After authorizing the use of the Pfizer/BioNTech vaccine, the European Medicines Agency (EMA) warned that it should only be given to pregnant women in certain cases.
“We recommend a case by case decision,” Harald Enzmann, the chair of EMA Human Medicines Committee (CHMP), said during a briefing. According to the official, the agency believes that the companies that developed the vaccine did not produce enough data in their clinical trials on the potential risks that it may pose to pregnant women.
While this is currently the EMA’s position, Enzmann was clear that if Pfizer or BioNTech conduct further tests and present more data showing it has no negative impact on pregnant women, then they are open to changing their recommendation.
Last week, while the EMA was assessing the vaccine, it released a statement discussing the approval process: “A vaccine’s benefits in protecting people against COVID-19 must be far greater than any side effect or potential risks.”
Along with the concerns around giving the jab to pregnant women, the EU regulator indicated that it has reservations about the effects it could have on children, stating it should only be given to people over the age of 16.
The Pfizer/BioNTech Covid-19 jab has faced some problems before, as several individuals who received it experienced allergic reactions. However, there is no information on any massive setbacks during the vaccination or a growing number of people experiencing negative effects.
Still, the UK updated its guidance shortly after the rollout began, warning people who have a history of severe allergic reactions to avoid the vaccine.
In the US, the FDA revealed that five individuals experienced allergic reactions, suggesting it could be down to the polyethylene glycol that is present in the Pfizer/BioNTech and Moderna vaccines.