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Mozambicans participate in Covid vaccine trial for pregnant women

Drug maker Pfizer and its German partner BioNTech have started trials in nine countries to test the safety and effectiveness of their Covid-19 vaccine in pregnant women. The companies announced on Thursday (18-02) that the first volunteers from among the about 4,000 healthy, pregnant women aged 18 and over had already been dosed.

Women from the United States, Canada, Argentina, Brazil, Chile, Mozambique, South Africa, Spain and the United Kingdom were included.

William Gruber, senior vice-president of vaccine clinical research and development for Pfizer, said in a statement that “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,” added  Gruber.

The Phase 2/3 trial is designed as a randomised, 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 randomised to receive the vaccine or placebo.

The study will also 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.

Source: Deutsche Welle via clubofmozambique

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