Mark S. Senak's Blog, page 5

Passport Please – An App to Verify Your Status in a World Re-Shaped by COVID-19

This week New York became the first state to make available a means for mobile digital confirmation that an individual has been vaccinated for COVID-19. Popularly known as “immunity passports” they are in fact more than that. The New York app, dubbed “Excelsior Pass” can also carry information regarding an person’s latest COVID-19 test result. The idea has been floated for some time, and while New York is the first state in the U.S. others are poised to follow. And outside the U.S., Israel – much further along in its vaccination process – has implemented their version called “Green Pass” and France is set to launch one soon. We have upon us a new aspect of the pandemic. There are questions that immediately arise.

First, how does it work? It is an opt-in program whereby people can utilize an app to supply evidence of their status if it is needed, just the way you download your boarding pass to get on an airplane – except instead of a seat number, this explains your vaccine status or you negative PCR or antigen test for COVID. When you download the app, you will be directed to provide information to confirm your identity. Once you do, a QR code is posted in your app that can be scanned when you need to provide proof of status. (For those who do not have a smart phone, there is an ability to print out the code which presumes ability to access a computer and printer). Those who are screening will have an app that will read your passport and provide verification. Which leads to the second important question.

Why have this? What is to be gained? Plenty, for both businesses seeking a pathway to recovery as well as individuals who wish to have more normalized access. Emerging from the pandemic, particularly as recovery may be undermined by emergent strains and complicated further by vaccine hesitancy, individuals may want to be reassurance regarding any environment they want to access. This can include a health care provider to a theatre to perhaps even in their own workplace. And therefore it follows suit that in the future businesses may see it as a competitive edge to offer an environment where both patrons and employees all have provided evidence of vaccination. Would you rather stay in a hotel that offers a stay where all staff and guests have been vaccinated or one that could not make that claim?

Who would use it? From theoretical to real – specific uses for the app are already emerging. In the New York announcement it was noted that several venues in New York State were already planning on its use, including Madison Square Garden with statements of support from the New York State Hospitality and Tourism Association, the New York State Tourism Industry Association, the New York State Restaurant Association, the Empire State Restaurant and Tavern Association and the MTA all citing the app as a means to resume in-person events and to return to more normal times. From your gym to your doctor to your employer, the possibilities are vast.

What is the impact? The app is not just about the mechanics of having a “pass” but ultimately in what having it means in one’s life. Some may not choose to participate – it does require one to opt-in. Choice has played a big role in this pandemic, with some seeing it as a choice whether to restrict their movements, socially distance or to wear a mask. And whether or not one gets vaccinated is clearly at this point a matter of choice, but the existence of the app may heavily influence that choice. Someone who is reticent about getting vaccinated may feel passionate about attending a football game. For many, the existence of the app and the requisite for vaccination for entry to multiple venues and services may be more of an incentive than protecting one’s health.

And as foreign countries consider opening up their borders once again, vaccination may be a foundational requisite for entry. In the old days, all sorts of shots were often required as a means for entry into foreign countries. Now your phone will serve just as an important means of entry as your actual passport. The app facilitates decision making regarding access not only to countries, but to many venues and services and perhaps even employment, particularly once the vaccine migrates from emergency use authorization to full licensure in the future. Having an app such as this, or one instituted by airlines, will likely be essential to at least foreign travel. And we all remember the stress of passengers on cruises early in the pandemic.

It almost certainly appears we are about to enter a new vista in the complex terrain of this pandemic and one that will most certainly raise ethical and legal questions as it plays out. But it will also raise practical questions. Will the various states be able to coordinate the technology so that a reading from the Excelsior Pass will be read when going to a sports game in New Jersey or to a government building in Washington, D.C.? Will it be translatable to whatever platform the airlines use. Will hotels be able to read the apps from all 50 states? These questions are all as inevitable as the emergence of the app itself. Stay tuned.

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“Can You Hear Me?” – The (Hopefully) Coming Transition from Virtual Meetings

Today, FDA published notice in the Federal Register of an upcoming meeting of the Arthritis Drugs Advisory Committee that will be held May 6. The meeting will be held virtually.

