Pfizer
PFE
and its partner
BioNTech
BNTX
have completed the submission of an amendment request to their emergency use authorization (EUA) for their COVID-19 vaccine to the FDA, seeking authorization for use in children six months to under five years of age. Per a Reuters
article
, the FDA accepted their amendment request on Wednesday.
Pfizer and BioNTech have filed the EUA request to include a two-dose primary series followed by a third or booster dose for use in this younger population.
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.
The EUA amendment request for children below five years of age will be discussed by an FDA advisory panel scheduled to meet on Jun 15. The EUA request was filed based on strong immune response, high efficacy, a favorable safety profile of Pfizer and BioNTech’s primary series, and the booster dose of their COVID-19 vaccine in a clinical study.
The top-line data from a phase II/III study showed that the three-dose vaccine was as effective in the 6- to 24-month-old population and the 2- to under 5-year-old population as the second dose in the 16- to 25-year-old population. The vaccine’s efficacy was 80.3% in the above-mentioned age group.
Per a Reuters
article
, the U.S. government plans to start vaccination in children below five years of age as early as Jun 21. A potential authorization to Pfizer and BioNTech’s COVID-19 vaccine for these children will lead to the first authorized COVID-19 vaccine for this younger population. Although rival
Moderna
MRNA
is seeking EUA for the use of its COVID-19 vaccine in children below five years of age, there is uncertainty regarding a potential authorization from the FDA.
Moderna’s Spikevax is currently authorized/approved for use in adults only in the United States. Although it has gained authorization for certain younger population in other countries, a EUA request for the use of Spikevax in adolescents has been under review with the FDA since late last year. Additional data related to the safety and immunogenicity of a lower dose in adolescents compared to the requested dose in the EUA is delaying the authorization. Moderna is planning to file data from a study evaluating the lower dose soon. The company is also evaluating a booster dose of Spikevax for use in adolescents.
Moderna has also filed EUA requests with the FDA for the use of Spikevax in children aged 6 months to 11 years. However, the FDA is unlikely to authorize its use in the younger population before deciding on the use of Spikevax in adolescents.
In the year so far, Pfizer’s shares have declined 10.8% against the
industry
’s 4.4% increase.
Image Source: Zacks Investment Research
In a separate press release, Pfizer announced that it has filed a supplemental new drug application (sNDA) for its fibroids drug, Myfembree, to include long-term safety and efficacy data in its label from a phase III LIBERTY randomized withdrawal study. The withdrawal study included women who had completed the 24-week pivotal LIBERTY 1 and 2 studies, followed by an open-label extension study for additional 28 weeks. The top-line data from the withdrawal study demonstrated that continuation of treatment with Myfembree resulted in sustained improvements in menstrual bleeding for two years in 78.4% of women compared to 15.4% who discontinued the treatment and were given placebo.
The FDA is expected to provide its decision on the label expansion of Myfembree in January 2023.
Zacks Rank & Stock to Consider
Pfizer currently carries a Zacks Rank #3 (Hold).
Alkermes
ALKS
is a better-ranked biotech stock, sporting a Zacks Rank #1 (Strong Buy). You can see
the complete list of today’s Zacks #1 Rank stocks here
.
The Zacks Consensus Estimate for Alkermes’ 2022 loss per share has narrowed from 14 cents to 3 cents in the past 60 days. Shares of ALKS have risen 27.9% year to date.
Earnings of Alkermes beat estimates in each of the last four quarters, the average being 350.48%.
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