FDA

January 10, 2018

The U.S. Food and Drug Administration is working with the Centers for Disease Control and Prevention (CDC), and state and local authorities in an investigation of an outbreak of Shiga toxin-producing Escherichia coli (E. coli) O157:H7 illnesses. The FDA has also been in contact with Canadian food safety authorities on this outbreak, since cases were first identified in Canada. 

Whole genome sequencing showed that the U.S. and Canadian E. coli O157:H7 strains are closely related, suggesting a common source of illness. Canadian health officials identified romaine lettuce as the likely source of their outbreak. CDC has been working to determine the source of the outbreak in the U.S., and today announced it believes that this outbreak is likely linked to leafy greens. Health officials have not identified a specific type of leafy greens that sick people ate in common.

The known illnesses in the U.S. had illness onsets in late November and early December. This suggests that suspect leafy greens linked to this outbreak are likely no longer in the food supply.

The FDA’s outbreak investigation team is working with CDC and state and local officials to determine what ill people ate, where they bought it, and the distribution chain — all with the goal of reaching where these foods were produced, to see if there’s any common food or point where the food might have become contaminated. At this point, we have not identified a common or single point of origin for the food that made people ill. We want to make sure the information we provide is accurate and when we have information that consumers can use – such as any foods to avoid – we will share it immediately.

FDA Offers Tips about Medical Devices and Hurricane Disasters

General Safety

• Keep your device and supplies clean and dry.
• If you depend on your device to keep you alive, seek emergency services immediately. If possible, notify your local Public Health Authority to request evacuation prior to adverse weather events.
• Always use battery powered flashlights or lanterns rather than gas lights or torches when oxygen is in use (to minimize the risk of fire).
• If your device appears to be damaged, or if you need a back-up device, contact your distributor or device manufacturer.
• Check all power cords and batteries to make sure they are not wet or damaged by water. If electrical circuits and electrical equipment have gotten wet, turn off the power at the main breaker.
• Maintain your device only in a well lit area so you can assess your device’s performance (e.g., refilling your insulin pump, checking your glucose meter).
• Keep your device in as clean and secure location as possible: off the ground, away from animals or crowded areas.
• Always check your device for pests before you use it (e.g., syringes, mechanical devices).

Power Outage

• Notify your electric company and fire department to let them know you have a medical device that needs power (e.g., ventilator, apnea monitor).
• Read your user instructions or call your distributor or device manufacturer to find out if your device can be used with batteries or a generator.
• Locate a generator if possible.
• Make sure you check for water before plugging in your device. Do not plug in a power cord if the cord or the device is wet.
• When the power is restored, check to make sure the settings on your medical device have not changed (often medical devices reset to a default mode when power is interrupted).

Water Contamination

Some medical devices and equipment, such as dialyzers or IV pumps, require safe water in their use, cleaning, and maintenance.

Hurricanes, especially if accompanied by a tidal surge or flooding, can contaminate the public water supply. In the area hit by a hurricane, water treatment plants may not be operating; even if they are, storm damage and flooding can contaminate water lines.

Listen to and follow public announcements about the safety of the municipal water supply.

In an emergency situation, follow these steps to ensure that your water is safe for use with your medical device:

• Use only bottled, boiled, or treated water until your supply is tested and found safe.
• If you use bottled water, be sure it came from a safe source. If you do not know that the water came from a safe source, you should boil or treat it before you use it.
• Boiling water, when practical, is the preferred way to kill harmful bacteria and parasites. Bringing water to a rolling boil for 1 minute will kill most organisms.
• When boiling water is not practical, you can treat water with chlorine tablets, iodine tablets, or unscented household chlorine bleach (5.25% sodium hypochlorite). If you use chlorine tablets or iodine tablets, follow the directions that come with the packaging.
• If you use household chlorine bleach, add 1/8 teaspoon (~0.75 mL) of bleach per gallon of water if the water is clear. For cloudy water, add 1/4 teaspoon (~1.50 mL) of bleach per gallon. Mix the solution thoroughly and let it stand for about 30 minutes before using it.

Note: Treating water with chlorine tablets, iodine tablets, or liquid bleach will not kill parasitic organisms.

Use a bleach solution to rinse water containers before reusing them. Use water storage tanks and other types of containers with caution. For example, fire truck storage tanks and previously used cans or bottles may be contaminated with microbes or chemicals.

For additional information on keeping water safe, see http://www.bt.cdc.gov/disasters/foodwater.asp.