Last year when the pandemic reality started setting in, like everyone else FDA had to change operations – in some cases shutting down or curtailing activities altogether and moving others to a virtual stage. The last in-person meeting of an advisory committee – by coincidence a meeting of the Vaccines and Related Biological Products Advisory Committee – occurred on March 4, 2020. A meeting of the Non-prescription Drugs Advisory Committee scheduled for one week later was “postponed” with subsequent meetings scheduled for April either postponed or cancelled entirely. A meeting scheduled for May 8 of the Cellular, Tissue and Gene Therapies Advisory Committee was slated to be a hybrid event – with members of the committee participating virtually and FDA staff appearing onsite at the agency campus, but was altered to become an all-virtual event via Adobe Connect.

You get the idea. Afterward there were more cancelled meetings, but by mid-June the agency was moving all meetings to a virtual platform as the realization that the pandemic was going to be long-term sank in. FDA expanded the types of platforms utilized in making the meetings available to view, including use of YouTube. I recently attended all three Vaccines and Related Biological Products Advisory Committee meetings on the COVID-19 vaccine candidates.

Those meetings included multiple exchanges like this:

“Hi. Good Afternoon. Can you hear me now?”

“We can hear you just fine. We are having trouble seeing your slides.”

“I see them. I don’t know why other people don’t see them.”

While the virtual meeting has become a regular fixture now, the exchanges such as the one above are nevertheless common and extremely repetitive and time consuming. In fact, if you added up the time spent addressing technical issues associated with the virtual meeting, you would probably find that several minutes had been eaten up, depriving the conversation of valuable time and thereby eroding the quality of the deliberation. Operating virtually is obviously better than not operating at all, whether we are talking about advisory committee meetings, our offices or even our personal relationships. But it becomes painfully obvious that it is not a substitute for the real thing.

In May the American College of Cardiology will be holding their annual meeting – . Originally and perhaps optimistically it was envisioned as a hybrid meeting model – half in- person and half virtual, but has now transitioned to an all virtual meeting, leaving open the question as to who will have the first in-person meeting. As noted in the ACC statement on the switch to an all virtual venue, the decision was made not only based on the continued spread of the virus – and now in the form of a new strain which may be more readily transmissible, but by policies in place by institutions that are restricting travel during this time. You can’t hold an in-person meeting if no one is allowed to come.

So which will come first, the chicken or the egg? As we move from a non-vaccinated world to a partially vaccinated world to a mostly vaccinated world, where will the tipping point? Yesterday the New York Times noted that 26 percent of Americans have had at least one dose of vaccine and that if we continue at the same trajectory, by May 11 (just a few days after ACC.21) we will reach the half way mark of first vaccine dosing, with 9 in 10 being reached by the end of July. In the meantime, what policies will be in place to usher in a new era as we approach mass vaccination? Will there eventually be vaccine requirements imposed for entry to some venues, services or to take public forms of transportation?

We are fortunate in the respect that the pandemic has occurred at a time when we were able to pivot to virtual platforms. Can you imagine had it been otherwise – how much more damage would have been done. But it is time to start thinking about how we engineer the return journey.

There will be a tipping point and it will likely be sometime in the coming months, perhaps the autumn when enough people are vaccinated that it seems safe to go out in the world again.. And when it comes, hopefully we will be spared the pain – and the loss of benefit from in-person deliberation – and we will finally be able to throw the phrase “you are muted…” into our verbal trash bin. And hopefully someday later this year, we will have the first FDA Advisory Committee meeting that is held in person, or at least is a hybrid.

Can you hear me?

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OPDP Warning and Untitled Letters – A Separation; a New Letter from OPDP

This is sort of a two-for posting. First we will look at a change in how FDA is reporting regulatory actions by OPDP on the FDA website, and second we will cover the most recent such action.

OPDP Warning Letter Change. Not as compelling perhaps as Harry and Meghan splitting from Buckingham Palace, but there has been a split at FDA’s OPDP between Warning and Untitled letters. For anyone tracking enforcement, take note. It just got a little more difficult.

As an agency, FDA issues Warning Letters from multiple sources covering a span of topics and concentrated on various segments of the subject matter jurisdiction of the agency – from food to devices to cosmetics and of course, to the communication by the manufacturers of medicine about their products.

When it comes to the Office of Prescription Drug Promotion (OPDP), the regulatory actions that came from that source were up until now all stored on a single page within the OPDP portion of the FDA website listing the letters in chronological order and making distinct which ones were Warning Letters and which ones were Untitled Letters. No more.

For reasons indiscernible to this author, the agency recently split Warning Letters from Untitled Letters and now displays them in separate parts of the FDA site. Untitled Letters are still located on the OPDP site, but the Warning Letters have been moved to a portion of the FDA website where all agency-wide warning letters are being housed – no matter from where they originated. To find those specific to OPDP you must now (inconveniently) conduct a search.

