COVID-19 Alaska Clinical Update
Wednesday, September 22, 2021
Johnson & Johnson announces results of booster shot trial claiming large increase in vaccine efficacy against symptomatic and severe COVID infections
On September 21, Johnson & Johnson (J&J) announced results from their Phase 3 Ensemble 2 study showing that a second shot of the J&J vaccine given 56 days (8 weeks) after the first dose provided 100% vaccine efficacy against severe and critical COVID-19, 75% vaccine efficacy against symptomatic COVID-19 globally, and 94%efficacy against symptomatic COVID-19 in the US. The efficacy against severe disease is based on only 8 cases among the control group and zero among those who received the second dose. The low number of cases yields a large confidence interval (30-100%) and should be interpreted with caution. The press release also says that antibody levels rose “four to six times higher than observed after the single shot.” When the booster shot was given six months after the initial vaccination, antibody levels “increased nine-fold one week after the booster and continued to climb to 12-fold higher four weeks after the booster. All rises were irrespective of age.”
*These results have not gone through peer review and were announced as a press release by the sponsoring pharmaceutical companies. The results might contain errors and report information that has not yet been accepted or endorsed in any way by the scientific or medical community.
Pfizer-BioNTech announce “robust” antibody response following lower-dose COVID mRNA vaccination in children age 5-11 years old
On September 20, Pfizer-BioNTech announced results from a Phase 2/3 trial of 2,268 participants age 5 to 11 years old that measured SARS-CoV-2 antibody levels following a two-dose regimen of the mRNA vaccination authorized for adolescents age 12 and older. In this study, children age 5 to 11 years received a two-dose regimen of 10 µg administered 21 days apart, which was a smaller dose than the 30 µg dose used for people 12 and older. Levels of SARS-CoV-2 neutralizing antibody were measured in the study group and compared to controls who were age 16 to 25 years and received the higher dose vaccination. According to the press release, antibody levels in the children (geometric mean titer 1,197.6; 95% CI 1106.1-1296.6) were noninferior to the antibody levels in the older age group (geometric mean titer 1146.5; 95% CI 1045.5-1257.2), which demonstrates “strong immune response in this cohort of children one month after the second dose,” and the side effect profile was similar among the studied age groups.
*These results have not gone through peer review and were announced as a press release by the sponsoring pharmaceutical companies. The results might contain errors and report information that has not yet been accepted or endorsed in any way by the scientific or medical community.
From June to August 2021, COVID-19 vaccinations could have prevented more than 280,000 COVID-19 hospitalizations and saved the health system more than $5.7 billion
A report by the Kaiser Family Foundation released on September 14 estimated the number and cost of hospitalizations due to COVID-19 that could have been prevented by higher rates of vaccination uptake. The authors took the number of adults older than 18 years hospitalized with COVID-19 from June through August 2021, removed the estimated number of cases that were vaccinated but hospitalized with breakthrough infections (assuming a conservative 14% of hospitalizations were breakthrough), and then adjusted for an estimated vaccine efficacy of 84%, to produce an estimate of the number of preventable hospitalizations if all adults were vaccinated. The cost to the health system was calculated by multiplying the number of preventable hospitalizations by the typical cost of a COVID-19 hospitalization derived from multiple estimates of non-COVID pneumonia admissions. From June through August 2021, the authors estimate that 287,000 hospitalizations were preventable. At an estimated $20,000 per admission, these cases cost the healthcare system $5.7 billion. This cost is likely an understatement because it doesn’t account for outpatient treatment and the cost of a COVID-19 hospitalization is likely higher than the typical cost of a bacterial pneumonia hospitalization.
