COVID-19 Data Dispatch

Category: Vaccines

  • Vaccines are shipping out, but is the U.S. ready to track them?

    Vaccines are shipping out, but is the U.S. ready to track them?

    This past Friday, the Food & Drug Administration (FDA) officially issued Emergency Use Authorization for America’s first COVID-19 vaccine. This is a monumental achievement. One year ago, no Americans had even heard of the novel coronavirus; now, the federal government is beginning to ship out vaccine doses for our frontline healthcare workers.

    But as excitement builds, so do concerns about the nation’s capacity to deploy vaccine doses to all who need them. The Atlantic’s Sarah Zhang wrote this week that we are entering a phase of “vaccine purgatory,” in which a myriad of challenges could delay the country’s path to herd immunity. Already, four states are claiming that they will be unable to start administering vaccinations until January, while several other states have deferred the decision about who gets a shot first to healthcare providers. While the CDC has issued guidances, many logistics are left up to states—the same type of fractured system which has prevented America from getting its testing under control.

    True to my beat, I am most concerned about vaccine data. Earlier this week, the New York Times’s Sheryl Gay Stolberg reported that some states are refusing to report vaccination data to the CDC.

    Historically, each state has tracked vaccinations independently, through Immunization Information Systems (or IIS). While the CDC does report some national immunization information, such as its flu vaccination dashboard, this information typically comes from outside surveys and is not reported in real-time. Of course, this won’t do for COVID-19. To build up a national system, the CDC has asked every state to sign a Data Use and Sharing Agreement promising to send vaccination counts and associated demographic data to the CDC.

    It seems simple, right? But according to Stolberg’s reporting, the CDC has asked states to send personal information—such as names, birth dates, ethnicities, and home addresses—for each vaccine recipient. While demographic information should be tracked for COVID-19 vaccines in order to monitor equity in distribution, there is no need for the CDC to collect such specific information as names or home addresses. In fact, such a practice both discourages people from getting vaccinated and discourages states from cooperating with the federal public health agency.

    Stolberg quotes an official from Minnesota who is concerned about privacy:

    In Minnesota, officials are refusing to report any identifying details to the C.D.C., but they will submit “de-identified doses-administered data” on a daily basis once the vaccine campaigns begin.

    “This is a new activity for us, as we don’t typically report this level of detail on this frequency to the federal government,” Doug Schultz, a spokesman for the Minnesota Department of Health, said in an email. He added, “We will not be reporting name, ZIP code, race, ethnicity or address.”

    States which refuse to send personal data to the federal government may still report anonymous demographic information, such as the races and ethnicities of individuals who get vaccinated, on state-level dashboards. But it seems increasingly likely that vaccination data will face the same challenges as testing data: with every state deciding on a different reporting practice, it could be difficult to standardize and answer basic questions at the national level.

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    Other vaccine data news and resources from this week:

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  • Vaccine news: data and concerns on early distribution

    Vaccine news: data and concerns on early distribution

    Everyone in the science communication world is talking about COVID-19 vaccines right now. I’ve attended three vaccine webinars in the past week alone.

    We’re all gearing up for next Thursday, when the FDA’s Vaccines and Related Biological Products Advisory Committee will meet to discuss Emergency Use Authorization (EUA) for Pfizer and BioNTech’s vaccine. If the vaccine is authorized for distribution, doses will go out to every state within days. Meanwhile, Moderna’s vaccine continues to demonstrate promising results. Moderna has also applied for EUA; FDA’s committee will meet to discuss this candidate on December 17.

    Here are a few major data sources and issues that I’ll be watching as these vaccine candidates progress:

