Regulatory Pfizer's Prevnar 20 approved for use in infants and...

Pfizer’s Prevnar 20 approved for use in infants and children


Pfizer recently announced that its pneumococcal conjugate vaccine, Prevnar 20, has been given the green light by the U.S. Food and Drug Administration (FDA) for use in infants and young children. The approval of Prevnar 20, which is the only 20-valent pneumococcal conjugate vaccine available, could have a significant impact on the prevention of pneumococcal disease in young children.

Pneumococcal disease is a serious and potentially deadly illness brought on by Streptococcus pneumoniae bacteria. It can lead to meningitis, pneumonia, bloodstream infections, and also other health problems. Children under 2 years of age are particularly susceptible to pneumococcal disease, which can be life-threatening.

Prevnar 20 is designed to protect against 20 different types of Streptococcus pneumoniae bacteria, which is more than any other pneumococcal conjugate vaccine currently available. The vaccine is administered in a four-dose series after an infant is older than 2 months. 

Prevnar 20 will be competing with Merck’s Pneumovax 23 and GlaxoSmithKline’s Synflorix, which are also pneumococcal vaccines. However, Prevnar 20 has the advantage of protecting against a wider range of the bacteria.

The approval of Prevnar 20 is based on data from clinical trials involving over 6,000 infants and young children. The vaccine was shown to be safe and effective in preventing pneumococcal disease caused by the 20 bacterial types covered by the vaccine.

Prevnar 20 is expected to generate significant revenue for Pfizer. The vaccine is already approved for use in adults aged 18 and older, and it is estimated to bring in around $5 billion in sales in 2021 alone. With the addition of the pediatric indication, Prevnar 20 could become a top-selling vaccine for Pfizer.

The approval of Prevnar 20 is good news for parents and caregivers who are looking to protect their children against pneumococcal disease. The vaccine’s ability to protect against more types of pneumococcal bacteria could make it a more effective option than its competitors.

However, some experts have raised concerns about the high cost of Prevnar 20. The vaccine is priced at $243 per dose, which is significantly more expensive than Merck’s Pneumovax 23, priced at $122 per dose. The high cost could pose a barrier to access for families with limited financial resources, particularly in low- and middle-income countries where pneumococcal disease is most prevalent.

Despite the potential access challenges, Prevnar 20’s approval is a positive development in the fight against pneumococcal disease. As Pfizer’s Prevnar 20 hits the market, it will be interesting to see how it competes with Merck’s Pneumovax 23 and GlaxoSmithKline’s Synflorix. Ultimately, the availability of multiple effective vaccines will benefit parents and caregivers seeking to protect their children against this deadly disease.

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