Pfizer In Spotlight As FDA Reportedly Mulls Withdrawing Authorization For COVID-19 Vaccine For Kids Under 5: Retail Says Stock Is Undervalued

According to a Bloomberg report, Pfizer has requested that the approval stay in place through the coming fall season.

The U.S. Food and Drug Administration (FDA) is reportedly considering revoking the authorization granted to Pfizer Inc. (PFE) to sell its COVID-19 vaccine to children under five.

According to a Bloomberg report, the company said that the agency informed it that it might not renew its pandemic-era authorization for younger children. Pfizer, however, has requested that the approval stay in place through the coming fall season, the report added.

Pfizer is currently in discussions with the FDA on potential paths forward, the firm said in a statement to Bloomberg. On Stocktwits, retail sentiment around PFE fell from ‘extremely bullish’ to ‘bullish’ territory over the past 24 hours, while message volume slipped from ‘extremely high’ to ‘high’ levels. However, retail chatter around Pfizer has soared 467% in the past 30 days.

PFE’s Sentiment Meter and Message Volume as of 10:06 a.m. ET on Aug. 12, 2025 | Source: Stocktwits

If the FDA does not renew authorization for younger children, kids with no health concerns will have no available COVID-19 shots, the report noted. While Moderna’s (MRNA) COVID-19 vaccine is approved in children, it is only approved for children under 12 at increased risk of the disease due to underlying conditions.

A Stocktwits user opined that Pfizer stock is undervalued, given all its assets and pipeline.

Another highlighted Pfizer’s data from a late-stage trial earlier in the day, and noted that it might serve as a potential catalyst.

Earlier on Tuesday, Pfizer announced positive results from a late-stage trial evaluating Astellas Pharma’s Padcev in combination with Merck’s cancer drug Keytruda in patients with muscle-invasive bladder cancer (MIBC) who are not eligible for cisplatin-based chemotherapy.

The trial demonstrated a clinically meaningful and statistically significant improvement in event-free survival and overall survival with the use of Padcev and Keytruda before and after surgery versus surgery alone. PFE stock is down by 7% this year and by about 13% over the past 12 months. 

Read also: Tesla Robotaxi Updates: Guggenheim Highlights ‘Mixed Signals’ From Market, But Retail’s Turned Exuberant For Now

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