    • The CDC has recommended that the first available vaccine doses go to healthcare workers and residents of long-term care facilities (nursing homes, assisted living facilities, etc.) The agency did not specify how state and local governments should prioritize among these groups.
    • How many people are actually in those high-priority groups in each state? To answer that question, see the Vaccine Allocation Planner for COVID-19, a new data tool from the Surgo Foundation, Ariadne Labs, and other collaborators. For each state, the tool uses population estimates from the Census, the CDC, and other sources to show how many healthcare workers, first responders, teachers, people with severe health conditions, and other high-risk individuals will need to be vaccinated. The tool is automatically set to calculate each state’s available doses as a population-adjusted share of 10 million, but users can adjust it to see how different scenarios may play out.
    • How many vaccine doses are actually going to each state? To answer this question, see the new COVID-19 Vaccine Allocation Dashboard from Benjy Renton. Renton is compiling information from local news sources on dose distributions from Pfizer and Moderna’s early shipments. Remember that both of these vaccines require two doses per person. In Texas, for example, the first Pfizer shipment of 224,250 doses will allow about 11 in every 1,000 Texas to get vaccinated.
    • How will vaccination be tracked? The CDC has promised to set up a national dashboard similar to its flu registry, but until then, we must rely once again on state data. This CDC list of state immunization registries should be a useful starting point for any local reporters hoping to get a jump start on vaccine data. You’d better believe that I will be spending a lot of time with these registries in future issues.
    • The Kaiser Family Foundation is setting up a new dashboard to track public opinion on COVID-19 vaccines. This initiative, called the COVID Vaccine Monitor, will compile the results of regular focus groups and surveys on whether Americans plan to get vaccinated and why. The dashboard is not live yet, but you can learn more about it and hear past KFF findings in the foundation’s December 3 briefing. One notable statistic: 67% of Black adults are “not too confident” or “not at all confident” that vaccines will be distributed fairly, as of a KFF poll conducted in August-September.
    • For vaccine coverage outside the U.S., see this map of procurement data from the Launch & Scale Speedometer. This research group from the Duke Global Health Innovation Center has compiled the total vaccine doses purchased by over 30 nations. The dashboard also estimates the share of each nation’s population it could be able to cover with advanced vaccine purchases. Canada is highest on the scale at 601%; the nation’s extra doses will likely be donated to other countries.
    • STAT’s Helen Branswell has written a comprehensive feature on the vaccine-related challenges that lie ahead. Some of the big challenges: coordinating a speedy early rollout, overcoming vaccine distrust, distributing vaccine doses equitably, protecting vulnerable populations (such as pregnant women and children) on whom vaccine candidates have not yet been tested, and continuing to study additional vaccines once the first candidates to win EUA are rolled out.
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    What questions do you have around COVID-19 vaccines?

    It’s time for our next brief reader survey, and this time, I want to hear your vaccine concerns. As this continues to be a major coverage topic for me, I’d like to be sure I’m prioritizing the needs of my readers in choosing specific vaccine-related issues and data sources to investigate.

    This is a one-question survey. A few reader responses (from those who indicate they’re comfortable with it) will be shared next week.

  • Thinking about vaccine results (AstraZeneca redux)

    Thinking about vaccine results (AstraZeneca redux)

    Two weeks ago, after Pfizer announced its preliminary results, I posed a set of questions that can guide how you understand the details in COVID-19 vaccine press releases.

    I’m revisiting those questions now in the wake of AstraZeneca and the University of Oxford’s news. The 70% effectiveness rate announced last Monday is promising at first glance, but details about this vaccine’s clinical trials have puzzled epidemiologists. Here’s what to consider as we await more details on AstraZeneca and Oxford’s findings, drawing on reports from STAT News, Nature, and the New York Times.

