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Pfizer (PFE) Pneumococcal Vaccine BLA Gets FDA's Priority Tag

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Zacks Equity Research
·3 min read
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Pfizer, Inc. PFE announced that the FDA has accepted and granted priority review to its biologics license application (BLA) seeking approval for its 20-valent pneumococcal conjugate vaccine candidate, 20vPnC, for adults.

With the FDA granting priority review, a decision is expected in June 2021.

Pfizer’s 20vPnC vaccine candidate includes all the 13 serotypes contained in its popular 13-valent pneumococcal conjugate vaccine, Prevnar 13 along with seven additional serotypes. This way it covers more serotypes responsible for the majority of invasive pneumococcal disease and pneumonia than any other marketed vaccine or those in clinical development.

Please note that Merck MRK is developing a 15-valent pneumococcal conjugate vaccine candidate, V114, in late-stage studies.

Merck’s phase III clinical development program for V114 includes 16 late-stage studies that evaluated the vaccine candidate in a variety of populations who are at increased risk for pneumococcal disease. Merck remains on track to file a regulatory application seeking approval for V114 in the United States by year-end.

Pfizer’s shares have risen 8.6% this year so far compared with the industry’s 2.8% increase.

 

 

The share price has increased mainly due to Pfizer and its Germany-based partner, BioNTech’s BNTX rapid progress on the development and regulatory plans for its mRNA-based coronavirus vaccine candidate, BNT162b2.

BNT162b2, a two-shot vaccine, was approved for emergency use in the United Kingdom and Bahrain this month. The companies have also filed for emergency use in the United States, EU and India. In addition, the companies have initiated rolling submissions with regulatory agencies in Australia, Canada, and Japan.

BNT162b2 proved quite effective in preventing COVID-19 in phase III clinical studies. Final data from a phase III study on BNT162b2, announced last month, showed that the candidate was 95% effective in preventing COVID-19. Pfizer/BioNTech’s close competitor is Moderna MRNA, which has also applied for emergency use in the United States and EU for its coronavirus vaccine candidate, mRNA-1273, which uses the same mRNA-based technology as Pfizer/BioNTech. Moderna’s candidate achieved efficacy rate of 94.1% in primary efficacy analysis.

Pfizer currently 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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Pfizer Inc. (PFE) : Free Stock Analysis Report
 
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Moderna, Inc. (MRNA) : Free Stock Analysis Report
 
BioNTech SE Sponsored ADR (BNTX) : Free Stock Analysis Report
 
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