Tag: mumps

Court Confirms Merck Lied on Mumps Vaccine Label — But Lets Drugmaker Off the Hook in Antitrust Lawsuit

An appeals court this week ruled that even though Merck misrepresented critical data to the U.S. Food and Drug Administration (FDA) to gain approval for its updated mumps vaccine — and even though the FDA knew about the false claims — because the agency approved the vaccine anyway, Merck can’t be held responsible for unfairly hurting competitors.

The ruling stems from a class action lawsuit brought by a group of physicians and physicians groups who alleged Merck violated the Sherman Antitrust Act by making false claims about the efficacy of its mump vaccine on the product’s label in order to stifle competition and maintain a monopoly in the marketplace.

The Sherman Antitrust Act prohibits companies from conspiring to create a monopoly.

The U.S. 3rd Circuit Court of Appeals didn’t dispute the plaintiffs’ allegations that Merck lied to the FDA about the vaccine’s efficacy.

However, citing the Noerr-Pennington doctrine, the court ruled that because the FDA took no action against Merck after discovering the false claims, it was the FDA’s decision — not Merck’s fraud — that injured competitor GSK and the physicians and physicians groups who bought the ineffective vaccine at inflated prices.

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Majority of mumps cases are among the vaccinated, CDC finds

Mumps cases continue to circulate in the U.S., largely among vaccinated people, including children.

Cases of mumps, once a common childhood illness, declined by more than 99 percent in the U.S. after a vaccine against the highly contagious respiratory infection was developed in 1967. Cases dropped to just 231 in 2003, down from more than 152,000 in 1968. But cases began climbing again in 2006, when 6,584 were reported, most of them in vaccinated people. 

According to the report from the Centers for Disease Control and Prevention, one-third of mumps cases in the U.S. from 2007 to 2019 were reported in children and adolescents. As many as 94 percent of those who contracted the illness had been vaccinated.

“Before that, large outbreaks of mumps among people who were fully vaccinated were not common, including among vaccinated children,” said Mariel Marlow, an epidemiologist at the CDC who led the new study. “But the disease symptoms are usually milder and complications are less frequent in vaccinated people.”

Experts aren’t sure why vaccinated people get mumps, but multiple factors appear to be affecting immunity in vaccinated people, including a lack of prior exposure to the virus, waning immunity and the circulation of genotypes the vaccine doesn’t contain. 

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