Immunologist rejects idea Covid-19 vaccines were approved too fast

Prof Luke O’Neill says pharmaceutical sector has highest standards of regulation and validation


Environment & Science Editor

Any notion that new Covid-19 vaccines are being rolled out across the world too quickly, and without sufficient evaluation of their safety does not stand up to scrutiny, according to immunologist Prof Luke O’Neill.

Speaking at online BT Young Scientist & Technology Exhibition forum on the science of vaccine development, he acknowledged “the speed question” was cropping up.


There was a lot of Pfizer-BioNTech vaccines being left on the shelf in the US, he pointed out, and the answer coming back from some people not taking it was that it was all happening “too quick”.

Prof O'Neill, who is based at Trinity College, rejected any suggestion they were being approved too hastily. The pharmaceutical sector had the highest standards of regulation and validation prior to approval, which were on a par with those of the aviation sector, he noted at the event in which some of Ireland's leading specialists on vaccines participated.

Dr Sarah Hudson of the University of Limerick, who specialises in drug delivery, highlighted the extensive research gone into mRNA vaccines over many years, though the vaccines using this technology developed by Pfizer-BioNTech and Moderna were new.

It was all about packaging the vaccines correctly in the biological sense and a lot of design strategy had gone into their delivery systems. Developing new Covid-19 vaccines would have been a lot slower if normal development routes were taken, she added.

There was much more sharing of research “because the need is great” in the current pandemic.

In the past, vaccines were developed in line with securing incremental funding, which inevitably led to delays, said UCC immunologist Dr Anne Moore.

With Covid-19 that approach was wiped out because of the urgent need for effective vaccines and there was “an opportunity to do things in parallel”. The lesson from all of this was the need for science to be continuously funded, she believed.

Ireland was fortunate to be part of the European Medicines Agency, which did not bend to political pressure on approvals, said Prof Abina Crean of UCC school of pharmacy. "There was no short cuts with this in the face of pressure to get it out there faster."

She underlined the critical need for vaccines with easy storage options. This had to be put in the context of the developing world, “where even a fridge is a potential issue and that last kilometre” before a vaccine is administered.

The potential from combining proteins with vaccines and then freeze-drying them was emerging, she confirmed, though new forms of injectables such as self-administered patches or microneedles were some time away.

Prof Crean said she expected that Pfizer was testing the possibility of freeze-drying their vaccine – currently it has to be stored at minus 70 degrees. "I would say there is a high chance of success on this."

On the issue of severe allergic reactions to the vaccine, Prof O’Neill said it had arisen in a very small number of cases due to known allergens; the additive polyethylene glycol and egg which were often used in delivery systems.

Those affected were already carrying EpiPens because of having “a slightly more active immune system”.

“The cases were easy to treat, but it’s something to keep an eye on,” he said.

As for advice for pregnant women, Dr Moore said they were not included in clinical trials because of “a theoretical risk”, though some women in the Pfizer trial became pregnant soon after getting the vaccine.

Studies were due to be submitted to regulators on this issue in coming weeks, she said, adding that she “would be shocked if there’s any risk”. The best advice in the meantime was to “wait a few weeks after vaccination if you want to become pregnant”.

Kevin O'Sullivan

Kevin O'Sullivan

Kevin O'Sullivan is Environment and Science Editor and former editor of The Irish Times