CDC Archives - Medical Design Sourcing

Device strategies to prevent healthcare-associated infections

[Image courtesy of the National Institute of Allergy and Infectious Diseases]

Device design, sterilization before use and proper cleaning of reusable equipment can prevent infections and save lives.

By Ted Eveleth, AvantGuard

Nosocomial infections, also commonly known as healthcare-associated infections (HAIs), are a multibillion-dollar problem and a leading cause of morbidity and mortality around the world. On any given day, about 1 in 31 hospital patients has at least one HAI, according to the Centers for Disease Control and Prevention.

A significant cause for many of these HAIs are medical devices that touch or are implanted in the body, such as surgical implants, catheters and endoscopy devices.

For example, 75% of urinary tract infections in healthcare settings are associated with urinary catheters. Central line-associated bloodstream infection (CLABSI), another category of HAIs associate…

FDA issues new COVID-19 testing guidance to avoid false negatives

New at-home COVID-19 antigen testing guidance recommends repeat testing after a negative result. [Image courtesy of Abbott]

COVID-19 testing should be repeated following a negative result on any antigen test, the FDA said in a move that could increase demand for diagnostics manufacturers.

The latest guidance from the federal health agency is for negative COVID-19 antigen test results regardless of the presence or absence of symptoms. The federal agency said recent studies from people likely infected by the omicron variant shows repeat testing increases the chance of an accurate result, reducing the likelihood of spreading the virus.

“At-home COVID-19 antigen tests detect proteins, called antigens, from the SARS-CoV-2, the virus that causes COVID-19,” the FDA said yesterday. “At-home COVID-19 antigen tests are less likely to detect the SARS-CoV-2 virus than molecular tests, such as polym…

3 critical monkeypox vaccine questions

Scanning electron micrograph of monkeypox virus (orange) on the surface of infected VERO E6 cells (green).[Image courtesy of NIAID]

In the U.S., federal authorities have allowed two vaccines to be used to reduce the risk of monkeypox virus infection. The preferred option is the Jynneos vaccine from Bavarian Nordic (OMX:BAVA), followed by Emergent BioSolutions’ (NYSE:EBS) ACAM2000.

While vaccination efforts are ramping up, California, New York and Illinois have declared states of emergency as the monkeypox virus spreads.

As the monkeypox outbreak continues to gain momentum, here are three questions to keep in mind.

1. How effective are monkeypox vaccines?

CDC notes that the effectiveness of the vaccines is unknown in the current outbreak.

While some media outlets have reported that the smallpox vaccines are 85% effective in protecting against monkeypox, that figure is based on a small stu…

Young children in U.S. now eligible for COVID-19 vaccination

Some 18 months after adults became eligible for COVID-19 vaccines, children between 6 months to 4 years old can now be vaccinated in the U.S.

FDA authorized the shots for young children on June 17, while CDC did so a day later.

“The United States is now the first country in the world to offer safe and effective COVID-19 vaccines for children as young as six months old,” said President Joe Biden in a press briefing. “And for the first time in our fight against this pandemic, nearly every American can now have access to life-saving vaccines.”

Biden noted that the U.S. government had ample supplies of vaccines for young children and had coordinated with states, local health centers, pharmacies and pediatricians to help administer the shots.

“My administration, with the help of the CDC, has been planning and preparing for this moment for a long time,” Biden said.

The federal government has also created a webs…

3 ways to reduce implicit bias in predictive analytics for better health equity

Image courtesy of Arcadia

The COVID-19 pandemic has brought into sharp focus the racioethnic and socioeconomic disparities inherent in the U.S. healthcare system. These disparities take the form of increased adverse health outcomes and reduced quality of life for affected groups.

For example, a study of cities that reported COVID-19 deaths by race and ethnicity found that 34% of deaths were among non-Hispanic Black people. This group accounts for just 12% of the total U.S. population, according to the U.S. Centers for Disease Control and Prevention (CDC), citing “long-standing systemic health and social inequities” among the reasons for the racial and ethnic disparities in COVID-19 deaths.

This heightened awareness around inequities and disparities in healthcare has also resulted in some much-needed attention to similar bias-related problems in the growing sector of healthcare artificial intelligence …

CDC’s ACIP deprioritizes Johnson & Johnson’s COVID-19 vaccine

CDC’s Advisory Committee on Immunization Practices (ACIP) voted 15 to 0 to prioritize the Pfizer-BioNTech and Moderna COVID-19 vaccines over Johnson & Johnson’s.

One of the main reasons for the recommendation is a rare side effect associated with the Johnson & Johnson vaccine that results in low blood clots and blood-platelet levels.

CDC officials revealed that there had been 54 cases of the condition, known as thrombosis with thrombocytopenia syndrome.

FDA temporarily paused the use of the vaccine in April over blood clot concerns.

The J&J vaccine has lagged behind the mRNA-based Pfizer-BioNTech and Moderna vaccines in terms of demand.

To date, U.S. health workers have administered 17 million doses of the Johnson & Johnson vaccine compared to 286 million Pfizer-BioNTech doses and 187 million Moderna doses, according to CDC data.

The J&J vaccine also trails its rivals in terms of vaccine efficacy.

That said…

CDC authorizes fourth COVID-19 vaccine dose for some immunocompromised patients

As a growing number of Americans become eligible for a third dose of COVID-19 vaccines, CDC continues to expand its booster guidelines.

