Pfizer, BioNTech start testing COVID-19 vaccine in pregnant women

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Pfizer, BioNTech start testing COVID-19 vaccine in pregnant women

CHICAGO, Feb 18 (Reuters) – Pfizer Inc and BioNTech
SE have started an international study with 4,000
volunteers to evaluate the safety and effectiveness of their
COVID-19 vaccine in healthy pregnant women, the companies said
on Thursday.

Pregnant women are at higher risk of developing severe
COVID-19, and many public health officials have recommended some
women in high-risk professions take coronavirus vaccines even
without proof they are safe for them.

Dr. William Gruber, senior vice president of vaccine
clinical research and development for Pfizer, said in an
interview the company could have results by the fourth quarter
of 2021.

Gruber said data so far suggest that pregnant women with
COVID-19 have higher rates of severe disease. They also have
higher rates of pregnancy complications, such as premature
birth, compared with pregnant women not infected by the
coronavirus.

That increased risk is why U.S. regulators and public health
advisers “are interested in doing this in the first place – so
people can be fully informed about the safety profile,” he said.

Last week, the U.S. National Institutes of Health called for
greater inclusion of pregnant and lactating women in COVID-19
vaccine research.

Bioethicists, vaccine and maternal health experts have
argued for years that pregnant women should be included early in
trials of pandemic vaccines so they would not need to wait until
long after a successful one emerges.

Nevertheless, pregnant women were excluded from the large
U.S. trials used to obtain emergency use authorization of
COVID-19 vaccines.

Drugmakers have said they first need to make sure the
vaccines are safe and effective more generally.

In the United States, regulators require drugmakers to
conduct safety studies in pregnant animals before vaccines are
tested in pregnant women to ensure they do not harm the fetus or
lead to a miscarriage. The companies said those studies revealed
no new risks.

Pregnant women in the United States have already received
their first doses, the companies said.

The new study will test pregnant women aged 18 and older in
the United States, Canada, Argentina, Brazil, Chile, Mozambique,
South Africa, the UK and Spain.

Women will receive the vaccine during weeks 24-34 of
gestation, getting two shots 21 days apart – the same regimen
used in the larger clinical trial.

Shortly after giving birth, participants who got a placebo
in the trial will be given an opportunity to get the actual
vaccine, while remaining part of the study, the companies said.

The trial will also assess whether vaccinated pregnant women
transfer protective antibodies to their babies.

(Reporting by Julie Steenhuysen in Chicago and Michael Erman in
Maplewood, New Jersey
Editing by Bill Berkrot)