Pfizer Inc. (NYSE:PFE)
Currently, the bivalent BA.4/BA.5 Omicron-targeting COVID-19 vaccine is only approved for use in children older than two years; however, Pfizer Inc. (NYSE:PFE) and its partner BioNTech (BNTX) have filed a modification to the marketing authorization (MA) to broaden the label to include children ages 5 to 11. But despite this, Pfizer stock plunged in the market.
With this regulatory submission, Pfizer Inc. (NYSE:PFE) and BioNTech request permission to expand the label so that the 10-g booster dose of their bivalent COVID-19 vaccine may be used in children.
Currently, a 30-g booster dose of this vaccine is permitted for use in people 12 years old or older. This bivalent vaccination comprises 15 ng of an mRNA that codes for the spike protein that was included in the first vaccine and 15 ng of an mRNA that codes for the spike protein that is shared by the Omicron BA.4 and BA.5 variants.
The submission that Pfizer Inc. (NYSE:PFE) and BioNTech have made to receive authorization for using the Omicron BA.4/BA.5 booster in children is based on clinical studies that they have conducted on their bivalent Omicron BA.1-adapted vaccine as well as pre-clinical data from studies that they have conducted on their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine. These studies were conducted to determine the safety and efficacy of the vaccine.
On the other hand, the statistics on the bivalent booster injection are not backed by data from any human clinical trials confirming the vaccine’s efficacy. This contrasts with all other COVID-19 vaccines that have been previously licensed or permitted. Even though the businesses have started clinical tests on the Omicron BA.4/BA.5-adapted bivalent vaccine, the findings won’t be ready for a few months.
Pfizer’s stock price has fallen by 24.8% this year, which is far worse than the industry’s overall decrease of 6.7%.
Pfizer stock fell after the company sought approval from the European Union for its omicron booster in children.
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