Covid-19 roundup: In­dia to re­sume vac­cine ex­ports as its own cam­paign is un­der con­trol; Pfiz­er to file for vac­cine OK in chil­dren ages 5-11

Af­ter vac­cine ex­ports were halt­ed to fo­cus on pro­vid­ing its own peo­ple with enough dos­es, In­dia will be­gin ship­ping its Covid-19 vac­cines to the Co­v­ax pro­gram again, the health min­is­ter said Mon­day.

In April, the coun­try halt­ed ship­ments as it faced a bru­tal wave of the pan­dem­ic, which saw dai­ly case num­bers sky­rock­et from around 25,000 in mid-March to more than 400,000 a day by May. Since then, how­ev­er, the vac­cine out­put has more than dou­bled, and min­is­ter Man­sukh Man­daviya said that it is set to quadru­ple to more than 300 mil­lion dos­es in Oc­to­ber. On­ly the ex­cess sup­ply will be sent to Co­v­ax, he said.

Prime Min­is­ter Naren­dra Mo­di is in Wash­ing­ton this week, as vac­cines will like­ly be dis­cussed at a sum­mit that fea­tures the US, In­dia, Japan and Aus­tralia. He has a goal of vac­ci­nat­ing every­one in In­dia, about 944 mil­lion peo­ple, by De­cem­ber. About 64% of peo­ple in In­dia have re­ceived at least one dose of the jab so far, while 22% are ful­ly vac­ci­nat­ed.

The Serum In­sti­tute of In­dia an­nounced in Ju­ly that the fi­nal batch of No­vavax’s vac­cine had been pro­duced, and the com­pa­ny man­u­fac­tured As­traZeneca’s jab at its Pune, Ma­ha­rash­tra site as well. No­vavax went on record to say that some 350 mil­lion would be set to be shipped by Q3.

Com­pa­nies in In­dia have the ca­pac­i­ty to pro­duce al­most 3 bil­lion Covid-19 vac­cines a year, the Arab News re­port­ed. The coun­try sold or do­nat­ed near­ly 66 mil­lion dos­es be­fore the ex­port halt in April.

Pfiz­er to file for vac­cine OK in chil­dren ages 5-11

Just a day af­ter NIH di­rec­tor Fran­cis Collins said on Fox News Sun­day that a time­line for when chil­dren ages 5-11 can be vac­ci­nat­ed should be com­ing in the next few weeks, Pfiz­er and BioN­Tech an­nounced that their Covid-19 vac­cine is safe and in­duces an­ti­body re­spons­es to the virus in that age group.

Chil­dren were giv­en two 10 µg dos­es three weeks apart, which gen­er­at­ed a com­pa­ra­ble re­sponse to par­tic­i­pants who re­ceived 30 µg in a study of the vac­cine ages 16 to 25. The re­sults are the first to come from a study of this age group.

Pfiz­er CEO Al­bert Bourla said in a press re­lease:

Over the past nine months, hun­dreds of mil­lions of peo­ple ages 12 and old­er from around the world have re­ceived our Covid-19 vac­cine. We are ea­ger to ex­tend the pro­tec­tion af­ford­ed by the vac­cine to this younger pop­u­la­tion, sub­ject to reg­u­la­to­ry au­tho­riza­tion, es­pe­cial­ly as we track the spread of the Delta vari­ant and the sub­stan­tial threat it pos­es to chil­dren. Since Ju­ly, pe­di­atric cas­es of Covid-19 have risen by about 240 per­cent in the U.S. – un­der­scor­ing the pub­lic health need for vac­ci­na­tion. These tri­al re­sults pro­vide a strong foun­da­tion for seek­ing au­tho­riza­tion of our vac­cine for chil­dren 5 to 11 years old, and we plan to sub­mit them to the FDA and oth­er reg­u­la­tors with ur­gency.

Re­sults for chil­dren un­der the age of 5 are ex­pect­ed lat­er this year, Pfiz­er said.

The da­ta comes from a Phase II/III study of chil­dren 6 months old to 11 years old, 2,268 of which were be­tween the ages of 5 and 11. Chil­dren un­der the age of 5 re­ceived a 3 µg dose for each in­jec­tion. Side ef­fects ex­pe­ri­enced were sim­i­lar to those felt by adults, the press re­lease said.

“We are pleased to be able to sub­mit da­ta to reg­u­la­to­ry au­thor­i­ties for this group of school-aged chil­dren be­fore the start of the win­ter sea­son,” BioN­Tech CEO Ugur Sahin said in the press re­lease. “The safe­ty pro­file and im­muno­genic­i­ty da­ta in chil­dren aged 5 to 11 years vac­ci­nat­ed at a low­er dose are con­sis­tent with those we have ob­served with our vac­cine in oth­er old­er pop­u­la­tions at a high­er dose.”

