A Cork-based expert in advanced therapies has said that approval of the Pfizer/BioNTech vaccine in Europe is positive news that gives us “highly needed means to fight the pandemic and return to normal”.
It was confirmed today by Minister for Health Stephen Donnelly that the European Medicines Agency (EMA) will conduct a final review of the Pfizer/BioNTech vaccine on December 29 and, if approved, could begin to be distributed in Ireland from early January.
Mr Donnelly said that the EMA indicated that the approval of a second vaccine from Moderna will be decided upon at a second meeting on January 12.
Lecturer in advanced therapies at the University College Cork’s (UCC) School of Pharmacy, Dr Piotr Kowalski said that the news “is very positive”.
“It gives us highly needed means to fight the pandemic and return to normal,” he said.
Explaining how the mRNA vaccine works, Dr Kowalski, who is an HRB funded Emerging Investigator for Health and the inventor of two patents on RNA delivery technologies, said: “Traditional vaccines utilize the inactivated virus or antigen protein itself, manufactured in a cell-based process that takes months to set up and run. With mRNA vaccines, the patient’s own body becomes the antigen factory.
“The speed with which mRNA vaccine candidates can be designed and produced is a key advantage of this new vaccine technology, for Moderna, it took a total of 25 days from sequence selection to vaccine manufacture,” he said.
Speaking of the effectiveness of the vaccine, he said that the clinical trials, which showed 94% effectiveness in protecting against Covid-19, “revealed no serious safety concerns, with potential transient reactions that should not dissuade people from getting vaccinated”.
“Two months of follow-up safety data after the second dose are required for the regulatory approval by the FDA, while long-term safety is being evaluated,” he said.
Speaking about the rollout of the vaccine, Dr John Sheehan of Blackpool Bridge Surgery, said that general practices would be good places to administer the vaccine.
“We know our patients and we can identify who is at risk and if there's a limited supply, it would be easier to follow the criteria. It's quite hard to identify people at a population level in terms of who is at high risk, it would be easier with nursing homes, but in terms of the general population, I think it would be harder,” he said.
Dr Sheehan said that difficulties in storing the vaccine in general practices may occur if the vaccine is “required to be stored at temperatures that normal freezers can't sustain”, in which case he said it would “make more sense to do it as was done with the Swine Flu vaccine which was given at vaccination clinics in Neptune Stadium and big centralised places”.
Pfizer and Moderna have this week submitted their vaccine trial data to the EMA with Moderna set for its final examination by experts on January 12.
The Pfizer drug is being rolled out in the UK and Northern Ireland next week after it was approved by the UK’s Medicines and Healthcare Products Regulatory Agency.