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.

The EUA sub­mis­sion will come less than 11 months af­ter sci­en­tists be­came aware of the ex­is­tence of the virus now known as SARS-CoV-2, mark­ing by sev­er­al years the fastest a vac­cine has ever gone from de­sign to reg­u­la­to­ry re­view. The ef­fi­ca­cy re­sults Pfiz­er showed this week sug­gest­ed the vac­cine was 95% ef­fec­tive at pre­vent­ing symp­to­matic Covid-19.

Pe­ter Marks, head of the agency’s vac­cine and bi­o­log­ics di­vi­sion, told Busi­ness In­sid­er this week that, once a sub­mis­sion is in, the EUA process will like­ly take “weeks.” The FDA’s in­ter­nal re­view­ers will pour over da­ta from the ap­pli­ca­tion and then send it to their ad­vi­so­ry com­mit­tee to pub­licly de­bate, ques­tion and pro­vide a rec­om­men­da­tion for or against au­tho­riza­tion.

Mon­cef Slaoui, the sci­en­tif­ic head of Op­er­a­tion Warp Speed, pre­dict­ed that an au­tho­riza­tion would come in mid-De­cem­ber. FDA re­view­ers have re­port­ed­ly been told to set aside Dec. 8 through Dec. 10 on their cal­en­dars for hear­ings on the vac­cine.

Mod­er­na, which al­so showed around 95% ef­fi­ca­cy in the first look at their Phase II read­out, is al­so ex­pect­ed to file im­mi­nent­ly for FDA au­tho­riza­tion af­ter they re­lease their fi­nal re­sults. Both Slaoui and Mod­er­na CEO Stéphane Ban­cel said an FDA ad­vi­so­ry hear­ing could cov­er both Mod­er­na and Pfiz­er’s vac­cine.

In ad­di­tion to be­ing the first Covid-19 vac­cine to reach reg­u­la­tors, the Pfiz­er and Mod­er­na can­di­dates will al­so be the first mR­NA vac­cines or ther­a­peu­tics to go be­fore the agency.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

DC District Court Judge Christopher Cooper today granted Vanda Pharma’s request to require the FDA to disclose more info on the complete response letter for its sleep disorder drug Hetlioz.

The melatonin receptor agonist is approved by the FDA to treat non-24-hour sleep-wake disorder, a circadian rhythm disorder. But in 2018 Vanda filed a supplemental application to market Hetlioz as a treatment for jet lag, which the FDA rejected in August 2019, with few details on what Vanda needed to correct course, according to the company.

Republican members of Congress want FDA Commissioner Robert Califf and his agency to provide more information on the research FDA has funded that manipulates certain viruses like the SARS-CoV-2 virus — after the FDA confirmed that certain studies it funded involved viral manipulation, but in standard ways that are common in molecular biology.

The three-page letter, signed Monday by House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) and Subcommittee Chairs Brett Guthrie (R-KY) and Morgan Griffith (R-VA), kicked things off by saying that the committee was looking into FDA’s oversight of “FDA-funded research that may pose significant biosafety or biosecurity risks.”

The FDA has scheduled or planned for three advisory committee meetings in May: one for an over-the-counter birth control pill, one for a nasal spray version of the EpiPen, and another for  Intarcia Therapeutics, which has all but completely folded already as a company.

Perrigo will bring its daily contraceptive, Opill, to the joint Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee on May 9 and 10 for its over-the-counter birth control application.

Republican leaders of the House Committee on Energy & Commerce sent a five-page letter yesterday announcing an investigation into the ongoing drug shortages that have rankled the US during the pandemic and the FDA’s response to it.

The letter, signed by Chair Cathy McMorris Rodgers (R-WA), explains how shortages have become more common over the past decade, while pointing to a report from the National Academies of Science, Engineering and Medicine finding that drug shortages have been “on the rise” over the past several decades and are lasting longer, with new drug shortages in the US seeing a 30% increase from 2021 to 2022.