Phase 1 Study of Potential COVID-19 Vaccine Shows Promise

Positive interim clinical data of the mRNA-1273 vaccine (Moderna, Inc) against the coronavirus disease 2019 (COVID-19) were reported from a phase 1 study led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).

Data are currently available for the 25 µg and 100 µg dose level, ages 18-55 years, after 2 doses at day 43, and at the 250 µg level, ages 18-55 years, after 1 dose at day 29. Dose dependent increases in immunogenicity were seen across the 3 dose levels and between prime and boost within 25 µg and 100 µg levels, according to a Moderna press release.

All participants across the 3 dose levels seroconverted by day 15 after a single dose. At day 43 at the 25 µg dose level, levels of binding antibodies were at the levels seen in convalescent sera, or blood samples from those who have recovered from COVID-19, tested in the same assay. At day 43 at the 100 µg dose, levels of binding antibodies significantly exceeded the levels seen in convalescent sera. Samples are not yet available for remaining participants, according to the press release.

Neutralizing anitbody data are available only for the first 4 participants in each of the 25 µg and 100 µg dose level cohorts, and the mRNA-1273 vaccination elicited neutralizing antibodies in all 8 of these participants, according to the study authors. The levels of neutralizing antibodies shown at day 43 by researchers were at or above levels generally seen in convalescent sera.

mRNA-1273 was safe and well-tolerated, with a sole incidence of a grade 3 adverse event (AE) in the 25 µg and 100 µg dose cohorts reported in a single participant at 100 µg, who experienced grade 3 erythema around the injection site. The most notable AEs were seen at the 250 µg dose level, comprising 3 participants with grade 3 systemic symptoms only following the second dose. No grade 4 AEs or serious AEs have been reported, according to the press release.

Based on the interim phase 1 data, the phase 2 study will be modified to study 2 dose levels, 50 µg and 100 µg, with the aim of selecting a dose for pivotal studies, according to the study authors. Further, Moderna is planning on a dose for a phase 3 study to be between 25 µg and 100 µg, with hopes of beginning trial initiation in July.

“These interim phase 1 data, while early, demonstrate that vaccination with mRNA-1273 elicits an immune response of the magnitude caused by natural infection starting with a dose as low as 25 µg,” said Tal Zaks, MD, PhD, chief medical officer at Moderna, in the press release. “When combined with the success in preventing viral replication in the lungs of a pre-clinical challenge model at a dose that elicited similar levels of neutralizing antibodies, these data substantiate our belief that mRNA-1273 has the potential to prevent COVID-19 disease and advance our ability to select a dose for pivotal trials.”

Moderna Announces Positive Interim Phase 1 Data for its mRNA Vaccine (mRNA-1273) Against Novel Coronavirus [news release]. Cambridge, Mass.; Moderna: May 18, 2020. Accessed May 18, 2020.
NACDS Urges Government to Consider Pharmacies’ Critical Role in COVID-19 Prevention
2020-05-18 20:09:00
Alana Hippensteele, Editor
To support the successful reopening of the country in a manner that prevents further coronavirus disease 2019 (COVID-19) outbreaks, the National Association of Chain Drug Stores (NACDS) has issued a report in which it urges government action on 3 key objectives related to testing, contact tracing, and vaccines or treatments.1

The national organization, which represents 40,000 traditional, grocery, and mass retail pharmacies and employs 155,000 pharmacists, outlines the following operational considerations for the government in its report:1

Maximize rapid COVID-19 testing operations across all platforms and venues.
Support public health surveillance and related contact tracing efforts.
Prepare now to accelerate access to forthcoming COVID-19 vaccines and treatments.

The report explains that in the approach to each of these operational considerations, state and federal governments should strive for uniformity in order to allow private sector partners to seamlessly participate. As some private sector partners operate in multiple states, a state-by-state approach would hinder companies’ abilities to effectively participate in enacting company-wide operational efforts.1

Furthermore, the report emphasizes that community pharmacies must remain a critical component of the COVID-19 response, since they have been able to collaborate with public health officials and inform them of information that remains necessary for state health and economic decisions.1

“As our nation moves forward, we proffer that federal and state governments should enhance engagement with pharmacies across the response continuum from scaling community testing to executing a national pandemic immunization plan,” the NACDS explained in the report.1

