Drug companies start pregnancy vaccine study
The Associated Press
February 28, 2021
NEW YORK — Drugmaker Pfizer and German partner BioNTech have
begun a nine-country study of their COVID-19 vaccine in pregnant
The companies said the first volunteers have received shots
in the study, which is to enroll about 4,000 healthy pregnant
women 18 years old and older. Some will receive the two-dose
vaccine and others dummy shots, three weeks apart, and between
24 weeks and 34 weeks into their pregnancies.
The volunteers will be followed for seven months to 10
months, depending on whether they received vaccine or placebo,
to see how effective and safe the vaccine is in pregnant women.
Women in the U.S., Canada, Argentina, Brazil, Chile, Mozambique,
South Africa, Spain, and the U.K. will be included.
"Pregnant women have an increased risk of complications and
developing severe COVID-19," Dr. William Gruber, Pfizer’s head
of vaccine clinical research and development, said in a
statement. "It is critical that we develop a vaccine that is
safe and effective" for them.
Women known to be pregnant were excluded from prior studies
of the vaccine, which has emergency use authorization in the
U.S., the European Union, and other countries.
Once the babies are born, mothers who received dummy shots
will be given the vaccine.
The study will assess effects on the infants for about six
months, checking for safety and whether they received
potentially protective antibodies from their mothers.
The companies plan later this year to begin vaccine testing
in children, ages 5 to 11 and younger than five, and to test
their vaccine in people with weakened immune systems. Results of
their study in children between 12 and 15 years old are
currently being evaluated.