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Moderna (MRNA) Starts Omicron-Specific Bivalent Booster Study
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Moderna, Inc. (MRNA - Free Report) announced that the first participant has been dosed in the mid-stage study of its Omicron-specific bivalent booster candidate (mRNA-1273.214).
This bivalent booster candidate (mRNA-1273.214) combines Moderna’s Omicron-specific booster candidate (mRNA-1273.529) and its COVID-19 vaccine (mRNA-1273), which was developed to protect against the original COVID-19 strain.
The study will evaluate the immunogenicity, safety and reactogenicity of the candidate as a single booster dose in adults aged 18 years and above. These adults must have previously received the two-dose primary series of Moderna’s original COVID-19 vaccine and a 50 µg booster dose of mRNA-1273 with the booster dose being administered at least three months ago.
Moderna expects to enroll approximately 375 participants in the United States.
We note that the FDA approved the biologics license application (BLA) for MRNA’s COVID-19 vaccine to prevent the same in 18-year-old individuals and older. The regulatory body also authorized a booster dose of COVID-19 vaccine at the 50 µg dose level for adults aged 18 years and older. However, authorization for the use of mRNA-1273 in adolescents is pending in the United States.
Moderna is also evaluating its Omicron-specific booster candidate in a mid-stage study in the United States. This booster candidate is also being evaluated in a phase III study in the UK in collaboration with the National Institute for Health Research (NIHR). Moderna expects to begin dosing with mRNA-1273.214 in that study soon.
Strong sales of its COVID-19 vaccine boosted revenues, significantly, in 2021.
Shares of Moderna have declined 43.2% in the year so far compared with the industry’s 17.8% decrease.
Image Source: Zacks Investment Research
Moderna has several advance purchase agreements valued at $19 billion for its COVID-19 vaccine with multiple countries during 2022. MRNA believes that the SARS-CoV-2 virus will evolve into an endemic in 2022 and expects its sales to grow more in the second half of 2022 than in the first half.
Pharma and biotech companies like Pfizer (PFE - Free Report) and Moderna played a key role in combating the pandemic to a great extent by developing vaccines in record time.
Pfizer and BioNTech (BNTX - Free Report) lead the race for successfully developing a COVID-19 vaccine, which is approved as a two-dose series to prevent the infection in individuals aged 16 years and above in the United States. The booster dose of both companies’ COVID-19 vaccine is also authorized for use in adults in the United States.
The consensus estimate for Vertex’s 2022 earnings has increased $1.20 over the past 60 days to $14.52. Shares of VRTX have gained 9.2% in the past year.
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Moderna (MRNA) Starts Omicron-Specific Bivalent Booster Study
Moderna, Inc. (MRNA - Free Report) announced that the first participant has been dosed in the mid-stage study of its Omicron-specific bivalent booster candidate (mRNA-1273.214).
This bivalent booster candidate (mRNA-1273.214) combines Moderna’s Omicron-specific booster candidate (mRNA-1273.529) and its COVID-19 vaccine (mRNA-1273), which was developed to protect against the original COVID-19 strain.
The study will evaluate the immunogenicity, safety and reactogenicity of the candidate as a single booster dose in adults aged 18 years and above. These adults must have previously received the two-dose primary series of Moderna’s original COVID-19 vaccine and a 50 µg booster dose of mRNA-1273 with the booster dose being administered at least three months ago.
Moderna expects to enroll approximately 375 participants in the United States.
We note that the FDA approved the biologics license application (BLA) for MRNA’s COVID-19 vaccine to prevent the same in 18-year-old individuals and older. The regulatory body also authorized a booster dose of COVID-19 vaccine at the 50 µg dose level for adults aged 18 years and older. However, authorization for the use of mRNA-1273 in adolescents is pending in the United States.
Moderna is also evaluating its Omicron-specific booster candidate in a mid-stage study in the United States. This booster candidate is also being evaluated in a phase III study in the UK in collaboration with the National Institute for Health Research (NIHR). Moderna expects to begin dosing with mRNA-1273.214 in that study soon.
Strong sales of its COVID-19 vaccine boosted revenues, significantly, in 2021.
Shares of Moderna have declined 43.2% in the year so far compared with the industry’s 17.8% decrease.
Image Source: Zacks Investment Research
Moderna has several advance purchase agreements valued at $19 billion for its COVID-19 vaccine with multiple countries during 2022. MRNA believes that the SARS-CoV-2 virus will evolve into an endemic in 2022 and expects its sales to grow more in the second half of 2022 than in the first half.
Pharma and biotech companies like Pfizer (PFE - Free Report) and Moderna played a key role in combating the pandemic to a great extent by developing vaccines in record time.
Pfizer and BioNTech (BNTX - Free Report) lead the race for successfully developing a COVID-19 vaccine, which is approved as a two-dose series to prevent the infection in individuals aged 16 years and above in the United States. The booster dose of both companies’ COVID-19 vaccine is also authorized for use in adults in the United States.
Moderna currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is Vertex Pharmaceuticals (VRTX - Free Report) , which currently has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
The consensus estimate for Vertex’s 2022 earnings has increased $1.20 over the past 60 days to $14.52. Shares of VRTX have gained 9.2% in the past year.