US pharma giant Pfizer and its German partner BioNTech have kicked off an international study into the safety and effectiveness of their coronavirus vaccine in pregnant women, with 4,000 volunteers from nine countries taking part.
Healthy pregnant women in the US have already received their first shots of the Pfizer/BioNTech jab as part of the research, the companies announced on Thursday. They’ll soon be joined by fellow test subjects in Canada, Argentina, Brazil, Chile, Mozambique, South Africa, the UK and Spain.
Women aged 18 and older are to be inoculated during weeks 24-34 of gestation, the later stages of pregnancy. The interval between the two shots will be 21 days – the same as during the general clinical trial for the jab last year.
Each woman will be part of the study for around seven to 10 months, depending on whether she was given the actual vaccine or a placebo, according to the details of the trial. Those injected with a placebo are to be provided with an opportunity to receive the vaccine after giving birth, while remaining a part of the trials.
The Pfizer/BioNTech jab had previously been tested on pregnant animals and no new risks were revealed, the companies said in a statement on Thursday. US regulators forbid human trials until it’s proven that the vaccine doesn’t harm the fetus or cause miscarriage in animals.
However, the study isn’t intended to establish if the immunization provides any protection against the coronavirus to babies after they’re born.
The creators of the British vaccine, AstraZeneca and the University of Oxford, recently said that they’re planning to start a study on the effects of their jab in pregnant women in the coming months.
Pregnant women are believed to be at higher risk of developing severe forms of Covid-19, with some studies also linking the virus to premature birth. However, they have been excluded from previous vaccine trials due to the lack of information on the safety and effectiveness of the jabs on pregnancy.
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In late January, the World Health Organization (WHO), which had previously advised pregnant women against receiving the vaccine from another US drugmaker Moderna, said that those at high risk of exposure to Covid-19, including medical workers, may choose to be inoculated with it after consulting a doctor.
“Based on what we know about this kind of vaccine, we don’t have any specific reason to believe there will be specific risks that would outweigh the benefits of vaccination for pregnant women,” the WHO pointed out.
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