Disclaimer: Mandeep Sohal, PharmD and Joshua Murdock, PharmD are employees of CVS Health. Any statements contained herein are solely the opinions of the authors and do not reflect the views of CVS Health, Aetna, CVS Caremark or any of CVS Health’s affiliates or subsidiaries.

Are you a healthcare professional? Read the healthcare professional version of this article here.

What is hemophilia?

Hemophilia is a type of rare genetic bleeding disorder that mainly affects males.¹ It can be categorized into two main types of hemophilia – hemophilia A and hemophilia B.¹

Both types of hemophilia are caused by a lack of ‘factor,’ a key component of the coagulation cascade, which is a step-by-step process that occurs in your body to stop bleeds by the formation of a blood clot. It is important to have a quantity of factor within a normal range to prevent bleeding episodes. Hemophilia A is caused by a lack of factor VIII (8) and hemophilia B is caused by a lack of factor IX (9).¹ Blood clotting is a part of normal bodily function, and many patients that lack factor suffer from bleeding into joints, muscles, and skin (bruising); repeated bleeding into joints can lead to disability.²

However, similar to other medical conditions, not all patients with hemophilia have the same symptoms. Some patients are more severe than others, which is usually related to how much the factor levels are under the normal range.² Due to these differences, treatment is individualized to the patient’s needs.²

The care of a hemophilia patient is complex and requires a number of healthcare professionals, like hematologists, nurses, pharmacists, and physical therapists. For the majority of patients who aren’t of a mild severity, treatment requires the use of factor drug products or antibodies that help improve symptoms.³ Some patients require the use of drug products on a regular basis, while others use them after bleeding episodes.

There are several different categories of drug products used to treat hemophilia today, one of which includes the plasma-derived and recombinant replacement factor products.³ Plasma-derived products come from blood donors while recombinant factor products are made in a laboratory setting.³

The benefit to recombinant products is that they are often safer than plasma-derived products because they have a very low risk of carrying disease causing micro-organisms.³ However, one study did show that the use of recombinant products resulted in a greater incidence of inhibitor production.⁴ Inhibitors are antibodies formed in hemophilia patients that recognize the drug product as non-self. This causes the patient’s immune system to attempt to eliminate the foreign threat, the factor drug product, and prevents the factor drug product from working normally. Certain inactivation techniques have nearly eliminated transmission of disease causing micro-organisms in plasma-derived products, but there still exists risk for unknown viruses and prions (abnormal proteins) in these products.⁵

Furthermore, replacement factor drug products can also be divided into standard half-life vs. extended half-life products.² Standard half-life products typically need to be administered to a patient more frequently than extended half-life products, as they do not last quite as long in the patient’s body. As many patients using factor in a preventative manner need to administer drug product several times a week, extended half-life products are often preferred by patients as they need to be administered less frequently.

Additionally, there is an FDA-approved monoclonal antibody used for hemophilia treatment. Hemlibra (emicizumab-kxwh), while not a replacement factor product, is an antibody that helps reduce the frequency of bleeding episodes.⁶ It has been shown to be more effective than traditional factor products in one study, and it can be administered as an injection under the skin as infrequently as every 4 weeks.⁷ While we do see significant advances in hemophilia treatment options, we are at the cusp of a changing hemophilia treatment landscape in this decade.

While these are some of the current treatment options available for patients with hemophilia, there are other drug products currently being studied in clinical trials that have potential to help patients with hemophilia in a new way.

What is gene therapy?

Gene therapy is a new way to treat diseases, which can help many patients that have abnormal or absent gene function. For medical conditions like hemophilia, gene therapy is emerging as a treatment option.

Specifically, gene therapy is a developing therapy class that allows healthcare professionals to treat diseases by inserting a functional copy of a gene into a patient’s cells. As hemophilia is a genetic bleeding disorder caused by a single faulty gene, it is a reasonable candidate for this therapy class.² Today, hemophilia is treated by a number of different medications. However, for many with severe disease, frequent injections of replacement factor into a patient’s vein or antibodies under the skin is an inescapable reality.²

While there are currently no FDA-approved gene therapies for use in hemophilia patients, there are several drug products being studied that may change how hemophilia is treated in the future, including Roctavian (Manufacturer: BioMarin) and AMT-061 (Manufacturer: uniQure) among others.⁸ It is likely that we will see the approval of a hemophilia gene therapy in the near future. 

What is Roctavian (valoctocogene roxaparvovec)?

Roctavian is the brand name of the gene therapy valoctocogene roxaparvovec for hemophilia, which was previously known by the brand name of Valrox.⁹ It is one of many being studied for hemophilia treatment, today.

Roctavian uses a vehicle, a non-disease causing virus, called Adeno-Associated Virus Type 5 (AAV5), to deliver a functional factor gene to a patient. This is given by infusion into the patient’s vein.^9,10 This gene therapy, like many other existing gene therapies for other conditions, can only be tried a single time. Once administered, it causes the patient’s immune system to create antibodies to the vehicle.¹¹ If the therapy is given again, the patient’s immune response will neutralize the gene therapy, likely rendering it ineffective.¹¹

However, there are other new, innovative technologies in development, which can be given more than once, because they use a different type of vehicle.

For example, Generation Bio’s lipid nanoparticle has shown the possibility of redosing a gene therapy without provoking an immune response, which may alter how gene therapy is delivered in the future.¹² In other words, Generation Bio’s product may be administered to a patient more than once, but it is far from FDA approval and hasn’t yet been studied in humans. While it is unknown if future vehicles for delivery will be mostly viral or non-viral, it is likely that gene therapy will need to be given in a hospital setting, so patients can be monitored to help ensure that they tolerate the therapy.

In the Roctavian clinical study protocol (a document that describes study details), patients were initially screened and several examinations were conducted, including physicals, urine tests, and blood tests.¹³ After screening, Roctavian was administered to eligible patients via an infusion into a patient’s vein, and BioMarin estimated that the maximum infusion time would not exceed four hours.¹³ However, the patients were hospitalized for an entire day for observation to evaluate how they responded.¹³ Prior to being allowed to participate in a research study, patients have to meet certain requirements or criteria. While patients enrolled in the Roctavian study had to meet many criteria to be included, it may be useful to understand what some of the higher level requirements were.

It is important to note that this gene therapy is still being studied in clinical trials, and it has yet to achieve FDA approval. The final FDA-approved product, if approved at all, may or may not be used in an identical population to the study criteria. Furthermore, this is just the criteria for Roctavian for one study; the studies for other gene therapies to treat hemophilia may have different criteria.

Patients included in the study were males with severe hemophilia above the age of 18.¹³ These patients also had to have no inhibitors on two occasions within the last twelve months.¹³ At this time, BioMarin is recruiting participants for a study that does include patients with inhibitors.¹⁴ Furthermore, if patients had antibodies to AAV5, the vehicle, they were also excluded.¹³ This is a point of concern as many patients have been exposed to AAV during childhood and adolescence and already have formed antibodies as a result; the prevalence of neutralizing antibodies for AAV5 ranges from 4% to 50%, which would exclude many hemophiliacs from this therapy.¹⁵ Patients that were eligible and did receive therapy were quite significantly affected.

