New Laboratory Test To Detect Human Infections With Avian Influenza A/H5 Viruses

HHS’ Food and Drug Administration (FDA) today announced the approval of a new laboratory test to diagnose H5 strains of influenza in patients suspected to be infected with the virus. The test was developed by another HHS agency, the Centers for Disease Control and Prevention (CDC).

The product approved today is called the Influenza A/H5 (Asian lineage) Virus Real-time RT-PCR Primer and Probe Set. The test provides preliminary results on suspected H5 influenza samples within four hours once a sample arrives at the lab and testing begins. Previous testing technology would require at least two to three days to render results. If the presence of the H5 strain is identified, then further testing is conducted to identify the specific H5 subtype (e.g., H5N1).

“This laboratory test is a major step forward in our ability to more quickly detect cases of H5 avian influenza and provides additional safeguards to protect public health,” HHS Secretary Mike Leavitt said. “Thanks to the expeditious and collaborative efforts of CDC and FDA, the availability of this new test gives us one more tool to keep up with the ever changing nature of influenza viruses.”

Since December 2003, more than 160 human cases of avian flu caused by the H5N1 strain of influenza have been reported in Thailand, China, Vietnam, Cambodia, Indonesia, Turkey and Iraq. More than half of the people infected with the H5N1 virus have died. Nearly all of these cases are believed to have been caused by exposure to infected poultry. The concern is that H5N1 will evolve into a virus capable of human-to-human transmission and lead to an influenza pandemic.

“Preparing for a possible flu pandemic is a top priority for our nation, and FDA acted quickly to evaluate and expedite CDC’s request for approval of this test,” Acting FDA Commissioner Dr. Andrew von Eschenbach said. “Using flexible regulatory authorities, FDA was able to prioritize this expedited approval based on the clear critical need without compromising the quality or integrity of the FDA review process.”

A flu pandemic occurs when a new influenza virus emerges for which people have little or no immunity and for which there is no vaccine. In an influenza pandemic, the disease spreads easily from person to person in a sustained manner, causes serious illness, and can sweep across the country and around the world in very short time. It is difficult to predict when the next influenza pandemic will occur or how severe it will be.

This test will be distributed to Laboratory Response Network (LRN)-designated laboratories to enhance early detection and surveillance activities as well as increase laboratory response capacity associated with a potential pandemic. Domestically the LRN is a system of about 140 labs in all 50 states. LRN labs have special experience and training in molecular testing methods, special bio-safety facilities and containment procedures as well as communication networks connected to public health programs across the country. The testing kits will be distributed by CDC beginning next week. CDC has also shared the test technology with the World Health Organization and its collaborating centers around the world.

“The use of this test by laboratories that are part of the LRN, in conjunction with other laboratory testing and clinical observations, may enable earlier detection of influenza cases caused by this specific virus and allow public health agencies to investigate sources of infection and more quickly respond with control and prevention activities,” said CDC Director Dr. Julie Gerberding.

Information obtained from this test will be used to track cases of illness with this strain of virus. Testing for this virus is indicated when a patient has symptoms of severe respiratory illness and a risk of exposure (e.g., direct contact with sick, dead or infected poultry in a country with outbreaks of influenza H5N1 among poultry).

CDC recommends that testing for influenza A/H5 (Asian lineage) should be considered on a case-by-case basis in consultation with local or state health departments. If a clinician suspects a patient may be infected with an avian influenza virus, they should contact their state or local health department. CDC’s full recommendations are available at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm55e203a1.htm. Further information on the expedited review process used by FDA for this approval can be found at: http://www.fda.gov/oc/opacom/hottopics/avianflu/process.html.

For information on pandemic influenza, state summits and preparedness activities go to http://www.pandemicflu.gov.

Pilot Study to test Mobile phone radiation effect

Research Professor Dariusz Leszczynski said on Friday, a pilot study to be conducted in next week and which expose a small area of skin on volunteers’ arms to cellphone radiation for the duration of a long phone call, or for one hour. Researchers then take a skin sample to study and compare with one taken before the radiation exposure.Leszczynski’s group found evidence of mobile phone radiation causing cell-level changes such as shrinkage, but he said it was still impossible to say if that had significant health effects. The results of the study are due by the end of the year.

Source:

- Reuters Health

 

Vaccine (Streptorix) reduces ear infection in toddlers

Researchers at the University of Defense in Hradec Kralove in the Czech Republic tested a New Vaccine from GlaxoSmithKline Plc, against middle ear infection, or otitis media, reduced cases of the illness by about 30 percent in babies who had been vaccinated in the first six months of life. Roman Prymula et al, in their Phase III trial results Published in Lancet says that a reduction in ear, nose and throat specialist-confirmed episodes of acute otitis media by about a third in infants in the vaccine group compared with controls. The researchers tested the vaccine on nearly 5,000 infants who were either given three doses of the new vaccine — Streptorix — and a booster before 15-months-old or a vaccine for hepatitis A. Children who received the hepatitis vaccine acted as the control group. They reported that the study showed a statistically significant and clinically relevant reduction in episodes of acute otitis media.

Glaxo plans to submit the product for regulatory approval in Europe in 2007.

- Reuters Health

FDA recommendations in developing influenza vaccines.

The Food and Drug Administration (FDA) today issued recommendations to aid manufacturers in developing seasonal and pandemic influenza vaccines. FDA’s goal is to expedite the development and availability of safe and effective vaccines needed to protect against influenza.

“This action illustrates FDA’s high level of commitment and key role in preparing for influenza pandemic, which is a top priority for our nation” said Acting FDA Commissioner Dr. Andrew von Eschenbach.

