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Merck's (MRK) Pneumococcal Vaccine sBLA Faces FDA Delay

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Merck (MRK - Free Report) announced that the FDA has delayed its decision on its supplemental biologics license application (sBLA) seeking approval for Vaxneuvance, its newly approved pneumococcal 15-valent conjugate vaccine, for use in children and infants by three months. The FDA’s decision is now expected on Jul 1 this year.

The FDA needs more time to analyze Merck’s data from the pediatric studies on Vaxneuvance, which has been cited as a reason for the delay. The FDA has not requested for any new studies to be conducted.

In December, the FDA had accepted and assigned priority review to the sBLA seeking approval of Vaxneuvance in children six weeks through 17 years of age. 

Merck’s stock has risen 3.9% this year compared with an increase of 1.6% for the industry.

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Merck’s Vaxneuvance vaccine includes pneumococcal serotypes 22F and 33F, which are not included in the currently licensed 13-valent conjugate vaccines. These two serotypes, along with the leading serotype 3, contribute significantly to the burden of invasive pneumococcal disease (IPD). The vaccine was approved in the United States in July and Europe in December last year.

Pfizer’s (PFE - Free Report) Prevnar-20, a 20-valent pneumococcal conjugate vaccine, was also approved in the United States in June last year and in Europe in February 2022 (to be marketed as Apexxnar).

Prevnar 20 includes all the 13 serotypes contained in Pfizer’s popular 13-valent pneumococcal conjugate vaccine, Prevnar 13 along with seven additional serotypes. Pfizer is also conducting studies to evaluate the co-administration of its Prevnar-20 vaccine with its COVID-19 vaccine

Zacks Rank & Stocks to Consider

Merck currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the drug/biotech sector include Solid Biosciences (SLDB - Free Report) and BELLUS Health (BLU - Free Report) , each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

BELLUS Health’s stock has risen 12.7% this year. The Zacks Consensus Estimate for BELLUS Health’s 2022 bottom line has narrowed from a loss of 99 cents to 77 cents per share, while that for 2023 has narrowed from $1.34 per share to $1.11 per share over the past 60 days.

Solid Biosciences’ stock has declined 3.2% this year. The consensus estimate for Solid Biosciences bottom line has narrowed from a loss of 77 cents to 72 cents per share, while that for 2023 has narrowed from 69 cents per share to 59 cents per share over the past 60 days.

Solid Biosciences beat estimates in the last four quarters, with the average negative surprise being 17.1%.