EU lawmakers warn against ‘hasty’ approval for Covid vaccines after UK authorises Pfizer jab for general use

UK becomes first country in the world to give green light to Covid-19 vaccine

European lawmakers have described the UK’s emergency market authorisation of the Pfizer-BioNTech vaccine as “problematic”, as the EU’s drug regulator urged members states not to grant “hasty” approvals.

The UK has become the first country in the world to approve the Covid-19 vaccine developed by the two pharmaceutical companies, with an estimated 800,000 doses set to be made available next week.

In a statement released on Wednesday, the Department of Health and Social care said the government had accepted the recommendation from the UK’s independent regulators, the Medicines and Healthcare products Regulatory Agency (MHRA), to approve the vaccine for use among the general population.

“This follows months of rigorous clinical trials and a thorough analysis of the data by experts at the MHRA who have concluded that the vaccine has met its strict standards of safety, quality and effectiveness,” the statement read.

The request for emergency authorisation was submitted by BioNTech and Pfizer to the MHRA last month, though the agency — along with other regulators across the world — had already begun a rolling review of the phase-three trial data in order to accelerate the approval process.

Vaccines would typically be authorised by the European Medicines Agency (EMA) until the end of the Brexit transition on 31 December. However, under UK law, the MHRA has the power to temporarily authorise products in times of urgent public need.

The EMA, which oversees the approval process for vaccines in the EU, said its longer procedure to authorise vaccines was appropriate as it was based on more evidence and required more checks than the emergency procedure chosen by the UK regulator.

Asked about the British approval of the Pfizer-BioNTech vaccine, the agency said: “EMA considers that the conditional marketing authorisation is the most appropriate regulatory mechanism for use in the current pandemic emergency.”

EMA had said on Tuesday that, under this procedure, it would decide by 29 December whether to authorise Pfizer’s vaccine.

EU lawmakers were critical of the UK’s emergency approval, describing it as “hasty”.

“I consider this decision to be problematic and recommend that EU Member States do not repeat the process in the same way,” said Peter Liese, an EU lawmaker who is a member of German chancellor Angela Merkel’s party.

“A few weeks of thorough examination by the European Medicines Agency is better than a hasty emergency marketing authorisation of a vaccine,” added Mr Liese, who sits on the European Parliament's Committee on the Environment, Public Health and Food Safety.

"BioNTech only a few hours ago sent the data to the medical agency in Europe, the EMA, for a conditional market licensing.

"That is why it is a bit problematic to say that ‘now everything is fine and you can start with the vaccination’."

It was "not a Brexit issue" — Germany could also have approved the vaccine under emergency powers — but EU member states had decided to wait for EMA, Mr Liese added.

"Other member states decided not to go for a national emergency authorisation," he said, except for Hungary, which is planning to use the Russian Sputnik V vaccine.

"The other member states think that it is necessary to look more carefully.”

Under EU rules, the Pfizer vaccine must be authorised by EMA, though member states can use an emergency procedure — like the UK has done — that allows them to distribute doses among their populations for temporary use.

“There is an obvious global race to get the vaccine on the market as fast as possible,” said Tiemo Wolken, an EU lawmaker from the socialist grouping, the second largest in the EU Parliament.

“However, I do believe that it is better to take the time and make sure that the quality, effectiveness and safety is guaranteed and matches our EU standards.”

Dr June Raine, head of the MHRA, said "no corners have been cut" in assessing the safety and efficacy data for the Pfizer-BioNTech vaccine.

"The safety of the public will always come first,” she told a Downing Street press briefing.

"This recommendation has only been given by the MHRA following the most rigorous scientific assessment of every piece of data so that it meets the required strict standards of safety, of effectiveness and of quality."

The checks conducted by the MHRA on the Pfizer vaccine are "equivalent to all international standards", Dr Raine added.

"The public can be absolutely confident that the standards that we have worked to are equivalent to standards around the world," the MHRA chief said.

Özlem Türeci, chief medical officer and co-founder of BioNTech, said the company has had “very positive experiences with all regulators around the world, including MHRA, FDA [the US Food and Drug Administration] and EMA.”

“You have to be aware of the fact that regulators are working on very compressed timelines around the clock to go through the dossiers of data. We have to come back with questions to answer,” she told a press briefing on Wednesday. “They have all been highly committed and engaged.”

Sean Marett, chief business and commercial officer at BioNTech, also defended the speed at which the MHRA had moved in granting emergency approval for the vaccine.

“The MHRA has asked the same level of detailed questions as any other agency and have focused on efficacy, the tolerance of the drug and the quality of production,” he said. “These three elements are key elements to any vaccine that any regulator will look in detail at. 

"I think the MHRA has been no different in that respect.”