That sounds easy enough, though it deprives you of the former chronological view of what OPDP is doing by way of enforcement. You will have to put the two groups into your own chronology. Not a big deal, but it adds a step. However, the way the new page/search function has been set up may also lead to some confusion. There is a drop down menu that includes all of the various points of origin for a Warning Letter within FDA. When looking for letters from OPDP the drop down menu includes the option to search for Warning Letters from either “Office of Prescription Drug Promotion” or “The Office of Prescription Drug Promotion”. But if you happen to search under both, you will get different results. When you select the tab for “The Office of Prescription Drug Promotion“, you will see the two letters issued and posted this year. When you select the tab for “Office of Prescription Drug Promotion” you get a different result that lists two additional Warning Letters posted in 2021, but which were sent in 2017.

This is hopefully a bug to be worked out over time, but the separation of Warning and Untitled nevertheless will likely stand. Hopefully FDA will sort out the different results for different tabs for the same office. Ultimately not a huge deal, just inconvenient.

However, perhaps most importantly, the search tool for Warning Letters does not go past 2017 and there is no link from the search page to the archives. So it is unclear whether or not one can access letters prior to that year when using this new page. In fact, if you visit yet another page, you can find a link to the archives, even though there is no direction in relation to that on the Warning Letters search page. This is on a page entitled “Warning Letters and Notice of Violation Letters to Pharmaceutical Companies” even though this page only actually contains links/tabs to Untitled Letters. When you go to the Archives, the tabs are all labeled “Warning Letters” but in fact, if you click on them, you go to archives that contain both Warning Letters and Untitled Letters. All in all this is a rather confusing reconfiguration.

OPDP Issues First Untitled Letter of the Year. With two Warning Letters having already been issued this year, OPDP has issued its first Untitled Letter of the year, with two of the three regulatory actions so far this year being attributed to the “Bad Ad” program. Remarkably, this is the second letter to be issued by OPDP involving a Kardashian. Go figure – though also remarkably – it involves a second Kardashian. The subject matter was a DTC video. While there are many takeaways from this letter, here are a few of the highlights:

A point I have always made when conducting a training related to promotional communications is that the use of a spokesperson is one of the riskier tactics one can undertake. That is because personal experience with a medication is highly subjective – the “what it did for me” factor, which is not always in lock step with what was found in the clinical trials. That is what happened here – a statement made that “[i]t literally works within, for me, 15 minutes…” was different from the clinical studies of the drug which was closer to two hours for expected relief. A statement included in the video that “results may vary” was considered insufficient by OPDP to mitigate what they considered to be a misleading statement;Further use of language referring to the medicine as a “game changer” and comparing it to other medicines sets up a superiority claim;Finally the presentation of risk information in the context of relating a personal experience with a medication can be challenging and here the information appeared briefly in text format at the end of the video where the agency felt it was unlikely to draw viewer attention.

That is the third regulatory action by OPDP three months into the year. If that keeps up, 2021 should be a much more active year than those in recent memory. Even if we have to hunt and pick to find them all.

Photo by Goh Rhy Yan on Unsplash

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2020 OPDP Enforcement

Last month we looked at a review of FDA press releases for last year and as one might have expected, there was an enormous spike in communications as a result of the COVID-19 pandemic. Looking now to a review of enforcement by the Office of Prescription Drug Promotion (OPDP) in 2020, we see a different picture. We instead see the same pace as we have the past several years – that is anemic levels of enforcement. And as in recent years, the regulatory action letters were exclusively aimed at smaller, less experienced companies. Whether that is by design, or by virtue of the fact that they are more prone to regulatory error, is not clear. The collection of letters issued by OPDP during 2020 can be found here.

Characteristics of Enforcement for 2020 – One thing that stands out this year was the fact that the bulk of the letters issued to companies regarding violations were Warning Letters rather than Untitled Letters. Warning Letters are the more serious of the two types of letters sent by the agency. So when OPDP did act, they meant business. Let’s look to the other characteristics of the letters for 2020:

Five of the six letters were Warning Letters rather than the less serious Untitled LetterFive of the letters involved products with Boxed Warnings Four of the letters involved digital communications, two sponsored links and two emails were the subject of actionTwo were focused on traditional direct-to-consumer ads – one radio and one televisionHalf of the letters were prompted through the Bad Ad Program (see below)

The Violations – In recent years, there has been an uptick of activity aimed at the promotion of an unapproved drugs. While this year did not see such a violation, there was a violation related to promotion of an unapproved use. In addition, the omission or limitation of risk information – the most common subject matter of a regulatory action letter by FDA, was represented in each of the letters issued during 2020. In all there were 6 letters containing 13 violations – 6 for risk; 1 for an unsubstantiated claim; 2 for broadening indication; 1 for unapproved use and 3 in the “other” category which included a failure to use the established name in the promotion.

