EU regulator says Pfizer vaccine should be considered case by case for pregnant women
The European drug regulator on Monday said the use of the COVID-19 vaccine jointly developed by U.S. company Pfizer and its German partner BioNTech on pregnant women should be considered case by case.
The European Medicines Agency (EMA) does not have enough data from the companies’ clinical trials on the potential risks to pregnant women, Harald Enzmann, chair of the EMA’s Human Medicines Committee, said in a briefing.
The agency can change its recommendation if more information becomes available, he said without disclosing the circumstances under which the vaccine might by deemed appropriate for pregnant women.
Enzmann also said he would urge caution in using the vaccine on people with a known history of anaphylaxis reaction after several cases of allergic reactions to the vaccine in the United States and United Kingdom.
His comments followed the regulator’s approval for use of the COVID-19 vaccine for people over the age of 16, putting Europe on course to start inoculations within a week.
Enzmann defended the independence of the EMA in the approval process despite suggestions in some quarters that there may have been political pressure to speed the process for the EU after Britain had already begun vaccinations.
“The focus was exclusively on the science,” he said, adding that the number of member states involved meant there could be “political whitewashing or adaption”.