Roctavian treatment resulted in more than a 90% decrease in annual bleeding rate and more than a 90% decrease in factor VIII use 3 years after having received an effective dose of gene therapy. From a safety perspective, Roctavian did affect the patient’s liver enzymes, but the effect was temporary and non-serious. One patient was found to have experienced treatment related serious adverse events during the study, which included a high fever, muscle pain, and headache. Reassuringly, this patient’s symptoms resolved within 48 hours after receiving acetaminophen (Tylenol).

BioMarin, the manufacturer of this gene therapy, submitted their study data, but their application was denied in August 2020 due to differences in the submitted studies with concerns for how long the effect of the gene therapy would last after it was administered to the patient.¹⁶ FDA requested additional data from one of BioMarin’s studies.¹⁶ Now, BioMarin is working to obtain additional data, and they will likely resubmit Roctavian to the FDA for potential approval in the future.

While this class of therapy holds significant promise, many outstanding questions remain. At this point, it is difficult to say how long the effects of this gene therapy will last. For Roctavian, or any other gene therapy, factor levels would ideally be sustained over the entire lifetime of the patient. As adult patients, 18 years or older, were eligible for the trial therapy, the gene would have to be functional for several decades in order to be considered a curative success. Even with current data, it is not yet possible to know if this will happen. Only additional data and time will allow us to realize the true effect of gene therapy.

 Other gene therapies for various medical conditions will likely become available over time. Roctavian (valoctocogene roxaparvovec) for the treatment of hemophilia, although still being studied in clinical trials, is one example of many hemophilia gene therapies in the drug development pipeline.

References:

1. What is Hemophilia? Centers for Disease Control and Prevention website. Accessed March 1, 2021. https://www.cdc.gov/ncbddd/hemophilia/facts.html
2. DiPiro JT, ed. Pharmacotherapy: A Pathophysiologic Approach. Tenth edition. McGraw-Hill Education; 2017.
3. Treatment of Hemophilia. Centers for Disease Control and Prevention website. Accessed March 1, 2021. https://www.cdc.gov/ncbddd/hemophilia/treatment.html
4. Peyvandi F, Mannucci PM, Garagiola I, et al. A Randomized Trial of Factor VIII and Neutralizing Antibodies in Hemophilia A. N Engl J Med. 2016;374(21):2054-2064. doi:10.1056/NEJMoa1516437
5. Teitel JM. Viral safety of haemophilia treatment products. Ann Med. 2000;32(7):485-492. doi:10.3109/07853890009002024
6. HEMLIBRA uniquely addresses the factor deficiency of hemophilia A. hemlibra website. Accessed March 1, 2021. https://www.hemlibra.com/hcp/about-hemlibra/mechanism-of-action.html
7. Reyes A, Révil C, Niggli M, et al. Efficacy of emicizumab prophylaxis versus factor VIII prophylaxis for treatment of hemophilia A without inhibitors: network meta-analysis and sub-group analyses of the intra-patient comparison of the HAVEN 3 trial. Curr Med Res Opin. 2019;35(12):2079-2087. doi:10.1080/03007995.2019.1649378
8. Gene therapy for hemophilia: So close, yet so far away. biopharmadive website. Accessed March 1, 2021. https://www.biopharmadive.com/news/hemophilia-gene-therapy-biomarin-uniqure-pfizer-roche/594168/
9. Roctavian (formerly Valrox/BMN 270). hemophilianewstoday website. Accessed March 1, 2021. https://hemophilianewstoday.com/bmn-270/
10. Grieger JC, Samulski RJ. Packaging Capacity of Adeno-Associated Virus Serotypes: Impact of Larger Genomes on Infectivity and Postentry Steps. J Virol. 2005;79(15):9933-9944. doi:10.1128/JVI.79.15.9933-9944.2005
11. Thwarting AAV-Neutralizing Antibodies Could Improve Gene Therapy. the-scientist website. Accessed March 1, 2021. https://www.the-scientist.com/news-opinion/thwarting-aav-neutralizing-antibodies-could-improve-gene-therapy-67981
12. Generation Bio Announces Two Non-Viral Gene Therapy Milestone Achievements: Target Levels of Factor VIII Expression in Hemophilia A Mice and Translation of Expression from Mice to Non-Human Primates. generationbio. Accessed March 1, 2021. https://investors.generationbio.com/news-releases/news-release-details/generation-bio-announces-two-non-viral-gene-therapy-milestone
13. Pasi KJ, Rangarajan S, Mitchell N, et al. Multiyear Follow-up of AAV5-hFVIII-SQ Gene Therapy for Hemophilia A. N Engl J Med. 2020;382(1):29-40. doi:10.1056/NEJMoa1908490
14. Study 270-205. biomarin website. Accessed March 1, 2021. https://www.biomarin.com/clinical-trials/hemophilia-a/
15. Kruzik A, Fetahagic D, Hartlieb B, et al. Prevalence of Anti-Adeno-Associated Virus Immune Responses in International Cohorts of Healthy Donors. Mol Ther Methods Clin Dev. 2019;14:126-133. doi:10.1016/j.omtm.2019.05.014
16. FDA Delays Decision on Roctavian, Potential Hemophilia A Gene Therapy, for a Year or More. hemophilianewstoday website. Accessed March 1, 2021. https://hemophilianewstoday.com/2020/08/19/fda-delays-decision-roctavian-hemophilia-a-gene-therapy/

Pharmacists are popularly known for helping patients control and improve various conditions, disease states, and other related ongoings through medication-based treatments alone. 

However, as pharmacists, it is also our duty to help ensure that patients are getting the care they need from a more holistic approach. That is, an approach that combines medications, social-based resources, and lifestyle interventions when needed. 

Almost all conditions and disease states require this multi-pronged approach. Mental health conditions, as diverse in nature as they are, are no exception. Be it centric to depression, anxiety, bipolar disorder, schizophrenia, etc., social help and counseling services are crucial for most patients.

No matter if a patient needs acute mental health counseling for a crisis or if they need ongoing mental health services for maintenance purposes, there are a wide variety of resources available that everybody can access and utilize.

This article discusses a sampling of nine free mental health resources. Anybody can use these resources no matter their financial state, insurance coverage status or lack thereof, or any other status. 

Important – it does not require an official diagnosis of a mental health condition to utilize the below resources. Everybody’s mental health can exist on a continuum and in the moments where mental health may need some support, confidential and private assistance can be obtained through the resources listed below. 

The Trevor Project

Image courtesy of The Trevor Project

An organization first founded in 1998, The Trevor Project is described as a “leading national organization providing crisis intervention and suicide prevention services to lesbian, gay, bisexual, transgender, queer & questioning (LGBTQ) young people under 25,” according to its website. 

The Trevor Project has five main avenues to support individuals who may benefit from their services: TrevorLifeline (suicide prevention phone service), TrevorText (confidential text messaging with a counselor), TrevorChat (confidential instant messaging with a counselor), TrevorSpace (peer-to-peer social platform for LGBTQ young people aged 13-24 years), and Trevor Support Center (directory of FAQs and other resources).

TrevorLifeline is available by calling 1 (866) 488-7386 and TrevorText is also available by texting ‘START’ to 678-678.

Crisis Text Line

Image courtesy of the Crisis Text Line

Founded in 2013, the Crisis Text Line is a free service available to anyone going through a crisis, no matter how mild or severe the circumstance may be.