All of the letters involved risk minimization or omission A reminder that risk information cannot be incorporated by link to “full prescribing information” or any other sourceRisk information cannot be cherry-picked, particularly from a Boxed WarningOne of the letters involved a promotion that did include the boxed warning in the communication, but lacked other risk information and placed the risk information out of proximity to the statements of benefit – Presence of risk information alone is not adequate, but rather the presentation must be balanced One letter included a violation for promotion of an unapproved use where there was a suggestion that the compound relieved respiratory symptoms associated with COVID-19

Heightened Role for “Bad Ad Program” – A recent interview with the new Acting Director of OPDP revealed that a primary focus for the office this past year was in relation to the biosimilars market. It was also noted that the “Bad Ad” program turned 10 years old this year. The Bad Ad program, for those new to this, was instituted to deputize healthcare professionals in the role of helping to referee when promotional communications are perceived to go outside regulatory parameters. Notably, it appears that at least half of the six regulatory action letters issued this year were prompted through Bad Ad program reporting. The article states that the program had received over 2000 reports over its lifetime. Since there have been no where near that number of enforcement actions by OPDP during that time, it appears that there is a lot to sift through.

Social and Digital Work Left Undone – With regard to social and digital media, the Acting Director echoed the sentiments of the past when saying that FDA is focused more on the message than the medium. This is despite the fact that the guidance work that was put into motion in April 2009 framework set up during the public meetings about social media remains partially undone. There are still distinct questions relatable to digital and social media which have never been addressed which are platform specific – such as optimization of a branded web site for mobile, the responsible use of links, and adverse event reporting. CDER Guidance Agendas in the past had included some of these topics, but are no longer included in the recent agendas and appear to have been dropped.

One resource to examine when considering the potential directions for OPDP enforcement and guidance development is the identified “Research in Progress” which the office is undertaking that often informs future direction. If interested to see what they are looking at in terms of digital and social, you will be disappointed. The agenda still has a focus on DTC print and television ads. Nothing about risk presentation on mobile sites.

Conclusion – Finally, in the OPDP interview referenced above, it was indicated that a priority for the coming year will be to make the work of the office more visible and relatable, as well as to continue vigilance for claims being made around COVID-19 treatments. Overall, it would seem that despite the change in leadership, priorities remain the same – reviewing launch materials for new drugs and focusing on enforcement with respect to specific categories where there is high risk (pain medications) and situations where there is a greater risk as represented by the presence of a boxed warning. In other words, they are concentrating their resources on the greatest risk areas rather than spreading it out across the spectrum as was done when the number of regulatory action letters in a year far exceeded the current output.

For 2021? So far, no letters. Last year, the first regulatory action by OPDP did not occur until March. Stay tuned.

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What They Said – Overview of FDA Press Releases for 2020

Well. They said a lot. A lot more than ever, as one might expect. This past year, FDA issued a whopping 420 press releases, more so by far than any year previously.

COVID certainly made a big impact – a whopping 65 percent of FDA press releases had to do with the subject of the pandemic. In late March FDA began issuing Coronavirus Updates labeled as a “Daily Roundup” except they weren’t actually always a daily release – some days got skipped. In all there were 165 of them. Then in addition, FDA began issuing releases containing updates independently of the daily updates that relayed news of a special development. And then on top of that, sometimes the agency issued a regular press release having to do with a COVID-related matter. In any case, they talked a lot about COVID-19 this year, as one might expect. In all there were 274 releases about COVID.

What were they talking about? There were 104 releases involving approvals (compared to 92 the previous year) – 58 of which were about the approval of drugs; 42 of which involved the approval of devices; 1 gene therapy; 1 involving an animal product and 2 of which were vaccines. Approval announcements includes those related to Emergency Use Authorization (EUA) which is not technically an approval. There were 28 releases announcing an approval related to an EUA, which overwhelmingly involved the approval of one of the many tests authorized by the agency this past year, as well as those involving the use of remdesivir and blood plasma.

