Swine Flu Vaccine Pushed as Severity Rates High in Studies
By Jason Gale and John Lauerman
May 14 (Bloomberg) -- Sanofi Aventis SA, GlaxoSmithKline Plc and other drugmakers may start plans to make a vaccine for the swine flu virus that health experts say causes higher rates of pneumonia and other complications than the seasonal strain.
Drug regulators and scientists will confer today at the World Health Organization with company officials to consider whether and when to begin the three-to-six-month process of making shots to protect people against swine flu, known as A/H1N1.
Pharmaceutical companies have been waiting for data on the flu’s severity to determine how soon to begin producing an inoculation. A study in the May 11 edition of the journal Science found that 4 of every 1,000 people infected with the bug in Mexico by late April died, and the WHO said the virus “appears to be more contagious” than seasonal flu.
“It’s almost a no-brainer,” Robert Webster, a flu expert at St. Jude Children’s Research Hospital in Memphis, Tennessee, said yesterday in a telephone interview. “It makes sense for vaccine companies to get all their ducks lined up, as it were, to make a vaccine for this new strain.”
The Geneva-based WHO says the virus that has spread to 33 countries may touch off the first flu pandemic since 1968 and is more dangerous than the germs that cause seasonal epidemics, which kill 250,000 to 500,000 people each year. The Science study estimates the virus is as severe as the 1957 Asian flu pandemic strain that caused about 2 million deaths.
The new vaccine would be produced after manufacturers finish making shots for the seasonal strain, Marie-Paule Kieny, director of the WHO’s initiative on vaccine research, said May 6.
Roaring Back
While some experts have said they expect the virus to recede in the Northern Hemisphere until at least October, it may return in a more dangerous form, said William Schaffner, an infectious disease specialist at Vanderbilt University in Nashville, Tennessee, who advises the U.S. Centers for Disease Control and Prevention on flu.
“If you don’t make the vaccine and the virus comes back, even in a moderate form, we will not have prepared at all,” he said yesterday in a telephone interview. “If it comes back in a more virulent form, we in public health would have egg on our face. Making the vaccine has almost no downside, except for the expenditure of money.”
Vaccine Debate
WHO’s teleconference today is scheduled for two hours and will be chaired by David Salisbury, head of the U.K.’s immunization program. After the meeting, a panel of 12 vaccine experts from the WHO, the United Nations’ health agency, and other organizations may make a recommendation on vaccine production to the agency’s Strategic Advisory Group of Experts, or SAGE. SAGE will consider making a recommendation about a vaccine to Margaret Chan, director general of the WHO.
Sarah Alspach, a spokeswoman for London-based Glaxo, declined to comment on research concerning swine flu’s severity.
“We continue to engage in active discussions with WHO, CDC and other public health authorities about how we can assist in the development of a vaccine and we expect to receive the strain when it becomes available,” she said yesterday in an e-mail.
Public health advisers on CDC’s Advisory Committee on Immunization Practices met yesterday to discuss whether pneumonia caused by bacteria called pneumococci is a significant complication of swine flu infection, Schaffner said. They may recommend the U.S. government purchase and stockpile pneumococcal vaccine for use in health-care workers likely to be exposed to swine flu, he said.
Mexico’s Toll
In Mexico, where the outbreak has hit hardest with 60 confirmed deaths among about 2,500 infections, health officials are investigating why some young adults died quickly of swine flu. Most deaths from seasonal influenza occur in patients aged 65 and older, according to the Atlanta-based CDC.
The situation calls for a vaccine, said Samuel Ponce de Leon, director of the Biologics and Reagents Laboratories of Mexico, or Birmex, a state-owned vaccine company.
Ponce de Leon said while Birmex has an agreement to purchase seasonal flu shots from Paris-based Sanofi, he began talking with companies last week that say they can make swine flu vaccine for later this year, when the season returns to the Northern Hemisphere.
“Yes, we need a vaccine,” said Ponce de Leon, who left New York-based Bristol-Myers Squibb Co. in 2007 to lead Birmex. “We feel like we were on the right track, but we never thought this would happen so soon, right here.”
Manon Cox, chief operating officer of Protein Sciences Corp. in Meriden, Connecticut, said she met with Ponce de Leon last week to discuss licensing her company’s technology to Mexico to bolster swine flu vaccine supplies. Using available production facilities in Mexico, Cox estimated closely held Protein Sciences could make as much as 500,000 doses of swine flu vaccine a week, starting in June.
“Mexico has the most substantial experience with this flu and they don’t want to see it again,” said Vanderbilt’s Schaffner. “That sounds prudent.”
To contact the reporter on this story: John Lauerman in Boston at jlauerman@bloomberg.net; Jason Gale in Singapore at j.gale@bloomberg.net.
Last Updated: May 13, 2009 21:20 EDT |
