Pfizer gets an FDA fast-pass for an old vaccine with potential military applications

2021-02-24

疫苗优先审批信使RNA

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

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