Outside of COVID, there were some notable approvals, including the first treatment for peanut allergies in children, the first therapy for children with a rare and disfiguring rare disease, a new therapy for heart failure, the first treatment for Ebola and the first imaging for Tau Pathology in patients being evaluated for Alzheimers.

FDA’s policy for translating press releases into Spanish is mystical. Some releases are translated, some are not. The subject matter sometimes seems to be a guiding factor, but it is really unclear. It is a handy thing, of course, for the nation’s Spanish-language newspapers and for patient organizations making information available. But this year, they only got about 20 percent of the time, 12 percent of the COVID-related releases. The Daily COVID-19 updates were not translated.

One additional note on FDA’s communications this past year. As late as December, FDA continued the ill-advised though infrequent practice of politicizing press releases with the use of the term “Trump Administration” in the headline. While that temptation will necessarily evaporate in a few days time, it speaks to an issue that FDA has before it for 2021 which is specifically to restore any damage to the agency’s credibility from the events of this year. The agency took some pains to demonstrate transparency during the vaccine authorization process – holding an advisory committee meeting on each vaccine and issuing a press release prior and subsequent to the meetings. That is a beginning. During 2021, the agency will have to do more.

Photo by AbsolutVision on Unsplash

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Approvals in the Crazy Year of 2020

Each year in January, it is relevant to look back on the activities of FDA during the course of the previous year and look at how it was the same or different from prior years, and to look at trends in new direction. This past year, needless to say was a doozy on all fronts. Let’s begin by looking at approvals.

One might have surmised that the advent of the COVID-era might have thrown off new approvals and that NMEs approved would go diminish. That, however, was not really the case. During 2020, FDA was able to approve 53 – not surpassing the 2018 all time record of 59, but certainly an admirable second place.

One has to also take into account that the approval mechanism at FDA was particularly busy this year. The agency had a number of Emergency Use Authorization (EUA) applications to consider, many of which were for devices (tests) but some for therapeutics and two for vaccines that included the staging of two advisory committee meetings within a week of one another, resulting in the authorization of two mRNA vaccines – a platform never before commercially available. While not full licensure, the mechanisms for approval did utilize agency resources.

Notably, the 2020 NME approvals included 22 related to oncology, with 2 new GIST treatments, 3 in breast cancer and 2 approvals in prostate cancer. There were 2 new treatments for Ebola as well as an approval for a diagnostic in Alzheimer’s. And there were at least 14 approvals for conditions considered rare.

The number of FDA Advisory Committee meetings held for 2020 to consider new drug or biologic applications numbered 19, down from the previous year when there were 23 which was down from 2018 when there were 28. That may be less a reflection on the impact of COVID than it is the fact that so many investigational compounds come through the system with an enhanced status that may diminish the need for advisory committee input.

It was certainly reasonable on the part of many to expect that FDA’s capacity for keeping the pipeline moving through the regulatory process might have been negatively affected by the COVID-19 pandemic. Certainly the shift to virtual advisory committees must have been a challenge (and trying at times to listen to) as was the shift to remote work for employees, but in the end, the agency and the pipeline delivered the second highest number of NMEs to date, while some PDUFA dates have been missed or postponed.

Looking ahead, the interesting question for the year to come will be whether or not the pandemic will have affected the completion of clinical trials for new investigative compounds that were underway or recruiting during 2020 and what impact, if any, that will have on future numbers of approvals and NMEs.

Happy New Year, by the way.

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Vaccine Development and Approval in a Time of Pandemic

Sometimes in the midst of events, perspective is elusive. Today the Food and Drug Administration will hold a meeting of the Vaccines and Related Biologics Advisory Committee (VRBAC) to consider the application for an Emergency Use Authorization (EUA) submitted by Pfizer/BioNTech for their investigative vaccine for COVID-19. Usually prior to an FDA Advisory Committee meeting where a product is being considered for approval, the posting of the FDA Reviewer comments is greatly anticipated for what it will say about the potential shortcomings of the investigative compound under consideration. The review that was posted regarding the vaccine candidate was extremely positive. Three other countries (United Kingdom, Bahrain and Canada) have already approved the vaccine for emergency use.

We are at a point in time in the United States where this could not come soon enough. We are running out of intensive care beds in hospitals across the nation. Yesterday the U.S. set a world record with over 3000 deaths, nearly as many people dying daily as died in the 9/11 attack. And there were approximately 220,000 new cases reported yesterday and the day before alone. Worse, there is complacency among some about these numbers and their impact on individual human lives. It is as if the lives, and the process for the development of a solution, have been taken for granted. Experience has taught us well that should not be the case.

