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Moderna's (MRNA) Omicron Based Jab gets Approval in Australia
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Moderna (MRNA - Free Report) announced that its Omicron bivalent booster candidate, mRNA-1273.214 (Spikevax Bivalent Original/Omicron), was granted provisional approval in Australia by the Therapeutic Goods Administration (TGA) as a booster dose in adults above 18 years of age. This is the first bivalent COVID-19 vaccine approved for use in Australia.
The Spikevax Omicron booster is a next-generation bivalent vaccine containing 25 µg of mRNA-1273 (Spikevax) targeting the ancestral strain and 25 µg of a vaccine candidate targeting the BA.1 sub-variant of the Omicron variant of the virus
The TGA approval for Spikevax booster dose is based on results from a phase II/III study in which mRNA-1273.214 met all primary endpoints. Per the study, the booster vaccine led to a strong neutralizing antibody response against Omicron subvariant BA.1, compared to a 50-µg booster dose of mRNA-1273 in previously uninfected participants.
Additionally, the Spikevax Bivalent Original/Omicron exhibited a superior immune response against the Omicron subvariants BA.4 and BA.5,the most prevalent variants in the United States as of now. Moderna plans to ramp up the manufacturing of mRNA-1273.214 to deliver doses in Australia by September.
Moderna’s mRNA-1273.214 has also received approval in the UK and Switzerland. The company has also completed worldwide regulatory submissions for the booster vaccine and is currently expecting further authorization decisions in the upcoming weeks.
Last week, Moderna also submitted a regulatory application to the FDA, seeking Emergency Use Authorization (EUA) for the use of a 50-µg booster dose of its bivalent BA.4/BA.5 Omicron-targeting COVID-19 vaccine, mRNA-1273.222, in individuals 18 years of age and older.
Moderna shares have plunged 46.9% compared with the industry’s decline of 22.6% in the year-to-date period.
Image Source: Zacks Investment Research
TGA had granted provisional registration to the Moderna’s COVID-19 Vaccine in Australia for use in individuals 18 years of age and older in August 2021. Moderna further received provisional registration in Australia from the TGA for Spikevax (mRNA-1273),in a two-dose series of 25 µg per dose, for kids aged six months to five years in July 2022. Until then, children under six years of age were not eligible for COVID-19 vaccination in Australia.
Presently, Pfizer/BioNTech’s vaccine Comirnaty is provisionally approved in Australia as a primary course for individuals less than six years of age and as a booster dose for individuals aged 12yeras and above.
The TGA has also commenced evaluation of Pfizer (PFE - Free Report) /BioNTech (BNTX - Free Report) ’s mRNA-based COVID-19 vaccine, Comirnaty, for use as a three-dose course in children less than six years of age.
Like Moderna, Pfizer and its partner BioNTech have also completed filing an application with the FDA seeking 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.
AstraZeneca’s (AZN - Free Report) COVID-19 vaccine Vaxzervria was also granted provisional approval in Australia by the TGA back in 2021 for use in individuals aged 18 years or older.
Additionally, TGA provisionally approved a booster dose of AstraZeneca’s Vaxzervria for individuals aged 18 years and older earlier in 2022.
Image: Bigstock
Moderna's (MRNA) Omicron Based Jab gets Approval in Australia
Moderna (MRNA - Free Report) announced that its Omicron bivalent booster candidate, mRNA-1273.214 (Spikevax Bivalent Original/Omicron), was granted provisional approval in Australia by the Therapeutic Goods Administration (TGA) as a booster dose in adults above 18 years of age. This is the first bivalent COVID-19 vaccine approved for use in Australia.
The Spikevax Omicron booster is a next-generation bivalent vaccine containing 25 µg of mRNA-1273 (Spikevax) targeting the ancestral strain and 25 µg of a vaccine candidate targeting the BA.1 sub-variant of the Omicron variant of the virus
The TGA approval for Spikevax booster dose is based on results from a phase II/III study in which mRNA-1273.214 met all primary endpoints. Per the study, the booster vaccine led to a strong neutralizing antibody response against Omicron subvariant BA.1, compared to a 50-µg booster dose of mRNA-1273 in previously uninfected participants.
Additionally, the Spikevax Bivalent Original/Omicron exhibited a superior immune response against the Omicron subvariants BA.4 and BA.5,the most prevalent variants in the United States as of now. Moderna plans to ramp up the manufacturing of mRNA-1273.214 to deliver doses in Australia by September.
Moderna’s mRNA-1273.214 has also received approval in the UK and Switzerland. The company has also completed worldwide regulatory submissions for the booster vaccine and is currently expecting further authorization decisions in the upcoming weeks.
Last week, Moderna also submitted a regulatory application to the FDA, seeking Emergency Use Authorization (EUA) for the use of a 50-µg booster dose of its bivalent BA.4/BA.5 Omicron-targeting COVID-19 vaccine, mRNA-1273.222, in individuals 18 years of age and older.
Moderna shares have plunged 46.9% compared with the industry’s decline of 22.6% in the year-to-date period.
Image Source: Zacks Investment Research
TGA had granted provisional registration to the Moderna’s COVID-19 Vaccine in Australia for use in individuals 18 years of age and older in August 2021. Moderna further received provisional registration in Australia from the TGA for Spikevax (mRNA-1273),in a two-dose series of 25 µg per dose, for kids aged six months to five years in July 2022. Until then, children under six years of age were not eligible for COVID-19 vaccination in Australia.
Presently, Pfizer/BioNTech’s vaccine Comirnaty is provisionally approved in Australia as a primary course for individuals less than six years of age and as a booster dose for individuals aged 12yeras and above.
The TGA has also commenced evaluation of Pfizer (PFE - Free Report) /BioNTech (BNTX - Free Report) ’s mRNA-based COVID-19 vaccine, Comirnaty, for use as a three-dose course in children less than six years of age.
Like Moderna, Pfizer and its partner BioNTech have also completed filing an application with the FDA seeking 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.
AstraZeneca’s (AZN - Free Report) COVID-19 vaccine Vaxzervria was also granted provisional approval in Australia by the TGA back in 2021 for use in individuals aged 18 years or older.
Additionally, TGA provisionally approved a booster dose of AstraZeneca’s Vaxzervria for individuals aged 18 years and older earlier in 2022.
Moderna currently has a Zacks Rank #3 (Hold).
You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.