Novartis Opens First Vaccine Manufacturing Facility in the U.S.
December 10, 2009
by Dr. Sherri Tenpenny
On November 24, 2009, Novartis officially opened its first, large-scale vaccine manufacturing facility in the U.S. Located in Holly Springs, North Carolina. The project is a collaborative effort between Novartis and the U.S. Department of Health and Human Services, which contributed $457M for the design, construction, and licensing of the facility.
For its part in the deal, Novartis is required to provide two commercial-scale lots of “pre-pandemic” vaccine annually for a minimum of three years. In addition, the government has the right to exercise options to purchase influenza vaccine over the next 17 years. (1) Currently, 191 employees work at the plant but that will increase to 350 persons when fully operational, anticipated to be sometime in 2011. The Holly Springs facility will be able to roll out 150 million flu shots per year.
Even though its use has not been approved by U.S. regulators, the plant will be producing MF59 as early as December 2009.(2) MF59 is Novartis’ proprietary and controversial adjuvant composed of squalene and a surfactant called Tween80, also known as polysorbate 80. Back in July, 2009, the department of HHS purchased over $343.8M of “oil-in-water” adjuvant from Norvartis.(3) It looks like the government may want to take delivery on its purchase some time soon.
All flu shots used in the U.S. are made from eggs, a time- and labor-intensive process. But the new plant will provide something different. Vaccines will be brewed from animal cells mixed with viruses in six 1,320 gallon fermenters which are owned by the U.S. government and the Department of HHS, as identified by a bright yellow, plastic plaque on the sides of the giant vats. (4)
The use of human and animal cells for biological and pharmaceutical research is big business, particularly in Europe. For example, the European Collection of Cell Cultures (ECACC), established in 1984, is an international depository of cell culture collections. The ECACC describes itself as having one of the “premier collections of authenticated cell cultures in the world.” It holds more than 40,000 cell lines representing 45 different species and 50 different tissue types. (5) Many of these lines are used in cancer research; some are specifically made for use with vaccines.
To replicate, influenza viruses need to be mixed with living cells and several types of mammalian cells have been used for this purpose since the 1950s. Examples include calf lymph for smallpox vaccines, African green monkey cells (AGMK cells and VERO cells) for polio vaccines, and mouse brain cells for Japanese encephalitis vaccines. In the 1960s, tissues from aborted human fetal tissue, called MRC-5 and WI-38 cells, were developed and are still used for the manufacture of rubella, hepatitis A, chickenpox, and shingles vaccines. Since 2000, new cells under investigation for making flu shots include cells derived from retinas of aborted fetuses (PER.C6), cells from ovaries of Chinese hamsters, and even cells from insects.
Perhaps even the FDA agrees that a vaccine made from infected caterpillar eggs is just a little too weird. On November 19, an FDA panel voted 6 to 11 against the approval of FluBlok, flu shots made from bugs, citing “lack of safety data” as the reason. Made by Protein Sciences Corp. of Meriden, Connecticut, FluBlok would have been the first cell-line influenza vaccine licensed in the U.S. (6) Novartis must have been thrilled that its closest U.S. cell-line competitor was knocked out of the running days before it officially announced the launch of its Holly Springs plant.
Novartis still needs approval of its cell line, MDCK cells originating from dog kidneys, before it can ramp up flu shot production. Novartis has been using MDCK cells for several years to make its European-approved influenza vaccines: Optaflu, for seasonal flu, and Celtura, for swine flu. I find it interesting that the plant has been built, the vats are in place and the opening ceremony has been announced…and yet, flu shots made from dog cells have not been approved by U.S. regulators.