We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Pfizer (PFE), BioNTech Test COVID-19 Vaccine in Pregnant Women
Read MoreHide Full Article
Pfizer Inc. (PFE - Free Report) and partner BioNTech SE (BNTX - Free Report) announced that the first participants have been dosed in a mid-to-late-stage study on their COVID-19 vaccine in healthy pregnant women 18 years of age and older.
The global phase II/III study will further evaluate the safety, tolerability and immunogenicity of the Pfizer-BioNTech’s COVID-19 vaccine (BNT162b2) in the above-mentioned population group. The study will enroll approximately 4,000 healthy pregnant women (18 years of age or older) in the United States and various other countries, vaccinated during 24 to 34 weeks of gestation.
The study will evaluate two doses of BNT162b2 or placebo that will be administered 21 days apart. Each woman will participate in the study for approximately 7 to 10 months, depending on whether she was randomized to receive the vaccine or placebo.
Moreover, the study will assess the safety of infants of the vaccinated pregnant women and the transfer of potentially protective antibodies to their infants. These infants will be monitored through approximately six months of age. The pregnant women enrolled in the study will be unblinded shortly after giving birth to allow those women who originally received placebo to be vaccinated while being part of the study.
We note that the vaccine has been authorized for emergency use by the FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older.
Expansion in additional population groups will further increase the growth potential.
Pfizer and BioNTech plan to initiate further studies in children between 5 years and 11 years over the next couple of months and in those younger than 5 years, later in 2021. Meanwhile, the safety and efficacy in subjects 12 to 15 years of age are already being evaluated in the phase III study (C4591001) and the relevant data are planned to be submitted to the regulatory authorities in the second quarter of 2021. Studies to further evaluate the vaccine in people with compromised immune systems are also being planned.
Pfizer’s stock has lost 6.1% in the year so far compared with an increase of 0.9% for the industry.
The FDA has also granted an EUA to Moderna’s (MRNA - Free Report) COVID-19 vaccine, mRNA-1273, in individuals 18 years of age or older.
Meanwhile, Johnson & Johnson (JNJ - Free Report) recently submitted a conditional Marketing Authorization Application (cMAA) to the European Medicines Agency (EMA) seeking authorization for its investigational single-dose Janssen COVID-19 vaccine candidate.
The COVID-19 outbreak has shifted consumer behavior dramatically, and a handful of high-tech companies have stepped up to keep America running. Right now, investors in these companies have a shot at serious profits. For example, Zoom jumped 108.5% in less than 4 months while most other stocks were sinking.
Our research shows that 5 cutting-edge stocks could skyrocket from the exponential increase in demand for “stay at home” technologies. This could be one of the biggest buying opportunities of this decade, especially for those who get in early.
Image: Bigstock
Pfizer (PFE), BioNTech Test COVID-19 Vaccine in Pregnant Women
Pfizer Inc. (PFE - Free Report) and partner BioNTech SE (BNTX - Free Report) announced that the first participants have been dosed in a mid-to-late-stage study on their COVID-19 vaccine in healthy pregnant women 18 years of age and older.
The global phase II/III study will further evaluate the safety, tolerability and immunogenicity of the Pfizer-BioNTech’s COVID-19 vaccine (BNT162b2) in the above-mentioned population group. The study will enroll approximately 4,000 healthy pregnant women (18 years of age or older) in the United States and various other countries, vaccinated during 24 to 34 weeks of gestation.
The study will evaluate two doses of BNT162b2 or placebo that will be administered 21 days apart. Each woman will participate in the study for approximately 7 to 10 months, depending on whether she was randomized to receive the vaccine or placebo.
Moreover, the study will assess the safety of infants of the vaccinated pregnant women and the transfer of potentially protective antibodies to their infants. These infants will be monitored through approximately six months of age. The pregnant women enrolled in the study will be unblinded shortly after giving birth to allow those women who originally received placebo to be vaccinated while being part of the study.
We note that the vaccine has been authorized for emergency use by the FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older.
Expansion in additional population groups will further increase the growth potential.
Pfizer and BioNTech plan to initiate further studies in children between 5 years and 11 years over the next couple of months and in those younger than 5 years, later in 2021. Meanwhile, the safety and efficacy in subjects 12 to 15 years of age are already being evaluated in the phase III study (C4591001) and the relevant data are planned to be submitted to the regulatory authorities in the second quarter of 2021. Studies to further evaluate the vaccine in people with compromised immune systems are also being planned.
Pfizer’s stock has lost 6.1% in the year so far compared with an increase of 0.9% for the industry.
The FDA has also granted an EUA to Moderna’s (MRNA - Free Report) COVID-19 vaccine, mRNA-1273, in individuals 18 years of age or older.
Meanwhile, Johnson & Johnson (JNJ - Free Report) recently submitted a conditional Marketing Authorization Application (cMAA) to the European Medicines Agency (EMA) seeking authorization for its investigational single-dose Janssen COVID-19 vaccine candidate.
Pfizer currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
These Stocks Are Poised to Soar Past the Pandemic
The COVID-19 outbreak has shifted consumer behavior dramatically, and a handful of high-tech companies have stepped up to keep America running. Right now, investors in these companies have a shot at serious profits. For example, Zoom jumped 108.5% in less than 4 months while most other stocks were sinking.
Our research shows that 5 cutting-edge stocks could skyrocket from the exponential increase in demand for “stay at home” technologies. This could be one of the biggest buying opportunities of this decade, especially for those who get in early.
See the 5 high-tech stocks now>>