Once COVID-19 vaccines and treatments become available, the NACDS explained that retail pharmacies would be able to help vaccinate 80% of the population 7 weeks earlier than would be possible otherwise, according to a study conducted by the CDC. Since 90% of Americans live within 5 miles of a retail pharmacy, the report adds that pharmacies’ accessibility will be incredibly valuable.1

Furthermore, the CDC’s Advisory Committee on Immunization Practices (ACIP) is meeting on June 24, at which time the NACDS recommends that the committee takes action to permit all pharmacists to provide a forthcoming COVID-19 vaccine. The NACDS also outlines further recommendations for the ACIP to consider for a vaccination program that would take place across the country.1

In regard to COVID-19 testing, the NACDS recommended several policy barriers to be removed; the inclusion of pharmacist-provided testing in state Medicaid programs; partnerships among pharmacies, local businesses, and public health officials facilitated by states; and the management of coverage and reimbursement issues that can scale and sustain testing programs.1

Ultimately, the NACDS urged the government to establish a national program that allows private and public partnerships to collaborate in order to provide a single access point for COVID-19 data, which mirrors the recent strategy detailed by NIH officials last week.1

“As states consider recovery plans to safely reopen, we urge them to recognize the tremendous value of pharmacies and remove any remaining barriers and limitations on accessing COVID-19 testing and forthcoming treatment and vaccines,” the NACDS states in the report. “States should deploy pharmacies and pharmacists to their fullest extent to contain and defeat the COVID-19 pandemic and ensure the health of communities and the health of our nation.”1

National Association of Chain Drug Stores (NACDS). Pharmacies: A Vital Partner in Reopening America. NACDS website. Published May 2020. Accessed May 18, 2020.
NACDS - Representing 40,000 pharmacies with 155,000 Pharmacists - Issues New COVID-19 Report on Reopening America [news release]. Washington, DC: National Association of Chain Drug Stores (NACDS); May 15, 2020. Accessed May 18, 2020.
Ripretinib Approved for Fourth-Line Treatment of Advanced Gastrointestinal Stromal Tumors
2020-05-18 18:52:00
Jill Murphy, Assistant Editor
The FDA has approved ripretinib (Qinlock, Deciphera Pharmaceuticals) tablets as a fourth-line treatment for advanced gastrointestinal stromal tumor (GIST), a type of tumor that originates in the gastrointestinal tract.

Ripretinib is indicated for adult patients who have received prior treatment with 3 or more kinase inhibitor therapies, including imatinib, according to an FDA press release.

The approval was based on the results of a clinical trial that enrolled 129 patients with advanced GIST who had received prior treatment with other FDA-approved targeted therapies—imatinib, sunitinib, and regorafenib. The trial compared patients who were randomized to receive placebo to determine whether progression-free survival (PFS) was longer in the ripretinib group compared with the placebo group.

Patients received ripretinib or placebo once per day in 28-day cycles repeated until tumor growth was found or the patient experienced intolerable adverse effects (AEs). After disease progression, patients who were randomized to placebo were given the option of switching to ripretinib.

The PFS rate in patients in the ripretinib group was 6.3 months compared with 1 month for patients in the placebo group, according to the press release.

The most common AEs with ripretinib were alopecia, fatigue, nausea, abdominal pain, constipation, myalgia, diarrhea, decreased appetite, palmar-plantar erythrodysesthesia syndrome, and vomiting. Serious AEs included skin cancer, hypertension, and cardiac dysfunction manifested as ejection fraction decrease.

FDA approves first drug for fourth-line treatment of advanced gastrointestinal stromal tumors. Silver Spring, MD; FDA: May 15, 2020. Accessed May 18, 2020.

NIH Experts Detail Strategic Approach Needed for Development of a COVID-19 Vaccine
2020-05-18 17:33:00
Alana Hippensteele, Editor
A harmonized and collaborative approach to coronavirus disease 2019 (COVID-19) vaccine research and development (R&D) is necessary for a successful outcome, according to a perspective published in Science.  As COVID-19 vaccine development continues in the United States, different vaccine candidates have been presented by the government, industry, and academia for further trials.1

However, the authors note that it is likely that more than 1 effective vaccine approach will be necessary to prevent the global spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the cause of COVID-19. Prevention of the virus will require a strategic approach to vaccine R&D that would allow essential data to be available for multiple vaccine candidates that are being tested in tandem.1

The coauthors of the perspective are Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases (NIAID); Francis Collins, MD, PhD, director of the National Institutes of Health (NIH); Lawrence Corey, MD, professor in the Vaccine and Infectious Disease Division at the Fred Hutchinson Cancer Research Center in Seattle; and John R. Mascola, MD, director of NIAID's Vaccine Research Center.1

