Pfizer-BioNTech’s COVID-19 Booster Gets FDA Approval for People 18 & Above

The booster dose of Pfizer (PFE) and BioNTech’s (BNTX) COVID-19 vaccine has received extended authorization for emergency use from the U.S. Food and Drug Administration (FDA) for people aged 18 years and older.

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The booster dose provided by the healthcare companies 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 clinical data, which demonstrated strong immune responses following the booster dose of the vaccine, exceeding the response reflected after two-dose primary vaccinations. Additionally, these data show that the vaccine has a high potential to protect against tested variants, including Delta.

CEO Comments

The CEO of Pfizer, Albert Bourla, said, “As we near the two-year mark in our fight against COVID-19, we have reached another critical milestone with the expanded authorization of a booster dose of our COVID-19 vaccine in individuals 18 years and older. With boosters, more adults will now have the opportunity to help preserve a high-level of protection against this disease.”

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Prior Approvals

Last month, positive topline results announced from the trial showed that a booster dose administered to individuals who previously received the Pfizer-BioNTech primary two-dose series reflected efficacy of 95% versus those who did not receive a booster.

Previously, the booster dose of the vaccine received FDA’s approval for emergency use after completing a primary series in people aged 65 years and older, 18 through 64 years of age at high risk of severe COVID-19, and individuals of 18 through 64 years of age with frequent occupational exposure to SARS-CoV-2. Notably, people with primary vaccinations with any other authorized or approved COVID-19 vaccine were also eligible.

Wall Street’s Take

On November 18, BMO Capital analyst Evan Seigerman initiated coverage on Pfizer with a Buy rating and a price target of $60 (18.1% upside potential).

Seigerman foresees a “longer-than-projected tail” from the COVID vaccine business, along with a “rich pipeline” and “financially solid” fundamentals.

The rest of the Street is cautiously optimistic about Pfizer and has a Moderate Buy consensus rating based on 4 Buys and 9 Holds. The average Pfizer price target of $47.67 implies 6.2% downside potential to current levels. Shares have increased 39.1% over the past year.

On November 11, Goldman Sachs analyst Chris Shibutani maintained a Hold rating on BioNTech and lowered the price target to $289 from $433.

Shibutani commented, “While vaccine marketplace trends continue to provide tailwinds for mRNA-vaccine manufacturers, more hesitant management commentary around the endemic phase booster markets prompts a downward revision of our revenue projections in FY2023 and beyond.”

The rest of the Street is cautiously optimistic about BioNTech and has a Moderate Buy consensus rating based on 4 Buys and 7 Holds. The average BioNTech price target of $307.91 implies 6.27% upside potential. Shares have gained 48.7% over the past six months.