AIDS Vaccine Shows Promise for First Time in Thai Study

By Simeon Bennett

(Bloomberg) — An experimental vaccine prevented HIV infections for the first time, a breakthrough that has eluded scientists for a quarter century.

A U.S.-funded study involving more than 16,000 volunteers in Thailand found that a combination of ALVAC, made by Paris- based Sanofi-Aventis SA, and AIDSVAX, from VaxGen Inc., of South San Francisco, cut infections by 31.2 percent in the people who received it compared with those on a placebo, scientists said today in Bangkok. Neither vaccine had stopped the virus that causes AIDS when tested separately in previous studies.

The finding represents a revival in a campaign that appeared to stall just two years ago when use of Merck & Co.’s experimental Ad5 vaccine boosted some people’s chances of infection in a study. The latest result will transform future research, said Mitchell Warren, director of the New York-based AIDS Vaccine Advocacy Coalition.

“Wow,” said Warren, who was not involved in the study, in a telephone interview today. “We are in a new place in the search for an AIDS vaccine. It’s safe to say that the scientific community is caught off-guard.”

The findings don’t mean the vaccine can be delivered worldwide, because of the complexity of the process and the fact that it’s based on old technology, Warren said. Instead they will serve to spur scientists to look for better combinations in more user-friendly regimens with higher success rates, he said.

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FDA Opens the Reportable Food Registry Electronic Portal for Industry

Food facilities now required to report potentially dangerous products

The U.S. Food and Drug Administration has a new way to head off potential cases of foodborne illness – the Reportable Food Registry (RFR), where food industry officials must use to alert the FDA quickly, through an electronic portal when they find their products might sicken or kill people or animals. The requirement, a result of legislation, took effect with the launch of the portal.

Facilities that manufacture, process or hold food for consumption in the United States now must tell the FDA within 24 hours if they find a reasonable probability that an article of food will cause severe health problems or death to a person or an animal.

The reporting requirement applies to all foods and animal feed regulated by the FDA, except infant formula and dietary supplements, which are covered by other regulatory requirements. Some examples of reasons a food may be reportable include bacterial contamination, allergen mislabeling or elevated levels of certain chemical components.

The opening of the RFR electronic portal reflects a fundamental principle of the President’s Food Safety Working Group that “preventing harm to consumers is our first priority.”

“President Obama has pledged to strengthen food safety,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “The opening of the Reportable Food Registry electronic portal represents a significant step toward that pledge.”

“By fostering real-time submission to the FDA of information on food safety hazards, the registry enhances FDA’s ability to act quickly to prevent foodborne illness,” said Michael R. Taylor, senior advisor to the commissioner. “Working with the food industry, we can swiftly remove contaminated products from commerce and keep them out of consumers’ hands.”

The requirements apply to any person who has to submit registration information to the FDA for a food facility that manufactures, processes, packs, or holds food for human or animal consumption in the United States. These people are termed responsible parties.

A responsible party:

  1. Must investigate the cause of the adulteration if the adulteration of food may have originated with the responsible party
  2. Must submit initial information; followed by supplemental reports
  3. Must work with the FDA authorities to follow up as needed

A responsible party is not required to report if it found the problem before the food was shipped, and corrected the problem or destroyed the food.

The agency issued draft guidance on the RFR in June and sought comment. The FDA also held three public workshops across the country in which FDA representatives explained the RFR requirements and how the portal will work. A Federal Register notice was issued today announcing the opening of the RFR electronic portal and the availability of final guidance to assist the food industry in complying with the requirements of the RFR.

For more information:

The RFR Guidance
www.fda.gov/ReportableFoodRegistry