It is not even a year ago that this virus emerged to threaten pandemic, lives and livelihoods. Within that short amount of time, research identified the virus, routes of transmission and began exploring therapeutics to treat and pathways to prevention. Phase 1 trials of vaccine candidates were designed and executed while plans were underway to engage in Phase 3 trials involving tens of thousands of people around the world. Study subjects had to be administered vaccine or placebo in huge numbers, wait and receive a second dose, and then to wait and see if it worked to prevent illness. All of this has brought us to this day to a VRBAC meeting to consider an EUA for a candidate vaccine for the first of at least two applications, with more to follow.

By contrast, looking back to the AIDS epidemic, the first really effective therapeutic took a decade and a half, an extremely painful and bleak time for people who were infected and their care partners. There has been criticism of the governmental response in COVID-19, but the AIDS epidemic began in 1981 and it was not until 1985 that President Reagan referred publicly to the epidemic. By the end of 1985, there had been a cumulative total of over 44,000 cases diagnosed in the United States with over 24,000 dead. After nearly 40 years, a vaccine still eludes us.

It is not simply the speed of the COVID-19 research response that has been breathtaking, but there has been a dogged determination in overcoming substantial obstacles that were in the way to get us to this point – practical, political, bureaucratic and even financial barriers – that frankly merit our admiration at the accomplishment.

While the speed and process for approval have been a point of concern and criticism for many, there is also the prospect of what weighs against those concerns. As of yesterday over 286,000 people have died from COVID-19. Many others suffer lingering illness. Economies are strained. The global pandemic out of control, but particularly in the U.S. These things are a heavy counterweight. We should not lose sight of it. FDA will likely make its decision in very short order after the conclusion of the meeting.

In the coming days and weeks, as people are considering their personal decisions about whether to vaccinate, other people will be getting this jab and will experience adverse events and reactions. Many of these will be reported on in the media and exploited by some with political agendas as well as vaccine deniers, all of which will be discouraging to those who are fence sitting about whether to take a vaccine. There will be problems in distribution, in uptake and in administration. In some respects, all of these are good problems to have because they come to us solely as a result of the fact that we have viable choices. And there is much for an individual to weigh – from their own health status to that of those with whom they live, among other things.

Speaking for myself, roll up a van to my front door right now. My sleeve is pulled up and my arm is out there and I’m waiting. And as I do so, I’m thanking my lucky stars that this time, it was not a fifteen-year wait.

Photo by Elena Mozhvilo on Unsplash

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COVID-19 Vaccinations – Where a Commitment to Diversity is Essential

In my last posting on preparedness for a post-vaccination world I touched on some of the questions facing employers in general – policy questions that should be considered now for the eventualities of later. But digging a little deeper, there are also questions to consider with respect to support for ensuring access to vaccines by communities of color. All employers have a stake in the issue of enhancing access for minorities to vaccination, but large multi-state employers, those that may be smaller/regional employers with a disproportionate share of minority employees, and of course minority owned businesses all are enhanced stakeholders. Particularly for those businesses that have supported initiatives for diversity and inclusion as a response to the issues of social justice, this is where the rubber meets the road.

Here is the issue. First of all disparities in healthcare have had an overwhelming impact on minority outcomes and causing a disproportionate impact of burden across many disease states. COVID-19 has cast a particularly harsh light on this fact where minorities in the U.S. are dying at younger agents and in greater numbers than non-minorities. Conversely, while vaccine hesitancy has been identified as a factor in the uptake of vaccines, there is a higher reserve of mistrust regarding vaccines on the part of African-Americans. With higher and harsher incidence, and higher mistrust, access to, and education about, COVID-19 vaccines is an imperative – both ethically and from a public health perspective.

However, once a COVID-19 vaccine, or multiple vaccines, are licensed and approved, distribution of the vaccines will be guided by states. The Centers for Disease Control (CDC) directed U.S. health jurisdictions to develop plans for distribution which were submitted and reviewed by the agency. A recent review of these state plans by the Kaiser Family Foundation (KFF) found the following:

53 percent of the states had “at least one mention incorporating racial and/or ethnic minorities or health equity considerations in their targeting of priority populations”, meaning that nearly half do not;In identifying providers for vaccinations, only one-fourth of the state plans discuss making use of providers needed to reach racial minorities;Only half of the plans address communications approaches/needs for outreach to minorities or vulnerable populations;Only one-third of the plans mentions the consideration for addressing vaccine misinformation, but even those that did lacked specific strategies for countering misinformationIn addition, states indicated that there were limitations in collecting ethnicity data on vaccinated individuals.

