It could take as little as three weeks for US regulators to approve Pfizer and partner BioNTech’s emergency authorization request for their Covid-19 vaccine – with the first Americans being offered the first inoculation outside clinical trials in early December.
The major turning point in the worsening coronavirus pandemic came on Friday morning when the pharmaceutical partners submitted their bid to the Food and Drug Administration (FDA) for their vaccine to be reviewed.
Under that schedule, the vaccine, which the developers claim to be 95% effective and without any major safety issues, could be cleared for use after a meeting with outside infectious disease advisors to the FDA scheduled for 8-10 December.
Dean of Brown University school of public health Ashish Jha, interviewed on the NBC Today show, said it’s probably going to take “a couple of weeks” for the FDA to issue emergency use authorization for this vaccine.
Jha raised the prospect that the agency could bring forward its meeting schedule to discuss the vaccine. “Obviously these are extraordinary times so it may get reviewed before that but I’m expecting early December really as the time when we will have authorization and it will start getting distributed hours after that.”
Other experts echoed Jha’s analysis. “I don’t find that time frame to be unreasonable in light of the amount of data the agency needs to analyze and in order to ensure full participation by all stakeholders in the advisory committee,” said John Taylor, who served as counselor to the head of the FDA during the Obama administration, told Bloomberg.
In the interim, Taylor said: “The agency can conduct a well run, well attended advisory committee in order to ensure maximum transparency, which I think will be an important factor in patients’ willingness to take the vaccine.”
Pfizer/BioNTech’s emergency authorization request for its vaccine, registered as BNT162b2, could significantly speed up FDA approval, which typically takes six to 10 months depending on priority.
This week, FDA commissioner Stephen Hahn said the agency will post documents related to its review with the aim of “contributing “to the public’s confidence in the agency’s rigorous review of scientific data and the appropriate use of authorized products.”
General Gustave Perna of the Trump administration’s Operation Warp Speed coronavirus vaccine program told ABC’s Good Morning America on Friday that states would decide, with guidance from the FDA and the Centers for Disease Control and Prevention (CDC), who will first get the vaccine.
“States are going to tell us exactly where they want it to be ... and as soon as they figure out their distribution plan across their states, we will ensure that the vaccine gets there in a timely manner,” Perna said.
Healthcare workers and those in nursing homes and other vulnerable people are expected to get the first vaccines. Health experts say it likely will be spring or later before there’s enough vaccine for early distribution to the general public.
Perna added that the speed of Pfizer’s application for emergency use authorization was “remarkable”, and said that within 24 hours of the hoped-for authorization being issued his team would have vaccines “moving throughout the country”.
The four-star general indicated that the Trump administration’s refusal to cooperate with Joe Biden’s transition speed would “absolutely not” hinder his distribution mission: “I have clear guidance: ‘get the vaccine to the American people’,” he said.
