Immune boosting vaccine may only help babies – not adults, study finds

The Food and Drug Administration (FDA) overstated the benefits of vaccines among adolescents when it approved a product, the company behind the product has determined.

Genetics tests proved that a vaccine that is intended to boost antibodies in young children and not targeted at children under one year of age only works as a booster when that booster vaccine is given to infants and toddlers. This evidence was presented at a scientific meeting on 27 November in The Hague.

The company behind the product, Merck, collaborated with Mayo Clinic, The Hudson Institute and colleagues to conduct the tests to determine whether an adjuvant in a childhood vaccine would enhance the ability of the vaccine to provoke an immune response in adults. The product, Gardasil, is an adjuvant found in vaccines for infectious diseases including HPV (human papillomavirus), shingles, meningitis and bronchitis.

The results showed that the vaccine only enhanced the immune response to the disease when the vaccine is given to an infant or toddler, when the immune system remains immature.

“The results of this study provide firm scientific backing for our observation that these vaccines only stimulate and extend the vaccine safety benefits when administered to infants and toddlers, and not when used to vaccinate adolescents and adults,” said Jeffrey Bierman, global head of vaccine at Genentech, the US-based subsidiary of Roche.

“It is no surprise that underdeveloped immunity to the herpes simplex virus causes soreness and blisters. The question that remains is whether this immunity will remain or be degraded.” Dr. James Bridle

Gardasil was approved in 2008 and sold by Merck for use against HPV-associated cancers, genital warts and precancerous lesions (cervical and vulvar).

Gardasil contains a very active live, weakened form of the human papillomavirus (HPV) virus, which subsequently stimulated the body’s immune response to protect against infection.

But while Gardasil had always been considered as a booster vaccine, the FDA said in 2016 that Gardasil was a vaccine targeted at women (when they are ages nine to 26) or women and girls aged 11 and 12 and needed to be given annually. The FDA’s ruling was based on numerous studies that showed protection from HPV, particularly the HPV types that cause cancer in women, did not fully kick in until 10 to 20 years after vaccination.

Just last month, the US Centre for Disease Control and Prevention (CDC) announced it now has guidelines for vaccinating adolescents against cancer-causing HPV types, regardless of whether they are two or five years of age. “A new CDC/CDCER Report on HPV vaccination supports high rates of HPV vaccination in children aged 13 to 26 who can be vaccinated,” the CDC said.

Meanwhile, the Indian drugmaker Cipla, which supplies the adjuvant required for the over-the-counter version of Gardasil for India, and another company, Emami Health Sciences Ltd, have filed a complaint before India’s National Drugs Standard Control Organisation (NDSCO) alleging a complete breach of intellectual property rights.

The complaint stated that while Genentech conducted and sponsored the clinical trials for the benefit of Genentech, the clinical trials were published in prestigious medical journals as FDA-approved. Further, it alleged that Genentech promoted its product worldwide as a “vaccine” against cervical cancer, when the FDA only considers it to be a treatment, not a vaccine.

Gardasil’s maker, along with US-based testing agency CVS Labs, said it will take legal action against the trial group unless their inquiry is resolved.

The US has not approved the vaccine for use on young children but it has so far approved it for use by people aged one to 49.

“These findings raise concerns about how the FDA and U.S. population view vaccines. It is no surprise that underdeveloped immunity to the herpes simplex virus causes soreness and blisters. The question that remains is whether this immunity will remain or be degraded,” said Dr. James Bridle, an infectious disease physician and co-founder of Sense about Science, a UK-based independent network for biomedical research.

“We need a vaccine that ensures lifelong protection against genital herpes. That is where we’re really at.”

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