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Albert Bourla, Pfizer CEO (Steven Ferdman/Getty Images)

It's of­fi­cial: Pfiz­er and BioN­Tech have sub­mit­ted their Covid-19 vac­cine to the FDA — and the agency cir­cled a date for the ad­comm

Pfizer and BioNTech’s request for emergency authorization of its Covid-19 vaccine is now in the FDA’s hands. Regulators caught the application Friday afternoon in an open field dash to the goal line.

The agency immediately marked Dec 10 on the calendar for an advisory committee meeting to discuss the request. Pfizer and BioNTech first announced the submission was coming on Friday morning, and Pfizer CEO Albert Bourla confirmed the filing in a video statement later that afternoon. The “historic day,” as Bourla called it, came just 248 days after the pharma first announced plans to develop the candidate with BioNTech — a process which typically takes years.

Albert Bourla, Pfizer CEO (Gian Ehrenzeller/Keystone via AP Images)

Pfiz­er and BioN­Tech are send­ing the first Covid-19 vac­cine to the FDA to­day

The first Covid-19 vaccine is heading to regulators.

Pfizer and BioNTech announced Friday morning that they would ask today for the FDA to issue an emergency use authorization for their Covid-19 candidate.

The submission, a major milestone in the fight against the pandemic and in history’s most intensive and closely-watched drug development race, will put the ball in the agency’s court, where regulators will pour over all the data the companies have generated since winter and solicit recommendations from outside advisors before making a decision.

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Covid-19 roundup: WHO rec­om­mends against 'high cost' remde­sivir, dis­ap­point­ing Gilead; EU deals with Pfiz­er/BioN­Tech, Cure­Vac top $10B — re­port

Veklury, or remdesivir, may be the first Covid-19 treatment to earn full approval at the FDA, after it won a full-throated endorsement from President Trump. But the WHO is taking the opposite view.

The UN agency said a panel tasked with developing its guidelines has recommended against the use of remdesivir, an antiviral Gilead originally developed for Ebola, for Covid-19, citing limited data supporting its benefits on one hand and “relatively high cost and resource implications associated” with the intravenous drug on the other.

Eli Lil­ly picks up an­oth­er Covid-19 EUA as reg­u­la­tors wave through its Olu­mi­ant plus remde­sivir com­bo

Eli Lilly has picked up another win at the FDA, crossing the finish line again in the Covid-19 treatment race despite some mixed data. And the authorization comes before Regeneron’s antibody therapy, which notably was used to treat President Donald Trump back in October, could pick up an EUA.

Regulators have given the green light to Lilly’s Olumiant, in combination with Gilead’s remdesivir, to treat suspected or confirmed Covid-19 cases in both hospitalized adults and children over 2 that need supplemental oxygen, ventilators or life support. The authorization was based on data showing the median time to recovery from Covid-19 was seven days on the combo vs. eight days for remdesivir by itself.

Ugur Sahin, BioNTech CEO (Andreas Arnold/picture-alliance/dpa/AP Images)

CEO Ugur Sahin: BioN­Tech and Pfiz­er will file for a Covid-19 vac­cine EUA on Fri­day

The first application for a Covid-19 vaccine will reach the FDA’s desk tomorrow.

BioNTech CEO Ugur Sahin told CNN Wednesday that they and Pfizer plan to file for an emergency use authorization for their jointly developed vaccine on Friday. The two companies said that the submission could come “within days” after they announced their final efficacy results yesterday, but they had not given an exact date.

A new study breathes life in­to an all-but-dead ap­proach to treat­ing se­vere Covid-19

Maybe Roche’s IL-6 drug works for Covid-19 after all.

Actemra, the rheumatoid arthritis drug, was widely used by doctors early in the pandemic on the theory that it could douse the overactive immune response that leads to severe symptoms in many patients. But multiple studies in the spring and summer appeared to find that neither the Roche drug nor a similar antibody from Regeneron and Sanofi had any effect.

HHS secretary Alex Azar at the CDC, Oct. 21, 2020 (Alyssa Pointer/Atlanta Journal-Constitution via AP)

Alex Azar, re­fus­ing to ac­knowl­edge elec­tion re­sults, says they're not work­ing with Biden team on vac­cine roll­out

With data now out on two experimental vaccines, the course of the raging US outbreak and the success of the federal government’s $18 billion vaccine acceleration program hinges in part on whether officials can successfully roll doses out to the general public, should they receive FDA authorization.

It’s a delicate and highly technical process, one that officials have been game-planning in military tabletop style for months. But so far neither those officials nor other representatives from the federal government have spoken to the administration that will take over just a month into the likely rollout, HHS secretary Alex Azar said Wednesday.

Alex Gorsky, J&J CEO (Evan Vucci/AP Images)

Covid-19 roundup: J&J en­ters PhI­II with a two-dose reg­i­men to play safe; As­traZeneca, Ox­ford tout promis­ing da­ta in el­der­ly

Johnson & Johnson had the first single-dose Covid-19 vaccine to enter Phase III trials — but to be cautious, the pharma is launching a second Phase III study evaluating the candidate in a two-dose regimen.

“Janssen’s COVID-19 vaccine program has been designed to be extremely thorough and driven by science,” the company announced on Sunday. “As such, we are investigating multiple doses and dosing regimens to evaluate their long-term efficacy.”

Pfizer CEO Albert Bourla (Drew Angerer/Getty Images)

Pfiz­er, BioN­Tech say vac­cine is 95% ef­fec­tive, EUA sub­mis­sion 'with­in days'

Pfizer and BioNTech have done the final efficacy analysis for their Phase III Covid-19 trial, and the results confirm the headline-grabbing release from last week: Their vaccine is 95% effective at preventing Covid-19.

They also said the vaccine was 94.5% effective in older adults, mitigating concerns that the first Covid-19 vaccines might not work as well in one of the populations most susceptible to severe disease.

Stephen Hahn, FDA commissioner (AP Images)

Covid-19 roundup: FDA seeks vac­cine ad­comm meet­ings on Dec. 8-10 — re­port; Hahn to make all EUA da­ta pub­lic

With Pfizer releasing its completed Phase III efficacy and safety data Wednesday morning, the FDA is reportedly asking its adcomm to set aside dates in early December to discuss Covid-19 vaccines.

The adcomm will likely convene on Dec. 8, 9 and 10 to go over not only Pfizer’s vaccine candidate, but also Moderna’s, according to a CNBC report. The plans are not yet finalized, per two sources quoted in the story.