Although not an all-inclusive list, the Crisis Text Line can help particularly with concerns related to anxiety, suicide, depression, eating disorders, emotional abuse, self-harm, loneliness, and mental health complications of COVID-19. 

For individuals in the United States or Canada, text ‘HOME’ to 741-741 to get started. For individuals in other countries, more information is available on the Crisis Text Line website. 

National Suicide Prevention Hotline

Image courtesy of National Suicide Prevention Lifeline

Launched in 2005, the National Suicide Prevention Lifeline (1-800-273-8255) is a free phone-based resource that is available at all hours of the day. This line can be used by anyone experiencing emotional distress of any form or of any severity. Lifeline is administered by Vibrant Emotional Health. 

As an additional service of the National Suicide Prevention Lifeline, the Lifeline Crisis Chat can be utilized if an online platform is preferred in lieu of a phone call. 

Office of Minority Health Resource Center

Image courtesy of US Department of Health and Human Services

The Office of Minority Health (OMH), a subsidiary organization of the US Department of Health and Human Services HHS), is a resource that can inform individuals of statistics, news, and treatment-related information for individuals of minority background living in the United States. 

Although this resource should not be utilized to help with an immediate mental health crisis, it can be used by patients and healthcare professionals alike to obtain more information about mental health conditions related to individuals of minority background. 

OMH can be contacted via phone (1-800-444-6472) or email ([email protected]). 

Safe Horizon 

Image courtesy of Safe Horizon

Safe Horizon is a nonprofit organization that helps with the treatment and referral of individuals who have fallen victim to domestic violence, child abuse, rape, assault, human trafficking, stalking, homelessness, or other types of abuse. 

Safe Horizon offers a 24-hour hotline (1-800-621-4673) and there is also an online chat feature available called SafeChat.  

Substance Abuse and Mental Health Services Administration (SAMHSA)

Image courtesy of SAMHSA

The Substance Abuse and Mental Health Services Administration, commonly abbreviated SAMHSA, is a subsidiary organization of the US HHS. 

SAMHSA is an all-encompassing, government-based resource that can direct you or someone else for in-person treatment when it is needed. SAMHSA has a general tool to use to be able to find a treatment center for general mental health conditions, but it also has specific tools such as a substance use treatment locator, a behavioral health treatment locator, a buprenorphine practitioner & treatment locator, an early serious mental illness treatment locator, an opioid treatment program (OTP) directory, a veteran’s crisis line, a disaster distress helpline (mentioned below), etc. 

If you or someone you know needs help and you do not know where to begin, SAMHSA could be an ideal place to start.  

SAMHSA Disaster Distress Helpline 

Image courtesy of SAMHSA

The SAMHSA Disaster Distress Helpline is similar to the above-mentioned resources, but it commands a unique avenue. According to its website, it is “a 24-hour-a-day, seven-day-a-week and free resource that responds to people who need crisis counseling and support in dealing with the traumatic effects of a natural or human-caused disaster”. 

For example, if you or someone you know is experiencing negative mental health due to COVID-19 or a weather event, for example, this resource can help. 

Like the image above begins to describe, call 1-800-985-5990 or text TalkWithUs to 66746 to get connected with the SAMHSA Disaster Distress Helpline. 

National Alliance on Mental Illness (NAMI)

Image courtesy of NAMI

Founded in 1979, the National Alliance on Mental Illness (NAMI) identifies itself as “the nation’s largest grassroots mental health organization dedicated to building better lives for the millions of Americans affected by mental illness.”

NAMI offers a variety of different resources. For immediate assistance in the instance of a mental health crisis, “NAMI” can be texted to 741-741 or the NAMI HelpLine can be accessed by calling 1-800-950-NAMI. Of note, this resource is linked with the Crisis Text Line mentioned above. 

For mental health situations outside of the crisis setting, NAMI also offers other resources that can be accessed here. Examples of these resources include online discussion groups, support groups, video resources, and various other mental health education resources. 

NAMI also offers state and local resources and these services vary by geography. NAMI also offers advocacy-based resources for those that are interested in being an advocate for mental health and wellness.  

The National Council for Behavioral Health

Image courtesy of the National Council for Behavioral Health

The National Council for Behavioral Health, commonly referred to as simply the National Council, is a nonprofit organization that acts as a unifying body that connects mental health organizations in the United States. 

Although not a resource that directly offers assistance for imminent mental health crises, it is a resource that can be used by everyday individuals and healthcare practitioners alike to learn more about how to be a mental health advocate. One of its signature member organizations, Mental Health First Aid USA, is a resource that can be used to teach everyday individuals how to help others cope with negative mental health and where to find help. 

Additionally, the National Council offers copious amounts of learning materials about mental health-related conditions. Once the National Council’s website is accessed, the tab titled “Topics A-Z” can be leveraged to learn more about a variety of different mental health-related conditions. 

By being more informed about mental health conditions and how to access help in a general sense, it is helpful for individuals experiencing a mental health crisis and mental health advocates alike. 

Interested in learning about more other mental health resources that can be utilized? Access this list from our friends over at Social Work License Map. 

“Just because no one else can heal or do your inner work for you doesn’t mean you can, should, or need to do it alone.”

Lisa Olivera

Disclaimer – this list is not an all-encompassing list of mental health services available. 

Pharmacists are one of the most accessible healthcare providers and they play a crucial role on the healthcare team. Most Americans live within a 5-mile radius of a pharmacy. Yet, many patients still have unmet chronic and preventive health needs. 

For years, pharmacists and pharmacy organizations have been advocating for provider status, which would result in compensation of the services they are trained to offer because of their Doctor of Pharmacy-based education. Examples of these services include providing vaccinations and medication counseling. 

As a patient, it is crucial to know that the pharmacist can help with other health needs.

Available on the front line as readily accessible healthcare providers, pharmacists can assist with additional aspects of disease prevention, patient education, health promotion, and prescribing medications within varying scopes of practice. In fact, many pharmacists are already doing all of this across the country in ambulatory care settings and in the United States Department of Veterans Affairs. 

Slowly, community pharmacists are also gaining more responsibility. This includes many states allowing their community pharmacists to prescribe various classes of medications under collaborative practice agreements (CPAs). Some of these medication classes include, but are not limited to, oral contraceptives, blood pressure medications, insulin, smoking cessation aids, and more. For reference, every state in the United States has slightly different pharmacy practice laws.  

Studies have shown that allowing pharmacists to practice at the top of their licenses not only helps patients, but it also saves money for patients and the government alike. For example, in one study dating all the way back to 1999, it was illustrated that for every $1 invested in clinical pharmacy services, more than $4 in benefit was seen in the Veteran Affairs. Also, in 2006, Kaiser Clinical Pharmacy Cardiac Risk Services illustrated that 92% of their patients had decreased cholesterol levels as a result of pharmacist-based interventions which saved more than $9 million in projected hospitalizations.

Despite pharmacists having the training and ability to provide this care, they are not being compensated for their efforts. Legislation needs to be better optimized on both the state and federal levels to allow pharmacists to reach their full potential for helping to improve patient care outcomes. 

Under the Social Security Act, pharmacists are omitted as providers in Medicare B. Many private health insurance plans parallel their policies to Medicare B plans. Thus, pharmacist omission does not allow patients to receive comprehensive patient care through their insurance benefits. While pharmacy organizations and pharmacists across the country are advocating for change to provide patients with vital services, their campaign has been going on for years.

