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Pfizer (PFE), BioNTech Seek FDA Nod for Omicron Variant Booster
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Pfizer (PFE - Free Report) and BioNTech (BNTX - Free Report) announced that they have completed filing an application seeking Emergency Use Authorization (EUA) for a 30-µg booster dose of their bivalent Omicron-based COVID-19 vaccine that targets the BA.4/BA.5 Omicron variant for individuals 12 years of age and older. The subvariants, BA.4 and BA.5, are the most prevalent variants of concern in the United States as of now
The filing includes data from studies on their bivalent Omicron BA.1-adapted vaccine as well as pre-clinical and manufacturing data from their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine. Pfizer/BioNTech have already scaled production of the Omicron BA.4/BA.5-adapted bivalent boosters and will be ready to ship doses as soon as the FDA grants EUA. In June, Pfizer signed a $3.2 billion new agreement with the U.S. government to supply 105 million doses of its COVID-19 vaccine including its Omicron-adapted COVID-19 jabs if they are granted EUA by the FDA.
The companies have also initiated the filing of a conditional marketing authorization application with the European Medicines Agency (EMA) for the Omicron BA.4/BA.5-adapted bivalent vaccine, which is expected to be completed in the coming weeks.
Pfizer’s stock is down 17.2% this year so far against an increase of 0.7% for the industry.
Image Source: Zacks Investment Research
Germany-based BioNTech’s shares are down 42.5% this year so far compared with the industry’s decrease of 20.8%.
Image Source: Zacks Investment Research
Pfizer/BioNTech’s Omicron BA.4/BA.5-adapted bivalent vaccine contains mRNA encoding the spike protein present in the original vaccine as well as mRNA encoding the spike protein of the now dominant Omicron BA.4/BA.5 variants. In pre-clinical studies, the Omicron BA.4/BA.5-adapted bivalent vaccine generated a strong neutralizing antibody response compared to Omicron’s BA.1, BA.2 and BA.4/BA.5 variants as well as ancestral strain. However, Pfizer/BioNTech’s request for EUA is not supported by data from any human clinical studies demonstrating the effectiveness of the vaccine, which has been questioned by some health experts.
Earlier in June, Pfizer announced data from a phase II/III study on its bivalent Omicron adapted vaccine, which is a combination of the ancestral strain and the Omicron BA.1 subvariant. Data from the phase II/III study showed that participants, given the booster dose of the vaccine generated a substantially higher immune response against the Omicron subvariant BA.1 compared to Comirnaty, Pfizer/BioNTech’s currently authorized vaccine. Pfizer and BioNTech submitted an application for the Omicron BA.1-adapted bivalent COVID-19 vaccine in July based on the above data.
A couple of months back, the FDArecommended modifying the current strain composition of available COVID-19 vaccines to target the Omicron variant and its subvariants. Accordingly, vaccine makers like Pfizer, BioNTech, and Moderna (MRNA - Free Report) began rapidly working on modified boosters of their COVID vaccinesto provide better protection from the virus, which has been mutating rapidly. Pfizer/BioNTech’s Omicron BA.4/BA.5-adapted bivalent vaccine has been developed at the FDA’s recommendation.
Moderna has also developed mRNA-1273.222, a bivalent booster candidate containing its original vaccine, Spikevax plus the Omicron BA.4/5 strain mRNA. Moderna is expected to seek EUA from the FDA soon. Moderna has also signed supply contracts with the U.S. government for its Omicron BA.4/5 adapted booster doses.
The Biden government expects to start a booster campaign in October to prepare for an expected surge in infections in autumn. The Omicron BA.4/BA.5-adapted boosters of Pfizer and BioNTech and Moderna could be used in this fall booster campaign.
Image: Bigstock
Pfizer (PFE), BioNTech Seek FDA Nod for Omicron Variant Booster
Pfizer (PFE - Free Report) and BioNTech (BNTX - Free Report) announced that they have completed filing an application seeking Emergency Use Authorization (EUA) for a 30-µg booster dose of their bivalent Omicron-based COVID-19 vaccine that targets the BA.4/BA.5 Omicron variant for individuals 12 years of age and older. The subvariants, BA.4 and BA.5, are the most prevalent variants of concern in the United States as of now
The filing includes data from studies on their bivalent Omicron BA.1-adapted vaccine as well as pre-clinical and manufacturing data from their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine. Pfizer/BioNTech have already scaled production of the Omicron BA.4/BA.5-adapted bivalent boosters and will be ready to ship doses as soon as the FDA grants EUA. In June, Pfizer signed a $3.2 billion new agreement with the U.S. government to supply 105 million doses of its COVID-19 vaccine including its Omicron-adapted COVID-19 jabs if they are granted EUA by the FDA.
The companies have also initiated the filing of a conditional marketing authorization application with the European Medicines Agency (EMA) for the Omicron BA.4/BA.5-adapted bivalent vaccine, which is expected to be completed in the coming weeks.
Pfizer’s stock is down 17.2% this year so far against an increase of 0.7% for the industry.
Image Source: Zacks Investment Research
Germany-based BioNTech’s shares are down 42.5% this year so far compared with the industry’s decrease of 20.8%.
Image Source: Zacks Investment Research
Pfizer/BioNTech’s Omicron BA.4/BA.5-adapted bivalent vaccine contains mRNA encoding the spike protein present in the original vaccine as well as mRNA encoding the spike protein of the now dominant Omicron BA.4/BA.5 variants. In pre-clinical studies, the Omicron BA.4/BA.5-adapted bivalent vaccine generated a strong neutralizing antibody response compared to Omicron’s BA.1, BA.2 and BA.4/BA.5 variants as well as ancestral strain. However, Pfizer/BioNTech’s request for EUA is not supported by data from any human clinical studies demonstrating the effectiveness of the vaccine, which has been questioned by some health experts.
Earlier in June, Pfizer announced data from a phase II/III study on its bivalent Omicron adapted vaccine, which is a combination of the ancestral strain and the Omicron BA.1 subvariant. Data from the phase II/III study showed that participants, given the booster dose of the vaccine generated a substantially higher immune response against the Omicron subvariant BA.1 compared to Comirnaty, Pfizer/BioNTech’s currently authorized vaccine. Pfizer and BioNTech submitted an application for the Omicron BA.1-adapted bivalent COVID-19 vaccine in July based on the above data.
A couple of months back, the FDArecommended modifying the current strain composition of available COVID-19 vaccines to target the Omicron variant and its subvariants. Accordingly, vaccine makers like Pfizer, BioNTech, and Moderna (MRNA - Free Report) began rapidly working on modified boosters of their COVID vaccinesto provide better protection from the virus, which has been mutating rapidly. Pfizer/BioNTech’s Omicron BA.4/BA.5-adapted bivalent vaccine has been developed at the FDA’s recommendation.
Moderna has also developed mRNA-1273.222, a bivalent booster candidate containing its original vaccine, Spikevax plus the Omicron BA.4/5 strain mRNA. Moderna is expected to seek EUA from the FDA soon. Moderna has also signed supply contracts with the U.S. government for its Omicron BA.4/5 adapted booster doses.
The Biden government expects to start a booster campaign in October to prepare for an expected surge in infections in autumn. The Omicron BA.4/BA.5-adapted boosters of Pfizer and BioNTech and Moderna could be used in this fall booster campaign.
Both Pfizer and BioNTech have a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.