UK data from January to July 2021 shows that COVID-19 deaths due to vaccine breakthrough infection are very rare
On September 13, the UK Office for National Statistics released a report on deaths due to COVID-19 vaccine breakthrough infections in England. Between January 2 and July 2, 2021, there were 51,281 deaths due to COVID-19 in England with 640 occurring in people who were fully vaccinated, including those who were infected before they were vaccinated. Vaccine breakthrough cases, in which the person’s first positive COVID test occurred more than 14 days after full vaccination, accounted for 256 deaths or 0.5% of all COVID-19 deaths during this time. 13.1% of the breakthrough deaths occurred in people who were immunocompromised compared to 5.4% for other deaths involving COVID-19.
In Phase 1 trial, third dose of Pfizer-BioNTech mRNA COVID vaccine shows increased antibody response
In a NEJM Correspondence to the Editor, researchers shared the early results of a Phase 1 trial evaluating the SARS-CoV-2 antibody response in 23 patients who received a 3rd booster shot of the Pfizer-BioNTech mRNA COVID vaccine. Participants were adults age 18-85 and they received their third dose 7.9-8.8 months after the second dose. Between dose 2 and dose 3, antibody titers in these patients “declined far more rapidly than vaccine efficacy.” When evaluated one month after dose 3, neutralizing antibody titers against wild-type virus increased to more than 5 times as high (in 18-to-55-year-olds) and to more than 7 times as high (in 65-to-85-year-olds) as the titers had been 1 month after the second dose. In addition, the third dose seemed to provoke a broader antibody response that was effective against multiple variant strains. This research was funded by Pfizer and BioNTech.
UK study shows daily contact testing of school contacts was non-inferior to self-isolation for control of COVID-19 transmission, however infection rates overall were low with few school contacts testing positive
Some school districts nationwide are implementing testing programs to try to keep more children in classrooms instead of having to quarantine at home after being exposed to a known COVID-19 case. The strategy, known as “test to stay” or modified quarantine, allows children to stay in school if they remain asymptomatic, participate in daily testing and continue to test negative, and follow other preventive measures. In this study from the UK, from April-June 2021, 201 schools were randomized to either self-isolation of school-based COVID-19 contacts for 10 days (control) or to voluntary daily testing for 7 days with negative contacts remaining at school (intervention). Coprimary outcomes in all students and staff were COVID-19-related school absence and symptomatic PCR-confirmed COVID-19, adjusted for community case rates, to estimate within-school transmission. There were 657 symptomatic PCR-confirmed infections during 7,782,537 days-at-risk (59.1 per 100,000 per week) in the control group and 740 during 8,379,749 days-at-risk (61.8 per 100,000 per week) in the intervention group. Among students and staff, there were 59,422 (1.62%) COVID-19-related absences during 3,659,017 person-school-days in the control group and 51,541 (1.34%) during 3,845,208 person-school-days in the intervention group. Neither the number of COVID-19 cases nor the number of COVID-19-related absences was statistically significant, thus the daily contact testing was found to be non-inferior to self-isolation for COVID-19 contacts in a school setting.
CDC Morbidity and Mortality Weekly Report (MMWR)s:
CDC’s ACIP gives standard recommendation for use of Pfizer-BioNTech COVID-19 mRNA vaccine in persons aged ≥16 years for the prevention of COVID-19
In December 2020, the CDC’s Advisory Committee on Immunization Practices (ACIP) had given an interim recommendation for the use of the Pfizer-BioNTech COVID-19 mRNA vaccine in persons aged ≥16 years for the prevention of COVID-19. During December 14, 2020–September 1, 2021, approximately 211 million doses of Pfizer-BioNTech COVID-19 vaccine were administered in the United States, and on August 23, 2021, the FDA fully approved the Pfizer-BioNTech COVID-19 vaccine, “Comirnaty”, in persons aged ≥16 years. On August 30, the CDC’s ACIP upgraded its interim recommendation to a standard recommendation for use of the Pfizer-BioNTech COVID-19 vaccine in persons aged ≥16 years for the prevention of COVID-19. This vaccine continues to have FDA authorization for emergency use and ACIP interim recommendation for use in adolescents aged 12–15 years, as well as an additional dose in persons aged ≥12 years who are moderately to severely immunocompromised.
