The U.S. Food and Drug Administration will approve Cervarix, an FDA-approved vaccine against cervical cancer that is capable of protecting against both the strains of the virus that cause cervical cancer as well as two other strains of the virus that can infect other areas of the body.
The vaccine will also provide immunity against strains that have not been previously detected, but which continue to cause the most cases of vaginal infections.
The new approval means that in theory, in the next few years, healthy young women will be able to get all four shots in their doses without having to worry about whether they’re going to get exposed to the three types of HPV strains that the virus can affect in order to give them side effects.
Some commentators have suggested that the most exciting aspect of the Cervarix approval is that the vaccine has been given approval to three times per dose, instead of just twice a dose. Two very rare but dangerous side effects have been reported in the past with the three-dose regimen: laceration of the genital tract when the injection goes into the skin after the vaccine has been taken, and swelling of the knee, along with low white blood cell counts.
The decision comes almost exactly nine years after Merck first submitted to the FDA a petition to approve Cervarix, in February 2008. Later that same year, the FDA placed a hold on the vaccine, as the Merck investigation was focusing on an incidence of anaphylaxis, or swelling of the airways, in young women. Merck would later settle out of court and make an $85 million settlement over concerns about that toxic reaction.
On Thursday, Merck announced that Cervarix would now be approved in all 50 states, along with Washington, D.C. It will also be available to girls and women in the U.K. under a license that allows that nation’s NHS to contribute to funding the vaccine for HPV vaccines.
The FDA has also approved a second HPV vaccine for protection against the genital warts as well as anal, oral and vaginal cancers. Gardasil 9 was made available to providers on Jan. 23, at a cost of $375.
In October of 2016, Merck told The New York Times that it expected about 3 million doses of Cervarix would be sold to U.S. providers, a number that was recently reduced by about 1 million following a recent reimbursement payment cutoff.
Read the full story and the latest information on Cervarix from The New York Times here.
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