For more than three decades Merck has had the exclusive license from the FDA to manufacture mumps vaccine in the USA. It was first approved in 1967 and the same strain used then is being used today. Originally, it was in a single dose vaccine but after 1971, it was incorporated in the MMR vaccine and seven million doses a year are sold in the USA.
In order to obtain that original license, Merck had to prove to the FDA that the vaccine had at least 95% efficacy. That means that over 95% of those getting the vaccine will show an adequate antibody response. This antibody response is assumed to be the same as being immunized, but that is not always the case – just having an antibody response to a vaccine does not mean one is immunized, but that is a minor point that gets ignored. Be that as it may, that is not what this post is about.
Without 95% efficacy then there is no “herd immunity” and you also just end up kicking the disease to an older population where there are more complications and risk infecting infants that can’t be vaccinated yet. This is why the FDA requires 95% efficacy.
The CDC predicted mumps would be eradicated by 2010, but starting in 2006 mumps started breaking out, the most recent break out is now taking place at Harvard. The reason is obvious… the vaccine doesn’t have 95% efficacy. In 1997, the FDA required Merck to prove their vaccine still had 95% efficacy, which they did show by manipulating data and falsifying test results as claimed by two former Merck virologists who filed a False Claims lawsuit against Merck.
The gold standard, called the PRN test, reveals the effectiveness of the vaccine (seroconversion) against the wild mumps virus. That is what one is supposed to do, but Merck apparently didn’t do that. They reportedly tested the vaccine against the stock mumps virus that was used to create the vaccine. Even then… the seroconversion rate was less than 80%. What they reportedly did then was come up with an enhanced PRN test by adding in rabbit antibodies that would enhance the activity of any human antibodies for the sole purpose of getting past the 95% benchmark. Apparently, the rabbit antibodies alone neutralized the virus and no human antibodies were required to be present. The test would show 95% efficacy even if the vaccine had 0% effectiveness.
This “007” protocol, as it was called, was not just the result of rogue scientists wanting to keep their jobs, Senior Management were reportedly in on the whole scheme. The CDC purchases almost $100 million dollars worth of MMR from Merck every year so this apparent fraud has allowed Merck to bilk the US Government out almost a hundred million of dollars every year for a vaccine that does not work.
The lawsuit is ongoing…