The two com­pa­nies ex­pect the da­ta to be in­clud­ed in a near-term sub­mis­sion for emer­gency use au­tho­riza­tion with the FDA and a re­quest to up­date the EMA’s con­di­tion­al mar­ket au­tho­riza­tion.

Since the pan­dem­ic be­gan, chil­dren have ac­count­ed for more than 15% of the to­tal Covid-19 cas­es in the US. As of the week of Sept. 9, chil­dren rep­re­sent­ed near­ly 30% of all week­ly cas­es, while mak­ing up just 22% of the pop­u­la­tion. Se­vere ill­ness is un­com­mon, but the long-term im­pacts on chil­dren are still not en­tire­ly known.

US boost­er da­ta com­ing in weeks — Fau­ci

The US is weeks away from re­leas­ing da­ta sur­round­ing the need for boost­er shots of Mod­er­na and J&J’s Covid-19 vac­cine, An­tho­ny Fau­ci said in an in­ter­view with CNN Sun­day.

While he said boost­ers are ex­pect­ed to be need­ed, Fau­ci en­cour­aged Amer­i­cans not to get the third shot un­til af­ter the FDA has giv­en ap­proval. On Fri­day an FDA ad­vi­so­ry pan­el rec­om­mend­ed a third shot of the Pfiz­er/BioN­Tech jab for those above the age of 65, or at risk of a se­vere case of the virus, but not the en­tire pop­u­la­tion.

The US tops the glob­al list of re­port­ed Covid-19 cas­es and deaths. Al­most 675,000 peo­ple have died dur­ing the pan­dem­ic, and there have been more than 42 mil­lion cas­es. In Au­gust, Pres­i­dent Joe Biden’s ad­min­is­tra­tion an­nounced his in­tent to roll out a boost­er plan for Amer­i­cans 16 and old­er. Fau­ci said Sun­day that the FDA’s de­ci­sion doesn’t negate that stance sup­port­ing boost­ers.

A chaot­ic FDA ad­comm meet­ing last Fri­day end­ed with a re­jec­tion of the Pfiz­er/BioN­Tech jab for all peo­ple above the age of 16 by a 16-2 vote, though the amend­ed rec­om­men­da­tion passed unan­i­mous­ly. Ad­comm mem­bers al­so not­ed that they’d be open to rec­om­mend­ing boost­ers for small­er, high-risk pop­u­la­tions.

Two mem­bers — Mar­i­on Gru­ber and Philip Krause — an­nounced their in­ten­tion to re­sign last month af­ter rais­ing con­cerns with boost­ers in the Lancet.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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Susan Galbraith, Executive VP, Oncology R&D, AstraZeneca

As­traZeneca on­col­o­gy R&D chief Su­san Gal­braith: 'Y­ou're go­ing to need or­thog­o­nal com­bi­na­tion­s'

 

Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC

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Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

Roche's Tecen­triq cross­es the fin­ish line first in ad­ju­vant lung can­cer, po­ten­tial­ly kick­ing off gold rush

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

Rahul Singhvi, Resilience CEO

A Bob Nelsen start­up turns to Har­vard to help sharp­en its tech, in­spir­ing first spin­out

One of Bob Nelsen’s latest projects is headed to Harvard.

Resilience, a company started with the goal of establishing itself as a “one-stop-shop” for companies looking to scale manufacturing, including for hard-to-develop cell and gene therapies, is less than a year old. Friday, it announced a five-year R&D deal with Harvard University that includes $30 million to develop biologics, including vaccines, nucleic acids and cell and gene therapies.

Susan Galbraith speaking at Endpoints News' virtual EUBIO21 summit

Imfinzi/treme­li­mum­ab com­bo scores As­traZeneca an­oth­er OS win — this time in liv­er can­cer

Is the tide turning on AstraZeneca’s battered PD-L1/CTLA4 combo?

A single priming dose of the experimental tremelimumab, followed by Imfinzi every four weeks, beat Nexavar (sorafenib) in helping a group of liver cancer patients live longer in a Phase III study, the company reported, meeting the primary endpoint.

Specifically, the two drugs extended overall survival for patients with unresectable hepatocellular carcinoma who had not received prior systemic therapy and were not eligible for localized treatment.

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FDA+ roundup: Marks on Wood­cock­'s tenure as act­ing com­mis­sion­er; FDA lead­ers of­fer per­spec­tive on bar­ri­ers to di­ver­si­ty in re­search

CBER director Peter Marks praised Janet Woodcock’s work as acting FDA commissioner, and while noting that Biden needs to nominate someone to fill the role permanently by Nov. 16, he said he has “no idea” when that actually might occur.

“Dr. Woodcock has been at the agency for over three decades and she, during that time, has proven herself to be a remarkably capable manager,” Marks said at the Alliance for Regenerative Medicine’s meeting Tuesday. “And she’s been managing as if she’s commissioner, unlike some previous acting [commissioners] who are afraid to actually do things. She doesn’t appear to be afraid to do things. I have not felt any different now from when we had a commissioner in place,” he added.

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