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Boris Johnson was unusually modest about the UK becoming the first Western country to authorize a Covid-19 vaccine. He was asked by the Sun newspaper if Britain’s swift authorization process was a “Brexit dividend”, the result of being free from EU rules.
The Prime Minister said he should be diplomatic and not answer the question, preferring instead to say that it was simply great news for everyone that a vaccine had been authorized.
Joining him at the Downing Street press conference, Dr. Jonathan Van Tam said it was wonderful that two scientists of Turkish descent had developed a vaccine in Germany, with financial backing from the United States, and then conducted trials clinicians in various countries, using people of all ages. and that the UK had played an important role in organizing a licensing process that, although it came first, met the highest scientific and safety standards.
Johnson’s diplomatic silence may have been due to the delicate stage in which the Brexit / Future Relationship talks are at. Or it may have been due to the fact that Britain was operating under EU rules when it issued its swift clearance.
This was clearly stated in the morning briefing of the Medicines and Healthcare Products Regulatory Authority (MHRA), the UK’s drug licensing body, when I made the formal announcement.
The agency’s director, Dr June Raines, said the UK was still subject to EU rules on medicines until the end of the month (when the transition period ends), but those same rules allow each member state to act independently if there is a public health problem. emergency (the so-called public health override).
That is what the UK did: it organized its own authorization process, in accordance with EU rules.
That process is an emergency authorization. It is not a blanket marketing approval for the vaccine, but is limited to an individual lot (lot number EJ0553). Additional lots must be individually approved by the MHRA.
This was clearly stated by BioNTech Medical Director Ozlem Tureci during a company press conference in Mainz, Germany this morning when she said: “We have to announce that today the first global emergency use authorization for the Phase Three Clinical data supports the COVID-19 vaccine by the MHRA, the UK regulatory agency.
“We have immediately started the delivery process for our vaccine. And we look forward to the UK launch of the vaccine in the next few days.”
The European Medicines Agency is taking a different approach to licensing the Pfizer / BioNtech vaccine.
While it is open to each EU state issuing its own Emergency Authorization, the EU 27 is seeking a Conditional Marketing Authorization (CMA). According to the EMA website:
“In the EU, CMAs allow the authorization of medicines that meet an unmet medical need on the basis of less complete data than is normally required. This happens if the benefit of the immediate availability of a medicine or vaccine for patients outweighs the risk inherent in the fact that all the data is not yet available.
“CMAs are being used in the context of the pandemic to rapidly respond to the threat to public health. However, the data must show that the benefits of the drug or vaccine outweigh any risks. Once a CMA has been granted , companies must provide more data from new or ongoing studies within predefined time frames to confirm that the benefits continue to outweigh the risks.
“If the EMA concludes that the benefits of the vaccine outweigh its risks in protecting against Covid-19, it will recommend granting a conditional marketing authorization. The European Commission will accelerate its decision-making process with a view to granting a conditional marketing authorization valid in all EU and EEA Member States in a few days. “
The EMA said today that the conditional authorization procedure was “more appropriate” than the British choice of the emergency authorization procedure, because it was based on more evidence and required more controls than the emergency procedure chosen by the United Kingdom.
Germany’s Health Minister Jens Spahn said Berlin had also considered the fast-track authorization chosen by the UK and allowed by EU law, but the task of convincing people of the safety of vaccines was crucial.
Medicines licensing is a sore spot in the UK. London used to be home to the European Medicines Agency, the European regulator. It was based there due to recognized UK expertise in the fields of pharmaceutical research and product licensing.
But after the Brexit referendum, the European Medicines Agency (and the European Banking Authority) had to move to have their physical base in the EU. That is why the EMA is now in Amsterdam (and the EBA in Paris).
The UK has won the “race to be first” to authorize a Covid-19 vaccine, but there is a lot of fine print attached to that authorization. If the goal was to beat the EU in speed, then it has done so, albeit using EU rules.
And if European leaders are feeling a bit upset (though they try hard not to show it), imagine how US President Donald Trump feels. His first policy in the United States led him to state that he wanted to buy BioNTech and relocate it to the United States in early March.
Politico reported yesterday that the president was pressuring the US regulator, the FDA, to win the vaccine race. After all, the United States, through government and industry, has invested billions in vaccine development in a project dubbed “Warp Speed” by the president.
Perhaps the prime minister was prudent in keeping diplomatic silence with the man in the sun.
“The idea is not that we are the first, but the idea is to have safe and effective vaccines in the pandemic and that we can build trust, and nothing is more important than trust with respect to vaccines,” he said.
Spahn said Germany wanted all European countries to be able to launch the vaccine at the same time.
“We have member states, including Germany, that could have issued such an emergency authorization if we wanted to,” he said.
“But we decided not to and opted for a common European approach to move forward together.”
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