Early Tuesday morning, Food and Drugs Administration Commissioner Stephen Hahn was summoned to the White House. The meeting, fueled by concerns that Britain would approve a coronavirus vaccine before the United States, saw Chief of Staff Mark Meadows asking Hahn exactly what the heist was. On Wednesday, Meadows’ fears came true.
Britain became the first Western country to approve a vaccine for the coronavirus, ahead of the United States and the rest of Europe. British regulators have authorized the immediate deployment of a vaccine manufactured by US pharmaceutical giant Pfizer and its German partner BioNTech, with the first immunizations due to take place within days. Meanwhile, FDA regulators aren’t even expected to meet to discuss the vaccine until next week, and Britain’s grand appeal has now put even more pressure on them.
Britain managed to rush for two main reasons: First, unlike the United States, UK regulators would rely heavily on the test analysis provided to them by the pharmaceutical companies – in this case, Pfizer. UK regulator director Dr June Raine explained on Wednesday that the amount of information Pfizer had provided them since the summer had allowed them to run ‘slippery’ analyzes for months – and then give a quick approval when final results arrived.
Insisting that no corners were cut, Britain’s leading medical regulator explained: “If you climb a mountain, you prepare and you prepare. We started this in June. By the time the interim results became available on November 10, we were at base camp. And then when we had the final analysis, we were ready for that final sprint that brings us to today.
People who have worked with the UK agency this year told the the Wall Street newspaper that he had been much more proactive in his interactions with drug companies than other agencies, often asking for additional data and explanation to speed up his ongoing analysis.
In America, the FDA is behind schedule. He is now expected to explore an impressive volume of raw data before making his decision. A spokesperson for the agency explained the laborious process to Axios earlier this week, saying, “The amount of data submitted to the FDA includes thousands of pages of technical information that must be broken up and reviewed by experts. from different disciplines. Once the reviews carried out by the various experts have been completed, they are then integrated into a global review. “
Commissioner Hahn called for patience, explaining: “We want to act quickly as this is a national emergency, but we will ensure that our scientists take the time they need to make an appropriate decision.”
British government complaints the second reason he managed to move first is a decision made by voters four years ago to leave the European Union. While the Brexit decision has caused unprecedented political upheaval and is expected to hurt Britain’s economy in the years to come, the government says it helped the country approve the Pfizer vaccine.
Within the EU, decisions on medicines and vaccines are usually taken by the European Medicines Agency. However, in post-EU Britain, those calls will be made by the London-based Medicines and Health Products Regulatory Authority. He approved the Pfizer vaccine on Wednesday while the EMA said he could not make a decision until the end of the month.
Before Brexit, the MHRA managed a significant part of Europe’s portfolio of medicines awaiting authorization, so a large part of its staff were already experienced in how to review a new vaccine, and Brexit released these scientists of some of the work they do for all of Europe.
A UK government official said The Guardian that the break with the EMA gave the advantage to Great Britain, saying: “This means that we will be three weeks ahead of all other countries in Europe in terms of deploying this vaccine … Germany could have a better diagnostic industry than us. but when it comes to deploying vaccines, we are number one.
However, the Financial Times noted that Britain used a long-standing regulatory provision which already allowed it to make its own decision outside the EMA “in times of urgent public need”.
Britain’s swift move drew criticism from the EU’s pharmaceutical regulator, who said it believed its slower approval process was the “most appropriate regulatory mechanism” for the drug. vaccine.
Nonetheless, the swift approval is good news for UK Prime Minister Boris Johnson, whose handling of the pandemic and his Brexit plan has come under fire. He called Wednesday’s development “fantastic” and added that the vaccines “will soon allow us to take back our lives and jumpstart the economy.”
Britain has ordered 40 million doses from Pfizer, enough to immunize 20 million people with the two-dose vaccine. An initial 800,000 doses are expected to arrive next week, when vaccinations begin. The first jabs will likely be given before the FDA approves the vaccine.
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