ACTION – as a patient or non-pharmacist in the healthcare system, research the senators and representatives relevant to your local area during the election. Know which candidates support pharmacists as part of the healthcare team. Know which ones have plans to decrease the spending of chronic medical conditions by providing more affordable and easier care. Pharmacists need the support of their patients to continue to provide the care and services to Americans across the country. By voting for officials that are pro-pharmacist, health outcomes for patients across the country can become better optimized. Pharmacists also need patients to write letters, pick up phones, and show legislators how their health has been impacted by pharmacist intervention.

Preface: this article marks the onset of a new Pharmacist Consult series that highlights a handful of news releases on a monthly cadence that are relevant to the world of pharmacy and public health. 

With ongoing news cycles contrastingly seeming both cyclic and endless, it is easy to potentially lose track of what events happen over time. This recap discusses a few of the key news releases that were announced during the month of November 2020 that affected the world of pharmacy and public health.

The ongoing COVID-19 pandemic is crowding out many other relevant news stories across all industries, and this sentiment also rings true for the healthcare professions. Although there were many exciting announcements about new therapeutics and advancements unrelated to COVID-19, this discussion has a heavy emphasis on pandemic-related content. 

Pfizer and Moderna Both Apply for COVID-19 Vaccine Emergency Use Authorization (EUA)

On November 20, Pfizer and BioNTech submitted an application to the United States Food & Drug Administration (FDA) to approve an emergency use authorization (EUA) for their COVID-19 vaccine candidate following news that the vaccine is greater than 95% effective. At the time of this article publication, the FDA is still performing a review of this EUA application. 

On November 30, Moderna followed suit and submitted an EUA application to the FDA for their own COVID-19 vaccine candidate following news that the vaccine is around 94% effective. At the time of this article publication, the FDA is still performing a review of this EUA application. 

Related links:

Three Different COVID-19 Medicines Issued EUAs by the FDA

Throughout the month of November 2020, the FDA issued EUAs for three different medicinal therapies to help treat patients with COVID-19. These three therapies are bamlanivimab, baricitinib/remdesivir, and casirivimab/imdevimab. 

Back in early October 2020, it was widely publicized that US President Donald Trump received an ‘experimental antibody treatment’ from the manufacturer Regeneron. That treatment from Regeneron specifically was a combination of casirivimab and imdevimab, and it officially was issued an EUA from the FDA on November 21. Bamlanivimab, a product of Eli Lilly, was also issued an EUA on November 9. 

Both bamlanivimab and casirivimab/imdevimab are indicated for the treatment of mild-to-moderate COVID-19 cases in adults and pediatric patients 12 years of age and older weighing at least 40 kg with positive results of direct SARS-CoV-2 viral testing and who are at high-risk for progressing to severe COVID-19 and/or hospitalization.

Baricitinib is a medication that is already on the market and it is approved for the treatment of rheumatoid arthritis. However, on November 19, the FDA issued an EUA for baricitinib when given in combination with remdesivir (Veklury) for patients with COVID-19 (hospitalized adults and pediatric patients 2 years of age or older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation). This EUA was issued as trial data showed evidence that baricitinib has efficacy in the setting of COVID-19 when used in combination with remdesivir.

Related links:

Wearing a Mask Can Help You and Others

In the early days of the pandemic, the Centers for Disease Control and Prevention (CDC) and the White House COVID-19 Task Force emphasized that wearing a mask is an important precaution to help protect others from the spread of COVID-19.  

However, there is increasing evidence that wearing a mask can help protect the mask wearer in addition to others. Although this does not alter universal recommendations to wear a mask while around others when possible, it helps to compile additional proof that wearing a mask is one important precaution to take for all members of society. 

Related links:  

New CVS Health CEO Highest Ranking Female CEO in the Fortune 500

On November 6, US healthcare giant CVS Health announced that Karen Lynch will take over from Larry Merlo as the CEO of CVS Health on February 1, 2021. CVS Health is considered to be one of the world’s biggest healthcare providers and is currently 5th on the Fortune 500 list behind Walmart, Amazon, Exxon Mobile, and Apple. 

Karen Lynch currently serves as an Executive Vice President of CVS Health and President of Aetna. This transition will not only be a big step forward for CVS Health, but it will be an empowering step forward for female leadership in the world of healthcare and business. 

Related links:

Global Hydroxychloroquine Shortages

Hydroxychloroquine is a medication that is a maintenance therapy for many patients that have autoimmune diseases (most notably rheumatoid arthritis and lupus). It can also be used to help treat or prevent malaria. However, a worldwide shortage of hydroxychloroquine has negatively affected patients with these types of conditions. 

For hydroxychloroquine to be effective, it needs to be taken consistently on a daily or weekly basis, depending on the patient. When the medication started to become unavailable due to high off-label prescribing trends for COVID-19 based on preliminary data, patients being treated for autoimmune conditions or malaria became negatively impacted by this shortage.  

In the early stages of the COVID-19 pandemic, there was an initial belief that hydroxychloroquine and/or chloroquine may be effective for the prevention and treatment of COVID-19. However, this has since been debunked as there is lacking evidence to support their usages in the setting of COVID-19. 

Related links:

$26 Billion Opioid Litigation Settlement

On November 5, it was reported that drug manufacturer Johnson & Johnson and wholesalers (drug distributors) McKesson, Cardinal Health and AmerisourceBergen came to a $26 billion settlement with cities and counties that sued them for damages related to the ongoing opioid epidemic.

Although there are a few logistical steps that still need to be worked out regarding this settlement, this settlement is one part of the largest federal court case in American history.

Related links:

The above links in this discussion are a sampling of some of the most relevant pharmacy news that stemmed from the month of November 2020. In early January 2021, Pharmacist Consult will deliver a recap of relevant news that stemmed from the month of December 2020.

After months of rapid vaccine development, the United States Food and Drug Administration (FDA) announced the emergency use authorization (EUA) for the first COVID-19 vaccine in the United States. This comes about a week after the United Kingdom authorized the same vaccine – the first governing body in the world to do so. 

The Pfizer-BioNTech COVID-19 vaccine, referred to here simply as the ‘vaccine’, is a vaccine that can help prevent COVID-19. 

FDA Announcement: “On December 11, 2020, the U.S. Food and Drug Administration issued the first emergency use authorization (EUA) for a vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. The emergency use authorization allows the Pfizer-BioNTech COVID-19 Vaccine to be distributed in the U.S.”

This discussion will sift through a series of common questions that are relevant to this vaccine. In addition, the table at the bottom of the article, Table 1,  includes various external links for additional information regarding this topic. 

What should I know about this vaccine in comparison to other vaccines? 

This vaccine uses mRNA technology – a relatively innovative vaccine delivery platform. However, the technology in itself is not new; it is just new for vaccines. 

Most other vaccines fall under the categories of being either ‘live’ or ‘inactive’, but mRNA vaccines do not fall under either descriptor and instead form their own grouping. Regardless, COVID-19 mRNA vaccines have been rigorously tested for safety before being authorized for use in the United States.

