event” (58 reports). It’s fairly obvious that not all of these adverse events were directly caused by the vaccine. Indeed, while the list can be fun to poke through and somewhat illuminating in what keeps popping up (headache, chills, pain, pyrexia/fever), finding the most common symptoms seems to be its main use.

    J&J distribution is paused right now because there were 6 cases of cerebral venous sinus thrombosis (CVST) combined with low platelets in a group where that is not common, and symptoms manifested between 6 and 13 days after vaccination. However, you can’t see that from this dataset. It doesn’t even seem like this dataset is fully updated—right now, there’s only one case of CVST recorded. (It was last updated on April 10.) The dataset also doesn’t actually say when the person got vaccinated and when the event was reported—just frequency. 

    In the April 14 emergency ACIP meeting, Dr. Tom Shimabukuro of the CDC COVID-19 Vaccine Task Force cited the 6 reports as of April 12, so it looks like the public dataset hasn’t been updated while the people actually making decisions are working with updated data. It doesn’t mean that this dataset isn’t useful, it just means that one should act with caution before using it to draw any conclusions. 

    The CDC clearly agrees with me, as they make you check a box stating that you’ve read the disclaimers like “reports may include incomplete, inaccurate, coincidental and unverified information” and “the number of reports alone cannot be interpreted or used to reach conclusions about the existence, severity, frequency, or rates of problems associated with vaccines” before they show you the goods in WONDER.

    There’s also a 17-page “VAERS Data Use Guide” which of course I found when I was almost done writing this up. Despite the limitations of the actual public dataset, I was extremely impressed by how much guidance that’s provided. I haven’t had my hand held this much while sifting through data in ages (I was very much on my own while going through the Global.Health database) and it really shows how much they want this data to be used with care. So I give serious props for solid and effective guidance on how to communicate this data—I just wish there was more data to communicate. 

    But WONDER isn’t the only way to sift through all the data. You can also download CSV files of every event reported (supposedly) back until 1990. That’d be a bit much for one post, but next week we might see what’s there.

    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.
  • there might be a link between the Oxford-AstraZeneca vaccine and those blood clots after all

    AstraZeneca still isn’t out of the woods yet. In fact, the woods seem to be just getting deeper, and now I’m fairly certain it’s not me jinxing things.

    Last time we covered AstraZeneca’s blood clot woes, the European Medicines Agency (EMA) had said in a March 18 press conference that “[t]he committee… concluded that the vaccine is not associated with an increase in the overall risk of thromboembolic events or blood clots.” (Thrombosis just means blood clotting.)

    But this week, authorities had enough data to posit a possible connection between blood clots known as cerebral venous sinus thrombosis (CVST) and the Oxford-AstraZeneca vaccine. The EMA has now advised, as of April 7, that “that unusual blood clots with low blood platelets should be listed as very rare side effects of Vaxzevria (formerly COVID-19 Vaccine AstraZeneca).” They are still recommending its use given the gravity of the COVID-19 pandemic, but it’s another blow to the vaccine that held much of the world’s hopes in inoculating the entire population. A mechanism by which the vaccine is causing these thromboses has not been discovered.

    As of April 4, there had been 222 cases of abnormal thromboses in Britain and the European Economic Area after receiving the Oxford-AstraZeneca vaccine, according to the New York Times. This is out of about 34 million people being vaccinated, and they estimated that the frequency was about 1 in 100,000. In total, the EMA committee looked at “62 cases of cerebral venous sinus thrombosis and 24 cases of splanchnic vein thrombosis reported in the EU drug safety database (EudraVigilance) as of 22 March 2021, 18 of which were fatal.” 

    This made us wonder how this compares to the early reports of anaphylaxis (serious allergic reactions) in recipients of the Pfizer-BioNTech and Moderna mRNA vaccines. According to an early report from the CDC, there were 21 cases out of 1,893,360 Pfizer-BioNTech first doses, for a frequency of 11.1 cases per million, or about 1 in 90,000. A later JAMA paper reported updated rates of about 4.7 cases per million doses for Pfizer-BioNTech and 2.5 cases per million for Moderna. To make the scales easier to compare, this works out to about 1 in 213,000 and 1 in 400,000, respectively.

    Comparing 1 in 213,000 and 1 in 400,000 cases of anaphylaxis to 1 in 100,000 cases of serious blood clots, it makes sense why some authorities are starting to hit the brakes on the AstraZeneca vaccine. No deaths were reported with the anaphylaxis reactions, but out of the sample of thromboses that the EMA examined, 18 people died. Not only are the numbers worse, but anaphylaxis reactions can also be easier to prepare for. In that early CDC report, 71% of anaphylaxis reactions occurred within 15 minutes of vaccination. For this reason, vaccine clinics monitor you for about 15 minutes (mine sure did). That’s harder to do with blood clots, which take much longer than 15 minutes to manifest and can’t be treated with an EpiPen on the spot. 

