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Valneva and Pfizer Announce Initiation of Phase 2 Study for Lyme Disease Vaccine Candidate

Press release content from Globe Newswire. The AP news staff was not involved in its creation.
Valneva and Pfizer Announce Initiation of Phase 2 Study for Lyme Disease Vaccine Candidate
VALNEVAMarch 8, 2021 GMT
The Phase 2 study will include both adult and pediatric subjects with an aim to support acceleration of the vaccine candidate’s pediatric program
VLA15 will be tested at two different schedules (Month 0-2-6 or Month 0-6) receiving the selected dose of 180µg
VLA15 is the only Lyme disease vaccine candidate in active clinical development
Saint-Herblain (France) and New York, NY, March 8, 2021 – Valneva SE (“Valneva”), a specialty vaccine company focused on prevention of diseases with major unmet needs, and Pfizer Inc. (NYSE: PFE) today announced initiation of study VLA15-221. The VLA15-221 study builds on previous positive Phase 2 studies, incorporates new dose regimens and is anticipated to be the final Phase 2 study readout before a dec ....

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Valneva and Pfizer Announce Initiation of Phase 2 Study for Lyme Disease Vaccine Candidate

Valneva and Pfizer Announce Initiation of Phase 2 Study for Lyme Disease Vaccine Candidate
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United States , New York , Kathrin Jansen , Bryan Dunn , Juan Carlos Jaramillo , Jerica Pitts , Us Centers For Disease , Drug Administration , Exchange Commission , Pfizer Inc , Head Of Pfizer Vaccine Research , Investor Relations Corporate Communications , Senior Vice President , Pfizer Vaccine Research , Carlos Jaramillo , Chief Medical Officer , North America , Fast Track , Primary Endpoint , Booster Phase , Disease Control , Breakthroughs That Change Patient , Annual Report , Looking Information , Factors That May Affect Future , Lyme Report ,

Pfizer Inc.: EMA Accepts Marketing Application for Somatrogon to Treat Pediatric Patients with Growth Hormone Deficiency

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- If approved, somatrogon will serve as a once-weekly treatment option -
Pfizer Inc. (NYSE: PFE) and OPKO Health Inc. (NASDAQ: OPK) announced today that the European Medicines Agency (EMA) has validated for review the Marketing Authorization Application (MAA) for somatrogon, a long-acting recombinant human growth hormone that is intended to be administered once-weekly for the treatment of pediatric patients with growth hormone deficiency (GHD). Pfizer expects a decision from the European Commission in 2022.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210226005102/en/
Today s announcement is an example of our decades-long commitment to actively support the pediatric growth hormone deficiency community through therapeutic options that help children reach their full potential, said Brenda Cooperstone, MD, Chief Development Officer, Rare Disease, Pfizer Global Product Development. If approved in t ....

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Pfizer and BioNTech Initiate a Study as Part of Broad Development Plan to Evaluate COVID-19 Booster and New Vaccine Variants

Pfizer and BioNTech Initiate a Study as Part of Broad Development Plan to Evaluate COVID-19 Booster and New Vaccine Variants
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Pfizer Inc.: Pfizer and BioNTech Initiate a Study as Part of Broad Development Plan to Evaluate COVID-19 Booster and New Vaccine Variants

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The evaluation is part of the Phase 1/2/3 trial and will study a third dose of the Pfizer-BioNTech COVID-19 vaccine, BNT162b2, at 30 µg that will be given to Phase 1 participants to evaluate the safety and tolerability of a booster vaccine
Discussions with regulatory authorities are ongoing regarding an additional registration-enabling study using an mRNA vaccine with a variant sequence; this would provide a flexible solution for rapidly adapting the vaccine for use against the B.1.351 lineage or other new strains that may emerge as possible immune escape virus variants
Based on in-vitro studies conducted to date and observations from real world evidence, the Companies have not observed changes to neutralizing antibody levels that would predict a significant reduction in protection provided by two doses of BNT162b2 ....

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