In its simplest form, mRNA could be described as “instructions” for the human cell on how to make a piece of the “spike protein” that is unique to the virus that causes COVID-19. After this piece of the spike protein is made from the prompting of the mRNA vaccine, the cell breaks down the mRNA strand and disposes of the remnants using certain enzymes. Once displayed on the cell surface, the piece of the spike protein helps cause the immune system to begin producing antibodies and certain cells to fight off what it falsely thinks is an infection. These antibodies are specific to the virus that causes COVID-19 and this means the immune system is better primed to help protect against future infection.

Mechanism aside, this vaccine should be administered alone and it should be separated from all other vaccines by at least 14 days both before and after vaccination. For example, if the vaccine is administered on December 15th, 2020, then no other vaccines should be given between December 1st and December 29th. 

Who are candidates to receive the vaccine?

Individuals who are 16 years and older are eligible to receive the vaccine in the United States. 

For individuals that have already recovered from a prior COVID-19 infection, vaccination is still recommended. However, individuals with a current, active COVID-19 infection should receive vaccination only after the illness has subsided and the corresponding quarantine period has ended in accordance with local, state, and/or federal guidelines. 

There is limited data (as of the publication date/time of this article) regarding this vaccine and its use in pregnancy and lactation. Individuals who are pregnant or lactating should speak with their healthcare provider to weigh the risks and benefits of receiving the vaccine. 

Individuals who have a history of severe allergic reaction to any ingredient within the vaccine should avoid receiving the vaccine. In addition, individuals who have had a severe allergic reaction to any vaccine or injectable therapy should not receive this vaccine at this time. 

How is the vaccine administered?

The vaccine is administered into the muscle of the upper arm, similarly to a flu shot. However, this is a 2-dose series given 21 days (3 weeks) apart. Both doses are necessary for optimal protection that may be gained from the vaccine series. 

If 21 days exactly is not possible due to scheduling conflicts, a reported 4-day grace period is permissible for the 2nd dose. However, if more than 21 days have lapsed since the 1st dose, the 2nd dose should be administered as soon as possible. No doses need to be repeated. 

This vaccine is not interchangeable with other COVID-19 products. If the Pfizer-BioNTech vaccine is given for the 1st dose, the Pfizer-BioNTech product must also be given for the 2nd dose. 

What ingredients are in the vaccine?

Ingredients within the vaccine include:

• Nucleoside-modified messenger RNA (mRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2
• Lipids ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 2[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 1,2-distearoyl-sn-glycero-3-phosphocholine, and cholesterol)
• Polyethylene glycol
• Potassium chloride
• Monobasic potassium phosphate
• Sodium chloride
• Dibasic sodium phosphate dihydrate
• Sucrose
• 0.9% Sodium Chloride Injection, USP
• Note: the vaccine does NOT contain preservatives or latex

What side effects might I expect if/when I receive the vaccine?

Potential mild-moderate side effects that have been reported thus far in clinical trials are injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, injection site swelling, injection site redness, nausea, feeling unwell, and swollen lymph nodes. A small number of severe side effects have been reported.

As time goes on, additional side effects will be collected and reported via VAERS (Vaccine Adverse Event Reporting System). 

Is it possible for this vaccine to cause COVID-19?

No – this vaccine does not contain SARS-CoV-2, the virus that causes COVID-19, thus it cannot cause COVID-19. Additionally, mRNA from the vaccine never enters the nucleus of the cell and does not affect or interact with a person’s DNA.

Table 1: Links and Resources

This is a topic that is ongoing and continually updated on a daily basis. Please continue to defer to the CDC and FDA for the most up-to-date information regarding the COVID-19 vaccination effort. 

Resources: 

Pharmacy benefit managers (PBMs) are entities that manage prescription drug benefits on behalf of health insurance plans. PBMs, thus, can be considered as extensions of health insurance plans. This oversight can include commercial health plans, self-insured employer health plans, Medicare Part D plans, union plans, state government employee plans, managed Medicaid plans, and so on. 

PBMs essentially can touch all aspects of the health insurance industry as it relates to medications. When thinking of the general pharmacy ecosystem, PBMs serve as a middle player between drug manufacturers, health insurance plans, and pharmacies. PBMs have frequent interactions with all three of these entities. 

PBMs were established to help increase the efficiency of health insurance plans while concurrently lowering costs for both health insurance plans and plan enrollees. However, PBMs commonly are the recipients of negative attention from common media outlets. Given the stark polarity that PBMs can evoke, this article is meant to be a neutral discussion that serves as an introductory dialogue that describes the roles that PBMs are intended to serve. 

PBMs have a variety of primary core functions:

• Prescription adjudication services at pharmacies (see Table 2)
• Formulary management services for health insurance plans (see Table 2)
• Utilization management services for health insurance plans (see Table 2)
• Provide mail order prescription services for health insurance plans 
• Negotiate rebates with drug manufacturers to pass cost savings onto health insurance plans and plan enrollees
• Negotiate discounts with drug manufacturers to pass cost savings onto health insurance plans and plan enrollees 
• Help to reduce waste while improving patient adherence 

For individuals interested in gaining an introductory knowledge about PBMs and what their roles are, there are four resources listed below to help further delve into this topic:

1. Illustration 1: Where PBMs Fit in the Pharmacy Ecosystem
2. Table 1: Tertiary Resources to Utilize (Stratified by Bias Type)
3. Table 2: PBM Introductory Terminology
4. Table 3: List of Major United States PBMs

Illustration 1: Where PBMs Fit in the Pharmacy Ecosystem

Image Source: Elizabeth Seeley and Aaron S. Kesselheim, Pharmacy Benefit Managers: Practices, Controversies, and What Lies Ahead (Commonwealth Fund, Mar. 2019). https://doi.org/10.26099/n60j-0886

Illustration 1 is an oversimplified concept map that demonstrates the basics of how a PBM is the intermediary player between drug manufacturers, health insurance plans, and pharmacies. Many other concept maps are available that are increased in complexity and provide a more thorough overview of how funds and services are distributed amongst the players in the map above. 

Table 1: Tertiary Resources to Utilize (Stratified by Bias Type)*

*Not an all-inclusive list

Table 1 describes a sampling of resources to utilize when conducting preliminary research about what a PBM entails. As the topics of PBMs are polarizing in nature due to government and media profiles of them, it is helpful to read through a variety of different resources that are written from varying perspectives. By reading through a combination of neutral, negative, and positive perspectives, a learner can begin to form their own opinions of PBMs based on published evidence. 

Table 2: PBM Introductory Terminology*

*Not an all-inclusive list

There are many terms that are utilized in PBM-related discussions. A bulk of the baseline terms that are utilized are included in Table 2. However, other resources external to Pharmacist Consult describe additional terms that are increased in complexity from what is mentioned above. But, these terms may be outside of the purview of everyday individuals and may be more relevant for healthcare professionals. 

Table 3: List of Major United States PBMs*

*Not an all-inclusive list

There are a plethora of PBMs that operate in the United States. However, the top 4 are listed within Table 3. CVS Caremark, Express Scripts, and OptumRx account for more than 80% of prescription claims in the United States; the top 6 PBMs handle more than 95% of them.  

References:

According to the Centers for Disease Control and Prevention (CDC), it is recommended to get an influenza (flu) vaccine by the end of October every year. 

