Showing posts with label Novartis. Show all posts
Showing posts with label Novartis. Show all posts

Monday, October 26, 2009

Obama Declares Swine Flu a National Emergency


President Barack Obama has declared the H1N1 swine flu a national emergency.

His proclamation, signed Friday night and released by the White House Saturday morning, will allow hospitals and doctors' offices to get legal waivers of federal rules so they can handle large numbers of sick people as the outbreak spreads.

"The H1N1 is moving rapidly, as expected. By the time regions or health-care systems recognize they are becoming overburdened, they need to implement disaster plans quickly," White House spokesman Reid Cherlin said Saturday, according to the Washington Post.

The waivers, which will be issued by U.S. Health and Human Services Secretary Kathleen Sebelius, still require individual requests by the hospitals, Cherlin noted.

The goal, according to the Associated Press, is to remove bureaucratic roadblocks and make it easier for sick people to seek treatment and for medical personnel to provide it immediately. That could mean fewer hurdles involving Medicare, Medicaid or health privacy regulations, the AP added.

The H1N1 swine flu is now widespread in 46 states, and there have been 1,000 laboratory-confirmed deaths since April, according to the latest estimates released Friday by U.S. health officials.

Dr. Thomas R. Frieden, director of the U.S. Centers for Disease Control and Prevention, told a news conference Friday, "We have already had millions of cases of pandemic influenza in the United States, and the numbers continue to increase."

At the same time, he said, production delays continue to hamper distribution of the H1N1 swine flu vaccine.

The vaccine is growing more slowly in egg-based cultures than manufacturers had anticipated, resulting in fewer available doses at this time, Frieden explained.

As of Friday, there were 16.1 million doses on hand nationwide, up from 14.1 on Wednesday, Frieden said. And there will be far fewer than the 40 million doses originally planned for the end of October, he added.

"Vaccine availability is increasing steadily, but far too slowly," Frieden said. "It's frustrating to all of us. We are nowhere near where we thought we would be by now. We are not near where the vaccine manufacturers predicted we would be."

The vaccine that is available comes in both nasal mist and injectable forms. The first doses were only the nasal spray, called FluMist, designed for healthy people 2 to 49 years of age. But now, more than half the doses are injectable, he said.

While children continue to be particularly vulnerable to the disease, Freiden said, "we are seeing it increasingly affect young adults as well as children. We are still not seeing significant numbers of cases among the elderly, and that's characteristic of this virus."

That's also a marked difference from run-of-the-mill seasonal flu, which typically poses a much bigger threat to the elderly.

There is encouraging news, Frieden said. The genetic makeup of the H1N1 virus hasn't changed, meaning the swine flu vaccine and the antiviral drug Tamiflu are a good match.

Frieden said the H1N1 flu would probably occur in waves, but "we can't predict how high, how far or long the wave will go, or when the next will come."

"We are now in the second wave of pandemic influenza and whether this will continue through the fall into the winter, whether it will go away and come back in traditional flu season, only time will tell," he said.


P.S. Boost your resistance against swine flu by eating lots of Vitamin C and Vitamin D rich foods and fruits.



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Friday, October 23, 2009

Novartis Says Most U.S. Swine Flu Shots Ready in 2010


Most of Novartis AG’s swine flu vaccine may not reach the U.S. until the first quarter of 2010, almost at the end of flu season, Chief Executive Officer Daniel Vasella said today in an interview on CNBC.

“I feel compassion for those people who are waiting,” he said.

The Basel, Switzerland, drugmaker is the biggest U.S. supplier of the new vaccine, and U.S. health officials have reported the country’s overall supply will reach 28 million doses by the end of the month after previously projecting 40 million to 50 million by mid-October. H1N1 is widespread in 41 states, has hospitalized more than 5,000 and has caused the deaths of 292 people since Sept. 1, 90 percent of whom were younger than 65, the U.S. Centers for Disease Control and Prevention reported Oct. 20.

Production at Novartis is not being held up now, Vasella said today. The initial problem was the lack of antigen, the key ingredient that induces immunity, he said.

“There was one-fifth of the normal yield,” Vasella said.

Novartis received the first seed strains from the CDC and Geneva-based World Health Organization and was forced to go back and get others, Sarah Coles, a spokeswoman for the company, said in an e-mail.

Half the Yield

All the other vaccine makers with contracts to supply to the U.S. -- Paris-based Sanofi-Aventis SA, London-based GlaxoSmithKline Plc and AstraZeneca Plc, and CSL Ltd. based in Melbourne -- received seed strains at the same time to develop the shots, CDC officials have said. The strains yielded half as much antigen as that for a typical seasonal flu, Aphaluck Bhatiasevi, a WHO spokesman, said Sept. 18.

Novartis is moving swiftly to increase the pace of its output including transferring 300 workers to the swine flu vaccine production lines, Vasella said.

U.S. Health and Human Services Secretary Kathleen Sebelius said yesterday there were “manufacturing glitches” because new production lines were set up to accommodate the swine flu vaccine. Sebelius didn’t specify which companies had the glitches. Novartis is contracted to deliver about 35 percent of the 250 million doses ordered by the U.S. government, according to statements from HHS.

Novartis Statement

“Novartis has taken steps to accelerate the post- production process and delivery of vaccine,” according to a statement from the company released after Vasella’s interview. “Among other things, we have prioritized production of pre- filled syringes despite substantially slower filling rates. Along with the low yields, these efforts have led to delays in vaccine supply.”

Novartis began a large-scale fill-and-finish operation on the swine flu vaccine in early September after completing its seasonal flu campaign, the company said in its statement.

AstraZeneca’s MedImmune Inc., producer of a nasal spray version of the vaccine, was about 300,000 doses behind in its production, Karen Lancaster, a company spokeswoman, said Oct. 20. MedImmune, based in Gaithersburg, Maryland, had shipped at least 6.5 million doses to the U.S. government and planned to send a total of 11 million by the end of October, she said.

Sanofi said it began shipping its vaccine on Sept. 29, “a little bit earlier than anticipated,” and was tracking “pretty much on schedule,” Donna Cary, a spokeswoman, said Oct. 20.

CSL was “on schedule” to delivery its 36 million doses, Sheila Burke, a spokeswoman, said Oct. 20.



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