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.

A lack of diversity in clinical trials has persisted despite decades of initiatives to try to turn the tide.

In a recent review of 17 years of clinical trials, drugmaker GSK found that there were some mismatches between the demographics of its US-based trials and how prevalent diseases were in those populations.

The results, the company says, will help GSK and others design studies that better represent epidemiological rates within races and ethnicities.

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

FDA announced today that doctors and pharmacists can now prescribe Paxlovid to patients without a positive test for Covid-19.

CDER Director Patrizia Cavazzoni reissued Paxlovid’s authorization letter Wednesday, saying it has revised the authorization to “no longer require positive results of direct SARS-CoV-2 viral testing.” The EUA now requires instead that adults and kids 12 years of age and older have a “current diagnosis of mild-to-moderate COVID-19.”