The perspective also discusses the importance of defining efficacy for a COVID-19 vaccine. According the authors, the 2 most common endpoints for vaccine efficacy are1:
Protection from infection as defined by seroconversion, which is when an antibody has developed and become detectable in the blood
Prevention of clinically symptomatic disease, especially amelioration of disease severity, including the frequency of disease requiring high-intensity medical care with some assessment of a decrease in hospitalization

Furthermore, these endpoints would require the close evaluation of COVID-19 vaccination in the context of different epidemiological and medical settings, among different age groups, and among underserved minorities.1

The authors noted that immunization efforts have been moving swiftly using different vaccine platforms, such as traditional recombinant protein, replicating and nonreplicating viral vectors, and nucleic acid DNA and mRNA approaches. With each platform comes specific characteristics that provide advantages and limitations. Characteristics to consider include speed and flexibility of manufacture, safety and reactogenicity, the profile of humoral and cellular immunogenicity, durability of immunity, scale and cost of manufacturing, vaccine stability, and cold chain requirements. However, since a single vaccine or vaccine platform is unlikely to meet the global need, a strategic approach that supports testing multiple candidates that use different platforms will be critical.1

In order to support discussion and consensus on vaccine trial designs, rapid data sharing, and collaborations between the public and private sectors, NIH partnered with its sister agencies in the Department of Health and Human Services, including the FDA, CDC, and Biomedical Advanced Research and Development Authority; other US government departments including the Departments of Defense and Veterans Affairs; the European Medicines Agency; and representatives from academia, philanthropic organizations, more than 15 biopharmaceutical companies, and the Foundation for NIH.1

Within these COVID-19 Prevention Networks established under the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program, there is a growing consensus that vaccine trials should either use common independent laboratories or contribute samples and data that allow for the generation of surrogate markers that speed licensure of vaccine candidates, and an overall comparison of their efficacy, the authors note.2

Furthermore, the authors recommend the development of a common institutional review board and a common cross-trial data and safety monitoring board (DSMB) for the establishment of a regulatory framework that would be coordinated throughout the networks. These regulatory agencies would be able to work with the public to assess the efficacy of different approaches.1

Although the focus for these networks and their regulatory agencies are primarily based in the United States, the COVID-19 Prevention Networks also have a global focus. Such a global collaboration will require coordination with the WHO, Coalition for Epidemic Preparedness Innovations, and other global philanthropic partners.1

The authors also emphasize that manufacturing hundreds of millions to billions of doses of vaccines will require use of the vaccine-manufacturing capacity of the entire world. This means that, although new technologies and factories can be developed for production, immediate funding is necessary for biomanufacturing infrastructure that can meet the needs of global vaccine distribution.1

Ultimately, all resources available in the public, private, and philanthropic sectors will need to collaborate strategically in order for the country to return to some semblance of previous normality, according to the authors. The ACTIV public-private partnership and collaborative harmonized efficacy trials are models that will allow this semblance of normality to occur.1


Corey L, Mascola JR, Fauci AS, Collins FS. A strategic approach to COVID-19 vaccine R&D. Science. 2020. doi: 10.1126/science.abc5312.
NIH experts: Coordinated strategy to accelerate COVID-19 vaccine candidates is key [news release]. NIH/National Institute of Allergy and Infectious Diseases; May 11, 2020. Accessed May 15, 2020.
Structuring COVID-19 Protocols for Pharmacies
2020-05-18 16:44:00
Jeffrey S. Baird, Esq, and Bradley W. Howard, Esq
We are facing an unprecedented challenge. Coronavirus disease 2019 (COVID-19) has spread rapidly across the world, affecting workforces, global economies, and individuals.

Although the virus has seemingly turned the world as we know it upside down, good news is on the horizon. Through concerted efforts of social distancing in the United States, it appears that the “curve is flattening” and states are slowly beginning to reopen.

With states reopening, pharmacies need to implement controls that will not only protect the safety and health of their employees, but also their patients. The motivation for a pharmacy to properly reopen is obvious and includes the desire to take care of patients; the desire to take care of employees; the desire to keep its doors open; and the desire to protect itself from plaintiffs’ attorneys who may come out of the woodwork 6 months from now and sue pharmacies for negligence.