Outbreak of Delta variant in federal prison had higher infection rate for unvaccinated persons but transmission rates were high among both unvaccinated and vaccinated persons
In this MMWR, the authors characterize a COVID-19 Delta variant outbreak that occurred in July 2021 in a federal prison in Texas. In the outbreak, 172 of 233 (74%) incarcerated persons in two housing units were infected. The attack rate was significantly higher among unvaccinated versus fully vaccinated persons (39 of 42, 93% versus 129 of 185, 70%). The attack rate was also significantly higher in persons vaccinated ≥4 months before the outbreak (83 of 93; 89%) than among those vaccinated 2 weeks to 2 months before the outbreak (19 of 31; 61%). Four persons were hospitalized, three of whom were unvaccinated, and one person died, who was unvaccinated. Nearly two thirds of staff members in this prison were unvaccinated, and at least nine were infected during this outbreak.
Vaccine efficacy against COVID-19 hospitalization found to be 93% for Moderna, 88% for Pfizer-BioNTech, and 71% for Johnson & Johnson vaccines
In this real-world study of vaccine efficacy (VE) for preventing COVID-19 hospitalization, the authors conducted a case-control analysis among 3,689 adults aged ≥18 years who were hospitalized at 21 U.S. hospitals across 18 states during March 11–August 15, 2021. Patients with immunocompromising conditions were excluded. VE against COVID-19 hospitalizations was higher for the Moderna vaccine (93%; 95% confidence interval 91%–95%) than for the Pfizer-BioNTech vaccine (88%; 95% CI 85%–91%) (p = 0.011); VE for both mRNA vaccines was higher than that for the Janssen vaccine (71%; 95% CI = 56%–81%) (all p<0.001). VE against COVID-19 hospitalization was slightly lower for the 2-dose Pfizer-BioNTech vaccine than the Moderna vaccine, with this difference driven by a decline in VE after 120 days for the Pfizer-BioNTech but not the Moderna vaccine.
In a random sample of recovered COVID-19 patients, one third of participants reported post-acute sequelae 2 months after their positive test result with indications that it may be common among persons who aged ≥40 years, Black, or who had preexisting conditions
To identify trends in post-acute sequelae after COVID-19 infection (PASC), the Long Beach, CA Department of Health and Human Services interviewed a random sample of 366 persons aged ≥18 years who received a positive SARS-CoV-2 test result during April 1–December 10, 2020. One third of the persons interviewed reported having at least one symptom 2 months after their positive test result, with higher odds of sequelae among persons aged 40–54 years, females, and those with preexisting conditions. Black or African American (Black) participants had higher odds of reporting dyspnea and myalgia/arthralgia compared with other racial/ethnic groups. Persons who were aged ≥40 years, female, Black, or who reported known preexisting conditions also reported higher numbers of distinct sequelae. The most common symptoms were fatigue, dyspnea, changes in smell or taste, and myalgias/arthralgias. These results are consistent with other published studies regarding age and female sex, as well as associations between sequelae and preexisting conditions. However, few reports have assessed variations by race/ethnicity, which is important because of existing inequities that might lead to higher risk for SARS-CoV-2 exposure, lower access to care and testing, and differences in the prevalence of preexisting conditions in some racial and ethnic groups.
RECURRENT TOPICS
Providing COVID-19 vaccinations
We recommend that all healthcare providers outreach to their patients who are immunocompromised and are candidates for a third vaccine dose. A third dose of mRNA COVID vaccine is recommended in certain immunocompromised individuals, specifically solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise (active lymphoma/leukemia treatment, stem cell transplant recipient, active treatment with high-dose corticosteroids).
