Covid-19 vaccine: Pfizer begins clinical trial in pregnant women
Pfizer and BioNTech have started testing their Covid-19 vaccine in pregnant women. Four thousand women who are between 24- and 34-week pregnant have been enrolled for the clinical trial.
”This marks the first such trials to include pregnant people in the United States,” reports say.
The trial is designed to assess safety and tolerability of the vaccine and how well it provoked an immune response.
According to report, Pfizer and BioNTech have started an international study comprised of 4,000 volunteers, including pregnant people aged 18 and older in the US, Canada, Argentina, Brazil, Chile, Mozambique, South Africa, the UK and Spain.
According to Pfizer, ”the first doses will be administered in the US, and pregnant people will receive the vaccine during weeks 24 through 34 of gestation and will get two injections 21 days apart, which is the same process used in the larger clinical trial.”
Then, 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 new study will evaluate the safety and effectiveness of the manufacturers’ Covid-19 vaccine in healthy pregnant people, including whether antibodies are transferred to babies.
The Centres for Disease Control described it as “big, important news” because pregnant people are at higher risk of developing respiratory complications that require intensive care versus those who aren’t pregnant and because pregnant people are also more likely to be placed on a ventilator.
“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,” Senior Vice President of Vaccine Clinical Research at Pfizer, Dr. William Gruber stated.
The announcement of the study follows the call by the US National Institutes of Health for greater inclusion of pregnant and lactating people in Covid-19 vaccine research.
In the meantime, in the coming months, AstraZeneca Plc. and Johnson & Johnson are also planning to run trials on pregnant people.