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Our Public Health Agencies are Still up to Their Old Tricks

Our Public Health Agencies are Still up to Their Old Tricks
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Pfizer Failed To Disclose Risks Of Preterm Birth And Neonatal Death To Pregnant Women In RSV Vaccine Trial – Infinite Unknown

Pfizer Failed To Disclose Risks Of Preterm Birth And Neonatal Death To Pregnant Women In RSV Vaccine Trial – Infinite Unknown
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Pfizer Failed to Disclose Risks of Preterm Birth and Neonatal Death to Pregnant Women in RSV Vaccine Trial

Pfizer Failed to Disclose Risks of Preterm Birth and Neonatal Death to Pregnant Women in RSV Vaccine Trial
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Concerns over informed consent for pregnant women in Pfizer's RSV vaccine trial

Some experts have criticised Pfizer for not informing pregnant women in its trial of maternal respiratory syncytial virus vaccine that trials of a similar vaccine were halted over a potential risk of preterm birth. Others think that notification would have been premature and caused unnecessary anxiety. Hristio Boytchev reports

A debate has broken out over whether Pfizer should have told pregnant women participating in its trial of maternal respiratory syncytial virus (RSV) vaccination that a trial of a similar vaccine was halted over a safety signal around preterm birth, The BMJ can report. Both GSK and Pfizer were developing recombinant RSV F protein vaccines to inoculate pregnant women and protect their babies against RSV, a major cause of infant death globally.

GSK halted its phase 3 vaccine trial on 28 February 2022 after a safety signal emerged: a possible increased risk of preterm births and neonatal deaths. In the vaccine arm, 6.81% of births were preterm (95% conf ....

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We'll soon have tools to curb RSV. Can we put them to good use?

There are sizable hurdles standing in the way of the implementation of both a new vaccine and a monoclonal antibody. ....

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