If you are interested in providing the COVID-19 vaccine in your office or clinic, please visit the COVID-19 Vaccination Program Provider Enrollment page. If you have additional questions, please email Matthew Bobo at matthew.bobo@alaska.gov
Monoclonal Antibodies
Monoclonal antibody treatment for COVID-19, REGEN-COV (casirivimab and imdevimab) and Eli Lilly’s bamlanivimab and etesevimab, have been approved to treat mild-moderate COVID-19 and for post-exposure prophylaxis of COVID-19 in individuals age 12 years and older who are at high risk for progression to severe COVID-19. The EUA for Eli Lilly’s monoclonal antibody product was updated on September 16 to include criteria for post-exposure prophylaxis for COVID-19 prevention.
If you are interested in providing monoclonal antibody therapy for COVID-19 in your office or clinic, please refer to this guide from the U.S. DHSS, and then send an email to Coleman Cutchins (coleman.cutchins@alaska.gov) and CJ Kim (cj.kim@alaska.gov) for local assistance.
For the latest recommendations, check out the CDC webpage on Monoclonal Antibodies for High-Risk COVID-19 patients and COVID-19 Monoclonal Antibody Resources for Healthcare Providers.
Ivermectin
On August 26, the CDC issued a Health Advisory about the increase in ivermectin prescriptions during the 2021 summer and an associated rise in the number of calls to poison centers reporting overdoses or adverse effects.
According to the Merck, the drug company that manufactures ivermectin, there is:
- No scientific basis for a potential therapeutic effect against COVID-19 from pre-clinical studies;
- No meaningful evidence for clinical activity or clinical efficacy in patients with COVID-19 disease, and;
- A concerning lack of safety data in the majority of studies.
A Cochrane Review published July 28 concluded, the “reliable evidence does not support the use of ivermectin for treatment or prevention of COVID‐19.” In addition, the FDA has recently created a webpage further explaining why you should not use ivermectin to treat or prevent COVID-19 and the potential harms of taking a veterinary formulation of this mediation. Infectious Disease Society of America (IDSA) guidelines do not recommend ivermectin
Post-acute Sequelae of COVID-19 (PASC)
For the latest recommendations, check out the CDC webpage on Post-COVID-19 Syndrome and Evaluating and Caring for Patients with Post-COVID conditions
Myocarditis
For the latest recommendations, check out the CDC webpage on myocarditis and COVID-19 vaccines
COVID-19 Speakers’ Bureau
Anyone can request a free presentation for a group interested in learning more about the COVID-19 vaccines available in Alaska.
Aside from COVID-19
CDC and ACIP release recommendations for seasonal Influenza vaccination
The 2021-2022 influenza season is expected to arrive late fall through early spring. Routine annual influenza vaccination is recommended for all persons aged ≥6 months who do not have contraindications. Detailed recommendations for influenza vaccination for persons currently infected with COVID-19 are available from CDC.
Influenza vaccine may be administered at the same time as COVID-19 vaccine.
Opioid overdose education and naloxone distribution programs decrease opioid-related mortality
An umbrella review of 87 studies performed by researchers in Canada found that programs focused on overdose education and naloxone distribution were effective at reducing opioid-related mortality. High-concentration intranasal naloxone (>2 mg/mL) was as effective as intramuscular naloxone, but lower-concentration intranasal naloxone was less effective. Evidence was inconclusive about the need for hospital transport after overdose reversal.
Benzodiazepine-involved overdose ER visits and deaths increased from 2019 to 2020
A recent MMWR report reviewing data on unintentional and undetermined intent drug overdoses found increases in rates of benzodiazepine overdoses and deaths from 2019 to 2020. Most benzodiazepine deaths involved concomitant opioids, especially fentanyl, but the rate of nonfatal benzodiazepine overdoses not involving opioids also increased. Deaths involving prescription benzodiazepines are much more common than those involving illicit benzodiazepines. The CDC and FDA both discourage co-prescribing of benzodiazepines and opioids.
