After last week’s announcement of a 95% efficiency rate, Pfizer and BioNTech are ready to ask for emergency authorization of its COVID-19 vaccine today.
In a press release, company officials confirmed that the pharmaceutical companies will submit the request to the U.S. Food and Drug Administration (FDA) on Friday.
“Filing for Emergency Use Authorization (EUA) in the U.S. is a critical step in making our vaccine candidate available to the global population as quickly as possible,” said Ugur Sahin, CEO and Co-founder of BioNTech.
At a press briefing Wednesday by Vice President Pence and members of the Coronavirus Task Force, an announcement was made that the vaccine will be able to be distributed 24 hours after the EUA approval.
Chief operating officer of Operation Warp Speed, General Perna, said, “we were going to be able to deliver the vaccine within 24 hours after EUA. That is distribution to the entire United States of America to include territories and metropolitan cities.”
Once Pfizer and BioNTech file for EUA, the FDA could authorize its vaccine as well as the Moderna vaccine in a matter of weeks.
“I think every American can be proud of the fact that we have a plan in place: that the moment that the FDA concludes that that vaccine is safe and effective, we have a system in place to begin, within 24 hours, shipping that vaccines to hospitals, healthcare facilities, and 24 hours after that, literally injecting that vaccine into Americans,” Pence said.
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TX Federal Judge takes ‘extraordinary’ step to ‘fast track’ ruling on Biden’s student loan forgiveness, forego trial
Just The News reported on an “extraordinary move” by one Texas judge who is prepared to cancel President Biden’s student loan debt forgiveness payments.
U.S. District Judge Mark T. Pittman, a Trump appointee, says he is ready to decide the merits of Biden’s plan and skip the preliminary injunction and customary trial.
“U.S. District Judge Mark T. Pittman had been holding a hearing on a request from the small business group Job Creators Network’s legal arm on behalf of two plaintiffs to issue a preliminary injunction blocking Biden from enacting the debt relief until the legality of his executive order was decided” Just The News reports.
However, Pittman declared “in a five-sentence, one-page order that the government and plaintiff lawyers had made all the necessary arguments and that a trial would not elicit further evidence so he is ready to move to a judgement on the merits of the case.”
“Having held a hearing on Plaintiffs’ Motion for Preliminary Injunction and reviewed the related briefing, the Court intends to consolidate as it appears that the Parties have presented their case and no evidence of significance would be forthcoming at trial,” wrote Pittman.
Pittman said he was prepared to advance the preliminary objection request “to a determination on the merits” and gave the Justice Department and plaintiff lawyers until Friday to file any objections to his plan.
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