Tick-borne encephalitis vaccine

This approval makes TICOVAC the only FDA-backed vaccine in the U.S. to protect people of all ages against the virus when visiting or living in TBE endemic regions. The U.S. Food and Drug Administration (FDA) has approved Pfizer’s tick-borne encephalitis (TBE) vaccine TICOVAC to prevent TBE in people aged 1 year and older. This approval makes TICOVAC the only FDA-backed vaccine in the U.S. to protect people of all ages against the virus when visiting or living in TBE endemic regions. TBE, a viral infection, is transmitted to humans via an insect bite. The infection, which affects the brain and spine, has been reported in over 35 countries across Asia and Europe but is not known to be endemic in the states. Recommendations from the European Centre for Disease Prevention and Control (ECDC) state that people who live or are traveling to endemic regions should receive TBE vaccination. Currently, experience with Pfizer’s TBE vaccine has been documented outside the U.S. for more than 45 years. Additionally, more than 170 million vaccine doses have been delivered to people since 1976. “We are proud to deliver the first vaccine to help protect people in the U.S. against TBE, if they are traveling to any risk areas,” said Pfizer’s global president of Vaccines, Nanette Cocero, Ph.D., in a statement . “This vaccine has helped to protect millions of people in TBE endemic regions since its first approval outside the U.S. 45 years ago. This authorization helps to ensure that people from the U.S. are also able to receive this vaccination if needed, reflecting our commitment to provide health for all.” The vaccine is marketed in Europe as FSME-Immun and TicoVac and in the U.S. as TICOVAC. The company says the vaccine was developed with “a master ‘seed’ virus that is similar to the TBE virus found in nature” and is capable of inducing “neutralizing antibodies against the natural TBE virus.” Clinical trials have assessed the safety and immunogenicity of the Pfizer TBE vaccine across patients aged 1 to 15 years as well as patients older than 16. Seropositivity rates after three doses were 99.5% in patients between 1 and 15 years and 98.7% to 100% in people older than 15 years. These studies also found TICOVAC was generally well-tolerated and corresponded with no unexpected side effects or serious adverse events related to the vaccine. Pfizer said after the FDA approval that the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) will soon discuss recommendations on the appropriate use of TICOVAC based on the available clinical evidence. On Thursday, the FDA also gave the amended Emergency Use Authorization for Pfizer and BioNTech’s COVID-19 vaccine, which allows a third booster shot for patients who are immunocompromised. The amendment specifically targets patients who have been diagnosed with illnesses considered “equivalent” to immunocompromising conditions as well as those who have received a solid organ transplant. News of the amendment arrive in the midst of rising cases attributable to the Delta variant. The CDC is also set to discuss additional recommendations for COVID-19 vaccine boosters in immunocompromised patients. These recommendations are expected sometime today. Amendments made to Pfizer and Moderna’s COVID-19 vaccine administration schedules were made after the FDA reviewed data that showed a booster shot, administered six months following the second dose, could offer increased protection for the immunocompromised. Additionally, the FDA states that people who are in close physical contact with these patients should also receive a booster shot. Featured Jobs on BioSpace

Pfizer spent the last year in a heated race to develop the world’s first coronavirus vaccine and the last few years jockeying with Merck and others to develop a sequel to their blockbuster pneumococcal vaccine, Prevnar. Now the FDA is giving the New York drugmaker an expedited review for an inoculation few were watching — one, in fact, that has already been in use for decades. Pfizer has received priority review for TicoVac, their vaccine for tick-borne encephalitis, setting the company up for a decision by August. If approved, Pfizer said, the vaccine could be given to Americans, including armed service members, traveling to regions where the virus is common, such as Europe and parts of Asia. It would potentially protect travelers against meningitis and long-term neurological symptoms the virus can trigger. Unlike the mRNA Covid-19 vaccine or Prevnar 2.0 (technically called 20vPnC), TicoVac doesn’t use any fancy new technology: It’s an old fashioned inactivated virus vaccine, the same platform Jonas Salk used for polio. The vaccine has been used widely in Europe for four decades, having been first rolled out by Baxter AG in the 70s in Austria, although tweaks were made over the ensuing decades. Pfizer acquired the product when they bought out Baxter’s vaccine unit for $635 million in 2014. It is highly effective — estimates are in the 96% to 99% range — but like most older vaccines, not a major money maker: Pfizer collected just $27 million from the vaccine last year, or a little less than what Ibrance earns them in a week. A Pfizer spokesperson said that the company has been working with the U.S. Army Medical Material Development Activity to gain approval in the US. Although military members stationed in Europe can choose to get the vaccine, the process is burdensome: They often have to obtain a referral and then travel to a different country for each of the three doses. It is “logistically difficult for Service Members and their families to obtain protection,” he said. A US approval would simplify the process. Pfizer is also now developing a vaccine for another tick-borne illness: Lyme disease. Last year, they signed a $308 million deal with Valneva to co-develop their Phase II shot, making a bid to develop the first inoculant against a growing infection since GlaxoSmithKline pulled theirs off the market in 2002. Social: zz/STRF/STAR MAX/IPx via AP Images