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Moderna's (MRNA) COVID-19 Vaccine Nears EUA in Pediatrics
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Moderna’s (MRNA - Free Report) COVID-19 vaccine received the FDA’s Vaccines and Related Biological Products Advisory Committee’s (VRBPAC) vote, backing immunization with two doses as primary vaccination for individuals aged 6 years to 17 years in the United States. The advisory committee observed that the benefits of Moderna’s vaccine outweigh its risks for use in adolescents 12-17 years of age and in children 6-11 years of age.
A decision from the FDA related to the emergency use authorization (EUA) for the use of Moderna’s COVID vaccine in adolescents and children may follow soon. Although the FDA generally follows the recommendation of its advisory committee, it is not obligated to do so. A potential EUA from the FDA is likely to be followed by a recommendation from the U.S. Centers for Disease Control and Prevention (CDC) on immunization practices. A meeting of the CDC’s advisor panel is scheduled to be held later this week.
Moderna has been waiting for several months for the inclusion of adolescents and the younger population in the EUA for its COVID-19 vaccine. The company first filed for EUA of its COVID-19 vaccine in adolescents in June last year. Additional data related to the safety and immunogenicity of a lower dose in adolescents compared to the requested dose in the EUA had delayed the authorization.
The company filed for EUA of its vaccine in children 6-11 years of age late last year. The delay in the decision related to the EUA for adolescents also delayed an authorization in children.
Shares of Moderna gained 3.8% on Jun 14, followed by a gain of 1.2% in after-hours trading after the VRBPAC voting. However, the company’s shares have declined 52.2% so far this year compared with the industry’s decrease of 30.2%.
Image Source: Zacks Investment Research
Following the unanimous vote from the VRBPAC, Moderna is likely to gain the long-awaited authorization for use in these populations. Please note that Moderna’s vaccine is already authorized for use in adolescents in many countries including Europe and Canada.
Moderna filed another EUA application in April for the use of its COVID-19 vaccine as primary series in infants aged six months to six years of age. An advisory committee meeting is scheduled today to discuss the application. The company has also filed similar applications in other countries. The meeting will also discuss the EUA application from its rival Pfizer (PFE - Free Report) and BioNTech (BNTX - Free Report) for the use of their COVID-19 vaccine in infants six months to under five years of age.
Pfizer and BioNTech’s COVID-19 vaccine and its booster dose are approved for use in adults as well as authorized for use in individuals aged five years and above. Pfizer and BioNTech’s vaccine has been enjoying a non-competitive market for the immunization of adolescents and children in the United States since its authorizations last year. The recent positive VRBPAC voting may lead to the entry of Moderna’s COVID-19 vaccine in the space.
However, the impact of the potential authorization for Moderna’s COVID-19 vaccine’s use in adolescents and children to the company’s topline remains uncertain. Per a Reuters article, only 30% and 60% of individuals aged 5 to 11 years and 12 to 17 years, respectively, are fully vaccinated in the United States so far. This may imply lower demand for vaccines among the younger population. Moreover, there has been pressure from European countries on Moderna as well as Pfizer and BioNTech to delay or reduce COVID-19 vaccine supply amid a marked slowdown in vaccinations, per another Reuters article.
Albeit low, Moderna’s COVID-19 vaccine also carries a risk of heart inflammation in young men. However, the impact of the risk remains to be seen.
Meanwhile, the demand for COVID-19 vaccines in infants below 5 years of age remains to be seen.
Alkermes (ALKS - Free Report) is a better-ranked biotech stock, sporting a Zacks Rank #1.
The Zacks Consensus Estimate for Alkermes’ 2022 loss per share has narrowed from 13 cents to 3 cents in the past 60 days. Shares of ALKS have risen 16.9% year to date.
Earnings of Alkermes beat estimates in each of the last four quarters, the average being 350.48%.