The agency has amended its criteria for moderately to severely immunocompromised people to allow a fourth dose of COVID-19 vaccine six months after receiving the third dose.

The criteria pertain to immunocompromised individuals who are 18 years of age or older who have received three doses of an mRNA vaccine.

CDC will allow COVID-19 vaccines from Pfizer-BioNTech (NYSE:PFE/NSDQ:BNTX), Moderna (NSDQ:MRNA) or Janssen (NYSE:JNJ) for the fourth dose. For Moderna recipients, the guidance recommends a 100-µg dose of mRNA for the third dose and a 50-µg dose for the fourth.

The guidelines, however, are more overt in their recommendations for moderately or severely immunocompromised individuals who have only received two doses of an mRNA vaccine. Assuming at least 28 days have elapsed since the second dose, CDC recommends t…

CDC panel unanimously backs J&J and Moderna vaccine boosters

CDC’s Advisory Committee on Immunization Practices (ACIP) has recommended the Janssen (NYSE:JNJ) COVID-19 vaccine booster at least two months after the initial dose.

The committee also recommended a booster of the Moderna’s (NSDQ:MRNA) COVID-19 vaccine for people 65 and a handful of other demographics. Also eligible for boosters are individuals at least 18 who are immunocompromised and those who have frequent occupational or institutional exposure to SARS-CoV-2.

The recommendation for the Moderna boosters pertains to the 50-µg dose level, which is half the level used in the primary series.

CDC Director Dr. Rochelle Walensky will now decide whether to accept or alter the ACIP recommendations. For the Pfizer-BioNTech booster, Walensky opted to support boosters for a larger segment of people than the ACIP had recommended.

Walensky is likely to issue a final decision in the coming days.

The CDC advisors also recommended allowing Americans to ch…

ACIP votes unanimously backs GSK’s shingles vaccine Shingrix for immunocompromised adults 19 and older

CDC’s Advisory Committee on Immunization Practices (ACIP) unanimously recommended two doses of GlaxoSmithKline’s (NYSE:GSK) Shingrix (a recombinant adjuvanted zoster vaccine) for adults 19 and older with immunodeficiency or immunosuppression as a result of disease or therapy.

CDC considers Shingrix to be an adult vaccine, and its recommendation is for the adult immunization schedule, which begins at the age of 19.

In addition, ACIP was unanimous in backing Merck’s (NYSE:MRK) and Pfizer’s (NYSE:PFE) pneumococcal vaccines in elderly and immunocompromised adults.

ACIP will share the recommendations with the director of the CDC and the US Department of Health and Human Services for review and approval.

Shingrix first won FDA approval in 2017 to prevent shingles in adults aged 50 and older. In July of this year, the agency extended approval to include adults aged 18 and older with an elevated risk of developing shingles as a result of immunodeficiency …

White House reveals plan to vaccinate children aged 5 to 11

Photo by Aaron Kittredge from Pexels

The White House says that vaccination will be readily available and free of charge for children between the ages of five and 11, assuming the FDA and CDC authorize them.

The authorization of a vaccine for that age group would make 28 million additional Americans eligible for vaccination.

Pfizer recently asked FDA to extend emergency use authorization (EUA) to its vaccine, which it jointly developed with BioNTech.

An FDA advisory committee will convene on October 26 to discuss Pfizer’s request to amend the EUA. While some members of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) have signaled concern about the risk of myocarditis linked to mRNA vaccines in children in the past, clinical trial data suggest the vaccines are safe and effective in five- to eleven-year-olds.

The White House said it would begin dispensing shots with…

CDC analysis finds COVID-19 boosters generally elicit mild-to-moderate side effects

Most third doses of mRNA COVID-19 vaccines elicit side effects in line with that of the second dose, according to a CDC report.

The study analyzed immunocompromised recipients of the Pfizer-BioNTech and Moderna COVID-19 vaccine recipients eligible for a third dose.

It pulled data from 22,191 V-safe registrations. V-safe is a CDC-created smartphone-based system for tracking adverse events. Just under one-third (31.8%) of participants reported health impacts, while 28.3% said they could not perform routine daily activities — most often on the day following receipt of the third dose.

Referencing the report at a White House briefing, CDC Director Dr. Rochelle Walensky, concluded “COVID-19 vaccine booster doses so far are well tolerated”

Injection site reactions were slightly more common among the mRNA vaccine recipients than after receiving the second dose. Systemic reactions were somewhat less common post-third dose for both Pfizer-BioNTe…

CDC director recommends boosters for more Americans

CDC Director Dr. Rochelle P. Walensky issued guidelines for COVID-19 boosters, clearing the way for tens of millions of U.S. citizens to obtain a third dose of the Pfizer-BioNTech COVID-19 vaccine.

While FDA and the Advisory Committee on Immunization Practices (ACIP) reached broadly similar conclusions regarding booster doses for seniors and high-risk individuals, Walensky went further. A CDC statement also recommends boosters for people 18 to 49 with underlying medical conditions and people 18 to 64 with a high risk of occupational or institutional exposure.

Dr. Rochelle Walensky

The eligible underlying medical conditions range from having a high body mass index and a history of smoking to HIV and cancer.

Walensky said CDC would review data related to the Moderna and J&J vaccines related to their use as boosters. Both companies have released early data suggesting that boosters of their vac…