Rachel Lutz

Health care workers responding to Ebola outbreaks, working in Ebola treatment facilities, or working in labs or biosafety facilities should receive Ervebo, the FDA’s first and only approved vaccine for the prevention of the Ebola virus, according to the 

Centers for Disease Control and Prevention (CDC) investigators created their guidelines based on the recommendations of the Advisory Committee on Immunization Practices (ACIP) after the vaccine received US Food and Drug Administration approval on Dec. 19, 2019.

The CDC recommendations also noted that 11 persons infected with Ebola have been treated in the US All of those cases were associated with the 2014-16 outbreak in West Africa, and 8 of those were responding to an outbreak.

Persons who are responding to an Ebola outbreak are among what the CDC is categorizing as the population with the highest risk for potential occupational exposure to the infection. Additionally, health care personnel at any of the US’s 11 federally designated Ebola treatment centers as well as laboratorians and other staff at any of the 8 biosafety level 4 facilities in the U.S. that handle replication-competent Ebola virus are vulnerable. In all, about 900 health care personnel, laboratorians, and staff work at those such facilities.

The CDC said that ACIP will discuss and consider additional populations for vaccine candidacy in the future. However, vaccination of a pregnant women should involve consideration of the patient’s risk for exposure to Ebola. There is no data yet on the Ervebo’s effect on breast milk production, presence in breast milk, or on the breast-fed child.

Additionally, persons with a history of severe allergic reaction should not receive Ervebo, the CDC said. It should also not be taken by persons allergic to rice, as the vaccine contains a rice-derived recombinant human serum albumin.

Further research will be conducted regarding the Ervebo for immunocompromised persons, pregnant women, and children, the CDC said.

Vaccine efficacy was judged to be 100 percent in the initial study for participants who received immediate vaccination. In a follow-up study, the efficacy was again judged to be 100 percent. There were 3 types of joint-related adverse events post-vaccination (vaccine-related arthralgia, severe arthralgia, and vaccine-related arthritis).

The most common adverse reactions to the vaccine were injection site pain, swelling, and redness. Headaches, fever, muscle pain, fatigue, joint pain, nausea, arthritis, rash, and abnormal sweating were also reported.

While Ervebo is not commercially available, the vaccine is made available to US civilians for free through the government according to ACIP recommendations after receipt of request, the CDC said.

Ervebo is administered as a single intramuscular 1 mL dose under the supervision of a physician. The CDC also suggested that the injection site be the deltoid area of the nondominant arm. It is designed to be administered immediately after thawing from frozen (it is frozen for long-term storage).

Following vaccination, a person may still test positive for Ebola glycoprotein. That being said, diagnostic testing for Ebola in a vaccinated person should include nonglycoprotein targets, the CDC recommended.

It is not currently known how long protections from Ervebo last, the CDC noted. The agency also said that vaccination with Ervebo may not protect all persons. Those who are vaccinated should continue to adhere to infection control practices, they said.

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The Ebola vaccine is not commercially available, but can be distributed upon request to the CDC and administered under the supervision of a physician.

Which Health Care Workers Should Receive the Ebola Vaccine Ervebo?

Pooled screening can find more false-negative cases of the novel coronavirus (COVID-19) and is decreased in sensitivity compared to single-sample testing, according to a 

Investigators from Duke University School of Medicine conducted a diagnostic study in order to determine if COVID-19 pool testing was comparable to single-sample testing for different populations. The authors said that as policy makers promote pooled testing as a strategy to increase the number of people tested for COVID-19 during the pandemic, considerations such as decreasing the sensitivity of these tests and increasing the complexity of the testing should be considered. Noting all of this, they developed their COVID19 Pool Tool, an online tool using actual COVID-19 virus copy number data to model how pooled testing compared to traditional testing.

The investigators modeled 3 curves based off the FDA’s Emergency Use Authorized PCR-qualitative tests. From there, their online model was able to show a defined sample size, pool size, positivity rates, and test characteristics. The model also allowed for the comparison between pooled and single-sample testing using actual virus copy number data pulled from preprocedural screening samples as well as outpatient diagnostic samples, the authors explained. Using both sets of data mimics symptomatic and asymptomatic COVID-19 patients.

