Sev­er­al coun­tries had restart­ed their por­tions of As­traZeneca’s glob­al Phase III Covid-19 vac­cine tri­al af­ter the study was paused world­wide in ear­ly Sep­tem­ber, but the US no­tably stayed on the side­lines — un­til now. Fri­day af­ter­noon the phar­ma gi­ant an­nounced the all clear from US reg­u­la­tors. And on top of that, J&J an­nounced Fri­day evening that it’s prepar­ing to re­sume its own Phase III vac­cine tri­al.

The FDA gave As­traZeneca the go-ahead to con­tin­ue the tri­al state­side af­ter con­clud­ing that it would be safe to press ahead, ac­cord­ing to a com­pa­ny state­ment sent to End­points News. The green light comes rough­ly a month-and-a-half af­ter the study had been vol­un­tar­i­ly stopped. Reg­u­la­tors had been in­ves­ti­gat­ing two cas­es of a pos­si­ble neu­ro­log­i­cal side ef­fect in the ex­per­i­men­tal vac­cine, but ap­pear sat­is­fied with their find­ings.

The news on the As­traZeneca tri­al was first re­port­ed by the Wall Street Jour­nal. The FDA did not find the vac­cine was re­spon­si­ble for the side ef­fects, ac­cord­ing to the Jour­nal, but could not rule out a link, ei­ther. Lat­er on Fri­day, J&J an­nounced that the in­de­pen­dent DSMB had rec­om­mend­ed re­sum­ing tri­al re­cruit­ment and fol­low­ing dis­cus­sions with the FDA, J&J is now prepar­ing to pro­ceed.

“The restart of clin­i­cal tri­als across the world is great news as it al­lows us to con­tin­ue our ef­forts to de­vel­op this vac­cine to help de­feat this ter­ri­ble pan­dem­ic,” As­traZeneca CEO Pas­cal So­ri­ot said in their state­ment. “We should be re­as­sured by the care tak­en by in­de­pen­dent reg­u­la­tors to pro­tect the pub­lic and en­sure the vac­cine is safe be­fore it is ap­proved for use.”

Go­ing for­ward, re­searchers and clin­i­cians at As­traZeneca tri­al sites will be re­quired to in­form vol­un­teers of the cas­es and look out for any po­ten­tial neu­ro­log­i­cal events, such as numb­ness.

As­traZeneca’s vac­cine had been on pace to re­ceive au­tho­riza­tion for emer­gency use be­fore the end of year pri­or to the tri­al’s halt in Sep­tem­ber. The com­pa­ny re­mains 3rd in End­points News’ Covid-19 vac­cine race track­er, be­hind on­ly Pfiz­er and Mod­er­na. With the US tri­al able to get back up and run­ning, As­traZeneca says it’s an­tic­i­pat­ing to have the re­sults of the study lat­er this year, de­pend­ing on the rate of in­fec­tion in the tri­al sites’ com­mu­ni­ties.

The two cas­es stud­ied by the agency in­clude an in­stance in Ju­ly when a pa­tient de­vel­oped what was thought to be trans­verse myelitis, a rare spinal in­flam­ma­tion dis­or­der, but turned out to be mul­ti­ple scle­ro­sis un­re­lat­ed to the vac­cine. Then in Sep­tem­ber, an­oth­er neu­ro­log­i­cal event in a British pa­tient al­so be­lieved to be trans­verse myelitis caused the glob­al tri­al halt.

Tri­als had al­ready re­sumed in the UK, home of As­traZeneca’s head­quar­ters, as well as Brazil, Japan, South Africa and In­dia. The EMA ini­ti­at­ed a rolling re­view of the vac­cine at the start of Oc­to­ber.

J&J had or­dered a pause to its late-stage Covid-19 vac­cine tri­als on Oct. 12 af­ter an in­ci­dent of a stroke, ac­cord­ing to an ear­li­er Wash­ing­ton Post re­port, though the ill­ness was orig­i­nal­ly undis­closed. J&J said that there was no clear cause of the event and no ev­i­dence it was a re­sult of its vac­cine.

The com­pa­ny al­so not­ed it will not say whether or not that par­tic­i­pant re­ceived an ex­per­i­men­tal vac­cine dose or place­bo in or­der to main­tain the dou­ble-blind­ed­ness of the study.

Like As­traZeneca, J&J is re­search­ing an ade­n­ovirus vac­cine, though the lat­ter’s vac­cine on­ly re­quires a sin­gle dose. J&J is plan­ning on re­cruit­ing 60,000 pa­tients.

Reuters had pre­vi­ous­ly re­port­ed that the As­traZeneca tri­al could re­sume this week, and Warp Speed chief Mon­cef Slaoui had told Bloomberg that he ex­pect­ed both to restart be­fore the end of the week.

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

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

North Carolina Republican Sen. Thom Tillis made a name for himself in the 2020 election cycle as the darling of the pharma industry, accepting hundreds of thousands in campaign contributions, even from the likes of Pfizer CEO Albert Bourla.

Those contributions have led Tillis to attempt to re-write patent laws in pharma’s favor, a move which failed to gain steam in 2019, and request for a third time since January that the FDA should help stop “the false narrative that patent protections are to blame for high drug prices.”

Sometimes, being late can give you an advantage.

That’s what Sanofi and GSK are trying to say as the Big Pharma partners report positive results from a late-stage trial of their next-gen bivalent Covid-19 vaccine, which was designed to protect against both the original strain of the SARS-CoV-2 virus and the Beta variant. Specifically, against Omicron, they note, the vaccine delivered 72% efficacy in all adults and 93.2% in those previously infected.