The CDC goes on to recommend that everyone 6 months of age or older should receive a flu vaccine every season with certain rare exceptions; this has been recommended by CDC and CDC’s Advisory Committee on Immunization Practices (ACIP) since 2010. These exceptions are specific to children less than 6 months of age and individuals that have serious allergies to the flu vaccine or any of its components.

For a listing of all available flu vaccines broken down by category for the 2020-2021 influenza season, reference this resource from the CDC. Flu vaccines are broken down into 4 broad categories: IIV4 (Quadrivalent), IIV3 (Trivalent), RIV4 (Recombinant), and LAIV4 (Live Attenuated). Similarly, this resource shows how the different flu vaccine types are produced. For reference, the four manufacturers that produce flu vaccines in the United States for the 2020-2021 season are Seqirus, GlaxoSmithKline, Sanofi Pasteur, and AstraZeneca. 

There are many flu vaccines available on the market, and certain individuals may have exception(s) to receiving certain flu vaccine type(s). In order to receive an appropriate flu vaccine, see below for a listing of considerations to mind prior to receiving a flu vaccine. 

NOTE: If you are an adult and none of the below categories apply to you, you most likely are able to receive any flu vaccine. However, ask a pharmacist or other healthcare provider for more personalized information. 

Individuals Aged 65+ Years

Unless directed otherwise or if applicable inventory stock is unavailable, it is recommended that individuals aged 65 years or older receive a high-dose flu vaccine or an adjuvanted flu vaccine. The flu vaccines that meet this recommendation are the Fluzone High-Dose Quadrivalent, Fluad, and Fluad Quadrivalent. 

The high-dose flu vaccine contains 4x the amount of inactivated virus that promotes a protective immune response. Alternatively, the adjuvanted flu vaccine can create a stronger immune response to vaccination compared to other flu vaccines. Either one of these vaccine types in this population is appropriate. 

However, any age-appropriate IIV formulation (standard dose or high dose, trivalent or quadrivalent, nonadjuvanted or adjuvanted) or RIV4 is an acceptable option. For one exception, the nasal flu vaccine (FluMist) should be avoided. 

Pregnant Women

It is important for pregnant and postpartum women to receive a flu vaccination as they are seen to be at higher risk for complications from the flu. Any age-appropriate inactivated flu vaccine may be administered via injection to pregnant women, but pregnant women should not receive the nasal flu vaccine (FluMist) as it is a live attenuated vaccine. 

Individuals with Egg Allergies

For the 2020-2021 season, the two flu vaccines that are considered egg-free are Flublok Quadrivalent and Flucelvax Quadrivalent.

Individuals with egg allergies should avoid the following flu vaccines: Afluria Quadrivalent, Fluad Quadrivalent, Fluarix Quadrivalent, FluLaval Quadrivalent, Fluzone Quadrivalent, Fluzone High-Dose Quadrivalent, and FluMist. 

Individuals with Immunocompromising Conditions and/or Take Antiviral Medication(s)

According to ACIP, immunocompromising conditions “[include] but are not limited to persons with congenital and acquired immunodeficiency states, persons who are immunocompromised due to medications, and persons with anatomic and functional asplenia.”

Similarly to pregnant women, any age-appropriate inactivated flu vaccine may be administered via injection to individuals that are immunocompromised, but these individuals should not receive the nasal spray flu vaccine (FluMist) as it is a live attenuated vaccine. This information holds true for individuals who take antiviral medications.

Adults and children with chronic pulmonary (including asthma), cardiovascular, renal, hepatic, neurologic, hematologic, or metabolic disorders (including diabetes)

Any age-appropriate flu vaccine. 

Children Ages 6 Months or Older

Children ages 6 months to 35 months may receive either Afluria, Fluarix, or FluLaval but children otherwise may receive any flu vaccine. Healthy children older than the age of 2 years may alternatively receive the nasal flu vaccine (FluMist). Children less than 6 months of age generally should not be vaccinated for influenza. 

Additionally, some children less than 8 years of age require 2 doses of flu vaccine. However, not all children less than 8 years of age need 2 doses of flu vaccine and many require only 1 dose of flu vaccine per year. As this operates on a case-by-case basis, a child’s healthcare provider can inform a parent if two doses may be needed.

Individuals with a History of Guillain-Barré Syndrome

Guillain-Barré Syndrome, commonly abbreviated GBS, is a neurological disorder by which the immune system attacks nerves in the body outside of the brain and spinal cord. This can lead to muscle weakness or paralysis in rare occasions, but most people eventually recover from GBS (per the NIH). GBS tends to affect 1 in every 100,000 people every year. 

The data on an association between influenza vaccines and GBS varies from season-to-season; the risk of GBS development remains low. However, in individuals that do develop GBS, it is important to be cautious while receiving future vaccines even if a past case of GBS is not thought to be caused by a vaccination.

For specific recommendations, it is imperative to follow the directions of a healthcare professional. Recommendations for this category fall on a case-by-case basis. 

References

The advancement of medical science, and the extent to which healthcare professionals (including pharmacists) can understand and treat medical conditions, depends in large part on reliable clinical trial results and outcomes.

Although the specific participants chosen for clinical trials varies depending on the study type, inclusion and exclusion criteria, and the situational research question at-hand, many clinical trials need healthy volunteers as a subset of study participants. 

The definition of a healthy volunteer varies in the context of a clinical trial. However, an individual without a significant past medical history of certain condition(s) is a considered healthy volunteer. Per the National Institutes of Health (NIH), an official definition of this is described as “someone with no known significant health problems who participates in research to test a new drug, device, or intervention”. 

Of note, a healthy volunteer is sometimes dubbed in the clinical trial world as a healthy participant. These terms are synonymous.

Whenever healthy volunteers are utilized in clinical trials, they are used to compare against a different subset of individuals that have a condition a medication or device is being used to treat. Alternatively, healthy volunteers can be used as a stand-alone group to test for safety and tolerability of a product at-hand.  

For example, let’s say pharmaceutical company XYZ is conducting a phase 1 clinical trial in attempt to get a new drug for depression approved by the United States Food & Drug Administration (FDA). The coordinators of the clinical trial need healthy patients (defined in this case as patients without a diagnosis of depression). To be able to evaluate how the new drug performs in terms of safety tolerability, healthy volunteers are necessary.

FAST FACTS: FAQs about Clinical Studies

As a healthy volunteer in a clinical trial, there is typically no direct health benefit to the volunteer themselves. However, study participation helps adds to the wealth of medical knowledge available across various literary resources and guidances. As an added perk, a number of clinical trials compensate their healthy volunteer participants. 

There are a variety of ways to search for clinical trials that a healthy volunteer may be eligible for. Although not an exhaustive list, below are four possible ways to gain insight about ongoing or recruiting clinical trials that are seeking healthy volunteers as study participants. 

Once an interested individual finds a clinical trial that that they may be eligible for, they can reach out to the clinical trial coordinators to express interest. After interest is expressed, clinical trial coordinators then can screen the interested individual and set up potential next steps to initiate the process. 

NIH Clinical Center

The NIH Clinical Center is a key resource for clinical trial information. This sentiment rings true for obtaining information about deducing which clinical trials are recruiting healthy volunteers. 

Through the NIH Clinical Center, there are three primary avenues to take in order to find opportunities related to this topic. 

The first of the three options is to enroll in the Clinical Research Volunteer Program by calling the NIH at +1 (301) 496-4763 to provide basic demographic and contact information. 