In two guidance documents released today, one for seasonal, and the other for pandemic influenza vaccines, the FDA provides manufacturers with clear guidance on developing and submitting clinical data to show safety and effectiveness for new vaccines. Consistent with the aims of FDA’s Critical Path Initiative to get products to market more quickly and to advance the development and use of new technologies, these documents outline specific approaches that vaccine developers may follow.

For licensed vaccines, they describe the process for changing rapidly from the currently-licensed seasonal vaccine to a new pandemic vaccine by supplementing the existing license. For new vaccines, they describe defined pathways for both traditional and accelerated approval approaches. Accelerated approval allows for evaluation based on biological indicators (e.g., the immune response to the vaccine) likely to demonstrate effectiveness.

Because these guidances will assist manufacturers in the development and evaluation of seasonal and pandemic influenza, the direction that they provide to new manufacturers, in turn, helps address the increased demand for influenza vaccine. The guidance also helps support and defines steps needed for development and evaluation of vaccines using new technologies (such as cell culture and recombinant manufacturing) and potential approaches to stretching limited pandemic vaccine supplies (such as with the use of ingredients added to a vaccine to improve the immune response it produces, known as adjuvants and different vaccine delivery methods).

The accelerated approval pathway was critical in allowing last year’s rapid approval of a new influenza vaccine, Fluarix, and broke new ground in that it was the first vaccine approved using that approval process.

In issuing this advice, FDA aims to facilitate manufacturers in increasing the number of doses to ensure that enough influenza vaccine is available to vaccinate each person in the at-risk population. Having additional diversity in our vaccine supply helps enhance the capacity to produce more doses of influenza vaccine and contributes to the nation’s pandemic preparedness.

“These guidance documents provide important advice for manufacturers on how to develop needed vaccines more quickly,” said Dr. Jesse Goodman, Director of the Center for Biologics Evaluation and Research, FDA. “FDA is committed to helping companies develop safe and effective vaccines to prevent influenza, including pandemic influenza, and is very engaged with product developers.”

The release of these guidances is part of the comprehensive effort that FDA is undertaking to work with manufacturers to facilitate the development of vaccines. Other examples include a recent CBER advisory committee meeting to discuss novel approaches to develop influenza vaccine such as using cell technology rather than eggs, frequent interactions with vaccine manufacturers to provide both scientific and regulatory guidance, as well as CBER’s preparation of material for testing the potency of new vaccines, which are made available to manufacturers.

A copy of the guidance, “Draft Guidance for Industry, Clinical Data Needed to Support the Licensure of Trivalent Inactivated Influenza Vaccines,” is available at: http://www.fda.gov/cber/gdlns/trifluvac.pdf.

A copy of the guidance, “Draft Guidance for Industry, Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines,” is available at: http://www.fda.gov/cber/gdlns/panfluvac.pdf.

The public has 90 days to comment on the drafts. When finalized, the guidances will represent the FDA’s current thinking on these topics

FDA Approves First Head & Neck Cancer Treatment

The Food and Drug Administration (FDA) today announced the approval of Erbitux (cetuximab) for use in combination with radiation therapy to treat patients with squamous cell cancer of the head and neck (SCCHN) that can not be removed by surgery (unresectable SCCHN). This is the first drug approved for head and neck cancer that has shown a survival benefit in this population. Erbitux was also approved today for use alone (monotherapy) to treat patients whose head and neck cancer has spread (metastasized) despite the use of standard chemotherapy.
“Patients suffering from all forms of cancer have a common goal – to treat the disease and prolong life,” said Steven Galson, MD, Director of FDA’s Center for Drug Evaluation and Research. “We consider this approval an important advance in the treatment of head and neck cancer because it has been shown to help some patients live longer. The approval of Erbitux monotherapy to shrink tumors in patients with metastatic disease who no longer respond to other forms of treatment is also important. Patients need as many effective treatment options as possible.”

Erbitux, which received a priority review, is the first drug approved to treat head and neck cancer since methotrexate became available in the 1950s. Approval of Erbitux in combination with radiation therapy was based on a study that showed it prolonged survival by 20 months compared to treatment with radiation alone. Approval of Erbitux monotherapy was based on evidence of tumor shrinkage in 13 percent of patients, lasting on average of 6 months. Standard cancer statistics databases estimate that there are about 29,000 new cases of head and neck cancer diagnosed every year in the United States.

The safety and effectiveness of Erbitux was established in two studies. The randomized clinical trial of 424 patients using Erbitux in combination with radiation therapy showed a survival time of 49 months versus 29.3 months on radiation therapy alone. In addition, delay in tumor growth was observed with the use of Erbitux and radiation, compared to radiation alone. Since tumor growth is associated with pain, difficulties swallowing, speaking and eating, control of tumor growth as long as possible is important for the patients’ well being. In a second trial of 103 patients with recurrent or metastatic SCCHN, Erbitux helped to shrink the patients’ tumors after the tumors no longer responded to platinum-based therapy, the current standard treatment for patients with this difficult to treat disease.

Commonly reported side effects of Erbitux were infusion reactions (fever, chills), skin rash, fatigue/malaise, nausea. The common side effects associated with radiation such as sore mouth, trouble swallowing, and radiation skin changes were similar in frequency in patients receiving Erbitux plus radiation and those receiving radiation alone.

Erbitux is manufactured by ImClone Systems Inc., Branchburg, NJ and will be distributed and marketed by Bristol-Myers Squibb Co., Princeton, NJ.

 Source:

FDA New Approvals March 1, 2006