EU Approves Pfizer-BioNTech COVID-19 Vaccine for Adolescents

BioNTech SE (BNTX) and its partner Pfizer (PFE) have received Conditional Marketing Authorization (CMA) in the E.U. for their COVID-19 vaccine, COMIRNATY, for use in adolescents. BioNTech stock jumped 3.19% on Friday to close at $204.

The companies collaborated to develop COMIRNATY, which became the first vaccine against coronavirus to be approved in the EU. The initial approval was for use in adults. The latest approval expands the access of the COMIRNATY vaccine to adolescents 12 – 15 years of age across the 27 E.U. member states.

“Making vaccines available to adolescents will help re-open schools and support the return to a normal day-to-day life,” said BioNTech CEO Ugur Sahin.

The E.U. based its decision to approve COMIRNATY for adolescents on the results of a pivotal Phase 3 clinical trial that enrolled 2,260 participants aged 12 to 15. The study showed the vaccine was 100% effective in all participants. (See Pfizer stock analysis on TipRanks)

BioNTech and Pfizer are working on further expanding access to COMIRNATY. They are studying the safety and efficacy of the vaccine in children aged between 6 months and 11 years. The plan is to seek U.S. and E.U. regulatory approval of COMIRNATY for children aged 2-11 years in September. Approval requests for children between 6 months and 2 years are expected to be placed in the fourth quarter. (See BioNTech stock analysis on TipRanks)

On May 18, Goldman Sachs analyst Chris Shibutani initiated coverage on BioNTech stock with a Hold rating and a price target of $173, which implies 15.20% downside potential.

“We remain conservative at this time on our attribution of value from the company’s expansive IO-directed pipeline, but do see potential and watch for data as clinical programs continue making steady progress,” noted Shibutani.

Consensus among analysts on Wall Street is a Moderate Buy based on 2 Buy and 6 Hold ratings. The average analyst price target of $186.50 implies 8.58% downside potential from current price levels.

BNTX scores a 6 out of 10 on TipRanks’ Smart Score rating system, indicating that the stock’s returns are likely to align with the market performance.