Pfizer (PFE), BioNTech Test COVID-19 Vaccine in Pregnant Women

Pfizer Inc. PFE and partner BioNTech SE BNTX 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 COVID-19 vaccine, mRNA-1273, in individuals 18 years of age or older.

Meanwhile, Johnson & Johnson JNJ 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>>


Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
 
Johnson & Johnson (JNJ): Free Stock Analysis Report
 
Pfizer Inc. (PFE): Get Free Report
 
Moderna, Inc. (MRNA): Free Stock Analysis Report
 
BioNTech SE Sponsored ADR (BNTX): Free Stock Analysis Report
 
To read this article on Zacks.com click here.
 
Zacks Investment Research

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

More Related Articles

Info icon

This data feed is not available at this time.

Data is currently not available

Sign up for the TradeTalks newsletter to receive your weekly dose of trading news, trends and education. Delivered Wednesdays.