Pfizer and BioNTech commence global clinical trial to evaluate COVID-19 vaccine in pregnant women

PfizerPfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today that the first participants have been dosed in a global Phase 2/3 study to further evaluate the safety, tolerability, and immunogenicity of the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) in preventing COVID-19 in healthy pregnant women 18 years of age and older.

"We are proud to start this study in pregnant women and continue to gather the evidence on safety and efficacy to potentially support the use of the vaccine by important subpopulations," said William Gruber M.D., Senior Vice President of Vaccine Clinical Research and Development, Pfizer. "Pregnant women have an increased risk of complications and developing severe COVID-19, which is why it is critical that we develop a vaccine that is safe and effective for this population. We are deeply thankful to the volunteers who are enrolling in the trial, and site investigators who are leading this work."

"Enabling broad access to our highly effective COVID-19 vaccine is an important goal for us. Now that we are seeing successful initial implementation of vaccine campaigns with BNT162b2 across the globe, it is time to take the next step and extend our clinical program to other vulnerable populations, such as pregnant women, to potentially protect both them and future generations," said Özlem Türeci, M.D., Chief Medical Officer of BioNTech.

The Phase 2/3 trial is designed as a randomized, placebo-controlled, observer-blind study in approximately 4,000 healthy pregnant women 18 years of age or older vaccinated during 24 to 34 weeks of gestation. The study will evaluate the safety, tolerability, and immunogenicity of two doses of BNT162b2 or placebo 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. The study will assess safety in infants of vaccinated pregnant women and the transfer of potentially protective antibody to their infants. Infants will be monitored through approximately six months of age. As established in the study protocol, after a participant's infant is born, maternal trial participants will be unblinded and those who were in the placebo group will receive the vaccine. Additional information about the study can be found at www.clinicaltrials.gov under the identifier NCT04754594.

Prior to conducting their COVID-19 vaccine clinical trial in pregnant women, Pfizer and BioNTech completed a developmental and reproductive toxicity (DART) study with BNT162b2, which was required by the regulatory authorities before starting the study in pregnant women. Those studies showed no evidence of fertility or reproductive toxicity in animals.

Pfizer is leveraging its expertise in conducting clinical trials in pregnant women, informed by the experience with its ongoing trials for vaccine candidates against Respiratory Syncytial Virus (Phase 3), and Invasive Group B Streptococcus Infection (Phase 2).

Pfizer and BioNTech expect to start additional studies in children between the ages of 5 and 11 over the next couple of months, and in children younger than 5 later in 2021. Safety and efficacy in subjects 12 to 15 years of age are already being evaluated in the global Phase 3 study (C4591001) and the relevant data are planned to be submitted to the regulatory authorities in the second quarter of 2021. The Companies are also planning studies to further evaluate the vaccine in people with compromised immune systems.

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564 (b) (1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. Please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) including Full EUA Prescribing Information available at www.cvdvaccine.com

The vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorizations Holder in the European Union, and the holder of emergency use authorizations or equivalent in the United States, United Kingdom, Canada and other countries in advance of a planned application for full marketing authorizations in these countries.

About Pfizer: Breakthroughs That Change Patients' Lives

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us.

About BioNTech

Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer.

Most Popular Now

AstraZeneca COVID-19 vaccine Vaxzevria authorised …

AstraZeneca's COVID-19 vaccine, Vaxzevria (ChAdOx1-S [Recombinant]), formerly AZD1222, has been granted a special approval for emergency use in Japan for active immunisat...

Pfizer and BioNTech to supply the European Union w…

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced a new agreement with the European Commission (EC) to supply 900 million doses of COMIRNATY®, the companie...

Takeda announces approval of Moderna's COVID-19 va…

Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) ("Takeda") today announced that the Ministry of Health, Labour and Welfare (MHLW) granted special approval under...

Sanofi and GSK initiate global Phase 3 clinical ef…

Today, Sanofi and GlaxoSmithKline plc (GSK) started enrolment in their Phase 3 clinical study to assess the safety, efficacy and immunogenicity of their adjuvanted recomb...

Sanofi and GSK COVID-19 vaccine candidate demonstr…

The Sanofi and GSK adjuvanted recombinant COVID-19 vaccine candidate achieved strong rates of neutralizing antibody responses, in line with those measured in people who h...

European Commission approves Venclyxto-based combi…

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission has approved Venclyxto® (venetoclax) in combination with hypomethylating agents, azacitidi...

Novartis reaches milestone delivery of 1 billion c…

Novartis announced that it has delivered one billion courses of antimalarial treatment since 1999. More than 90% of this artemisinin-based combination therapy (ACT) was s...

COVID-19 mRNA vaccines are immunogenic in pregnant…

Pregnant women with symptomatic COVID-19 have a higher risk of intensive care unit admissions, mechanical ventilation and death compared to non-pregnant reproductive age ...

Why are some COVID-19 vaccines working better for …

MSU researcher is studying, raising awareness about the role of sex in the efficacy of vaccines that make use of nanomedicine. If there's one take-home message for the...

Rogue antibodies wreak havoc in severe COVID-19 ca…

The development of antibodies to the COVID-19 virus has been the great long-term hope of ending the pandemic. However, immune system turncoats are also major culprits in ...

New vaccine platform: 'Two-one replicon-and-VLP-mi…

To stop the current SARS-CoV-2 pandemic, vaccines of high quality, safety, and efficacy are required. Scientists of the Paul-Ehrlich-Institut and the Ludwig Maximilian Un...

COVID-19 monoclonal antibodies reduce risk of hosp…

Monoclonal antibodies, a COVID-19 treatment given early after coronavirus infection, cut the risk of hospitalization and death by 60% in those most likely to suffer compl...