EU rebukes UK’s Pfizer coronavirus vaccine approval as FDA stands firm on timeline

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U.K. approves coronavirus vaccine, plans to roll out in coming week

John Hopkins School of Public Health professor Dr. Marty Makary with insight on the Pfizer vaccine developments in the U.K.

In the race to get a coronavirus vaccine into the hands of those who need it most, the U.K. jumped out in front on Wednesday by granting approval to Pfizer and BioNTech’s two-dose jab. The approval comes more than a week before the U.S. FDA is scheduled to meet regarding the companies’ application for emergency use authorization (EUA) and nearly a month before the European Union plans to issue its own decision.

The EU’s regulatory agency must approve a vaccine for use, but the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) used an emergency procedure to skirt the process and make it available for its own citizens.

The European Medicines Agency (EMA) said it plans to make a decision regarding the coronavirus vaccine for the EU by Dec. 29, and that it’s longer review process would mean a safer product for the public. The EMA starting a rolling review of Pfizer’s trial data on Oct. 6, according to Reuters, which was meant to speed the process up, but was still not as quick as the U.K.’s own review.

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The U.K. began its own rolling review on Oct. 30, but did not include as much data as the EMA’s process, according to Reuters’ report.

And while many were celebrating the news as a so-called 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 on Prime Minister Boris Johnson’s end.

“I consider this decision to be problematic and recommend that EU Member States do not repeat the process in the same way,” Peter Liese, an EU lawmaker from German Chancellor Angela Merkel’s party, said, according to Reuters. “A few weeks of thorough examination by the EMA is better than a hasty emergency marketing authorization of a vaccine.”

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In the U.S., the FDA is also facing scrutiny over its projected timeline, as the scheduled Dec. 10 meeting to consider Pfizer’s EUA application comes three weeks after the data was initially submitted.

“The FDA has been too bureaucratic, taking too much time,” Fox News medical contributor Dr. Marty Makary said on Monday while appearing on “Bill Hemmer Reports.” “And I don’t know if they’re scheduling around vacation times and tee times of the reviewers, but they should turn the application around 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 that’s needed to make the right call on this important decision,” he said in a statement provided to Fox News. “We want to move quickly because this is a national emergency, but we will make sure that our scientists take the time they need to make an appropriate decision. It is our job to get this right and make the correct decision regarding vaccine safety and efficacy.”

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While Hahn has been facing pressure from political leaders, including President Trump, over the projected timeline, the quickened pace of vaccine development seems to be contributing to overall vaccine hesitancy among Americans. So much so, that the nation’s leading infectious disease expert, Dr. Anthony Fauci, has spent weeks explaining how a process that usually takes years was condensed into just a few months.

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

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He added that the federal funding and billions of dollars invested at risk for development and pre-manufacturing orders have helped speed up the timeline by months, if not years.

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