    • What is the sample size? Or, how many people were involved in the trial, and how many of them were diagnosed with COVID-19? AstraZeneca’s Monday announcement reported results from ongoing trials in the United Kingdom and Brazil, which include about 11,400 participants. 131 patients in the trial have tested positive for COVID-19. But here’s where things get tricky: out of those 11,400 participants, about 2,700 were given a lower dose of vaccine in their first shot due to an error in the U.K. trial. The other 8,900 trial participants received a standard two shots, i.e. two full doses of the vaccine. So, that 70% effectiveness rate is actually the average of results from two groups. In patients who received two full doses, the vaccine was 62% effective, while in patients who received a half dose and full dose, the vaccine was 90% effective.
    • Wait, the vaccine worked better in a lower dose? Yes—or at least, that’s what the data tell us so far. The researchers who made that dosing error may have gotten lucky by giving patients an initial dose which better stimulated their immune systems to act against the coronavirus. Nature’s Ewen Callaway quotes immunologists who say a lower dose might more effectively turn on T cells—immune cells that support antibody production—or more quickly activate the immune system’s memory of the virus. Still, the effectiveness rates we’ve seen for this vaccine so far may have been skewed by a small trial size; AstraZeneca has not reported how many patients among the 131 diagnosed with COVID-19 received a half-dose of the vaccine as compared to two full doses. AstraZeneca and Oxford will continue to study both the half-dose and full-dose regimens, and the scientific community eagerly awaits more data (and more details on how these trials are operating).
    • Who is included in the sample size? Or, has this vaccine been tested on seniors, people of color, people with preexisting medical conditions that may garner worse COVID-19 outcomes, and other marginalized groups? In addition to their U.K. and Brazil trials, AstraZeneca and Oxford are conducting trials in the U.S., Japan, Russia, South Africa, Kenya, and Latin America with planned trials in other nations, including up to 60,000 total participants. AstraZeneca’s press release states that these global trials include “participants aged 18 years or over from diverse racial and geographic groups”; no further information on participant demographics is available.
    • Does the vaccine work for severe cases? Or, can this vaccine help reduce COVID-19’s severity by boosting immune system defenses for patients who may otherwise get seriously ill? So far, it seems possible: no patients in AstraZeneca and Oxford’s initial analysis group went to the hospital or otherwise reported severe illness. But more results are needed for a conclusion to be made.
    • Does the vaccine work for mild or asymptomatic cases? Or, can this vaccine prevent people from spreading COVID-19 even if they don’t cough, sneeze, or otherwise show symptoms? AstraZeneca and Oxford are more poised to answer this question than other potential vaccine makers because participants in the U.K. trial have routinely tested themselves for the coronavirus, regardless of if they exhibited any symptoms. Results so far show that yes, this vaccine may block COVID-19 transmission—but again, more data are needed from a wider study group.
    • Does the vaccine have any adverse effects? Or, what might happen to you when you get the shot? Pfizer has reported that a small number of patients got headaches or felt fatigued after receiving their shots; Moderna has reported similar side effects as well as fever and muscle pain. AstraZeneca and Oxford have yet to report side effects from their vaccine, but their ongoing global trials will give the researchers more opportunity to see and communicate possible small hazards of the vaccination experience.
    • What are the vaccine’s logistical needs? Like Pfizer and Moderna’s vaccine candidates, AstraZeneca and Oxford’s vaccine requires two doses given weeks apart. Unlike the other two candidates, this vaccine can be stored in a normal refrigerator for up to six months, making it much easier to distribute—particularly to remote and low-income areas. It’s also easier to mass-produce, and AstraZeneca will only be charging $3 to $4 a dose, making it cheaper for governments to buy in bulk. (The U.S. government has promised that COVID-19 vaccines will be free to all Americans.) More logistical needs for all three vaccine candidates will be finalized in the coming months.

    Meanwhile, in Russia, vaccine trial results have been reported after only 39 documented COVID-19 cases:

  • Who should get the first vaccine doses?

    Who should get the first vaccine doses?

    With this past Monday’s announcement from the University of Oxford and the pharmaceutical company AstraZeneca, three COVID-19 vaccine candidates have now demonstrated clinical trial results which could land them Emergency Use Authorization from the Food & Drug Administration (EUA from the FDA, for short). Pfizer, the first vaccine manufacturer to release its trial results, applied for EUA on November 20. The FDA advisory committee will meet on December 10 to review this application, and vaccines could start shipping out as early as December 12.

    These dates are incredibly exciting—December 12 is only three weeks away. But that first vaccine shipment will likely include 50 million doses, at most. Since two doses are required for a patient to be protected against COVID-19, this means up to 25 million people will be able to get vaccinated. That represents just 7.6% of the country’s population. So, who will get vaccinated first?

    As per usual in America’s fractured pandemic response, the answer to this question will largely depend on state and local public health authorities. Still, national guidances and data on health disparity allow us to see who should get the vaccine first—and evaluate our local public health authorities when the doses start rolling out.

    Earlier this week, the Advisory Committee on Immunization Practices (ACIP) released a report which aims to help local authorities make these decisions. The ACIP is a group of medical and public health experts affiliated with the Centers for Disease Control and Prevention (CDC), which develops recommendations on how vaccines should be used among U.S. residents. The committee has been considering COVID-19 vaccine ethics since April, through a Work Group which conducted literature reviews and presented its findings to the rest of the team.

