FDA Approves New Pandemic Influenza Vaccine

The U.S. Food and Drug Administration (FDA) has approved a new vaccine designed to protect against pandemic influenza A (H5N1).

Developed by Seqirus, Audenz is the first-ever adjuvanted, cell-based influenza vaccine designed to protect against H5N1 in the event of a pandemic. It was approved for children aged 6 months or older.

The World Health Organization states that an influenza pandemic occurs when "a new influenza virus emerges and spreads around the world, and most people do not have immunity."

Seqirus notes in a news release that Audenz is designed to be deployed rapidly and can be stockpiled for first responders in the event of pandemic.

The vaccine combines two technologies: MF59 adjuvant and cell-based antigen manufacturing.

The MF59® adjuvant and formulated prefilled syringes used in the Audenz vaccine are produced in a Seqirus production facility built and supported through a public-private partnership between the company and the Biomedical Advanced Research and Development Authority (BARDA). BARDA is part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.

In the Seqirus release, BARDA Director Dr. Rick Bright states, "Pandemic influenza viruses can be deadly and spread rapidly, making production of safe, effective vaccines essential in saving lives. With this licensure – the latest FDA-approved vaccine to prevent H5N1 influenza – we celebrate a decade-long partnership to achieve health security goals set by the National Strategy for Pandemic Influenza and the 2019 Executive Order to speed the availability of influenza vaccine. Ultimately, this latest licensure means we can protect more people in an influenza pandemic."

FDA Approves Duodenoscope With Disposable Endcap From Olympus

The U.S. Food & Drug Administration (FDA) has cleared the Olympus TJF-Q190V, a duodenoscope with a sterile, disposable distal endcap, the company announced.

This is the latest approval of a duodenoscope designed to improve the cleaning and reprocessing of the device, helping to reduce potential device contamination.

To date, the FDA has cleared five duodenoscopes with disposable components that facilitate reprocessing:

• Boston Scientific Corporation, EXALT Model D Single-Use Duodenoscope (fully disposable duodenoscope)

• Fujifilm Corporation, Duodenoscope model ED-580XT (disposable endcap duodenoscope)

• Olympus Medical Systems, Evis Exera III Duodenovideoscope Olympus TJF-Q190V (disposable endcap duodenoscope)

• Pentax Medical, Duodenoscope model ED34-i10T (disposable endcap duodenoscope)

• Pentax Medical, Duodenoscope model ED34-i10T2 (disposable elevator duodenoscope)

As we previously noted, FDA has advised providers to transition away from fixed endcap — and more infection-prone — duodenoscopes and begin using duodenoscopes with disposable components that help with or even eliminate the need for reprocessing.

It is encouraging to finally see the development and approval of these devices. We drew attention to the challenges associated with the cleaning, disinfection and sterilization of duodenoscopes in a 2015 Special Report and recently included "endoscopes testing positive for bacteria after cleaning and disinfection" on our list of "10 of the Scariest Healthcare Infections and Threats."

Coronavirus Guidance and Resources

At the time of this publication, there are 11 cases of confirmed coronavirus in the United States, including a case of human-to-human transmission in Chicago. Despite the significant attention being paid to the coronavirus, we should still be more concerned about the seasonal influenza that is circulating and has claimed more than 10,000 lives, according to the Centers for Disease Control and Prevention (CDC).

Furthermore, many of the precautions healthcare providers should implement for a virus like the new coronavirus are similar to those that should have been in place for the flu as well. Concerning the coronavirus, the CDC released the following statement: "We continue to believe that the immediate health risk from this new virus to the general American public is low."

With that being said, the team at Infection Control Consulting Services (ICCS) is not advising inaction. Rather, non-acute care settings — which are typically not as prepared to respond to a potential case of an illness like the coronavirus — should ensure they are screening at the point of entry and managing the flu season and coronavirus appropriately. You will ultimately need to make decisions regarding preparation as it suits your setting.

Recommendations for Coronavirus Preparation and Response

The following are recommendations worth considering, some of which you have hopefully already instituted:

• As soon as possible, institute enhanced screening of every patient by phone (as is typically done in the outpatient surgery setting) followed by screening upon admission (visitors, too) for elective admissions. Include questions about travel outside the United States, particularly China, and specific signs and symptoms such as a fever, sore throat, cough and runny nose. You do not want such patients in your facility in any event if they're symptomatic for the flu or other respiratory viruses.

• Reschedule if the patient on the phone is suspicious for a respiratory illness. The screening staff should ask patients to let them know by phone if they wake up in the morning with any symptoms of the flu before coming into the facility. Since that may not happen, it is imperative to be prepared if someone arrives at the facility and is exhibiting symptoms.

• If phone screening is not part of your practice, ICCS suggests that at the time of presentation at the front desk, staff should ask the same questions above of every patient and visitors. Front desk staff should have masks available to hand to patients and visitors, if necessary.

• Fully implement a respiratory hygiene program, especially in the waiting room, mandating the donning of a mask to anyone exhibiting symptoms of a respiratory illness and immediate exiting of the facility. Some patients may present in the waiting room despite being telephone screened. Encourage hand hygiene in the waiting room, particularly after use of tissues following wiping a nose, covering a cough, etc.

• There is a reported shortage of medical face masks. While the use of face masks is often warranted (as discussed earlier), and a shortage is quite concerning, at this juncture, staff members walking around in masks for the duration of a shift is impractical compared to placing a patient in a mask until they can leave the facility. However, if any healthcare worker must render care to a patient with a suspicious presentation, even if the patient is wearing a mask, we suggest healthcare workers wear one as well until the patient leaves.

• N95 respirator masks are part of an OSHA/NIOSH respiratory program that is complex and mainly used in the hospitals or extenuating circumstances in other settings. To learn more about what is required to run a respiratory protection OSHA/NIOSH program, click here. 

• To review the interim coronavirus guidance from CDC, which includes screening, click here. (Note: This guidance receives regular updates.)

Coronavirus Assistance

Guidance will continue to evolve, and the team at ICCS will continue to closely monitor the situation. Facilities in need of assistance with coronavirus management or providing PPE and respiratory hygiene training to employees can contact ICCS.