That there are deficits in these plans comes as no surprise given the gravity of the situation and the compressed timeframe for response. So what should businesses be considering? Given the high level of need and the considerable gaps there are some public affairs opportunities that may serve to help the situation.

Large employers may wish to review state plans in which they are doing business to assess the deficits that may exist with respect to their employees with particular regard to minority issues related to vaccination. A list of the state plans compiled by KFF can be found here. Identify the gaps in planning and communications that might be addressed through employer-based programs:Development of mechanisms to address vaccine misinformation and enhance education – or alternatively programs that curate third-party information and make it available;Assess potential of public/private partnerships that might address state or regional planning and communications deficits;Perform company-specific research of employee knowledge, attitudes and beliefs around vaccination to inform messaging and program development;Leverage public affairs clout to pressure state health officials to address gaps in planning and communications vis a vis minorities;Consider public statements of support (op-eds, paid advertising) for addressing healthcare disparities in COVID care and vaccination programs and seek and enter into coalitions with other employers.

How well we come out of this will depend on how well we manage the vaccination of enough people to actually make a difference in the course of the pandemic. Anything that falls short for any of us, falls short for all of us.

Photo by Clay Banks on Unsplash

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As the Prospect of a Vaccine Approaches, Business and Communications Challenges Are Just Around the Corner

Coincident to COVID-19 case levels in Europe and the United States entering new and serious levels comes welcome news on the development of a vaccine. Last week Pfizer and BioNTech announced findings from the first interim analysis of the Phase III studies of their candidate vaccine for COVID-19 demonstrating high efficacy levels followed this week by a similar announcement by Moderna. It was a much-craved dose of good news, spawning broad optimism during what is an extremely challenging phase of the pandemic. And while there are many questions left – from efficacy to safety to distribution – given the fact that both of these companies have stated that they will have doses ready in 2020 there appears more of a possibility that there will be more than one vaccine soon – even beginning in December.

But first there will be regulatory rites of passage. During the October 30 meeting of the CDC Advisory Committee on Immunization Practices (ACIP) which focused solely on COVID-19 vaccine development, FDA stated the prior to any approval for an Emergency Use Authorization (EUA) that the agency would reconvene the Vaccines and Related Biologics Advisory Committee tor review data submitted in support of such licensure. It would appear plausible based on the information gleaned from the data announcements that there could be a filing for an EUA very shortly which could in turn mean that limited vaccinations could start being administered very soon. Because the regulatory oversight of COVID became highly politicized, and after some missteps by FDA, some states have indicated that any federal decision will be reviewed, but that does not seem likely to present much a barrier in terms of timeline, if at all.

While vaccination may actually begin in December, the number of doses will be limited. In addition, the process of vaccination takes time. These two particular vaccines are two-dose vaccines administered weeks apart. Vaccination may start next month, but the effects will not occur until after a period following the second dose which would occur in 2021.

Nevertheless, the real prospect of a vaccine roll out raises some very practical and important questions for businesses now. This is true for business to consumer or business to business concerns – whether manufacturers or in the service sector. Vaccination for COVID-19 not only requires business planning, but communications planning in support of the decisions. Vaccination will occur in phases, with more and more people being able to access as increasing doses become available. While the initial vaccines may be utilized with very specific populations, over time there will be increasing numbers of people rolling up their sleeves. A post-vaccine world begs some specific questions:

