The UK has become the first country in the world to authorise the Pfizer/BioNTech vaccine for use, with the rollout due to start next week. Amid the excitement, Matt Hancock told an interviewer “It is absolutely clear that because we’ve left the EU I was able to change the law so that the UK alone could make this authorisation decision. So because we’ve left the EU, we’ve been able to move faster.”
Jacob Rees Mogg and Nadine Dorries made similar comments.
But it’s not correct. Here’s why, according to Channel.
Today’s decision comes from the UK’s independent Medicines and Healthcare products Regulatory Agency (MHRA). It’s long worked in tandem with the European Medicines Agency (EMA) deciding which drugs are safe for use.
When we were part of the EU, the EMA had areas of jurisdiction that meant only it could make decisions about certain types of medicine, including vaccines. National regulators like the MHRA couldn’t get involved.
When the UK left the EU on 31 January this year, we entered the “transition period”, which means the European regulations we adopted during our time in the trade bloc are still in effect until the end of 2020.
That includes the rule that says vaccines generally must be authorised by the EMA instead of national regulators.
But as a UK government press release from 23 November 2020 states: “if a suitable COVID-19 vaccine candidate, […] becomes available before the end of the transition period, EU legislation which we have implemented via Regulation 174 of the Human Medicines Regulations allows the MHRA to temporarily authorise the supply of a medicine or vaccine, based on public health need.”
So even if we were still a member of the EU, the UK regulator would have been able to take this decision on its own because EU law already allows it. Incidentally, that legislation took effect in the UK in 2012, long before Brexit was on the cards.
Asked whether Brexit had sped up the process, the head of the MHRA, Dr June Raine, said today: “We have been able to authorise the supply of the vaccine using provisions under European law which exist until 1 January.”
She added that the regulator’s “speed or our progress has been totally dependent on the availability of data in our rolling review, and the rigorous assessment and independent advice we have received”.
Leapfrogging the U.S. — and weeks ahead of a similar decision for the rest of Europe — among the first concerns is whether the U.K. has taken a shortcut in green lighting the Pfizer/BioNTech jab.
The message from the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) Wednesday was definitive. “No corners have been cut,” said Chief Executive June Raine during a televised briefing.
Expert scientists and clinicians have been “working around the clock, carefully and methodically, pouring over tables and analyses and graphs for every single piece of data,” she said.
That includes over a thousand pages of data. The work involved “critically analyzing pre-clinical evidence, clinical trials, manufacturing and quality controls and down to the final sampling,” Raine added.
Asked how the process differed from the European Medicines Agency and the U.S. Food and Drug Administration’s own approval regime, Raine said the MHRA process was “equivalent to all international standards.” There will, she added, be longer term follow up on the vaccine.
The MHRA backed a temporary authorization for supply of the jab, although manufacturer Pfizer said a regulatory review for a full license is running in parallel.
The European Medicines Agency said Wednesday it would potentially reach a decision by December 29 for its own conditional marketing authorization. Some raised concerns that the U.K. process accepted a lower level of evidence, or potentially a lower threshold for its risk-benefit assessment, given the emergency situation — but Pfizer pushed back.
“We have provided complete data packages unblinded to both regulators,” said Ben Osborn, Pfizer U.K.’s country manager, who argued it was more a case of the U.K. being quicker.
It’s a “difference in underlying processing timelines as opposed to any difference in data submission,” he said.
Meanwhile, “the world is looking at the U.K.,” said microbiologist Ralf Rene Reinert, Regional Lead Medical and Scientific Affairs, at Pfizer Vaccines, inferring that since the U.K. has successfully used an EU loophole to approve this vaccine during an emergency, other countries might be thinking of doing the same. “I just got an email [about this],” he began to say, but stopped short of revealing which country it came from.
“It’s a risk-benefit decision. There are many deaths a day,” he said, noting Germany, where he lives, on Wednesday recorded its highest number of daily deaths.
Via Channel 4 / POLITICO
