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New Anthrax Vaccine for ‘General Public’ in the Works + Smallpox Vax Stockpiles
06-21-2010, 10:30 AM,
New Anthrax Vaccine for ‘General Public’ in the Works + Smallpox Vax Stockpiles
Quote:New anthrax vaccine for ‘General Public’ in the works
June 19, 2010 by supermario

The following article was posted, then removed at the website

Efforts being made to label BioThrax for general use
by Jeffrey Bigongiari on June 17, 2010

Emergent BioSolutions, Inc., has recently sought to modify the label of BioThrax, its anthrax vaccine, for a general use prophylaxis indication, and to obtain a license for a post-exposure prophylaxis indication.

Gary Nabors, vice-president of product development and site operations for Emergent BioSolutions, Inc., told the 8th Annual Biodefense, Vaccines and Therapeutics Conference on June 15 in Washington, D.C., that Emergent BioSolutions, Inc., is also pursuing a strategy of meeting FDA requirements for Emergency Use Authorization for rPA, its so-called “second generation” anthrax vaccine.

The BioThrax label change has been in progress over the last decade, when, according to Nabors, “Our scientists asked two questions; whether or not it actually took six doses of BioThrax to accomplish protection and would it also be able to change the administration method from subcutaneous to intramuscular.”

Trials concluded that the vaccine was just as efficacious without a dose taken after two weeks, leaving a zero to four week and a 6-12-18 month regimen. The trials also showed that intramuscular administration was safer and just as effective as subcutaneous injection.

The label change was filed in June 2005 and accepted by the FDA in December 2008. A second label change was filed in February 2010 after studies revealed that the doses could be administered according to a 0-1-6 month regimen with boosters given every three years.

When asked why the initial approval took three years, Nabors said, “We had a number of Q and A’s with the FDA. They really wanted more safety data which took a lot of time to track down.”

Nabors pointed out that the attempt to obtain a PEP indication for BioThrax was a more intensive process, since animal trials were a requirement.

“There is a considerable amount of risk involved anytime we take core data from animals and apply it to humans,” Nabors said.

The data from clinical trials conducted with rabbits and non-human primates demonstrated that “the induction of toxin-neutralizing antibodies correlates with protection.”

These assays were the “key to bridge immunogenicity results from animal to human.” The Center for Disease Control also validated the modeling results.

Emergent BioSolutions, Inc., found that BioThrax was effective post-exposure when compared to anthrax-infected test subjects given only antibiotics. The FDA has yet to grant BioThrax a license for a PEP indication, but a formal meeting will be held between the FDA and Emergent BioSolutions, Inc., in July. They are expected to agree on an “overall licensing strategy for PEP indication,” according to Nabors.

“The BioThrax PEP program,” Nabors said, “is testing the FDA’s interpretation of the animal rule for licensure of a new anthrax vaccine indication, and may set some precedents.”

With rPA, BioSolutions is seeking to acquire Emergency Use Authorization from the FDA on its path to licensure. EUA is granted for the use, in a declared emergency, of an unapproved medical product to diagnose, treat or prevent serious or life-threatening diseases when there are no approved alternatives. An EUA can be very important to drug companies, as it allows the sponsor to be eligible for procurement contracts.

According to information provided by Nabors, to be licensed, BioSolutions will need to, among a myriad of requirements, undertake “at least one rabbit PEP and one GUP study with at least one consistency lot.” It must also demonstrate “proof of acceptable clinical safety and immunogenicity in at least two consistency lots,” and “provide product data supporting the consistency of its manufacture from at least three consecutive lots.”

The entire process is expected to take at least eight years.
There are no others, there is only us.
06-21-2010, 12:28 PM,
RE: New Anthrax Vaccine for ‘General Public’ in the Works
and in a related bio-terror story.. on that wasn't censored from the same site that originally posted the Anthrax article.

Quote:U.S. stockpile receives smallpox vaccine
by Ted Purlain on June 11, 2010

The first vaccine to be developed for civilian bioterrorism preparedness programs has been delivered to the U.S. stockpile, according to a CQ Healthbeat News report.

Officials with Bavarian Nordic, a Danish biotech company, told CQ Healthbeat News they began shipping their smallpox vaccine, Imvamune, to the Centers for Disease Control and Prevention’s national stockpile.

The stockpile is a reserve of medicines for use in the event of a biological attack on the United States.

The stockpile contains enough of the smallpox vaccine to inoculate an entire population. Officials said, however, that the doses are made from a live replicating virus, called a vaccinia, that can cause severe side effects in a small portion of the population, including those with compromised immune systems, the report stated.

Bavarian Nordic officials said their new vaccine lacks the ability to reproduce in human cells, meaning it can be used by people who normally wouldn’t be eligible.

Bavarian Nordic CEO Anders Hedegaard told CQ Healthbeat News that the success was made possible due to funding from Biomedical Advanced Research and Development Authority and Health and Human Services Department.

John Clerici, a founding principal of the Washington, D.C.-based consulting firm Tiber Creek Partners, said he is also pleased with the progress and said he will be watching as the Obama administration begins a review of biological countermeasures.

“I think it’s a good sign that, hopefully, whatever comes out with this review that’s being conducted, that it doesn’t throw the baby out with the bath water,” Clerici said. “It takes a long time to get an agency up and running and companies that have made the commitment are now beginning to see the fruits of their labor.”

More from, or should I say or maybe

* WMD Prevention and Preparedness Act of 2010 introduced
* Biolab opens in Ukraine
* Biodetection Technologies conference kicks off
* Federal offices receive powder filled envelopes
* New Manhattan Project needed to fight bioterror
* South Korea prepares for bioattack
* Chicago tests CBRN response teams
* Australian researchers pave way for new herpes vaccine
* Anthrax scare in Bootle, England
* NJIT announces new bioterror fighting technology

Interesting how they slipped the herpes vaccine by big pharma marketing plug into their featured stories.
There are no others, there is only us.

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