Pfizer Inc.
PFE
and
BioNTech
BNTX
announced that they have submitted the initial data from a pivotal phase II/III study evaluating COVID-19 vaccine, Comirnaty, in children 5 years to less than 12 years of age to the FDA. The companies plan to seek authorization for Comirnaty for emergency use in children in the aforementioned age group in the upcoming weeks.
Top-line data from the II/III study
were announced earlier this month. Data from the study showed that one month of immunization with two doses of Comirnaty resulted in SARS-CoV-2–neutralizing antibody geometric mean titer levels that were non-inferior to the level achieved in individuals aged 16 to 25 years of age in the previously completed clinical study. The safety profile of Comirnaty in children 5 years to less than 12 years of age was similar to that achieved in adults.
Please note that Pfizer and BioNTech evaluated a 10-microgram dose of Comirnaty in children 5 years to less than 12 years of age compared to the 30-microgram dose of the vaccine that is authorized/approved for adolescents and adults.
The study is also evaluating the vaccine in separate cohorts in children aged 6 months to 2 years and 2 years to 5 years. Data from these cohorts is expected in the fourth quarter of 2021.
Earlier this month, Comiranty became the first COVID-19 vaccine to receive EUA for a
third dose
for all adults aged 65 years and above in the United States.
Apart from Pfizer and BioNTech,
Moderna
MRNA
is also evaluating its COVID-19 vaccine in
children
.
Shares of Pfizer have gained 16.9% so far this year compared with the
industry
’s increase of 8.2%.
Image Source: Zacks Investment Research
In a separate press release, Pfizer and its partner
Valneva
VALN
announced positive data from a phase II study evaluating their Lyme disease vaccine candidate, VLA15-202. Data from the study showed that antibody titers, the measure of immune response against a viral infection, declined after 18 months of complete primary vaccination series and remained above baseline.
Based on the 18-month data, the companies went ahead to study a booster dose to increase immune response in previously vaccinated individuals with the Lyme disease vaccine candidate. Data following one month of immunization with a booster demonstrated 100% seroconversion rates with a significant rise in antibody titers. The study is currently monitoring the persistence of antibody responses following the booster dose.
Zacks Rank
Pfizer currently carries a Zacks Rank #2 (Buy). You can see
the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here
.
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