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Pfizer's (PFE) Comirnaty Booster Dose Achieves 95.6% Efficacy

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Pfizer Inc. (PFE - Free Report) and BioNTech (BNTX - Free Report) announced encouraging top-line data from a phase III study evaluating the efficacy and safety of the booster dose of its COVID-19 vaccine, Comirnaty, in individuals 16 years of age and older. The study evaluated the booster dose in individuals vaccinated who received Comirnaty during the initial regimen, with a median dosing interval of 11 months.

The booster dose has the same dosage strength of 30 micrograms as those in the primary series.

Data from the study demonstrated that Comirnaty’s booster dose achieved a relative vaccine efficacy of 95.6% compared to those who did not receive a booster. The booster dose restored vaccine protection against COVID-19 to the high levels achieved following completion of the initial two-dose regimen of the vaccine. The occurrence of symptomatic COVID-19 was measured from at least seven days after the booster, with a median follow-up of 2.5 months.

Pfizer and BioNTech are planning to submit the data from the late-stage study to several regulatory authorities across the globe, including the FDA and the European Medicine Agency, shortly.

Last month, the FDA granted emergency use authorization (EUA) to Pfizer’s booster dose of Comirnaty for individuals 65 years and older and individuals 18 through 64 years of age in high-risk groups. Data from the phase III study may support approval for the booster dose as well.

Meanwhile, Pfizer and BioNTech are looking to get authorization for Comirnaty for emergency use in children five years to less than 12 years of age. The companies submitted datafrom a pivotal phase II/III study to the FDA for the same last month.

Shares of Pfizer have gained 16.5% so far this year compared with the industry’s increase of 10.9%.

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Earlier this week, the FDA authorized a mix and match or heterologous administration of the booster doses of the three approved COVID-19 vaccines made by J&J (JNJ - Free Report) , Pfizer and Moderna (MRNA - Free Report) . The heterologous administration will allow inoculation of an individual with any of the three available booster jabs irrespective of the initial COVID-19 vaccine regimen. The Centers for Disease Control and Prevention (“CDC”) also recommended the use of booster dose for heterologous administration yesterday.

Tthe CDC also recommended the use of booster dose of COVID-19 vaccines from J&J and Moderna, which were authorized earlier this week.

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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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