Upcoming Events/Conferences/Presentations
Application deadline for Northwest Public Health & Primary Care Leadership Institute approaching on October 1, 2021
Applications for the 2022 Northwest Public Health & Primary Care Leadership Institute are due October 1, 2021 and some partial scholarship funds are available. The Leadership Institute is an offering from the Northwest Center for Public Health Practice and the Northwest Regional Primary Care Association. The program builds on the long-standing training programs of our collaborating organizations and is designed to help mid-career public health and primary care professionals become the next generation of leaders in their fields. The 9-month program runs from January - September 2022, and will develop collaborative, adaptable leaders who can work effectively within and across fields to improve community health.
ANTHC Tribal Health Webinar Series
The ANTHC Tribal Health Webinar series occurs on Friday from 12-1pm on Zoom and is open to the public. Here is the upcoming schedule for the fall and the Zoom link.
09/24: Jason Capo, MD and Ben Westley, MD: ANMC Septic Arthritis Guideline
10/01: Michelle Rothoff, MD: TB in Alaska 101
10/08: Rodrick Smith, MD: Diagnosis and Management of Childhood Seizures
10/22: Elisha Brownson, MD: Imaging Decisions in Pediatric Trauma
11/5: Rosalyn Singleton, MD: Respiratory/RSV/COVID Hospitalization trends and future interventions.
11/15: Mary Owen, MD: Tlingit People
11/19: Katie Presser, PharmD: Statewide Antimicrobial Stewardship
Join Zoom Meeting
https://anthc.zoom.us/j/98667611681
Meeting ID: 986 6761 1681
One tap mobile
+16699006833,,98667611681#
Free opioid prescribing education on October 26
On October 26 from 11am-2pm, the Division of Behavioral Health has partnered with Boston University School of Medicine to provide a free opioid prescribing education opportunity. This workshop is intended for physicians, nurse practitioners, registered nurses, physician assistants, nurses, dentists, pharmacists, and allied health professionals who manage acute and chronic pain. SCOPE of Pain is a series of continuing medical education/continuing nursing education activities designed to help you safely and effectively manage patients with acute and/or chronic pain, when appropriate, with opioid analgesics.
- Effective communication skills and the potential risks and benefits of opioids for managing acute and chronic pain
- The assessment of opioid misuse risk and recognition and treatment of opioid use disorder. Helping you safely and effectively manage patients with acute and/or chronic pain, when appropriate, with opioid analgesics
Registration required at scopeofpain.org (select Core curriculum from the top menu, choose Live conferences, select the red button)
Use of Valid Background Check Clearances by Multiple Employers
Providers who have applicants with pending background checks with DHSS BCU may allow individuals to start work prior to the Background Check Program completing their check IF the applicant has documented proof of having a current Alaska DHSS background check (provisional or complete) for another DHSS provider. The applicant must provide their new employer a copy of the final background check eligibility letter for the other provider, and providers are required to maintain a copy of that eligibly document in the employee’s file. Providers who hire employees in this manner MUST provide supervised access to those employees, i.e., to ensure the protection of recipients of services, the provider must maintain a prudent level of awareness of the whereabouts of an individual for whom supervised access is required. Employees working in this way may NOT be the only individual working in a facility or a setting, as another employee must be present to provide the supervised access. The provider’s oversight agency will monitor providers to ensure they are in compliance with these requirements, and providers must submit proof of compliance to those agencies upon request. Questions? Please contact your DHSS oversight division.
CDC Clinical Support: There is a Clinician On-Call Center, a 24-hour hotline with trained CDC clinicians standing by to answer COVID-19 questions. Call 1-800-CDC-INFO (800-232-4636) and ask for the Clinician On-Call Center.
All Alaskans and people who work or live in Alaska who are aged 12 years and older are eligible for vaccination against COVID-19. Appointments can be made at covidvax.alaska.gov.
The most up-to-date, evidence based COVID-19 treatment guidelines can be found at:
IDSA Guidelines on the Treatment and Management of Patient with COVID-19
NIH COVID-19 Treatment Guidelines
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