Pfizer Confirms It Ended COVID-19 Vaccine Pregnancy Trial Early

The Epoch Times Header

Pfizer has confirmed it stopped its clinical trial analyzing COVID-19 vaccine safety and efficacy in pregnant women early.

The company said that enrollment in the study stopped in the fourth quarter of 2021 after health experts, including the U.S. Advisory Committee on Immunization Practices, began recommending the Pfizer-BioNTech vaccine for pregnant women.

โ€œWith the declining enrollment, the study had insufficient sample size to assess the primary immunogenicity objective and continuation of this placebo controlled study could no longer be justified due to global recommendations,โ€ Pfizer told journalist Maryanne Demasi.

The U.S. Food and Drug Administration and European Medicines Agency both agreed to the proposal to halt the study, according to Pfizer. The regulatory agencies did not respond to requests for comment.

An internal email, disclosed in a court case, previously indicated Pfizer had stopped enrollment early.

โ€œThe study enrolment was stopped with incomplete numbers because recruitment was slow and it became unreasonable/inappropriate to randomize pregnant women to placebo given the amount of observational evidence that the vaccine is safe and effective, coupled with increasing number of technical committees supporting immunization of pregnant women,โ€ย Jelena Vojicic, vaccines medical lead at Pfizer Canada, wrote inย the 2022 email.

The randomized, placebo-controlled study in question was launched in early 2021 after pregnant women were excluded from the phase three trial that led to the authorization of the vaccine in the United States and a number of other countries.

Pfizer and BioNTechย saidย they expected to enroll some 4,000 pregnant women but actually enrolled just 349, according to theย trial record. Some of the participants were to receive a vaccine while others would receive a placebo, according to the original protocol. Women were expected to be studied for seven to 10 months.

The trial was listed as completed on Aug. 23, 2022, but no results have been released yet.

By Zachary Stieber

Read Full Article on TheEpochTimes.com

The Epoch Times
The Epoch Timeshttps://www.theepochtimes.com/
Tired of biased news? The Epoch Times is truthful, factual news that other media outlets don't report. No spin. No agenda. Just honest journalism like it used to be.

Columns

Viewers like you

There is no constitutional authority for any spending on public broadcasting โ€“ period. Any questions: See Article 1, Section 8 of the U.S. Constitution.

Beyond the Trump-Musk fallout?

We are witnessing an unprecedented, unhinged Democrat effort to use lawfare, big Democrat donors, street theater, congressional disruptions, potty-mouth videos, the administrative state, the legacy media, and discredited pollsters to stop the Trump agenda.

Trans-wormal

No worm ever said "I am anthropomorphizing, I am a butterfly" to a toad or flock of geese and expected acknowledgement and support.

In Greenlandโ€™s Icy Capital, Past Troubles Haunt Hopes for the Future

As geopolitical realities and ongoing economic growth raise the stakes, U.S. interest in Greenland and the dream of independence may change things in a big way.

How a Chinese Government Statistician Was Forced to Report Fake Data

Chinese local govt employee produced a non-authorized report on bees and was visited by police and threatened with being sent to a mental hospital.

News

Supreme Court Sides With DOGE in Social Security, Records Cases

The Supreme Court handed DOGE two big wins late on June 6 in its effort to reduce the size of the federal government.

Kilmar Abrego Garcia Returns to US to Face Criminal Charges

Kilmar Abrego Garcia, a citizen of El Salvador, is on his way back to the US, where he will face criminal charges for allegedly smuggling illegal immigrants.

White House Adviser Gives Update on DOGEโ€™s Future Amid Muskโ€“Trump Spat

A top White House adviser said DOGEโ€™s work will likely continue amid a spat between its former chief, Elon Musk, and President Donald Trump.

Trump Administration Asks Supreme Court to Allow Dismantling of Education Department

Trump admin asked Supreme Court to allow it to resume dismantling U.S. Dept of Education, following a lower courtโ€™s previous order halting process.

FTC Warns of Rising Student Loan Scams, Says Fraudsters Took Millions From Borrowers

FTC is warning borrowers to steer clear of student loan debt-relief scams, after shutting down group of companies that allegedly charged millions in illegal fees and left customers worse off.

Walmartโ€™s Drone Delivery Coming to 5 More US Cities

Walmart is set to launch its drone delivery service in five more U.S. cities: Atlanta, Charlotte, Houston, Orlando, and Tampa, the company.

Court Orders Trump Administration to Restore AmeriCorps Funding to States

Federal court ordered Trump admin to restore AmeriCorps funding to states. The ruling comes as part of a lawsuit filed by 24 states and DC.

Tax Deductions You Can Take Without Itemizing

Itโ€™s not always beneficial to itemize. With IRSโ€™s current standard deduction for 2025 most Americans who canโ€™t itemize go with standard deduction.
spot_img

Related Articles