Their tool also generated random virtual pools with positive samples pulled from virus copy number data which mirrored the expected positive rate, the authors explained. The tool used virus copy numbers combined with user-defined test characteristics to predict positive pools and samples that were detected or missed, as well as the sensitivity of pooled and single-sample testing, and the number of tests performed.

There were 74 preprocedural screening sample virus copy numbers and 2,910 outpatient diagnostic sample virus copy numbers used to simulate COVID-19 cases in the tool.

Pooled testing increased the number of false-negative cases per 1,000 cases and decreased the sensitivity of COVID-19 detection, especially for low virus copy number samples and asymptomatic patients, the investigators learned.

“For example, the mean sensitivity of 5-sample pooled testing for detection of asymptomatic patients with a 10% positivity rate in the population was 77.57% (4.40%) vs 92.83% (8.38%) for single-sample testing,” the authors explained.

Additionally, the investigators’ model showed that pooled testing decreased the number of tests needed to screen 1,000 patients, but this effect was reduced by repeat testing to identify cases from positive pools for contact tracing, they said, especially at a high prevalence. They also were able to demonstrate that pooled testing identified more positive patients per 1,000 tests performed by testing more patients, but repeat testing reduced this benefit.

The study authors said that pooled testing is useful for population screening and resource-restricted settings, due to its ability to stretch COVID-19 testing supplies, increase the number of patients tested, and increase the number of cases detected. However, there are drawbacks, including the complicated workflow, lower sensitivity, and the need to repeat tests from positive pools.

Using a sequential, 2-stage pooling may be a way to reduce the burden of retesting from positive large pools, the study authors added.

“This tool offers policy makers an easy to use tool to inform regional and national decision-making about the pros and cons of pooled testing,” the authors concluded.

Regional and national decision-making can be informed by the online model, called the COVID-19 Pool Tool. 

Model Shows Benefits and Drawbacks of COVID-19 Pool Testing 

High-dose trivalent influenza vaccine did not significantly reduce all-cause mortality or cardiac- or pulmonary-related hospitalizations in patients with high-risk cardiovascular disease compared to the standard-dose quadrivalent vaccine, according to a 

. However, influenza vaccination remains strongly recommended for this population.

Investigators from the United States and Canada conducted a randomized clinical trial of more than 5,000 patients throughout 3 influenza seasons in order to determine if either of the vaccines would reduce all-cause mortality or cardiopulmonary hospitalizations in these patients. All of the patients involved had a recent acute myocardial infarction or heart failure hospitalization, plus at least 1 additional risk factor.

“This trial was predicated on the concept that reducing influenza in a high-risk population would lead to reduction in cardiovascular and pulmonary hospitalizations and deaths,” the study authors explained. “High-dose trivalent influenza vaccine, compared with standard-dose trivalent vaccine, had previously reduced laboratory-confirmed influenza, hospitalizations, and serious cardiopulmonary events in medically stable older adults in a large randomized trial.”

The patients were vaccinated for up to 3 influenza seasons between September 2016 and January 2019 around the U.S. and Canada, the study authors said. The participants were randomly assigned to receive a high-dose trivalent vaccine (2,630) or a standard-dose quadrivalent (2,630) vaccine.

Across the 3 influenza seasons, there were 7,154 total vaccinations and 99 percent of the patients completed the trial, the study authors said.

In the high-dose trivalent vaccine group, for 884 patients during the study period, there were 975 primary outcome events, the study authors found, including 883 hospitalizations for cardiovascular or pulmonary causes and 92 deaths from any cause.

They said that in the standard-dose quadrivalent vaccine group, there were 924 primary outcomes (including 846 cardiopulmonary hospitalizations and 78 deaths from any cause) for 837 patients for the study period.

The study authors also noted there were no significant differences observed between treatment groups for the secondary outcomes, related to cardiovascular death or hospitalization in each vaccination season or across all 3 seasons.

Influenza or pneumonia occurred rarely in both treatment groups, the investigators learned, with 10 influenza cases in the high-dose group and 8 in the standard dose group and 47 cases of pneumonia in the high-dose group and 41 cases in the standard-dose group.

