A vol­un­teer in As­traZeneca’s Covid-19 vac­cine tri­al in Brazil has died, Brazil­ian health au­thor­i­ties said Wednes­day, trig­ger­ing fresh alarms over the fu­ture of the Ox­ford pro­gram. But lat­er re­ports not­ed that the death was in the place­bo group and As­traZeneca is­sued word that there were no con­cerns about con­tin­u­ing the study.

The Brazil­ian health agency An­visa said it had re­ceived da­ta from an in­ves­ti­ga­tion in­to the is­sue, per a Reuters re­port. The re­port was then up­dat­ed cit­ing a source fa­mil­iar with the mat­ter say­ing that the tri­al would have been sus­pend­ed had the vol­un­teer been giv­en the ex­per­i­men­tal Covid-19 vac­cine, im­ply­ing that they were part of the place­bo arm.

Ox­ford Uni­ver­si­ty, which is de­vel­op­ing the vac­cine in tan­dem with As­traZeneca, told Reuters that af­ter as­sess­ing the sit­u­a­tion, “there have been no con­cerns about safe­ty of the clin­i­cal tri­al.” An­visa added that the vac­cine tri­als will con­tin­ue in the wake of the death. The agency gave no fur­ther de­tails in­to the cir­cum­stances.

As­traZeneca $AZN share prices dipped about 2% as the news broke, but since lev­eled off and closed Wednes­day down 1.19%.

A com­pa­ny spokesper­son gave the fol­low­ing com­ment to End­points News:

We can­not com­ment on in­di­vid­ual cas­es in an on­go­ing tri­al of the Ox­ford vac­cine as we ad­here strict­ly to med­ical con­fi­den­tial­i­ty and clin­i­cal tri­al reg­u­la­tions, but we can con­firm that all re­quired re­view process­es have been fol­lowed. All sig­nif­i­cant med­ical events are care­ful­ly as­sessed by tri­al in­ves­ti­ga­tors, an in­de­pen­dent safe­ty mon­i­tor­ing com­mit­tee and the reg­u­la­to­ry au­thor­i­ties. These as­sess­ments have not led to any con­cerns about con­tin­u­a­tion of the on­go­ing study.

Re­ports ear­li­er Wednes­day not­ed that As­traZeneca was sched­uled to restart its Phase III study in the US some­time this week. Dos­ing came to a halt world­wide in ear­ly Sep­tem­ber af­ter a British vol­un­teer de­vel­oped a con­di­tion thought to be trans­verse myelitis, a rare spinal in­flam­ma­tion dis­or­der.

Tri­als have al­ready re­sumed in the UK, In­dia, Japan and South Africa in ad­di­tion to Brazil, and the EMA has since ini­ti­at­ed a rolling re­view of the vac­cine can­di­date.

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

With just days before President Joe Biden’s Covid-19 booster rollout is set to go into effect, an FDA advisory committee appeared on the verge of not recommending boosters for anyone in the US before a last-minute change of wording laid the groundwork for older adults to have access to a third dose.

The FDA’s adcomm on Vaccines and Related Biological Products (VRBPAC) roundly rejected Pfizer/BioNTech booster shots for all individuals older than 16 by a 16-2 vote Friday afternoon. Soon after, however, the agency posed committee members a new question limiting booster use to the 65-and-older population and individuals at high risk of disease due to occupational exposure or comorbidities.

AstraZeneca and Japanese drugmaker Daiichi Sankyo think they’ve struck gold with their next-gen ADC drug Enhertu, which has shown some striking data in late-stage breast cancer trials and early solid tumor tests. Getting into earlier patients is now the goal, starting with Enhertu’s complete walkover of a Roche drug in second-line breast cancer revealed Saturday.

Enhertu cut the risk of disease progression or death by a whopping 72% (p=<0.0001) compared with Roche’s ADC Kadcyla in second-line unresectable and/or metastatic HER2-positive breast cancer patients who had previously undergone treatment with a Herceptin-chemo combo, according to interim data from the Phase III DESTINY-Breast03 head-to-head study presented at this weekend’s #ESMO21.

In recent months, the battle for PD-(L)1 dominance has spilled over into early cancer with Merck’s Keytruda and Bristol Myers Squibb’s Opdivo all alone on the front lines. Keytruda now has another shell in its bandolier, and it could spell a quick approval.

Keytruda cut the risk of relapse or death by 35% over placebo (p=0.00658) in high-risk, stage 2 melanoma patients who had previously undergone surgery to remove their tumors, according to full data from the Phase III KEYNOTE-716 presented Saturday at #ESMO21.

Merck has worked hard to bring its I/O blockbuster Keytruda into earlier and earlier lines of therapy, and now the wonder drug appears poised to make a quick entry into early advanced cervical cancer.

A combination of Keytruda and chemotherapy with or without Roche’s Avastin cut the risk of death by 33% over chemo with or without Avastin (p=<0.001) in first-line patients with persistent, recurrent or metastatic cervical cancer, according to full data from the Phase III KEYNOTE-826 study presented Saturday at #ESMO21.

The FDA released briefing documents this week from the agency and Pfizer each outlining their arguments for today’s Covid-19 booster shot adcomm, but one thing conspicuously missing was the question on which panel members would be voting. But late Thursday night, regulators published that question.

Adcomm members will be asked whether or not the safety and efficacy data from Pfizer/BioNTech’s original Phase III study “support approval” of a booster shot at least six months after the second dose in individuals older than 16. The question notably excludes the real-world data from Israel and other analyses that Pfizer and the Biden administration had said would be a centerpiece of their arguments for boosters.