Sunday, May 12, 2024

BioPort gets FDA shipping approval

February 1, 2002

Okemos - The Food and Drug Administration gave the green light Thursday to BioPort Corp. to begin shipping their anthrax vaccine.

Its Spokane, Wash.-based contracted company, Hollister-Stier Laboratories, needed to get approval by the FDA before any shipment could begin.

The nation’s only FDA-licensed producer of the vaccine had its Lansing location, 3500 N. Martin Luther King Jr. Blvd., approved in December.

The FDA also approved three batches of the vaccine for use.

When the facility was purchased from the state in 1998 by BioPort, 2 million existing doses of the vaccine were distributed.

But no more of the vaccine has been approved since.

The FDA found problems with BioPort’s packing and refusal to address safety issues.

For three years, the pharmaceutical company has been working with the FDA to get approval, BioPort President Bob Kramer said.

Both the FDA and BioPort were pressured to complete the process after several outbreaks of the virus had been reported following the Sept. 11 terrorist attacks.

Once the vaccine is distributed, Kramer said he hopes rumors of it causing serious illnesses will be laid to rest.

“It’s clearly been a challenge to correct the misinformation,” he said. “We have been living in a fish bowl.”

The current supplies of the vaccine are committed to the Department of Defense. The military has already given more than 500,000 vaccinations to its troops.

Once the contract with the U.S. military has been filled, Kramer said the company will work toward making the vaccine available to police departments and fire departments.

The vaccination consists of six shots during an 18-month period and a booster shot every year.

To help produce more of the vaccine, the pharmaceutical company has been working to expand its production capacity, Kramer said.

“Our final need is a stockpile for use among the general public,” he said. “And we stand ready to make sure those are available.”

But not everyone says the vaccine is ready to be distributed.

Robin Hawes retired from her position with the Michigan National Guard as a systems analyst after she said she experienced serious illnesses from the vaccination.

Migraine headaches, chronic fatigue and recurring rashes are some of the side effects Hawes said she has received from the vaccination.

Taking eight to 15 pills every day to help relieve the symptoms, Hawes said allowing BioPort to produce the vaccine is a mistake.

“I don’t see where they have improved or corrected the problem,” she said. “I think the focus needs to go to developing another vaccine. There is just too many problems and questions surrounding the BioPort vaccine.”

Hawes said she began receiving the vaccine in September 1998. A year later she started to become sick.

“I will continue to protest it until all of the facts are found,” she said. “It is the only way to fix me.”

But FDA spokeswoman Lenore Gelb said she feels BioPort is ready to begin distribution.

“We have standards for good manufacturing processes, and we keep our companies to those standards,” she said.

There is no question in Kramer’s mind that the company is ready to distribute the vaccine.

“It is an insult to the 220 employees that have worked to get to this point, and it would be an insult to the FDA and Hollister-Stier,” he said.

Discussion

Share and discuss “BioPort gets FDA shipping approval” on social media.

TRENDING