EU berates approval of UK Pfizer coronavirus vaccine as FDA stands firm on schedule

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In the race to get a coronavirus vaccine into the hands of those who need it most, the UK took the lead on Wednesday by granting approval to Pfizer and BioNTech’s two-dose vaccine. The approval comes more than a week ahead of the scheduled U.S. FDA meeting on the companies’ Emergency Use Authorization (EUA) application and nearly a month before the European Union plans to make its own decision.

The EU regulatory agency must approve a vaccine for use, but the UK Medicines and Health Products Regulatory Agency (MHRA) has used an emergency procedure to bypass the process and make it available to its users. own citizens.

The European Medicines Agency (EMA) said it plans to make a decision on the coronavirus vaccine for the EU by December 29, and that longer review process would mean a safer product for the public. The EMA began an ongoing review of Pfizer’s test data on October 6, according to Reuters, which was aimed at speeding up the process, but was still not as fast as the UK’s own review.

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The UK began its own continuous review on October 30, but did not include as much data as the EMA process, according to the Reuters report.

And while many celebrated the news as a purported start to the end of the global pandemic, others in the EU criticized the swift action, even going so far as to question a possible political motive over the Prime Minister’s end. Boris Johnson.

“I see this decision as problematic and I recommend that EU member states not repeat the process in the same way,” said Peter Liese, a European lawmaker from the party of German Chancellor Angela Merkel, according to Reuters. “A few weeks of in-depth review by the EMA is better than a hasty emergency marketing authorization for a vaccine.”

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In the United States, the FDA also faces a careful review of its planned timeline, as the meeting scheduled for December 10 to review Pfizer’s EUA request comes three weeks after the data was initially submitted.

“The FDA was too bureaucratic, it took too long,” Fox News medical contributor Dr. Marty Makary said Monday as he appeared on Bill Hemmer Reports. “And I don’t know if they plan for vacation times and reviewers departure times, but they should be running the app in 24 hours. ”

On Tuesday, FDA commissioner Dr Stephen Hahn was summoned to the White House to discuss the approval process and defended his agency’s timeline.

“Let me be clear – our scientists have to make the decision and they will take the time necessary to make the right appeal on this important decision,” he said in a statement provided to Fox News. “We want to act quickly because this is a national emergency, but we will make sure our scientists take the time they need to make an appropriate decision. It is our job to do the right thing and make the right decision about the safety and effectiveness of vaccines. ”

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While Hahn has faced pressure from political leaders, including President Trump, over the scheduled timeframe, the accelerated pace of vaccine development appears to be contributing to Americans’ overall reluctance to vaccines. So much so that the country’s leading infectious disease specialist, Dr Anthony Fauci, spent weeks explaining how a process that usually takes years has been condensed into months.

“What we have to do, in a very clear and understandable way, is to explain and I try to do it as often as possible – that speed [of vaccine development] itself is a reflection of scientific progress, ”Fauci said in a recent chat with the Hastings Center. “In other words, the technology of making a vaccine is not your grandfather’s technology – it is 21st century technology. ”

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He added that federal funding and billions of dollars invested in risky development and pre-manufacturing orders have helped speed up the schedule by months, if not years.

“Speed ​​has nothing to do with compromising security or scientific integrity,” he said.

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