The purpose of this article is to provide guidance to pharmacies on structuring an appropriate written protocol that implements necessary controls, including what reliable governmental sources a pharmacy can turn to for COVID-19 guidance, recommended controls for pharmacy employees, and recommended controls for pharmacy patients.

Sources for Structuring Protocols
When structuring a protocol, a pharmacy needs to turn to reliable sources for COVID-19 guidance. One reliable source is the Centers for Diseases Control and Prevention (CDC), which continuously updates its guidelines for pharmacies. The CDC’s published guidelines are available on its website.

The Occupational Safety and Health Administration (OSHA) also has general guidelines and interim guidance for specific work groups and their employees. OSHA’s interim guidance for health care workers is available here. Finally, a pharmacy should consult applicable state governmental agencies for published guidance on how a business may reopen.

Although a pharmacy does not need to incorporate every available guideline, a pharmacy should diligently review and adopt guidelines that fit it the best. Further, a pharmacy should cite within its protocol the source for an incorporated guideline. Citations to a reliable source provide a pharmacy with the argument that it took reasonable steps to protect patients and employees.

Structuring the Protocol: Pharmacy Employees
A pharmacy’s protocol needs to adopt various controls specific to its employees. The protocol should touch on topics such as what personal protective equipment (PPE) the pharmacy requires, how the pharmacy responds to a sick employee, cleaning and disinfecting procedures, and a description of general good hygiene practices employees should adhere to.

The following are some example controls that a pharmacy may incorporate in its protocol:

Required PPE
A pharmacy may mandate the use of face coverings and gloves for all employees. In doing so, a pharmacy should make sure PPE is available to its employees. The protocol should also address the proper disposal, cleaning, and disinfecting of PPE.

Sick Employees
There is no requirement to close a pharmacy if an employee is exhibiting symptoms or tests positive for COVID-19. Under its protocol, a pharmacy should require all employees to notify the pharmacy if they test positive for COVID-19 or are exhibiting symptoms.

Further, a pharmacy should implement procedures on what to do if it receives notice from an employee that they tested positive for, or exhibited symptoms of, COVID-19. For example, a pharmacy should require the employee to self-quarantine for 14 days or until they test negative for COVID-19. A pharmacy may also adopt the CDC’s return to work criteria for health care professionals.

In addition to sick employees, the protocol should outline procedures for the treatment of employees who may have been in close contact with a suspected or positive COVID-19 employee. This may include notifying employees of possible exposure and closely monitoring the employees for symptoms.

Cleaning and Disinfection
Pharmacies should also incorporate regular cleaning and disinfection procedures in their protocol. For example, the protocol could require that employees routinely clean and disinfect frequently touched surfaces or objects. Separate procedures may also touch on how to clean and disinfect a pharmacy if an employee tests positive for COVID-19. The CDC and OSHA have published guidelines on how to properly clean and disinfect workplaces.

Good Hygiene Practices for Employees
Although there is constant chatter about the need to practice good hygiene to help limit exposure to COVID-19, it is still in a pharmacy’s best interest to include these practices in its protocol. The protocol should emphasize the importance of:

Washing hands with soap and water for at least 20 seconds or the use of hand sanitizer.
Avoiding touching the eyes, nose, or mouth.
Covering a cough or sneeze with an elbow or tissue.

Structuring the Protocol: Pharmacy Patients
A pharmacy’s protocol should also implement controls for patients who will enter the pharmacy. Specifically, the protocol should address how an employee should handle sick patients, how to protect high-risk patients, the implementation of communication procedures with prescribing practitioners or with patients, and the implementation of physical controls to encourage social distancing.

Sick Patients
It is inevitable that a pharmacy will encounter a COVID-19 positive patient on its premises; thus, the protocol should address various situations and applicable controls. For example, if a patient is exhibiting COVID-19 symptoms but does not have a diagnosis, then a pharmacy should advise the patient to get tested as soon as possible. Pharmacy employees should also encourage patients to sign up for home prescription delivery if available.

If a patient has a positive diagnosis, then a pharmacy may implement more stringent controls. Such controls may include directing the positive patient to a private, designated area of a pharmacy (or even to the patient’s car). It may also include minimizing contact between patients and staff, and ensuring the employee has proper PPE while interacting with the patient.

After interaction with suspected or confirmed COVID-19 patients, a pharmacy should require employees to properly clean and sanitize themselves and any possibly contaminated areas after the interaction.