First and foremost – will businesses require a vaccine of employees? And related – will businesses seek to set themselves apart by making it known that their environmental risk is being addressed with mandatory vaccination of staff? This is particularly relevant for retail establishments for example. On the heels of that, will there be circumstances where access to goods and services by consumers is reliant on vaccination? This is particularly relevant for the travel and hospitality industries, but perhaps also for some medical services. Related to both of these first two questions – what sort of documentation will be necessary for an individual – either employee or customer – to present evidence of inoculation? And also how will those who do not vaccinate because of medical or religious reasons be considered? What are the HIPAA and privacy implications, if any, related to all of these questions? What role, if any, will employers play in the facilitation of vaccinations? Currently many employers sponsor vaccines for the flu – will there be a role for COVID vaccination support? Several of the vaccine candidates are administered in two doses, several weeks apart. Will employees need assistance or support in accessing vaccines (and keeping track of which vaccine they have received), particularly if vaccinations are being required?Surveys have indicated that many are reticent about taking a vaccine – will that change when vaccination moves from the theoretical to the real? Will employers have a role in educating people about the safety and efficacy of vaccines, particularly if there are circumstances where vaccinations are being required? Where vaccines are required as a pre-condition to access to either employment or goods and services how will this be balanced by the fact that vaccination of the population will be a process, not an event, and that there may be many people who for one reason or another, are unable to access vaccination?All of these questions may likely have different answers in different regions of the U.S. Companies that are national in scope may have to formulate responses that take into account local or regional conditions. What are the implications of uneven vaccine implementation by region and geography? Finally, among the many unknowns connected with the mass production of a vaccine only developed and researched in the past few months is the long-term efficacy and safety. What is the contingency plan needed around diminishing effectiveness?

It may seem like we are a far way away from having to address these types of questions, given the fact that there is no approved vaccine yet and there are considerable distribution obstacles associated with the administration of COVID-19 vaccines to the general public. The fact that vaccination may begin as soon as December does not mean that answers to these questions are needed now. But the process for answering them is. A post-vaccine environment is going to demand business plans and external and internal communications plans that support and consider multiple scenarios and contingencies. If we have learned one thing in this pandemic, reality overtakes everything else – and the environment shifts rapidly. Public facing companies need to act now to consider strategic challenges and support responses with communications approaches that protect and preserve not only credibility, but the well-being and good will of their stakeholders.

Photo by Simon Berger on Unsplash

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FDA AdComm Agenda Covers the Bases

First of all, we are having a bit of a crisis with our crisis. As we appear to be moving into yet another wave of COVID-19 infections, and as research into a vaccine is aggressively underway, we also see serious drawbacks. Apart from the increasing numbers of cases in the United States, there has been a strong perception that the process has been politicized which in turn has brought on an increasing skepticism or crisis in confidence on the part of the public to embrace the outcome. And now, three agencies that have seen an erosion in public confidence – FDA, CDC and NIH, will participate in an FDA Advisory Committee meeting that will discuss vaccine development.

The agenda has been posted for the October 22 meeting, and the discussion will be available to view on YouTube, according to FDA Commissioner Hahn. One had to wonder what the meeting would actually be discussing since there was no candidate vaccine to consider for approval and given the fact that FDA has already issued guidance to provide a framework of understanding for how the agency will approach approval.

The order of the day includes presentations from all three stakeholder agencies – CDC, FDA and NIH and appears to be designed to add a little more meat to the bones on how each will play a role and to lay out some of the mechanics of the process. in the day they will establish a level playing field for understanding COVID-19, followed by the various key agencies explaining their part in the process, beginning with NIH, followed by BARDA with CDC discussing that agency’s role in monitoring use after either early use authorizations (EUA) or final licensure and CBER will follow up describing post-marketing surveillance systems. Another CDC presentation will discuss vaccine distribution and tracking, which is an important topic about which there are many questions, followed by a discussion on “vaccine confidence” presented by the Reagan-Udall Foundation. There will be a specific discussion of the manufacturing and control as well as the clinical considerations for EUAs and licensure. In short, broadly all the categories in which there are questions seem to represented in the agenda.

Apparently as well, they are expecting a higher degree of public participation in the Open Public Comment period, usually reserved as a 60-minute window, but which is cast for 90 minutes for Thursday. Presumably if that is the case, participation will be limited to a set number of minutes. The number of comments added to the docket that had been set up for the meeting numbered 34 as of yesterday and included two stakeholder companies engaged in clinical trials.

Hopefully what will come out of the discussion is not only the broad understanding of the background and mechanics of approval and distribution, but answers to a good number of the questions regarding the nuances of actual approval, distribution and uptake. Whatever is going to be offered up during the presentation from the Reagan-Udall Foundation about confidence, this meeting will actually be an important factor related to the confidence levels of people, particularly health care workers, in taking a vaccine once there is one to take. This meeting cannot settle for perfunctory presentations and must take the questions that were raised in the docket comments, and those that will be raised during the Open Public Comment period and respond to them in some way subsequent to the meeting. We are in unprecedented times that require unprecedented transparency, planning and sound communications that has so far been largely lacking. Meetings are often perceived as an event – but this one is the beginning of a process.

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