Pfizer
PFE
and partner
BioNTech
BNTX
announced positive data from a phase II/III study, which evaluated a booster/third dose of their mRNA-based COVID-19 vaccine Comirnaty in children aged between 5 years and 11 years.
The phase II/III study evaluated the safety and immunogenicity of a third dose of Comirnaty in 140 children who had already received a primary two-dose regimen of the vaccine. Data from a sub-analysis of 30 immune human sera from the study showed a 36-fold increase in neutralizing antibodies against the Omicron variant.
The immunogenicity data gathered from all study participants also showed a 6-fold increase in neutralizing antibodies against the SARS-CoV-2 wild-type strain after receiving the booster dose of the vaccine.
Based on these results, Pfizer/BioNTech intend to apply for an emergency use of Comirnaty’s booster dose among children in the United States and in the European Union (EU) besides other countries across the globe.
Shares of Pfizer have declined 10% this year so far against the
industry
’s 7.3% rise.
Image Source: Zacks Investment Research
The BioNTech stock has plunged 32% this year so far compared with the
industry
’s 13.3% decline.
Image Source: Zacks Investment Research
Comirnaty is currently the only vaccine authorized for emergency use by the FDA as a primary two-dose regimen in individuals aged five years and above. While a booster dose of the vaccine is authorized for use in individuals aged 12 years and above, the regulatory agency also authorized the same for certain immunocompromised children aged between 5 years and 11 years.
In the EU, while a primary two-dose regimen of Comirnaty is authorized for use in individuals aged five years and beyond, a booster dose of the vaccine is currently only authorized for 18 years and above. A regulatory application in the EU is currently under review seeking authorization for use of a booster dose in individuals aged 12 years and more.
Per a CNN
article
, the COVID-19 infection once again picked up the pace in the United States with nearly all of the infections resulting from the Omicron BA.2 subvariant. This spike in the number of infected cases once again reignited demand for the COVID vaccines. A rise in vaccination programs could help curb the infection spread.
Pfizer/BioNTech’s Comirnaty faces stiff competition from another mRNA vaccine marketed by
Moderna
MRNA
, a primary two-dose regimen of which is also approved by the FDA. The booster dose of Moderna’s COVID vaccine is also approved for use in adults. MRNA is yet to gain the FDA authorization for use of its COVID vaccine either as a primary-regimen or as a booster dose in individuals under 18 years of age.
Last month, the FDA
authorized
the use of a second booster dose of Pfizer/BioNTech and Moderna’s COVID vaccines for older adults (aged 50 years and above) and some immunocompromised people.
Zacks Rank & Key Pick
Both BioNTech and Pfizer currently carry a Zacks Rank #3 (Hold). A better-ranked stock in the overall healthcare sector is
Collegium Pharmaceutical
COLL
, which sports a Zacks Rank #1 (Strong Buy) at present. You can see
the complete list of today’s Zacks #1 Rank stocks here
.
Collegium Pharmaceutical’s earnings per share estimates for 2022 have increased from $3.79 to $5.59 in the past 60 days. The same for 2023 has increased from $4.79 to $7.44 in the past 60 days. Shares of COLL have risen 2.7% year to date.
Earnings of Collegium Pharmaceutical missed estimates in three of the last four quarters and beat the mark on one occasion, the negative surprise being 57.6%, on average.
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