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Moderna (MRNA) Up on Its COVID Vaccine's Receipt of Full FDA Nod
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Moderna, Inc. (MRNA - Free Report) announced that the FDA has approved the biologics license application (“BLA”) for its mRNA-based COVID-19 vaccine, Spikevax (mRNA-1273). The vaccine, which was until now approved for emergency/conditional use, has now been granted full approval to prevent COVID-19 in individuals aged 18 years and above.
Shares of Moderna were up 6.2% on Monday following the announcement of the news. The stock has rallied 7.5% in the past year against the industry’s decline of 39.3%.
Image Source: Zacks Investment Research
With the FDA’s approval of the BLA, Spikevax becomes the second vaccine to be granted full approval by the FDA, the first being Comirnaty, developed by Pfizer (PFE - Free Report) and BioNTech (BNTX - Free Report) . Comirnaty, also an mRNA-based vaccine, was granted full approval to prevent COVID-19 in individuals 16 years of age and older, last August.
We remind investors that Spikevax was first granted emergency use authorization for use in adults in December 2020 in the United States. Moderna’s COVID-19 vaccine has gained similar authorizations in more than 70 countries following its FDA authorization, with 807 million doses of the same shipped globally in 2021.
Spikevax is authorized for use in adolescents in Europe, Canada and several other countries. Per the company, the full licensure of Spikevax in the United States now joins those in Europe, Canada and other countries where the drug has been approved for adolescents.
Meanwhile, the FDA and the European Commission have granted authorization for a third or booster dose of Moderna’s COVID-19 vaccine for adults at high risk of severe COVID-19
A booster dose of Pfizer/ BioNTech’s COVID-19 vaccine was approved in the United States in 2021.
Currently, Moderna is developing its COVID-19 vaccine for use in kids aged six months to 11 years. The company is also developing an Omicron-specific booster dose for use in adults as well as adolescents to provide protection against the variant that is currently driving infection cases worldwide.
Pfizer and BioNTech have also recently started clinical studies on their Omicron-specific COVID vaccine candidate in adult participants aged between 18 years and 55 years.
Infection rates due to the Omicron variant are reaching record highs globally due to said variant’s ability to bypass the protection provided by currently available vaccines. Though these vaccines and their booster doses are preventing severe infections, hospitalization and death, the protection they offer eventually weakens over time. However, to maintain a high level of protection against Omicron and future variants over the long term, it is crucial to have variant-based vaccines.
Along with Moderna, Pfizer/ BioNTech pharma giant J&J (JNJ - Free Report) is also developing updated variant-based vaccines and boosters in order to respond to this variant.
A booster shot of J&J’s single-shot, adeno-virus-based COVID-19 vaccine has also been authorized by the FDA. J&J is also pursuing a new vaccine against Omicron.
Moderna benefited from the robust sales of its COVID-19 vaccine in 2021. Successful developments of the vaccine for new age groups and the Omicron-specific booster dose may bring additional revenues.
Pfizer and BioNTech’s mRNA-based COVID-19 vaccine, Comirnaty, is the leading COVID-19 vaccine in terms of sales figures. Moreover, Pfizer has also come up with an oral COVID-19 drug, Paxlovid, which is likely to bring in additional revenues. Successful launch of effective oral pills is likely to reduce demand for vaccines in the days ahead.
Image: Shutterstock
Moderna (MRNA) Up on Its COVID Vaccine's Receipt of Full FDA Nod
Moderna, Inc. (MRNA - Free Report) announced that the FDA has approved the biologics license application (“BLA”) for its mRNA-based COVID-19 vaccine, Spikevax (mRNA-1273). The vaccine, which was until now approved for emergency/conditional use, has now been granted full approval to prevent COVID-19 in individuals aged 18 years and above.
Shares of Moderna were up 6.2% on Monday following the announcement of the news. The stock has rallied 7.5% in the past year against the industry’s decline of 39.3%.
With the FDA’s approval of the BLA, Spikevax becomes the second vaccine to be granted full approval by the FDA, the first being Comirnaty, developed by Pfizer (PFE - Free Report) and BioNTech (BNTX - Free Report) . Comirnaty, also an mRNA-based vaccine, was granted full approval to prevent COVID-19 in individuals 16 years of age and older, last August.
We remind investors that Spikevax was first granted emergency use authorization for use in adults in December 2020 in the United States. Moderna’s COVID-19 vaccine has gained similar authorizations in more than 70 countries following its FDA authorization, with 807 million doses of the same shipped globally in 2021.
Spikevax is authorized for use in adolescents in Europe, Canada and several other countries. Per the company, the full licensure of Spikevax in the United States now joins those in Europe, Canada and other countries where the drug has been approved for adolescents.
Meanwhile, the FDA and the European Commission have granted authorization for a third or booster dose of Moderna’s COVID-19 vaccine for adults at high risk of severe COVID-19
A booster dose of Pfizer/ BioNTech’s COVID-19 vaccine was approved in the United States in 2021.
Currently, Moderna is developing its COVID-19 vaccine for use in kids aged six months to 11 years. The company is also developing an Omicron-specific booster dose for use in adults as well as adolescents to provide protection against the variant that is currently driving infection cases worldwide.
Pfizer and BioNTech have also recently started clinical studies on their Omicron-specific COVID vaccine candidate in adult participants aged between 18 years and 55 years.
Infection rates due to the Omicron variant are reaching record highs globally due to said variant’s ability to bypass the protection provided by currently available vaccines. Though these vaccines and their booster doses are preventing severe infections, hospitalization and death, the protection they offer eventually weakens over time. However, to maintain a high level of protection against Omicron and future variants over the long term, it is crucial to have variant-based vaccines.
Along with Moderna, Pfizer/ BioNTech pharma giant J&J (JNJ - Free Report) is also developing updated variant-based vaccines and boosters in order to respond to this variant.
A booster shot of J&J’s single-shot, adeno-virus-based COVID-19 vaccine has also been authorized by the FDA. J&J is also pursuing a new vaccine against Omicron.
Moderna benefited from the robust sales of its COVID-19 vaccine in 2021. Successful developments of the vaccine for new age groups and the Omicron-specific booster dose may bring additional revenues.
Pfizer and BioNTech’s mRNA-based COVID-19 vaccine, Comirnaty, is the leading COVID-19 vaccine in terms of sales figures. Moreover, Pfizer has also come up with an oral COVID-19 drug, Paxlovid, which is likely to bring in additional revenues. Successful launch of effective oral pills is likely to reduce demand for vaccines in the days ahead.
Zacks Rank
Moderna currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.