    The ACIP recommends that four ethical principles guide COVID-19 vaccine distribution:

    1. Maximize benefits and minimize harms. The first people to get vaccinated should be those who, when they are healthy, are better able to protect the health of others in their community. This includes healthcare workers, other essential workers, and people with preexisting health conditions who would likely need to be hospitalized if they became sick with COVID-19.
    2. Promote justice. Americans of all backgrounds and communities should have an equal opportunity to be vaccinated. The ACIP recommends that public health authorities work with external partners and community representatives to help make vaccines available (and attractive) to everyone—both when vaccine supply is limited and when everyone is able to get inoculated.
    3. Mitigate health inequities. People of color, especially Black Americans, Native Americans, and Native Hawaiians/Pacific Islanders, have been disproportionately impacted by COVID-19 in the U.S. The legacy of systemic racism in this nation’s healthcare system and economy, as well as disparities in testing availability and care, have contributed to these inequitable outcomes. Vaccine distribution must directly address such inequities by prioritizing racial and ethnic minorities, low-income communities, rural communities, and other marginalized groups.
    4. Promote transparency. All the decisions that public health authorities make about who gets the vaccine, when, and how must be communicated clearly to the public. Furthermore, communities should be invited to participate in the decision-making process whenever possible. This kind of transparency helps promote trust in both the vaccines and the people who administer them.

    The ACIP’s recommendations are also laid out more practically in two tables at the end of the report. The first table poses essential questions for public health authorities to consider for each ethical principle, while the second applies these principles to four key groups who will be prioritized in the first round of vaccinations: healthcare workers, other essential workers, adults with high-risk medical conditions, and adults over the age of 65.

    Dr. Uché Blackstock, the founder of Advancing Health Equity, critiqued the recommendations on Twitter for failing to specifically call out the role of systemic racism in shaping how COVID-19 has impacted Black communities. Still, these principles are a good start in providing us reporters and community members with a framework for watching how our public health authorities distribute vaccines.

    The federal government will simply be sending vaccine doses to states based on their overall populations rather than taking the ACIP’s recommendations, according to NPR’s Pien Huang. So, it will be entirely up to states and more local public health departments to prioritize justice, equity, and transparency. What tools should public health departments use in order to apply these principles?

    In a webinar last week on vaccine distribution, STAT News reporter Nicholas St. Fleur suggested turning to the CDC’s Social Vulnerability Index. Social vulnerability, as the CDC defines it, measures a community’s ability to recover from events that are hazardous to human health. These events can include tornados, chemical spills, and—of course—pandemics. CDC researchers have calculated the social vulnerability of every Census tract in the U.S. based on 15 social, economic, and environmental factors such as poverty, lack of vehicle access, and crowded housing.

    The most recent update of this index was released in March 2020 based on analysis of 2018 Census data. Here’s what it looks like, mapped by Esri’s Urban Observatory:

    The CDC’s Census tract-level Social Vulnerability Index, as mapped by Esri’s Urban Observatory. Communities colored in dark blue are more vulnerable to hazardous health events.

    Here’s the interactive map, and here’s the CDC page where you can download all the underlying data for this index. I highly recommend zooming in to your state and looking at which areas are ranked most highly—if COVID-19 vaccines are distributed equitably, these are the communities that should get priority.

    St. Fleur also recommends checking out how your state, city, or county defines essential workers, as these distinctions may vary from region to region. In New York, for example, essential workers include teachers, pharmacists, and grocery store workers. In Texas, essential workers include law enforcement and the Texas Forest Service. The Kaiser Family Foundation report which I featured in last week’s issue compiles links to draft COVID-19 vaccination plans for every state, some of which include these definitions.

    I anticipate that vaccine distribution and reporting will continue to be a major topic for this newsletter in the coming months. Questions and topic suggestions are always welcome; you can drop me a line at betsyladyzhets@gmail.com, on Twitter, or in the comments.

  • Federal data updates, Nov. 22

    America’s federal public health agencies are busy in the lead-up to Thanksgiving, as are the researchers and volunteer networks filling those agencies’ information gaps. Here are three major updates:

