Pfizer and BioNTech to Make mRNA-Based Shingles Vaccine

Pfizer PFE and its partner for COVID-19 vaccine BioNTech BNTX signed a new collaboration to develop an mRNA-based vaccine for the prevention of shingles, a painful and disfiguring disease.

Clinical studies on the mRNA-based shingles vaccine are expected to begin in the second half of 2022. The companies will make the vaccine by leveraging Pfizer’s antigen technology and BioNTech's proprietary mRNA platform technology, which has been used to make their successful COVID-19 vaccine.

For the deal, Pfizer will make an upfront payment of $225 million to BioNTech that will include an upfront cash payment of $75 million and an equity investment of $150 million. In addition, BioNTech will also be entitled to receive potential milestone payments of up to $200 million while being eligible for a future share of gross profits, if some products are successfully developed.

This is Pfizer and BioNTech’s third mRNA vaccine collaboration. Pfizer and BioNTech have successfully developed an mRNA-based vaccine for COVID-19, under a collaboration initiated in 2020, that is now authorized in several countries and is probably the most successful of all vaccines available. The COVID-19 vaccine has generated billions in revenues for companies. Pfizer and BioNTech also have a collaboration to make an mRNA-based influenza vaccine, which was initiated in 2018.

Pfizer’s stock has risen 56% in the past year compared with an increase of 22.1% for the industry.

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Germany-based BioNTech’s shares are up 125.7% in the past year against the industry’s decrease of 26.3%.

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Separately, the Centers for Disease and Control Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) recommended Pfizer/BioNTech’s booster shots for all individuals above 12 years of age five months after their initial Pfizer/BioNTech vaccination series.

Earlier this week, the FDA extended the Emergency Use Authorization (EUA) for the booster dose of Pfizer/BioNTech’s COVID-19 vaccine to allow its use in adolescents 12 through 15 years of age. Pfizer and BioNTech’s booster dose was granted emergency approval by the FDA in November 2021 for all adults 18 years of age and older, following the completion of primary vaccination with any FDA-authorized or approved COVID-19 vaccine. Last month, the EUA was extended to allow its use in individuals 16 and 17 years of age.

Along with the emergency approval for 12 to 15-year-olds, the FDA also amended the existing EUA to reduce the time between the completion of the primary series and booster dose for all eligible individuals to five months from six months previously set. The FDA also authorized a third primary series dose for children 5 through 11 years of age who are immunocompromised

The CDC recommended that people who have taken the Pfizer-BioNTech vaccine can take a booster shot of an mRNA vaccine after five months, which is a month earlier than six months previously recommended, in line with FDA’s authorization. However, the shorter time interval recommendation for the booster dose does not apply to people who had received the J&J JNJ vaccine or the Moderna MRNA vaccine. The timeline for booster shots of J&J ‘s and Moderna’s vaccine remains two months and six months, respectively.

The CDC also recommended that the children 5-11 years of age who are moderately or severely immunocompromised may be given the booster shot 28 days after their second shot

Pfizer’s COVID-19 vaccine booster is the only one approved for use in children.

The booster dose of Moderna’s vaccine has been granted EUA for use in adults at least six months after completing primary vaccination with any FDA-authorized or approved COVID-19 vaccine.

A booster shot of J&J’s adenovirus-based single-shot COVID-19 vaccine was granted EUA by the FDA in October for adults aged 18 and older at least two months after the primary vaccination with its vaccine or with Pfizer or Moderna’s two-shot mRNA COVID-19 vaccine regimen.

While Pfizer sports a Zacks Rank #1 (Strong Buy), BioNTech has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank stocks here.

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