Thursday, December 03, 2020

War of words after UK approves COVID-19 vaccine

This week Britain was the first country to approve a COVID-19 vaccine, namely the Pfizer/BioNTech mRNA vaccine. However, the swift approval has already triggered a war of words as the UK defends its approval process whilst being criticised by several corners of the EU and the US.

Claims that Brexit aided quick approval

Soon after the news was announced some UK politicians inferred that Britain's swift approval process was only possible because of Brexit.

"We could only approve this vaccine so quickly because we have left the EU. Last month we changed the regulations so a vaccine did not need EU approval which is slower," Tory MP for North East Somerset and Leader of the House of Commons, tweeted.

However he was immediately slammed down by the Senior Correspondent and Bureau Chief of ARD German TV in London.

Rees-Mogg's claim was, "Not true," Annette Dittert retorted on Twitter. "It was and is possible to accelerate the process while being a member of the EU. Which Britain did. While still formally being a member of the EU."

"The predictable attempts to make this into a big Brexit show are just misleading. Again," Dittert added.

Earlier the health secretary Matt Hancock had also asserted on Wednesday morning that "because of Brexit" the UK had been able to approve the Pfizer/BioNTech vaccine, rather than wait for the European Medicines Agency [EMA] to do so [Guardian / Sky News]. 

The MHRA was given power to approve the vaccine by the government under special regulations before 1 January, when it will become fully responsible for medicines authorisation in the UK after Brexit [Guardian].

Brexit was possibly a factor in Britain's approval process. But it was likely to mitigate potential problems of distribution and hold ups at ports due to extra documentation required.

Should the EMA have approved the vaccine prior to 31st December Brexit would not have been an issue per se, at least as regards its use. However, a late rubber stamp might have created issues concerning imports if paperwork wasn't in order post-Brexit. 

British exceptionalism

Adding further fuel to the fire on Thursday, Education Secretary Gavin Williamson claimed Britain's regulators were simply better than those in other countries. "We have obviously got the best medical regulators, much better than the French have, much better than the Belgians have, much better than the Americans have," he told LBC Radio, adding, "That does not surprise me at all because we are a much better country than every single one of them." [Evening Standard].

Business Secretary Alok Sharma also drew criticism after saying history would remember the "UK led humanity's charge against this disease."

Andreas Michaelis, Germany's ambassador to the UK, criticised his comments saying, "Why is it so difficult to recognize this important step forward as a great international effort and success. I really don't think this is a national story. In spite of the German company BioNTech having made a crucial contribution this is European and transatlantic."  

Indeed the criticism didn't stop on this side of the Atlantic. In the United States Dr Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, also appeared to echo sentiments expressed in Europe that Britain's approval of the vaccine was "hasty".

Undermining confidence

Speaking to Fox News overnight, one of the leading figures from America's response to the pandemic offered some criticism of the UK's approval process.

"If you go quickly and you do it superficially, people are not going to want to get vaccinated," Dr Anthony Fauci said.

"We have the gold standard of a regulatory approach with the FDA [Food and Drug Administration]," Fauci asserted while calling into question the speed at which Britain approved the vaccine.

"The UK did not do it as carefully. They got a couple of days ahead. I don't think that makes much difference. We'll be there, we'll be there very soon." [CNN / FNLondon / Sky News].

Meanwhile in an unusually blunt statement, the European Medicines Agency, which is in charge of approving COVID-19 vaccines for the EU, said its longer approval procedure was more appropriate as it was based on more evidence and required more checks than the emergency procedure chosen by the UK [Al Jazeera]. 

European legislators also weighed in on the issue, with Italian health minister Roberto Speranza telling the country's parliament he would demand the EMA continues to keep "the bar on surveillance very high" concerning possible approval of vaccines.

"When the vaccine will be administered to people it will certainly have to be a safe vaccine but it will have to be an effective vaccine," Speranza said.

Peter Liese, an EU legislator and member of German Chancellor Angela Merkel's Christian Democratic Union party, struck a firmer tone, saying he considered the MHRA's approval to be "problematic".

"I recommend that EU member states do not repeat the process in the same way," he said. "A few weeks of thorough examination by the European Medicines Agency is better than a hasty emergency marketing authorisation of a vaccine."

UK health agency defends approval

Announcing its decision less than four weeks after Pfizer published the results of a clinical trial, the MHRA said it had used overlapping trials and "rolling reviews".

"This vaccine has only been approved because those strict tests have been done and complied with and everyone can be absolutely confident that no corners whatsoever have been cut," said June Raine, the agency's head.

However, Britain's quick decision to rubber stamp a vaccine within days of initial results of a phase 3 trial will likely dampen confidence and increase doubts in others concerning safety and side effects. 

[pictured: Matt Hancock, Health Secretary, prime minister Boris Johnson, Dr June Raine, head of MHRA, and Alok Sharma Business Secretary]

tvnewswatch, London, UK