FDA Presses Pause on Pfizer Kids Vaccine

The U.S. Food and Drug Administration (FDA) told Pfizer Inc. (PFE, Financial) and BioNTech (BNTX, Financial) on Friday that it needs more time to review data before it can authorize the companies’ Covid-19 vaccine for children under five years old.

According to the agency, Pfizer indicated that new data has emerged that would impact an emergency use authorization request for its vaccine for children six months to four years of age. A meeting scheduled for Feb. 15 has been postponed. "We believe additional information regarding the ongoing evaluation of a third dose should be considered as part of our decision-making for potential authorization," FDA officials said in a statement.

The companies announced plans on Friday to extend their rolling submission to the FDA seeking to amend the Emergency Use Authorization of the Pfizer-BioNTech Covid-19 vaccine. The trial in children is ongoing and data on the first two 3-microgram doses in this age group are being shared with the FDA on an ongoing basis. Cases continue to accumulate according to the study protocol and more data are being generated because rates of infection and illness remain high in children of this age, especially due to the recent Omicron surge.

In December 2021, Pfizer and BioNTech announced that the ongoing clinical study would evaluate a third 3-micogram dose at least two months after the second dose of the two-dose series in this age group. Given that the study is advancing at a rapid pace, the companies will wait for the three-dose data as Pfizer and BioNTech continue to believe it may provide a higher level of protection in this age group. This is supported by recent observations of three-dose booster data in several other age groups that seems to meaningfully augment neutralizing antibody levels and real world vaccine protection for omicron compared to the two-dose regimen. The companies expect to have three-dose protection data available in early April.

At the close of trading on Friday, Pfizer shares stood at $50.78, a 0.36%% increase, or 16 cents per share. After hours, the share price went to $50.35, down 45 cents.

The news of the delay comes only three days after Pfizer reported fourth-quarter and full-year 2021 results. The company also raised its previous 2022 revenue guidance for Comirnaty, the Pfizer-BioNTech SE Covid-19 vaccine, and provided for the first time 2022 revenue guidance for its oral Covid-19 treatment, Paxlovid.

Full-year 2021 revenues were $81.3 billion, reflecting 92% operational growth. Excluding contributions from Comirnaty and Paxlovid, revenues grew 6% operationally to $44.4 billion.

Fourth-quarter revenues totaled $23.8 billion, reflecting 106% operational growth. Excluding contributions from Comirnaty and Paxlovid, revenues declined 2% operationally, driven primarily by the impact of fewer selling days compared to the prior-year quarter.

Full-year diluted EPS was $3.85, while adjusted diluted EPS was $4.42. Fourth-quarter diluted EPS was $0.59, with adjusted EPS of $1.08.

“In the early days of the Covid-19 pandemic, we committed to use all of the resources and expertise we had at our disposal to help protect populations globally against this deadly virus, as well as to offer treatments to help avoid the worst outcomes when infections do occur,” said Dr. Albert Bourla, Chairman and CEO, in a statement. “We put billions of dollars of capital on the line in pursuit of those goals, not knowing whether those investments would ever pay off. Now, less than two years since we made that commitment, we are proud to say that we have delivered both the first FDA-authorized vaccine against Covid-19 (with our partner, BioNTech) and the first FDA-authorized oral treatment for Covid-19.”

“Today we are issuing guidance for the coming year which, if achieved, would represent the highest level of annual revenues and Adjusted diluted EPS in Pfizer’s long history,” added Frank D’Amelio, Chief Financial Officer and Executive Vice President.