The second of the three options is to visit the Find NIH Clinical Center Trials webpage to independently search for trials that are recruiting healthy volunteers. Whenever an interested individual goes to this webpage, it is recommended to use the keyword ‘healthy’ as a search term. It is acceptable to enroll in the Clinical Research Volunteer Program, aforementioned, while also utilizing this search feature. 

The third of the three options is to visit Clinicaltrials.gov (via NIH/US Library of Medicine) to independently search for clinical trial volunteer opportunities. The process for this follows a similar process to the second option previously described. 

For more information, disclaimers, and answers to frequently asked questions about participating in clinical research, visit http://www.cc.nih.gov/participate.shtml. Also, be sure to read the NIH Privacy Notice. 

Contract Research Organization (CRO) Databases

In short, CROs are entities that work in conjunction with biotechnology/pharmaceutical companies to conduct clinical trials. Specifically, they often conduct many of the day-to-day logistics and nuances of the clinical trial process. By dealing with many of the preparatory and on-site logistic steps, this helps to reduce costs for biotechnology/pharmaceutical companies that are developing the study products. 

Of the logistical functions that CROs perform, one of the common functions can be recruiting clinical trial participants on behalf, or in conjunction with, companies that are developing the products being studied. 

For a list of CROs in the United States, there are many websites that summarize CROs in different locales while concurrently describing the type of research they tend to support. Of the websites available regarding this, one particularly helpful website is ICH GCP. 

For example, a popular CRO in the United States is a company called Medpace. To research clinical opportunities through Medpace, an interested individual would navigate to their website and click on the “Study Volunteers” tab at the top of the page. Once on the page, interested individuals would learn that they can call the Medpace Call Center at +1 (513) 366-3222 to inquire about opportunities. Alternatively, they could fill out a study participant sign-up form online and wait for a Medpace representative to reach out. 

Other CROs tend to follow a similar recruiting process to Medpace. 

Pharmaceutical Company Databases

Although not quite as common of a mechanism compared to options 1 and 2, described above, it is also possible to gain insight about healthy clinical trial volunteer opportunities through investigating a biotechnology/pharmaceutical company’s website or by calling them and speaking to a representative. 

For example, if someone lives in the vicinity of Boston, Massachusetts, United States and wanted to be a clinical trial volunteer for one of the many companies based out of the Greater Boston Metro Area, they could research specific companies available in the local area. Alexion Pharmaceuticals, for instance, is a company in Boston that commonly recruits volunteers for studies related to myasthenia gravis (MG). 

Local Healthcare Institutions 

Hospitals, outpatient clinics, and other healthcare institutions across the United States commonly participate in clinical research and concurrently recruit clinical trial participants. This recruiting process can be done independently by health institutions or it can be in conjunction with a CRO and/or biotechnology/pharmaceutical company. 

To determine if a local healthcare institution in a specific geographic area is participating in clinical research, reach out to that specific institution.

References: 

Disclaimer: this article is a simple summary of documented plans accessible on United States government-based multimedia resources. This article is not taking a political stance on the policies of the former or current US government administrations. 

Politics aside, a new administration every 4 to 8 years in the United States White House often dictates a revamp, or an overhaul, of priorities and strategies for the United States. This year, these new priorities are aiming to further turn vaccines into vaccinations.

The Biden-Harris administration was sworn in on January 20, 2021. During the administration’s first three days in office, 30 executive orders were issued. Of those, 14 related to COVID-19, 5 related to immigration, 4 related to the economy, 3 related to equity, 2 related to the environment, 1 related to ethics, and 1 related to the census. 

Of the 30 executive orders issued, a number had components that directly related to the new administration’s COVID-19 operational vaccination plans. The executive orders that directly relate to the vaccine production, distribution, and administration plans are as follows:

• Executive Order on Organizing and Mobilizing the United States Government to Provide a Unified and Effective Response to Combat COVID-19 and to Provide United States Leadership on Global Health and Security (Link)
• Executive Order on a Sustainable Public Health Supply Chain (Link)
• Executive Order on Ensuring a Data-Driven Response to COVID-19 and Future High-Consequence Public Health Threats (Link)
• Executive Order Ensuring an Equitable Pandemic Response and Recovery (Link)
• Memorandum to Extend Federal Support to Governors’ Use of the National Guard to Respond to COVID-19 and to Increase Reimbursement and Other Assistance Provided to States (Link)

In addition to these executive orders, the administration also released their comprehensive “National Strategy for the COVID-19 Response and Pandemic Preparedness” plan. Access the full 200-page PDF of the national strategy on WhiteHouse.gov. 

This comprehensive plan is structured around 7 distinct overarching goals. Like mentioned above, this plan includes details for COVID-19 vaccinations, but it is not limited to COVID-19 vaccinations. However, the focus of this article is on the vaccination components of the plan. 

Goal 1 is to “restore trust”. Goal 2 is to “mount an effective, safe, and equitable vaccination campaign”. Goal 3 is to “mitigate spread through expanding masking, testing, data, treatment, workforce, and clear public health standards”. Goal 4 is to “expand relief and exercise the Defense Production Act”. Goal 5 is to “safely reopen schools, businesses, and travel”. Goal 6 is to “advance equity, including across racial, ethnic and rural/urban lines”. Lastly, goal 7 focuses on advancing health science and being prepared for a hypothetical future public health threat. 

In accordance with coinciding executive orders, the Biden-Harris administration’s vaccination plans most directly relate to goals 2, 4, and 6 described above.

The plans overall can be informally grouped into three buckets related to distribution and access, production, and education. Those buckets are expanded upon in detail below. 

Vaccine Distribution & Access

Image courtesy of Third Way

Rather than being unique to individual states and territories, COVID-19 vaccine distribution and allocation is now gaining more of a federal sentiment.

One of the many recent executive orders in part established the White House COVID-19 Response Office to help coordinate uniform vaccination efforts across the entirety of the US government. It also restored the White House Directorate on Global Health Security and Biodefense that was previously dissolved. Of note, this White House COVID-19 Response Office will aim to establish channels for dialogue between governors, state public health officials, immunization managers, and local leaders for more proactive communications and rapid responses. 

The duties of the White House COVID-19 Response Office, amongst other tasks, include coordinating a government-wide effort to produce, supply, and distribute personal protective equipment (PPE), vaccines, tests, and other supplies for the COVID-19 response while also coordinating efforts to reduce disparities in the response, care, and treatment of COVID-19.

Similarly, per the White House, “to meet the aggressive vaccination target of 100 million shots by the first 100 days, the federal government will work with states and the private sector to effectively execute an aggressive vaccination strategy, focusing on the immediate actions necessary to convert vaccines into vaccinations, including improving allocation, distribution, administration, tracking, and support to State, local, Tribal and territorial governments.”