    Again, this is definitely a blow for what’s still a very effective vaccine. But taking these precautions is how faith in vaccines is earned and kept. We hold vaccines to a high standard for a reason.

    More vaccine coverage

    • Sources and updates, November 12
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    • 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
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    • COVID source shout-out: Novavax’s booster is now available
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  • Featured sources, April 4

    • Vaccination data update: Two more states are now reporting vaccinations by race/ethnicity. New Hampshire has reported the figures in one of the state’s recent daily updates, which include vaccination data on a weekly basis. And South Dakota has added race/ethnicity to the vaccines tab of its dashboard. As always, you can find detailed annotations on state and national vaccine data sources (updated yesterday) on the COVID Data Dispatch website.
    • KFF COVID-19 Vaccine Monitor: The Kaiser Family Foundation released the latest update for their Vaccine Monitor, an ongoing survey project to track public attitudes and experiences with COVID-19 vaccines. In this update, published this past Tuesday, KFF reports that 62% of those surveyed say they’ve already gotten a shot or plan to do so as soon as possible, while 17% want to “wait and see” how the rollout goes. That “wait and see” share is down from previous reports.
    • CDC Provisional Mortality Data for 2020: This past Wednesday, the CDC released death counts for 2020. As we’ve discussed before, mortality data tend to be reported with a lag compared to other types of public health numbers due to the complex processes involved with tallying up death certificates. About 3.3 million deaths occurred overall in 2020, according to these new data; this was a 16% increase from 2019. COVID was the third leading cause of death that year, accounting for 345,000 lives lost.
    • Federal COVID-19 Chart Gallery: Peter Walker, former data visualization co-lead for the COVID Tracking Project, has put together a new Tableau gallery using data from the CDC COVID Tracker and HHS Protect. The gallery includes many chart formats that CTP fans may recognize, such as national views, four-pane views, and regional comparisons. More charts are coming!
    • Pfizer COVID-19 Clinical Trials: An interactive, searchable map from Pfizer lets you look up vaccine trials around the world. For each trial, you can see the location, the trial’s phase, who’s eligible to join, and a link out to more information on ClinicalTrials.gov. Trials are happening in the U.S., the U.K., Spain, and Japan.
    • mRNA sequence for the Moderna vaccine: A group of scientists at Stanford used small amounts of Moderna vaccine left after all doses were extracted from vials to sequence the mRNA in that vaccine, then posted the sequence publicly on GitHub. The full sequence takes up two pages. You can read more about the scientists’ work and their decision to post the sequence in Motherboard.
    • Pulse of the Purchaser 2021 Report: This new report from the National Alliance of Healthcare Purchaser Coalitions examines how employer attitudes to healthcare have shifted during the COVID-19 pandemic. The report presents results from a survey of 151 major employers, representing diverse industries and sizes; it includes attitudes towards COVID-19 vaccines, telehealth, equity, and other healthcare topics.

  • Pfizer for the whole pfamily

    Good news for people with kids: this week, Pfizer and BioNTech released results for their trial involving adolescents aged 12-15. In the trial, no participants who received the vaccine contracted symptomatic COVID-19 out of a total of 2,260 participants, marking an efficacy rate of 100%. (Remember in December the efficacy rate was 95% for adults.) 18 participants in the placebo group did get symptomatic COVID-19. Additionally, Dr. Fauci said in the April 2 White House COVID-19 briefing that, by the end of the year, there should be enough data to safely vaccinate children of any age. 

    The results are, obviously, fantastic. But there was a wrinkle in reporting said results; one that pointed to the dangers of communicating science via press release. Originally, as Dr. Natalie Dean pointed out on Twitter, there was some confusion over whether there were no cases in the vaccinated group at all, or whether there were just no symptomatic cases:

    This is pretty important as infections in this group tend to be asymptomatic. Apoorva Mandavilli, who broke the Pfizer story for the New York Times, clarified that she had been told that there were in fact no infections:

    Until someone pointed out that STAT had clarified that there were no symptomatic infections: 

    Mandavilli decided to triple check, and turns out:

    Basically, someone at Pfizer messed up and incorrectly said that there had been no infections in the vaccine group at all when they really meant that there were no symptomatic infections. It doesn’t look like they regularly tested participants who had gotten the vaccine vs participants who got the placebo. This sounds like splitting hairs, but precision matters when communicating the results of highly anticipated trials. “No infections” and “no symptomatic cases” are different results. It’s a blow to Pfizer’s credibility in their press releases, and it was probably at least really annoying for Mandavilli. 

    In the meantime, Johnson & Johnson has also begun a trial in adolescents, so hopefully whoever is running PR for them saw this Twitter thread (or is reading this article 👀) and will know to be more careful than the Pfizer guy was. 

    But for now, we can rejoice in what is still very promising data. You get a Pfizer! And you get a Pfizer! How about a Pfizer for the little one? EVERYBODY GETS A PFIZER! (Well, when it gets actually authorized for that age group.)

    Related posts

    • 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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