Moderna
MRNA
received approval from Canadian regulatory authority, Health Canada, for its mRNA COVID-19 Vaccine, Spikevax (mRNA-1273), for kids aged six months to five years.
Moderna’s COVID-19 vaccine is already authorized for use in Canada for all adults and children aged six to 11 years.
Health Canada authorized a 25 µg two-dose series of Spikevax for active immunization for children six months through five years of age.
The approval was based on data from the KidCOVE study on Spikevax. Data from the interim analysis of the KidCOVE study, released earlier this year, showed that immunization with two 25 µg doses of mRNA-1273 28 generated a robust neutralizing antibody response in both age groups — six months to under two years and two years to under six years of age.
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Shares of Moderna have lost 34.3% year-to-date compared with the
industry
’s 20% decline.
In June, Moderna’s SpikeVax received FDA authorization for use in young kids in the United States. FDA also authorized the use of SpikeVax in children aged 6 through 11 years old for a 50 μg two-dose regimen and adolescents aged 12 through 17 for a 100 μg two-dose regimen.
Spikevax is already fully approved by the FDA for use in adults in the United States while being authorized in several countries. Moreover, a booster shot of the vaccine is also authorized for use in adults
SpikeVax is Moderna’s only commercial product authorized for use.
Moderna has now expanded its mRNA pipeline with two new development programs.
The first development program is a new combination of respiratory vaccine candidate (mRNA-1230) targeting three of the most significant viruses causing respiratory disease in older adults—SARS-CoV-2, influenza and respiratory syncytial virus (RSV).
The second program is a vaccine candidate (mRNA-1287) against endemic human coronaviruses (HCoVs).
Moderna’s mRNA-based COVID-19 vaccine face stiff competition from
Pfizer
PFE
/
BioNTech
BNTX
’s Comirnaty.
Like Moderna’s SpikeVax, Pfizer and BioNTech’s mRNA-based COVID-19 vaccine, Comirnaty, has also received full approval for adults in the United States.
In 2021, Comirnaty received authorization for use in children aged 6 months to 11 years old in the United States and Europe. The booster dose of the vaccine also received approval in the United States, in the same year. In March 2022, a second booster dose was authorized by the FDA.
Pfizer and BioNtech are working on a new Omicron-based vaccine candidate and on a bivalent COVID-19 vaccine candidate.
Zacks Rank and A Stock to Consider
Moderna currently carries a Zacks Rank #3 (Hold).
A better-ranked large drugmaker is
Merck & Co.
MRK
, carrying a Zacks Rank #2 (Buy). You can see
the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here
.
Merck’s earnings per share estimates for 2022 have remained steady at $7.31 for the past 30 days. The same for 2023 has decreased from $7.19 to $7.15 in the same time frame. Shares of MRK have returned 26.1% in the year-to-date period.
Earnings of Merck missed estimates in one of the trailing four quarters and beat the same on the remaining three occasions, the average surprise being 13.42%.
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