To help do this, a variety of different strategies will be used. Most notably:

• Conducting an inventory of available vaccines, supplies, and PPE to assess current stock of supplies to help assess where the biggest needs currently are. This inventory will help drive decisions related to the Strategic National Stockpile (SNS), use of the Defense Production Act, budget requests, government investments, and supply distribution
• Purchasing COVID-19 vaccine doses for the U.S. population by leveraging contract authorities, including the Defense Production Act
• Deploying onsite federal government support to monitor contract manufacturing operations
• Purchasing additional FDA-authorized vaccines by the federal government
• Purchasing and allocating supplies that could cause bottlenecks, including glass vials, stoppers, syringes, needles, and the “fill and finish” capacity to package vaccines into vials
• Utilizing the pharmacy partnership model for long-term care facilities, help develop additional partnerships with pharmacies and other related groups to assist with mass vaccinations of individuals in congregate settings. This includes, but is not limited to, individuals residing in homeless service facilities and correctional/detention facilities 
• Use federal resources to deploy thousands of federal staff, contractors, and volunteers to support state and local volunteer efforts. This will notably include resources from the US Public Health Commissioned Corps, US Department of Veterans Affairs, the Department of Defense (DOD), etc. 
• Provide 100% reimbursement to states for the use of National Guard personnel 
• Establish the White House COVID-19 Health Equity Task Force to help address health inequities related to the pandemic 
• Support ongoing research for pediatric COVID-19 vaccine availability and the effectiveness of COVID-19 vaccines in mutating viral strains
• Support ongoing research and development of future safe and effective vaccine candidates. For example, current vaccine candidates at the forefront of being studied for potential approval are from Janssen (Johnson & Johnson), AstraZeneca, and Novavax. Additional vaccines in the supply chain would help with more vaccines being widely available

Using the strategies described above, the administration is planning on accelerating the pace of vaccination administration by encouraging state and local governments to move through the priority groups more quickly than previously planned. 

To do this, there will be a reduction in federal hold back of doses. Because of this, there will be an updated priority to help ensure more people get first doses of vaccines rather than trying to ensure that highest priority groups get the 2 recommended doses before moving on to the next priority demographic. 

With this updated priority in mind, the administration wants to immediately begin vaccinating essential frontline workers (educators, first responders, grocery store employees, individuals 65+) rather than simply healthcare workers and residents of long-term care facilities. 

Even though this new strategy may draw a concern that vaccines may not be adequately available for 2nd doses, the administration is leaning on the utilization of the Defense Production Act to help ensure adequate vaccine supply. 

A separate, but important, aspect of vaccination acceleration is the physical location to which people can get vaccinated. With more people being targeted for vaccination, more vaccination sites need to become available. Accordingly, federal resources and emergency contracting authorities will be utilized by the federal government to stand up new vaccination sites. The Department of Defense (DOD) will help staff these clinics with the Federal Emergency Management Agency (FEMA) helping with set-up and operations. 

The federal government will also provide capital assets, such as land and buildings, for state use in community vaccination efforts and assistance sourcing, procuring, stockpiling, and shipping supplies directly to sites. It will additionally provide clinical and non-clinical staff needed to support or staff community vaccination centers. The federal government also plans to deploy mobile vaccination clinics to rural and hard-to-access locations. Other governmental agencies will also help with this effort (Department of Veterans Affairs, USDA staff, etc).

Federally Qualified Health Centers (FQHCs) serve more than 30 million patients every year and are described by the HRSA to be “community-based health care providers that receive funds from the HRSA Health Center Program to provide primary care services in underserved areas.” The federal government, via HRSA and the CDC, will help redirect resource allocation so FQHCs can receive additional vaccine supply. This is crucial for health equity and access concerns.

Additionally, in partnership with the federal government, grocery stores and pharmacies will be leaned on more heavily as predominant vaccination sites. This is important as nearly 90% of individuals within the United States live within 5 miles of a pharmacy.

While all of this is happening, the federal government will also aim to track national and state data on performance metrics such as COVID-19 cases, tests, vaccinations, hospital admissions, nursing home capacity, hospital bed capacity, supply chain shortages. The federal government will also help with interoperable data reporting from local and state governments to help ensure that common metrics will be collected, shared, and communicated in real-time so public health interventions can be made in a more timely manner. Accurate and advanced data collection is crucial for allowing a more opportune allocation of vaccines and vaccination supplies when and where they are most needed. 

For more details regarding data tracking, reference the coinciding executive order. 

Importantly, equity in the entire vaccination campaign is being stressed by the administration. Demographic data will be utilized to help identify communities hit hardest by the virus to better support vaccine access for those groups. This notably includes communities of color, immigrant communities, rural communities, and Tribal Nations. New vaccination sites being set up, mentioned previously, are using demographic data as one significant consideration when deciding where to set up new sites. 

The new White House COVID-19 Health Equity Task Force will engage experts of health equity on a regular basis for recommendations for ongoing system enhancements. These recommendations will focus on the equitable allocation of resources, disbursement of pandemic relief funding and culturally-responsive communication, messaging, and sustained engagement of communities of color and other underserved populations.

For more context on the necessity of this task force, please reference Figure 1. 

Figure 1. COVID-19’s Impact on Racial and Ethic Subgroups

Image courtesy of WhiteHouse.gov

For ongoing quality improvement for operational logistics, the COVID-19 Vaccinations Collaborative will be utilized. 

Production Efforts

Image courtesy of Pfizer

According to the administration’s plan, “timely vaccine production depends not only on sufficient supply of biological materials for the vaccine itself but also of appropriate equipment and materials for packaging the vaccine.” Thus, in brief, shortages of any of these materials can slow vaccine manufacturing and availability to the public.

The US plans to leverage contracting authorities, including using the Defense Production Act, to help strengthen the vaccination supply chain for raw materials and equipment and fill vaccination-related supply and distribution gaps. This will be done through purchase agreements, loans, and other similar mechanisms. The administration’s production support plan relies heavily on the utilization of the Defense Production Act to respond to shortfalls in PPE and the acceleration of COVID-19 vaccine manufacturing. 

The federal government will also invest in additional vaccine manufacturing facilities and will do its part to help accelerate vaccine candidate development alongside pharmaceutical companies. 

However, a proper vaccination campaign goes beyond simply vaccine availability. Adequate supplies also need to be available. 

One of the aforementioned executive orders also directed the establishment of a Pandemic Supply Chain Resiliency Strategy. The Pandemic Supply Chain Resiliency Strategy will address onshoring production of COVID-19 and related pandemic and medical supplies, creating a manufacturing base in the United States that can fill the Strategic National Stockpile, helping to avoid a reliance on other countries for medicines and supplies, and allowing the speed and flexibility required to help produce needed supplies and medicines for ongoing COVID-19 outbreaks and future public health crises.

Public Education 

Image courtesy of Al Seib (Los Angeles Times, Getty Images)

The administration announced plans to create education materials in multiple languages to focus on topics such as vaccination information, vaccine hesitancy, masking, and testing. These efforts will span to both the public and private sectors. There is also a significant effort by the administration to strategize a fight against vaccine disinformation and misinformation.

Specifically, public health campaigns will encourage vaccination administration, provide accurate information about vaccines in general, and provide clear direction about how people can get vaccinated. This is all centric to the CDC’s Vaccinate with Confidence campaign. 

There is also going to be a COVID-19 Vaccination Ambassadors Program created in the near future. This program will help to highlight stories and experiences of people who have received the COVID-19 vaccine to help communicate vaccine confidence. There will be a national program created and the CDC will also create a toolkit so local versions of the program can also be created.

However, all of this is simply the current tentative plan. For updates on how the situation progresses, it is crucial to stay up-to-date with Pharmacist Consult updates, CDC updates, and general news updates. 

References: