FDA Approves Swine Flu Vaccine For October
U.S. Health Secretary Kathleen Sebelius told lawmakers on Tuesday that the Food and Drug Administration approved the new swine flu vaccine and the government is gearing up to start mass vaccinations in October, Reuters reported.
Sebelius told Congress that limited supplies should start trickling out the first week of October – about a week earlier than expected. While about 45 million doses should arrive around Oct. 15, followed by more shipments each week.
The shots will be available at some 90,000 sites such as schools and clinics across the U.S. that state health departments have chosen as best at getting the shots out quickly and efficiently.
Sebelius said eventually they would have enough vaccine available for everyone who wants a shot, adding that the government has ordered 195 million doses but may order more if there’s enough demand.
While a recent Associated Press-GfK poll found that 57 percent of people said they were likely to get the vaccine, typically fewer than 100 million Americans seek flu shots each year, and it’s unclear whether swine flu will create more demand.
However, this year many people will have to line up twice for flu vaccines against regular winter flu and for the H1N1 vaccination.
Experts say the new swine flu seems no more deadly than regular winter flu, which every year kills 36,000 Americans and hospitalizes 200,000. But younger people are sickened more quickly by the H1N1 strain than the people over 65 who are the main victims of seasonal flu.
Therefore, higher-risk people like pregnant women; the young, from age 6 months up through age 24; and people younger than 65 who have flu-risky conditions such as asthma, diabetes or heart disease; caregivers of the at-risk, including newborns; and health workers will be among the first to receive vaccinations.
Sebelius noted that the vast majority of people who get swine flu so far are not terribly ill. She said that most will recover fine at home with some rest and fluids and that they shouldn’t race to doctors’ offices seeking tests to find out what kind of flu they have because both strains are treated in the same manner.
"The flu is the flu is the flu right now," Sebelius said.
Doctors should also refrain from handing out prescriptions for anti-flu medicines to be used to prevent flu, because "it could make them sicker in the long run," she added.
She stressed that the drugs Tamiflu and Relenza should be used for treatment only.
The FDA gave its approval of vaccine made by four of the expected five manufacturers: CSL Ltd. of Australia, Switzerland’s Novartis Vaccines, Sanofi Pasteur of France – which produces flu shots at its Swiftwater, Pa., factory – and Maryland-based MedImmune LLC, which makes the only nasal-spray flu vaccine.
Sebelius said only that a fifth manufacturer’s vaccine would likely be approved soon, pending some final steps. London-based GlaxoSmithKline also was expected to supply vaccine.
FDA licensing is an official government stamp that the vaccine is made properly and meets specific manufacturing and quality standards.
Last week, the National Institutes of Health announced studies showing that one dose appears to protect adults – and that protection kicks in just eight to 10 days after the shot, faster than scientists had predicted.
Ongoing studies in children and pregnant women are continuing to settle on the right dose for those populations.
The FDA said the H1N1 vaccine seems just as safe as the long-used regular flu vaccine, since both are made the same way. Some soreness or redness at the injection site and some fever are the only reported side effects from the vaccinations.
Sebelius confirmed that H1N1 vaccines will be free, but some healthcare providers may charge an administration fee. She added that the federal government is set to spend about $1.4 billion for states and hospitals to prepare for the virus.
While October to May is the usual flu season, U.S. officials noted H1N1 cases throughout the summer with an increase from summer camps and now schools.
But people will not be able to get the vaccine for weeks.
Sebelius said in her testimony the fact that vaccines won’t begin distribution until October makes preventing the spread of flu even more critical.
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