European Medicines Agency Begins Review of New Lyme Disease Vaccine

European Union (E.U.) officials will begin the study and review process for Pfizer and Valneva’s vaccine targeting Lyme disease, the world’s most common tick-borne illness. There is currently no commercially approved Lyme disease vaccine.^{1 2}

Pfizer, along with French-Swiss pharmaceutical company Valneva say trials have shown 70 percent efficacy in people ages five and older with administration of the vaccine formally called PF-07307405. The investigational vaccine is a six-valent outer surface protein A (OspA)- based vaccine.²

Lyme disease is rarely fatal but can cause flu-like symptoms, rashes, bell’s palsy and other neurological symptoms in individuals bitten by an infected tick. “We believe vaccination has the potential to provide an important new layer of protection against this debilitating disease,” Pfizer’s chief vaccines officer, Annaliesa Anderson, said in a joint statement.¹

Previous Lyme Disease Vaccine Pulled from Market After Three Years

In 1998, the U.S. Food and Drug Administration (FDA) approved a Lyme disease vaccine that utilized the same OspA technology, known as LYMErix. LYMErix received only a limited period of popularity after vaccine injury lawsuits and reports of vaccine side effects, particularly arthritis and other types of brain and immune system damage, were publicized.

Less than four years later, manufacturer GlaxoSmithKline voluntarily withdrew LYMErix  from the market after a class action lawsuit was filed against the pharmaceutical giant. Philadelphia law firm Sheller, Ludwig & Bailey filed the lawsuit claiming that the vaccine caused serious harm to genetically susceptible individuals and the manufacturer concealed evidence of potential risks.³

Public Concern Over LYMErix Vaccine Safety

After public concerns about the safety of LYMErix, the FDA was forced to re-examine adverse reactions and results of the published phase III clinical trial. The FDA found significantly more vaccine recipients than controls— 26.8 percent compared to 8.3 percent—experienced local reactions including soreness, redness, and swelling at injection site, while 19.4 percent compared to 15.1 percent experienced systemic symptoms such as fever, chills, and myalgias.

After VAERS reports of arthritis incidence following vaccination, further investigations by the vaccine manufacturer found that in patients with a specific genotype, “an immune response against OspA could translate into a cross-reactive autoimmune response” which could be the reason why the vaccine caused autoimmunity in some individuals.³

Genetic Susceptibility to Vaccine Risks

“Differential genetic susceptibility applied to immunization risk represents a new concept,” wrote authors of a 2006 journal article entitled “The Lyme vaccine: a cautionary tale.” The article, published in Epidemiology & Infection, outlined the timeline and details of the LYMErix vaccine, its marketing, and its downfall that led to withdrawal of the first Lyme vaccine from the market.³

First reports by Pfizer and Valneva state that the new OspA vaccine against Lyme disease was well tolerated with no identified safety concerns. The study enrolled over 9,000 participants ages five years and older receiving four doses over the course of one year.¹

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