Pfizer-BioNTech COVID-19 Booster Gets FDA Approval for Ages 16 & Older

The booster dose of the Pfizer (PFE) – BioNTech (BNTX) COVID-19 vaccine has received extended authorization for emergency use from the U.S. Food and Drug Administration (FDA) for people aged 16 years and older.

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The booster is to be administered a minimum of six months after the primary vaccination and at the same dosage level.

The U.S. regulator’s decision was based on the outcome of the Phase 3 trial, which evaluated the efficacy and safety of the 30-µg booster dose of the vaccine in more than 10,000 individuals aged 16 years and older in the United States, Brazil, and South Africa.

CEO Comments

Pfizer CEO Albert Bourla said, “Today’s decision by the FDA to further expand the Emergency Use Authorization of a booster dose of our COVID-19 vaccine is a critical milestone as we continue to stay vigilant in addressing the virus… While new variants, including Omicron, emerge across the globe, we believe that the best way to minimize the spread of COVID-19 and any future variants is getting all eligible people fully vaccinated with the first two-dose series and a booster dose as recommended.”

Approvals

Previously, the booster dose was authorized by the FDA for emergency use in individuals aged 18 and older, along with eligible individuals who completed primary vaccination with a different authorized COVID-19 vaccine.

Now, the companies’ next move will be the submission of a supplemental Biologics License Application (BLA) for approval of the booster in individuals aged 16 years and older. The application to be submitted will incorporate the efficacy and safety data from the Phase 3 trial. The data from the trial demonstrated that the booster dose received after the Pfizer-BioNTech primary two-dose vaccination has a relative 95% efficacy rate compared to those who did not receive the booster.

Wall Street’s Take

On December 9, Erste Group analyst Hans Engel upgraded Pfizer to Buy from Hold but did not assign a price target.

In a note to investors, Engel said that Pfizer’s organic sales growth supersedes many of its competitors and a number of potential successful drugs in clinical trials are under review. Furthermore, due to the ongoing COVID-19 pandemic, high vaccine sales remain a tailwind.

The rest of the Street is cautiously optimistic about Pfizer with a Moderate Buy consensus rating based on 6 Buys and 9 Holds. The average Pfizer price target of $52.33 implies that shares are fully valued at current levels. Shares have increased 24.8% over the past year.

On December 9, Deutsche Bank analyst Emmanuel Papadakis maintained a Hold rating on BioNTech and a price target of $225 (20.83% downside potential).

The rest of the Street is cautiously optimistic about BioNTech and has a Moderate Buy consensus rating based on 3 Buys and 7 Holds. The average BioNTech price target of $299.11 implies 5.24% upside potential. Shares have gained 18.5% over the past six months.