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Pfizer's (PFE) Tick-Borne Encephalitis Vaccine Gets FDA Nod

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Pfizer (PFE - Free Report) announced that the FDA has approved its tick-borne encephalitis (TBE) vaccine, Ticovac, for immunization of individuals aged 1 year or more who are visiting or living in TBE endemic areas. Ticovac is currently the only FDA-approved vaccine for this viral infection of the central nervous system.

The company informed that the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) is expected to recommend the safe and appropriate use of the vaccine following a discussion.

Please note that this vaccine is already approved outside the United States for people living in TBE endemic regions. With the recent approval, Ticovac will also be available to U.S. citizens, if needed. The vaccine is available as FSME-Immun and TicoVac in Europe.

Shares of Pfizer have rallied 31.7% so far this year compared with the industry’s growth of 17.3%.

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Pfizer’s Vaccine segment has been one of the key therapeutics area comprising its Biopharma business. The international sales of the company’s TBE vaccine has already contributed to the segment’s sales. The U.S. approval will likely generate revenues in the United States as well.

Approval of Pfizer’s mRNA-based COVID-19 vaccine, BNT162b, significantly boosted the Vaccine segment’s importance for the company. The company has developed the vaccine in partnership with BioNTech (BNTX - Free Report) . The COVID-19 vaccine generated $11.3 billion, a significant portion of the company’s sales in the first half of 2021. It is likely to generate more than a fifth of Pfizer’s total revenues in 2021. The delivery of the vaccine is likely to increase in 2022 with several advance purchase agreements in place.

Last week, the FDA expanded the emergency use authorization for Pfizer’s COVID-19 vaccine to include an authorization for the third dose for better immunization of certain immunocompromised individuals. The FDA also authorized another mRNA-based COVID-19 vaccine, Moderna's (MRNA - Free Report) mRNA-1273, for a similar patient population. However, J&J’s (JNJ - Free Report) single-shot COVID-19 vaccine failed to secure an EUA for additional dose due to insufficient data.

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Currently, Pfizer carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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