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Moderna's (MRNA) COVID-19 Vaccine Nears EUA in Pediatrics
Moderna’s (MRNA - Free Report) COVID-19 vaccine received the FDA’s Vaccines and Related Biological Products Advisory Committee’s (VRBPAC) vote, backing immunization with two doses as primary vaccination for individuals aged 6 years to 17 years in the United States. The advisory committee observed that the benefits of Moderna’s vaccine outweigh its risks for use in adolescents 12-17 years of age and in children 6-11 years of age.
A decision from the FDA related to the emergency use authorization (EUA) for the use of Moderna’s COVID vaccine in adolescents and children may follow soon. Although the FDA generally follows the recommendation of its advisory committee, it is not obligated to do so. A potential EUA from the FDA is likely to be followed by a recommendation from the U.S. Centers for Disease Control and Prevention (CDC) on immunization practices. A meeting of the CDC’s advisor panel is scheduled to be held later this week.
Moderna has been waiting for several months for the inclusion of adolescents and the younger population in the EUA for its COVID-19 vaccine. The company first filed for EUA of its COVID-19 vaccine in adolescents in June last year. Additional data related to the safety and immunogenicity of a lower dose in adolescents compared to the requested dose in the EUA had delayed the authorization.
The company filed for EUA of its vaccine in children 6-11 years of age late last year. The delay in the decision related to the EUA for adolescents also delayed an authorization in children.
Shares of Moderna gained 3.8% on Jun 14, followed by a gain of 1.2% in after-hours trading after the VRBPAC voting. However, the company’s shares have declined 52.2% so far this year compared with the industry’s decrease of 30.2%.
Image Source: Zacks Investment Research
Following the unanimous vote from the VRBPAC, Moderna is likely to gain the long-awaited authorization for use in these populations. Please note that Moderna’s vaccine is already authorized for use in adolescents in many countries including Europe and Canada.
Moderna filed another EUA application in April for the use of its COVID-19 vaccine as primary series in infants aged six months to six years of age. An advisory committee meeting is scheduled today to discuss the application. The company has also filed similar applications in other countries. The meeting will also discuss the EUA application from its rival Pfizer (PFE - Free Report) and BioNTech (BNTX - Free Report) for the use of their COVID-19 vaccine in infants six months to under five years of age.
Pfizer and BioNTech’s COVID-19 vaccine and its booster dose are approved for use in adults as well as authorized for use in individuals aged five years and above. Pfizer and BioNTech’s vaccine has been enjoying a non-competitive market for the immunization of adolescents and children in the United States since its authorizations last year. The recent positive VRBPAC voting may lead to the entry of Moderna’s COVID-19 vaccine in the space.
However, the impact of the potential authorization for Moderna’s COVID-19 vaccine’s use in adolescents and children to the company’s topline remains uncertain. Per a Reuters article, only 30% and 60% of individuals aged 5 to 11 years and 12 to 17 years, respectively, are fully vaccinated in the United States so far. This may imply lower demand for vaccines among the younger population. Moreover, there has been pressure from European countries on Moderna as well as Pfizer and BioNTech to delay or reduce COVID-19 vaccine supply amid a marked slowdown in vaccinations, per another Reuters article.
Albeit low, Moderna’s COVID-19 vaccine also carries a risk of heart inflammation in young men. However, the impact of the risk remains to be seen.
Meanwhile, the demand for COVID-19 vaccines in infants below 5 years of age remains to be seen.
Moderna, Inc. Price
Moderna, Inc. price | Moderna, Inc. Quote
Zacks Rank & Stock to Consider
Moderna currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Alkermes (ALKS - Free Report) is a better-ranked biotech stock, sporting a Zacks Rank #1.
The Zacks Consensus Estimate for Alkermes’ 2022 loss per share has narrowed from 13 cents to 3 cents in the past 60 days. Shares of ALKS have risen 16.9% year to date.
Earnings of Alkermes beat estimates in each of the last four quarters, the average being 350.48%.