H1N1 Flu Vaccine Tests Begin
Swiss drugmaker Novartis has begun injecting its H1N1 (swine) flu vaccine into people in the company’s first human tests, a spokesman said Wednesday.
The vaccine is being tested in a yearlong trial of 6,000 people of all ages in Britain, Germany and the United States, Novartis spokesman Eric Althoff told The Associated Press, adding that the vaccine will likely be on the market before the trial finishes.
A person in Britain became the first to get the swine flu vaccine about 10 days ago, he said.
Sanofi-Pasteur, which makes about 40 percent of the world’s flu vaccines, expects to start testing its swine flu vaccine within days in the U.S. and Europe, according to spokesman Benoit Rungeard. Sanofi-Pasteur is a unit of Paris-based Sanofi-Aventis SA.
Since swine flu was declared to be a pandemic, or global outbreak, by the World Health Organization in June, pharmaceuticals have been racing to get their vaccines ready. Last month, Australian drugmaker CSL became the first vaccine maker to start testing its vaccine in humans in Australia.
“We initiated clinical trials about 10 days ago,” Althoff said.
Half of Novartis’ vaccines being tested are grown in chicken eggs, the traditional way of making flu vaccines, while the other half use a new cell-based technology.
The trial will test the vaccine’s safety and whether one or two shots are necessary.
“Our assumption is that two doses will be required,” Althoff said.
The vaccines being tested in Europe use an adjuvant, an ingredient used to boost the body’s immune response. In the U.S., however, Novartis is only testing vaccines without adjuvants, Althoff said.
WHO recommends that countries use vaccines with adjuvants, to stretch the global supply of swine flu vaccine. However there are no licensed flu vaccines with adjuvants in the United States.
Once Novartis AG has preliminary data from the trial, they will submit that to drug regulators including the European Medicines Agency. European and U.S. regulators have a fast-track process for approving swine flu vaccine, to ensure it is available before the flu season starts in the fall, when swine flu is expected to surge.
The European Medicines Agency has previously said swine flu vaccines based on a pre-approved bird flu vaccine could be licensed within five days, even without extensive testing in humans.
Last month, WHO reported that the swine flu viruses being used to make the vaccine were not growing enough of a key ingredient, and said they were only producing half as much “yield” as regular flu viruses. The agency asked its laboratory network to produce a new set of viruses for vaccine makers to use.
Althoff confirmed that Novartis is only getting about 30 to 50 percent of the usual yield it gets from flu viruses to make vaccines. Novartis made its vaccines with WHO’s original set of flu viruses, and hasn’t yet started working with the new viruses.
The low virus yield could mean delays in when countries get their vaccine orders filled.
More than 35 countries have placed orders with Novartis for swine flu, or H1N1 vaccine, including France, the Netherlands, and Switzerland. The U.S. has ordered $979 million worth of bulk vaccine and Novartis’ adjuvant.
Althoff said the company expected to start shipping vaccine in the last quarter of 2009 and will continue the deliveries next year.
GlaxoSmithKline PLC, which has orders for 291 million doses of vaccine from countries including Britain, has not yet started testing its vaccine in humans. The U.S. has also ordered $250 million worth of vaccine ingredients from Glaxo.
Since swine flu emerged in April, it has killed at least 1,154 people worldwide and is estimated to have infected millions.
In India on Wednesday, hundreds of anxious people crowded a hospital waiting to be tested for swine flu. Panic spread in the city of Pune and fights broke out at the city’s top hospital after authorities reported the country’s first swine flu fatality two days ago.
In other efforts to fight swine flu, a Saudi health ministry official said Wednesday that authorities will require religious pilgrims to have a medical certificate showing they don’t suffer from chronic diseases.
Khaled al-Merghalani also said children and the elderly will be banned from the annual hajj pilgrimage
H1N1 Flu Vaccine Being Offered in Scotland County
The first shipment of the H1N1 flu vaccine arrived in Scotland County last week, and the local health department has sprung into action to inoculate the most needy patients in the community.
