COVID vaccines safe during pregnancy: EU watchdog

The European Commission is leading talks on a waiver of intellectual property (IP) rights on COVID vaccines and treatments. However, critics from the pharmaceutical industry argue that changes to the current IP system could jeopardise research and development in their sector. Photo: Shutterstock, siam.pukkato

Studies of pregnant women found the two most widely used COVID vaccines pose no risk to mothers or babies, the EU’s drug regulator said on Tuesday (18 January).

Research involving some 65,000 women showed “growing evidence” that the Pfizer and Moderna jabs did not cause pregnancy complications, the European Medicines Agency (EMA) said.

The shots also provided increased protection against hospitalisation and death, particularly in late pregnancy, said the watchdog.

“The review did not find any sign of an increased risk of pregnancy complications, miscarriages, preterm births or adverse effects in the unborn babies following mRNA COVID-19 vaccination,” the EMA said in a statement.

Pfizer and Moderna both use new Messenger RNA technology.

The Amsterdam-based regulator said it had carried out a “detailed review of several studies” involving around 65,000 pregnancies at different stages.

“The review of real-world evidence suggests that the benefits of receiving mRNA COVID-19 vaccines during pregnancy outweighs any possible risks for expectant mothers and unborn babies,” it said.

Pregnancy itself had been associated with a higher risk of severe COVID in the second and third trimesters, so expectant mothers should get vaccinated, it said.

The EMA said it would now review data for the other vaccines it has authorised “as they become available”.

Start working on upgrades

The European Union drugs regulator also said pharmaceutical companies should work on more than one upgraded COVID-19 shot, tailored to the fast-emerging Omicron variant and versions that address a combination of variants.

“What we are hearing from other regulatory agencies also is that it is important not to exclude any options,” the European Medicines Agency’s head of vaccines strategy, Marco Cavaleri, told a media briefing on Tuesday.

Vaccine makers working on redesigning their shots to address Omicron, which is crowding out the Delta variant in many regions of the world, include BioNTech-Pfizer, Moderna, and the alliance between them AstraZeneca and Oxford University.

BioNTech Chief Executive Ugur Sahin last week questioned the need to develop products tailored to more than just Omicron because immunity against Omicron is likely to confer protection against preceding virus variants.

“Omicron infection and an Omicron vaccine will most likely, with a high probability, also boost immune responses against all existing variants,” Sahin had said in an analyst call as part of J.P.Morgan’s virtual healthcare conference.

“What is the value if we now combine a potential Omicron vaccine with another variant as the Omicron vaccine alone would most likely do the job?” he added.

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