    • CDC’s COVID Data Tracker now reports more county-level data: Since it was first published in the spring, the CDC’s COVID-19 data dashboard has included cases and deaths by U.S. county, relying upon data compiled by USA Facts and verified by the agency. As of yesterday, the county dashboard now also reports total PCR tests and test positivity. Testing data have previously been available directly from the HHS (state-level) and the Center for Medicare & Medicaid Services (county-level), but the CDC dashboard is far more accessible. Users can select a specific county and see a variety of trends in cases, tests, and deaths. The data from this dashboard aren’t yet available for download; I’ll report back if this changes.
    • Pharmacies will be able to distribute COVID-19 vaccines: Last week, the HHS announced that the agency has set up partnerships with both national pharmacy chains and networks representing smaller pharmacies in order to broadly distribute COVID-19 vaccines as they become available. (Pfizer applied for Emergency Use Authorization this past Friday.) According to the HHS, these partnerships cover “approximately 60 percent of pharmacies throughout the 50 states, the District of Columbia, Puerto Rico, and the U.S. Virgin Islands.” The press release does not mention how these pharmacies will be plugged into their respective state vaccine registries.
    • How state COVID-19 dashboards are faring: Although many states are reporting more COVID-19 data than they were last spring, their dashboards are overall still not conveying some key metrics, according to a new report from Resolve to Save Lives. This research group, a nongovernmental initiative run by the global health organization Vital Strategies, first reviewed state dashboards in July. (See my first issue for more details.) The new report—along with an interactive map—reflects improvements that states have made since the summer while highlighting what crucial public health information is still missing. Case investigation and contact tracing are two key areas where “data… remained largely unavailable.”
    more federal data

  • How to think about vaccine results

    This past Monday, pharmaceutical company Pfizer announced preliminary clinical trial results for its COVID-19 vaccine. In an interim analysis of the vaccine’s phase 3 study, the vaccine was shown to be 90% effective in preventing COVID-19. In other words, based on the people in Pfizer’s study who have become diagnosed with COVID-19 so far, those who got vaccinated were 90% less likely to get sick compared with the people who did not.

    90% is an exciting number. The Food & Drug Administration (FDA) set a threshold of 50% effectiveness for COVID-19 vaccines to be authorized, and experts have been telling us for months that even a 60% or 70% effectiveness would still be incredibly useful in reducing infections across the population. Pfizer’s initial 90% rate blows those expectations out of the water.

    Plus, this effectiveness value bodes well for other vaccine candidates. Pfizer’s vaccine, developed through a partnership with German biotech BioNTech, uses a new vaccine technology based on synthetic messenger RNA, or mRNA; so does the vaccine developed by Moderna, which is also currently in clinical trials. (For more backstory on mRNA, BioNTech, and Moderna, I highly recommend Damian Garde’s feature in STAT News.)

    But we can’t get too excited. Pfizer reported its preliminary data not in a peer-reviewed scientific paper, but in a press release, and some key details about the company’s clinical trial are not yet public. I used information from STAT News, KHN, and SciLine to compile a few key questions that should be in all of our minds as we think about this and future vaccine data releases.

    • What is the sample size? Or, how many people were involved in the trial, and how many of them were diagnosed with COVID-19? For Pfizer’s trial, this is a question we can answer: about 44,000 people are enrolled in the study, and the 90% effectiveness rate is based on results from 94 people who contracted COVID-19, the majority of whom did not receive a vaccine dose. This may seem like a tiny fraction of the participants, but many experts are cautiously optimistic in hoping the 90% rate will hold up for a larger group.
    • Who is included in the sample size? COVID-19 has disproportionately impacted the elderly, people of color, people with certain medical conditions, and other marginalized groups. It is thus crucial that a vaccine is effective for people in these groups—in other words, these people must be represented in the vaccine trial. Pfizer reports that 42% of the overall study participants have “diverse backgrounds,” but the specific backgrounds of the patients who got sick are unknown.
    • Does the vaccine work for severe cases? While the majority of people diagnosed with COVID-19 are able to survive the disease with mild symptoms in their own homes, the minority of people who become seriously ill constitute the pandemic’s massive loss, as well as its burden on our nation’s healthcare system. A vaccine that reduces the disease’s severity through boosting immune system defenses may be incredibly valuable, even if it does not entirely prevent infection.
    • Does the vaccine work for mild or asymptomatic cases? A vaccine that prevents mild cases would help keep COVID-19 spread at bay, even if this vaccine does not reduce the disease’s severity. Pfizer’s press release does not include any specifics on the 94 patients who were diagnosed with COVID-19; experts are hoping that such details may be revealed in a forthcoming scientific paper.
    • Does the vaccine have any adverse effects? In other words, is the vaccine safe? We all know that flu vaccines make our arms sore, and other vaccines can give us mild colds. These types of common effects are usually nothing to worry about, but vaccines may pose a more severe danger to a small fraction of the population; for example, one in every ten thousand patients might have an allergic reaction that sends them to the hospital. So far, Pfizer has not reported any severe effects of its vaccine, but the current clinical trial gives the company a much wider pool of people in which dangerous reactions might be observed.
    • What are the vaccine’s logistical needs? One dose or two? At what temperature does the vaccine need to be stored? How long can it be at room temperature before it needs to be administered? How many doses can be manufactured in a day, a week, a year? What’s the price tag? Pfizer has given preliminary answers to some of these questions (two doses, -70 degrees Celsius) but the company is finalizing its manufacturing and distribution strategies as it completes its clinical trial.

