Authorisation from the European Medicines Agency will hold coronavirus vaccine makers liable should anything go wrong, MEP Peter Liese said on Thursday.
Liese was holding a virtual briefing discussing the EMA’s process of giving a market distribution license to a coronavirus vaccine developed by Pfizer-BioNTech, after Britain announced that it had granted emergency authorisation for the drug to be administered as from next week on Wednesday.
The German MEP, who sits on the European Parliament's Committee for the Environment, Public Health and Food Safety, said that while British authorities certainly have looked at the data and would not in good conscience approve a vaccine they thought to be unsafe, the EMA requests a higher volume of data and at a deeper granularity that required time to analyse.
“BioNTech needs to deliver more data to the EU than it did to the UK. When the granularity of the data is bigger, you are going deeper into the process which makes sure the product is more safe,” Liese said.
“When you’ re striving for safety, it’s good to wait an extra two or three weeks for results.”
Additionally, authorisation by the EMA would regulate the Pfizer-BioNTech vaccine under European law, holding the company liable for any foreseeable negative outcome related to the vaccine, Liese said.
While member states are free to regulate the jab imminently through an emergency authorisation, should they do so, liability no longer applies, he added.
Liese also said that the UK’s decision to license the vaccine ahead of the rest of Europe would not have an effect on the supply available to member states, as the stock allocated for use by the EU in January was already being manufactured and stored.
Up to 50 million doses will be available for member states to begin vaccinating people in January, with EU health ministers finalising their strategies for immunisation programs in the coming days.
Liese said that it was unlikely that there would not be a uniform date for member states to begin vaccinations, however, supply chains will start operating their routes to each member state on the same day.
Should the Moderna vaccine near closer to authorisation by the EMA, it is likely that more doses of the jab will become available to EU citizens, he said.
The treaty negotiated by the EU allocates 200 million doses from Pfizer-BioNTech with the option of extending to 300 million as necessary. The EU is also expecting some 160 million doses from Moderna.
“We will not have enough vaccines for all Europeans to be vaccinated until March or April. We have to prioritise and that is why member states are planning carefully,” Liese said.
“In the meantime it’s important that we start vaccination among frontliners and high risk groups and I am convinced that the pandemic will start to lose some of its power.”
“It would be a ridiculous horror if people continued to die just before the pandemic is over and a vaccine could have protected them.”