Sterility

• When performing medical procedures, maintain a clean environment by using bleach, alcohol, or a disinfectant in the area you are working (e.g., catheter changes, dressing changes, suctioning).
• Check sterile packaging to make sure it is dry and intact (e.g., sterile gauze). If the packaging is wet or damaged, do not use the product inside.
• When you purchase supplies, always check the packaging to make sure it hasn’t been damaged.

Re-use of Medical Devices

Do not reuse a medical device intended for single use.

If you find that you need additional single use products, contact a healthcare provider or emergency response personnel.

• If you need to reuse a device that is intended for multiple uses (e.g., infusion tubing, syringes), the device must be cleaned and disinfected or sterilized according to the device manufacturer’s instructions. Devices should not be boiled unless explicitly allowed on the product label or instructions for use.
• If you have supplies that are intended for multiple use with your medical device, follow the appropriate procedures for cleaning and disinfecting.
• If you need sterile water for cleaning, disinfecting, or sterilizing your device or its components, follow the above procedures for ensuring that your water is safe.

Dealing with Heat and Humidity

Heat and humidity can have an effect on home diagnostic test kits (including blood glucose tests used by people with diabetes). Test results may not be accurate. Read your owner’s manual to make sure your test kit is performing properly.

To protect your device from heat and humidity, follow the steps below:

• Use a dry cloth to wipe off your device regularly (e.g., mechanical infusion pumps).
• Keep your device out of direct sunlight.
• Enclose your medical products in plastic containers to keep them dry (e.g., wound care supplies).
• Do not use ice if there is a danger of water contamination; use dry ice or instant cold packs to keep your device cool (e.g., prefilled syringes).
• Do not use disposable devices that are wet (e.g., wound dressings, disposable thermometers, tubing).

FDA

Scientists at the U.S. Food and Drug Administration (FDA) have developed an assay that assesses the ability of antibodies to neutralize Ebola virus, using a technique that does not require the use of Ebola virus itself and can be automated for rapid testing of large numbers of samples.

The new FDA assay is important because the effectiveness of most licensed viral vaccines is based on their ability to trigger production of neutralizing antibodies. Therefore, methods for assessing neutralization activity of antibodies will likely be an important component for evaluating the effectiveness of Ebola virus vaccines and identifying correlates of protection (measurable signs of immunity).

The assay is based on a widely used technique called micro-neutralization, which measures the ability of antibodies to prevent viruses from infecting animal cells and reproducing themselves. The greater the neutralization of a virus by antibodies, the fewer the number of viruses are able to infect cells and the less the viruses can replicate themselves by making copies of viral genetic material.

A key attribute of the assay is built upon the use of a genetically modified, non-disease-causing virus called vesicular stomatitis virus (VSV). The modified VSV carries part of the genome from Ebola virus and can substitute for Ebola virus in certain assays—an approach previously used at FDA.

The use of genetically engineered VSV eliminates the need for additional precautions, like a BSL-4 laboratory, because the modified virus is incapable of causing Ebola disease. These laboratories are designed for working with pathogens that pose a high risk of life-threatening disease through aerosol transmission and for which there is no vaccine or treatment. The FDA assay is appropriate for BSL-2 laboratories, which are widely available and do not require the more elaborate containment requirements of BSL-4. The need for BSL-4 laboratories for scientists to work with Ebola virus has complicated the worldwide effort to study the virus and develop and assess the effectiveness of Ebola virus vaccines.

The FDA scientists genetically modified different versions of VSV, so each one carried on its surface one of four variations of a molecule called an envelope glycoprotein (GP) found on different strains of the Ebola virus. Then they used a technique called quantitative polymerase chain reaction to measure the amount of genetic material produced by the hybrid VSV after it had been exposed to commercially available antibodies to Ebola virus. Automating the process should offer an important time advantage to public health scientists during investigations of an outbreak. The assay can determine within 6 to 16 hours if antibodies are effective against the Ebola virus.

The scientists showed that the assay was able to assess whether specific antibodies targeting each GP neutralized the different hybrid VSV variants, preventing the virus from infecting the cells and multiplying. Moreover, the results of the Ebola antibody assays agreed with those obtained by other, more complex assays, now used for such testing. This suggests that the assay will be useful in evaluating the ability of antibodies, triggered either by vaccines or natural infection, to neutralize specific varieties of the virus. Moreover, it might be possible to adapt the assay to assess neutralizing antibodies against other viral pathogens.