    Even when a vaccine is authorized by the FDA, distributing and tracking it poses a whole new set of questions. I’ve written about vaccine data before, and I expect that this will be a topic I cover in increasing detail during the months to come.

    more vaccine coverage
  • The vaccines are coming

    The vaccines are coming

    Graphic of questionable quality via the CDC’s COVID-19 Vaccination Program Interim Playbook.

    If the title of this week’s newsletter sounds ominous, that’s because this situation feels ominous. While many scientific experts have pushed back against President Trump’s claims that a vaccine for the novel coronavirus will be available this October, state public health agencies have been instructed to prepare for vaccine distribution starting in November or December.

    Of course, the possibility of a COVID-19 vaccine before the end of 2020 is promising. The sooner healthcare workers and other essential workers can be inoculated, the better protected our healthcare system will be against future outbreaks. (And eventually, maybe, regular people like me will be able to attend concerts and fly out of the country again.) But considering the Center for Disease Control and Prevention (CDC)’s many missteps in both distributing and tracking COVID-19 tests this spring, I have a wealth of concerns about this federal agency’s ability to implement a national vaccination program.

    I’m far from the only person thinking about this. The release of the CDC’s interim playbook for vaccine distribution this past Wednesday, along with President Trump’s public contradiction of the vaccination timeline described by CDC Director Dr. Robert Redfield, has sparked conversations on whether America could have a vaccine ready this fall and, if we do, what it would take to safely distribute this technology to the people who need it most.

    In this issue, I will offer my takeaways on what the CDC’s playbook means for COVID-19 vaccination data, and a few key elements that I would like to see prioritized when public health agencies begin reporting on vaccinations.

    Data takeaways from the CDC playbook

    I’m not going to try to summarize the whole playbook here, because a. other journalists have already done a great job of this, and b. it would take up the whole newsletter. Here, I’m focusing specifically on what the CDC has told us about what vaccination data will be collected and how they will be reported.

    • We do not yet know which vaccines will be available, nor do we know vaccine volumes, timing, efficacy, or storage and handling requirements. It seems clear, however, that we should prepare for not just one COVID-19 vaccine but several, used in conjunction based on which vaccines are most readily available for a particular jurisdiction.
    • Vaccination will occur in three stages (as pictured in the above graphic). First, limited doses will go to critical populations, such as healthcare workers, other essential workers, and the medically vulnerable. Second, more doses will go to the remainder of those critical populations, and vaccine availability will open up to the general public. Finally, anyone who wants a vaccine will be able to get one.
    • “Critical populations,” as described by the CDC, basically include all groups who have been demonstrably more vulnerable to either contracting the virus or having a more severe case of COVID-19. The list ranges from healthcare workers, to racial and ethnic minorities, to long-term care facility residents, to people experiencing homelessness, to people who are under- or uninsured.
    • The vaccine will be free to all recipients.
    • Vaccine providers will include hospitals and pharmacies in the first phase, then should be expanded to clinics, workplaces, schools, community organizations, congregate living facilities, and more.
    • Most of the COVID-19 vaccines that may come on the market will require two doses, separated by 21 or 28 days. For each recipient, both doses will need to come from the same manufacturer.
    • Along with the vaccines themselves, the CDC will send supply kits to vaccine providers. The kits will include medical equipment, PPE, and—most notably for me—vaccination report cards. Medical staff are instructed to fill out these cards with a patient’s vaccine manufacturer, the date of their first dose, and the date by which they will need to complete their second dose. Staff and data systems should be prepared for patients to receive their two doses at two different locations.
    • All vaccine providers will be required to report data to the CDC on a daily basis. When someone gets a vaccine, their information will need to be reported within 24 hours. Reports will go to the CDC’s Immunization Information System (IIS).
    • The CDC has a long list of data fields that must be reported for every vaccination patient. You can read the full list here; I was glad to see that demographic fields such as race, ethnicity, and gender are included.
    • The CDC has set up a data transferring system, called the Immunization Gateway (or IZ Gateway), which vaccine providers can use to send their daily data reports. Can is the operative word here; as long as providers are sending in daily reports, they are permitted to use other systems. (Context: the IZ Gateway is an all-new system which some local public health agencies see as redundant to their existing vaccine trackers, POLITICO reported earlier this week.)
    • One resource linked in the playbook is a Data Quality Blueprint for immunization information systems. The blueprint prioritizes making vaccination information available, complete, valid, and timely.
    • Vaccine providers are also required to report “adverse events following immunization” or poor patient outcomes that occur after a vaccine is administered. These outcomes can be directly connected to the vaccine or unrelated; tracking them helps vaccine manufacturers detect new adverse consequences and keep an eye on existing side effects. Vaccine providers are required to report these adverse events to the Vaccine Adverse Event Reporting System (VAERS), which, for some reason, is separate from the CDC’s primary IIS.
    • Once COVID-19 vaccination begins, the CDC will report national vaccination data on a dashboard similar to the agency’s existing flu vaccination dashboard. According to the playbook, this dashboard will include estimates of the critical populations that will be prioritized for vaccination, locations of CDC-approved vaccine providers and their available supplies, and counts of how many vaccines have been administered.