The most frequent vaccine-related adverse events were injection site pain, myalgia, and swelling, but the study authors noted the vaccine was generally well-tolerated. These vaccine-related adverse events were more common in the high-dose group, they said. Severe vaccine-related reactions were self-reported by 55 patients (11 in the high-dose group and 44 in the standard-dose group). The study authors said 6 serious adverse events were reported, of which 2 were from the high-dose group and 4 were from the standard-dose group.

“Although this comparative effectiveness trial did not find a significant difference between the 2 vaccine formulations for the end points studied in a high-risk population, the incidence of hospitalization due to influenza was low in both vaccinated groups, and the benefit of either vaccine may be far greater than the incremental benefit of high-dose over standard-dose vaccines for influenza outcomes,” the study authors concluded. “Although these data do not refute the greater efficacy of high-dose vs. standard dose vaccines at reducing influenza among older adults, for the purposes of reducing death or cardiopulmonary hospitalizations in a high-risk cardiovascular population, the high-dose vaccine was not more effective than the standard-dose vaccine.”

Influenza and pneumonia, though rare, occurred at roughly the same rate in both the high-dose and standard-dose vaccine groups. 

Comparing Flu Vaccines for Cardiovascular Patients  

The US Food and Drug Administration (FDA) granted their authorization for a diagnostic home test based on patient samples that detects both the novel coronavirus (COVID-19) and influenza A and B infection, the 

The test comes from Quest Diagnostics and is meant for prescription use for individuals suspected of a respiratory viral infection consistent with COVID-19 symptoms, they added. The appropriate usage for home collection is to be determined by patient’s health care provider, they continued, and at such a time the patient can collect a home sample and ship the sample to a Quest Diagnostics lab for analysis. Instructions for this are included in the kit, the FDA said.

“With the authorization of this test, the FDA is helping to address the ongoing fight against COVID-19 while in the middle of the flu season, which is important for many, including the most vulnerable of Americans,” FDA Commissioner Stephen M. Hahn, MD, said in the statement. “With just one swab or sample, combination tests that are authorized for use with home-collected samples can be used to get answers to Americans faster, in the comfort and relative safety of their home, which allows patients to continue to quarantine while awaiting results. This efficiency can go a long way to providing timely information for those sick with an unknown respiratory ailment.”

Through the week ending Nov. 28, the U.S. Centers for Disease and Prevention (CDC) reports that seasonal flu activity remains 

"lower than usual for this time of year.”

 Surveillance this flu seasonal should be interpreted with caution, they warned, in the wake of the ongoing COVID-19 pandemic, though.

 noted that the flu vaccine is the first step in preventing the flu and can offer some protection against poor pregnancy outcomes. In addition, 

 suggested that having the flu during pregnancy was associated with an increased risk for pregnancy loss and reduced birthweight. 

 examined the different interventions used to vaccinate health care workers against influenza, finding that mandatory vaccination policies were an effective measure in achieving high overall vaccination covers, the study authors said.

“In clinics where policies are infeasible, multifaceted campaigns comprising on-site vaccination, vaccination stands and educational and promotional campaigns as well as incentives should be implemented,” the study authors wrote, adding that the lessons they learned from studying flu vaccine policies could be implemented in future COVID-19 vaccination campaigns.

Authors from the Tulane University School of Medicine in New Orleans 

Journal of the National Medical Association

 explaining barriers to “twindemic” vaccination for COVID-19 and the flu.

They noted that African Americans in particular experience a low vaccination uptake due to a variety of factors such as distrust of orthodox medicine, safety concerns, and barriers in the environment to vaccine access. As such, there may be low uptake of a COVID-19 vaccine when one is available—a disease that has disproportionately affected African Americans and other minorities.

“Robust educational campaigns, policy initiatives, and novel approaches to influenza immunization must be considered for the African American community to build trust in the health benefits of the influenza vaccination and, ultimately, to trust in the health benefits of potential SARS-CoV2 vaccines, when available for the general public,” the authors said.

Researchers from Mount Sinai say they are one more step closer to a universal flu vaccine, finding strong results in early stage human clinical trials. “An influenza virus vaccine that results in broad immunity would likely protect against any emerging influenza virus subtype or strain and would significantly enhance our pandemic preparedness, avoiding future problems with influenza pandemics as we see them now with COVID-19” Florian Krammer, PhD, corresponding author of the study, 

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A universal flu vaccine is also another step closer, according to researchers at Mount Sinai.