FDA backs four brands of H1N1 vaccine

FDA backs four brands of

By JUDY SIEGEL-ITZKOVICH
Although the Food and Drug Administration on Wednesday approved the marketing in the US of three new injectible vaccines and one nasal-spray vaccine against H1N1 (swine) flu, the Health Ministry in Jerusalem could not yet say when the first vaccines would arrive here. The brands have been produced and tested by CSL, Novartis and Sanofi Pasteur (injectible) and MedImmune (nasal spray). The FDA said the vaccines "will be distributed in the US after the initial lots become available, which is expected within the next four weeks. Today's approval is good news for our nation's response to the 2009 H1N1 influenza virus," said commissioner of food and drugs Dr. Margaret Hamburg. "This vaccine will help protect individuals from serious illness and death from influenza. All four firms manufacture the H1N1 vaccines using the same processes, which have a long record of producing safe seasonal influenza vaccines," the FDA said. FDA approval came a few weeks earlier than expected. "The H1N1 vaccines approved today undergo the same rigorous FDA manufacturing oversight, product quality testing and lot release procedures that apply to seasonal influenza vaccines," said Dr. Jesse Goodman, the acting chief scientist. According to preliminary data from adults participating in multiple clinical studies, the 2009 H1N1 vaccines "induce a robust immune response in most healthy adults eight to 10 days after a single dose, as occurs with the seasonal influenza vaccine." It had been expected that such protection would be provided only by two shots of vaccine. Clinical studies under way would provide additional information about the optimal dose in children, the FDA said. "The findings are expected in the near future." People with severe or life-threatening allergies to chicken eggs, or to any other substance in the vaccine, should not be vaccinated, it added. Potential side effects include soreness at the injection site, mild fever, body aches, and fatigue for a few days after the inoculation. For the nasal spray vaccine, the most common side effects include runny nose or nasal congestion for all ages, sore throats in adults, and - in children two to six years old - fever. These potential side effects are expected to be similar to those of seasonal flu vaccines. The ministry said that FDA approval "is the opening shot" towards Israeli approval of the vaccines. "Simultaneously, the negotiations between the State of Israel and the various pharmaceutical companies during the final stages" has begun, and "then we will know when the vaccines will arrive in Israel." In any case, the first 430,000 doses of H1N1 vaccine will be offered to high-risk populations, starting with medical staffers, pregnant women, people with chronic illness and weak immune systems, followed by children. A Health Ministry poll a few weeks ago found that 25 percent of the public would agree to be vaccinated against swine flu under any condition. The ministry expects that some people who intend to be vaccinated may wait a few weeks to see how those getting the first shots react. Vaccine against the annual seasonal flu will be offered to their members by the four health funds soon. Clalit Health Services said it would vaccinate against this type of flu starting with the day after Rosh Hashana (already next week). It has ordered a record number of doses for its members - 700,000 - both adults and children. Maccabi Health Services, the second-largest insurer, purchased 340,000 units - 100,000 more than last year - and will begin offering these shots after Rosh Hashana as well. Kupat Holim Meuhedet and Kupat Holim Leumit will wait until after Succot. Clalit said it will also provide free vaccine against the most common type of pneumonia (pneumococcal) to all members up to the age of 65; just one shot offers coverage until pension age. After that, members should receive the vaccine once every five years. The largest health fund said that given concern that the H1N1 and seasonal flu could hit at the same time, it was important to be covered for seasonal flu and pneumococcal pneumonia to reduce the numbers of sick people and the serious of the infection.