    I have to clarify, though: all of the guidelines set up in the CDC’s playbook reflect what should happen when vaccines are implemented. It remains to be seen whether already underfunded and understaffed public health agencies, hospitals, and health clinics will be able to store, handle, and distribute multiple vaccine types at once, to say nothing of adapting to another new federal data system.

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    My COVID-19 vaccination data wishlist

    This second section is inspired by an opinion piece in STAT, in which physicians and public health experts Luciana Borio and Jesse L. Goodman outline three necessary conditions for effective vaccine distribution. They argue that confidence around FDA decisions, robust safety monitoring, and equitable distribution of vaccines are all key to getting this country inoculated.

    The piece got me thinking: what would be my necessary conditions for effective vaccine data reporting? Here’s what I came up with; it amounts to a wishlist for available data at the federal, state, and local levels.

    • Unified data definitions, established well before the first reported vaccination. Counts of people who are now inoculated should be reported in the same way in every state, county, and city. Counts of people who have received only one dose, as well as those who have experienced adverse effects, should similarly be reported consistently.
    • No lumping of different vaccine types. Several vaccines will likely come on the market around the same time, and each one will have its own storage needs, procedures, and potential effects. While cumulative counts of how many people in a community have been vaccinated may be useful to track overall inoculation, it will be important for public health researchers and reporters to see exactly which vaccine types are being used where, and in what quantities.
    • Demographic data. When the COVID Racial Data Tracker began collecting data in April, only 10 states were reporting some form of COVID-19 race and ethnicity data. North Dakota, the last state to begin reporting such data, did not do so until August. Now that the scale of COVID-19’s disproportionate impact on racial and ethnic minorities is well documented, such a delay in demographic data reporting for vaccination would be unacceptable. The CDC and local public health agencies will reportedly prioritize minority communities in vaccination, and they must report demographic data so that reporters like myself can hold them accountable to that priority.
    • Vaccination counts for congregate facilities. The CDC specifically acknowledges that congregate facilities, from nursing homes to university dorms to homeless shelters, must be vaccination priorities. Just as we need demographic data to keep track of how minority communities are receiving vaccines, we need data on congregate facilities. And such data should be consistently reported from the first phase of vaccination, not added to dashboards sporadically and unevenly, as data on long-term care facilities have been reported so far.
    • Easily accessible resources on where to get vaccinated. The CDC’s vaccination dashboard will reportedly include locations of CDC-approved vaccine providers. But will it include each provider’s open hours? Whether the provider requires advance appointments or allows walk-ins? Whether the provider has bilingual staff? How many vaccines are available daily or weekly at the site? To be complete, a database of vaccine providers needs to answer all the questions that an average American would have about the vaccination experience. And such a database needs to be publicized widely, from Dr. Redfield all the way to local mayors and school principals.
    more vaccine coverage