High-Risk Patients
A pharmacy’s protocol should address how to ensure the safety and health of its high-risk patients. Such controls include posting signs on doors encouraging patients to return to their vehicles and call the pharmacy for services or use the drive-thru window. A pharmacy can also send notices to patients either by mail, telephone, or text messaging to inform patients of their options.

Communication Procedures
A pharmacy should work with physicians and hospitals to set up a COVID-19 positive patient notification system. Such a system could be set up to help a pharmacy prepare for a patient needing a prescription.

For example, proper notification could prepare a pharmacy to have patients receive their prescriptions via a drive-through window, curbside pickup, or home delivery. This will help limit exposure to employees and other patients. A pharmacy could also work with prescribers to submit prescription orders via telephone or electronically rather than through traditional paper prescriptions. A pharmacy should incorporate all communication procedures into its protocol.

Physical Controls
Physical controls also play a vital role in a pharmacy’s protocol. The goal in implementing physical controls is to promote social distancing and minimizing the risk of exposure between patients and employees. Physical controls include:

Installation of sneeze guards at pharmacy counters.
Discontinued use of magazines or other shared items in pharmacy waiting areas.
Closure of self-serve blood pressure units.
Limiting the total number of patients inside the pharmacy’s premises to prevent crowding.
Placement of markers 6 feet apart on the floor for patients waiting in line for service.
Requiring face coverings for anyone entering a pharmacy.
Placement of hand sanitizing stations throughout a pharmacy.

Jeffrey S. Baird, JD, is Chairman of the Health Care Group at Brown & Fortunato, PC, a law firm with a national health care practice based in Texas. He represents pharmacies, infusion companies, HME companies and other health care providers throughout the United States. Mr. Baird is Board Certified in Health Law by the Texas Board of Legal Specialization, and can be reached at (806) 345-6320 or [email protected].

Bradley W. Howard, JD, is Chairman of the Labor and Employment Law Group and a health care attorney at Brown & Fortunato, PC and works with numerous health care clients, handling governmental investigations, business disputes, and litigation involving health care providers including pharmacies, DME companies, home health agencies, and hospitals. Mr. Howard is Board Certified in Labor and Employment Law by the Texas Board of Legal Specialization, and can be reached at (806) 345-6310 or [email protected].

Study: Rising Rate of Mental Health Visits Among Youth to Emergency Departments
2020-05-18 15:11:00
Jill Murphy, Assistant Editor
Over the past 10 years, pediatric emergency department (ED) visits for mental health disorders have risen 60% and the rate of visits for deliberate self-harm have increased by 329%, according to a study published by Pediatrics.

Researchers at the Nationwide Children's Hospital looked at the number and reason for mental health-related pediatric ED visits. In addition, they also examined the geographic location of EDs and the overall number of children checking in to each ED.

Previous studies have shown that low pediatric volume EDs and EDs in rural settings are less prepared for all pediatric emergencies, whereas only one-third of rural facilities have pediatric mental health policies or mental health transfer agreements.

Over the study period of 10 years, most visits occurred at non-children's EDs in both metropolitan and non-urban settings. The data are representative of all US emergency departments, among children from 5 to 17 years of age.

The study found that the highest jump in ED visits was among individuals 15 to 17 years of age, which showed a 68% increase. Further, while the rate grew among both males and females, it was more common in girls by 74%.

Visits for substance use disorders rose by 75%, with alcohol-related disorders decreasing by nearly 40% and substance use disorders significantly increasing by more than 150%, according to the study authors. Meanwhile, the rate of visits for deliberate self-harm increased by 329%.

“Examining the characteristics of EDs that children present to was important because outcomes have been shown to be directly linked to the volume and geographic location of the EDs,” said lead study author Charmaine Lo, PhD, MPH, in a press release.

The study authors recommend further research to identify solutions that will better equip all EDs with the tools, personnel, and resources to better manage pediatric cases. One step to improving the quality of care for those being treated for behavioral health conditions, according to the authors, is universal screenings for suicidal ideation.

In addition, telehealth services can also provide an avenue for increasing access to behavioral health specialists who can provide screening, assist with acute interventions, and support connections to continued care within the community, according to the study authors.

“The overall goal of our work is to improve preparedness of EDs for children,” said Rachel Stanley, MD, in a press release. “Large children’s hospitals with psychiatric providers can offer outreach services to these smaller EDs in the form of telehealth. Another solution is more training for emergency physicians and nurses, so they know how to treat and triage children.”

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