Margaret Curry, Administrator of the Scotland County Health Department stated the first batch of H1N1 flu vaccine was received October 13th at the health department.
“This first round was distributed to those healthy 2-4 year olds, health care workers, EMS workers and contacts to infants under six months of age,” she said.
A portion of the initial batch was used for a special clinic held at the Scotland County R-I Elementary School on October 16th.
School Nurse Patty Eggleston reported more than half of the eligible students participated in the voluntary program. A total of 160 students were vaccinated, with the vast majority receiving the nasal spray version of the medication.
“Most of our shipment is Flu Mist, which is given in the nostrils,” Curry stated.
She noted that the Flu Mist can not be used on individuals with history of allergy to eggs, egg proteins, gentamicin, and gelatin or with reaction to previous flu vaccinations, and in children and adolescents receiving aspirin therapy. She added that if a patient has received a seasonal flu vaccine that was flu mist, they can not receive the H1N1 flu mist for 3 to 4 weeks. There is no waiting period between the seasonal and H1N1 otherwise.
“At this time we have a limited supply of injectable vaccine,” Curry stated adding it initially would only be available to the same high-risk patients.
A second vaccination will be administered to the participating students at SCR-I in approximately 30 days to complete the process. Eggleston noted additional availability of the vaccine at that time could allow the program to be expanded to include fifth and sixth graders at the elementary school as well as students throughout the district.
The Clark County School District announced October 19th that it was canceling classes for the remainder of the week after more than 200 students were out of school that Monday due to a flu outbreak.
To offset such risks, in addition to the H1N1 vaccine, the health department is recommending individuals receive a seasonal flu shot.
“This will provide protection against three other flu strains expected to circulate this season,” said Curry.
You can receive your vaccination at the health department’s regular clinic hours on Tuesdays from 12 to 2:30 p.m. and Fridays 8 a.m. to 3:30 p.m.
The health department is anticipating hosting additional clinics when further supplies of the vaccines become available.
For more information contact the Scotland County Health Department at 465-7275.
Missouri residents can call a new toll-free number for information about the H1N1 flu, from symptoms and basic medical advice to the availability of the new H1N1 vaccine.
The number, 1-877-FLU-4141 (1-877-358-4141), will be answered 24 hours a day, seven days a week.
Specialists with the H1N1 InfoLine will answer questions about flu symptoms, when to seek medical care and ways to limit the spread of the flu, including the new vaccine. Medical professionals will be available to assist the specialists with callers’ questions.
The information line is sponsored by the Missouri Department of Health and Senior Services.
“As we get further into flu season, we know many Missourians will have questions about the H1N1 flu,” said Margaret Donnelly, director of the state health department. “We urge Missouri residents to do everything they can to prevent the spread of the flu and keep their families healthy. The Flu InfoLine can help answer questions they might have.”
Health care professionals can also call the toll-free number for more information about the H1N1 flu and vaccine.
The state health department is encouraging Missourians to get the vaccine as it becomes available. Pregnant women, children and young adults are the most at risk of contracting the H1N1 flu, so they will be given priority to receive the vaccine first. Studies show that older people are less at risk because they appear to have some degree of resistance to the virus.
Missouri received its first shipment of aerosol mist vaccine early this month. Additional shipments of the aerosol mist and the injectable form of the vaccine began arriving from drug manufacturers this week.
The mist version of the flu vaccine can be used by healthy children and adults ages 2 through 49. Because it contains live virus, it is not appropriate for pregnant women, children under 2 years old or anyone with an underlying health condition such as asthma. Those groups should receive an H1N1 flu shot.
“Adequate supplies of the flu vaccine will be available for the high-risk groups,” Donnelly said. “As additional shipments of the vaccine arrive in Missouri, flu shots or vaccine mist should be available to everyone who wants them.”
H1N1 flu symptoms include fever, cough and sore throat. Most cases are relatively mild to moderate and do not require treatment. Most people with the H1N1 flu can recover at home. They should get plenty of fluids, take over-the-counter medication to reduce their fever and stay home and rest.