Title

Development of a micro-neutralization assay for ebolaviruses using a replication-competent vesicular stomatitis hybrid virus and a quantitative PCR readout

Vaccine 17 April 2017

DOI: 10.1016/j.vaccine.2017.03.019

Authors

Stella S. Lee, Kathryn Phy, Keith Peden ⇑, Li Sheng-Fowler

Laboratory of DNA Viruses, Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, United States

⇑ Corresponding author at: Building 52/72, Room 1220, CBER, FDA, 10903 New Hampshire Avenue, Silver Spring, MD 20993, United States.
E-mail address: keith.peden@fda.hhs.gov (K. Peden).

FDA

Update

August 5, 2016

The FDA has completed the environmental review for a proposed field trial to determine whether the release of Oxitec Ltd.’s genetically engineered (GE) mosquitoes (OX513A) will suppress the local Aedes aegypti mosquito population in the release area at Key Haven, Florida. After considering thousands of public comments, the FDA has published a final environmental assessment (EA) and finding of no significant impact (FONSI) that agrees with the EA’s conclusion that the proposed field trial will not have significant impacts on the environment.

FDA’s finalization of the EA and FONSI does not mean that Oxitec’s GE mosquitos are approved for commercial use. Oxitec is responsible for ensuring all other local, state, and federal requirements are met before conducting the proposed field trial, and, together with its local partner, the Florida Keys Mosquito Control District, to determine whether and when to begin the proposed field trial in Key Haven, Florida.

**  the Zika MAC test is used to gauge recent infection and can detect the virus as early as 4 days after symptoms begin.

FDA approval letter

“….. the Food and Drug Administration (FDA) issue an Emergency Use Authorization (EUA) for emergency use of the Centers for Disease Control and Prevention’s (CDC) Zika Immunoglobulin M (IgM) Antibody Capture Enzyme-Linked Immunosorbent Assay (Zika MAC-ELISA) for the presumptive detection of Zika virusspecific IgM in human sera or cerebrospinal fluid (CSF)……”

FDA

The U.S. Food and Drug Administration today approved a new indication for BioThrax (Anthrax Vaccine Adsorbed) to prevent disease following suspected or confirmed exposure to Bacillus anthracis, the bacterium that causes anthrax disease. The vaccine’s new use is approved for people 18 through 65 years of age in conjunction with recommended antibiotic treatment. BioThrax was initially approved by the FDA in 1970 for the prevention of anthrax disease in persons at high risk of exposure.

Anthrax disease, especially the inhalation form, is often fatal if not promptly treated. Anthrax is considered one of the more likely agents to be used in a biological attack, primarily because its spores are very stable and easy to disperse. Although it is rare, people may contract anthrax disease through natural exposures, such as contact with infected animals or contaminated animal products.

“With today’s approval of BioThrax, we now have a vaccine that can be used, together with antibiotic treatment, to prevent disease after exposure to anthrax spores,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research.

BioThrax is the first vaccine to receive approval based on the Animal Rule. The Animal Rule allows animal efficacy data to be used as a basis for approval when human efficacy studies are not ethical or feasible.

Protective antibody levels, which were determined in rabbit and monkey studies, were used to predict efficacy in humans based on an assessment of the extent of antibody response achieved in human study participants. A 70 percent probability of survival in animal models from inhalational anthrax disease was deemed a reasonable level of protection and likely to provide reasonable benefit in humans.

The ability of BioThrax to increase the probability of survival after stopping post-exposure antibiotic treatment was assessed in rabbits. Rabbits treated with both antibiotics and BioThrax had a survival rate of 70 to 100 percent, depending on the vaccine dose administered. In contrast, in two studies of rabbits that received only antibiotic treatment, survival rates were 44 and 23 percent respectively.

The safety and antibody responses to BioThrax in humans were evaluated in a multi-center study conducted in the United States. Subcutaneous (under the skin) injections were given to 200 healthy adults in three doses at zero, two, and four weeks. The majority of study participants generated antibody responses that correlated to a 70 percent probability of survival that was observed in animal models.

The observed adverse reactions were comparable with those observed when BioThrax is used for pre-exposure disease prevention. The safety profile for BioThrax is well-established, with the majority of localized adverse events reported as tenderness, pain, swelling, and redness at the injection site, as well as limited movement of the injected arm. The most common systemic adverse reactions were muscle aches, headache, and fatigue.

BioThrax is manufactured by Emergent BioDefense Operations Lansing LLC, based in Lansing, Michigan.