Covid-19 roundup: Sci­en­tists in­ves­ti­gate po­ten­tial safe­ty changes to J&J and As­traZeneca vac­cines; WTO lists crit­i­cal in­puts for vac­cine man­u­fac­tur­ing

Sci­en­tists from J&J, As­traZeneca and the Uni­ver­si­ty of Ox­ford are in­ves­ti­gat­ing po­ten­tial mod­i­fi­ca­tions to their Covid-19 vac­cines, to see if it’s pos­si­ble to re­duce or elim­i­nate the risk of blood clots as­so­ci­at­ed with both jabs.

The blood clots are rare, but po­ten­tial­ly fa­tal, as the J&J vac­cine has seen .3 in­stances of clot­ting per 100,000 dos­es ad­min­is­tered, ac­cord­ing to The Wall Street Jour­nal. As­traZeneca has seen be­tween one and two cas­es per 100,000 dos­es. As­traZeneca’s jab has yet to be grant­ed US ap­proval, while the use of J&J’s was briefly halt­ed in April.

Sci­en­tists in­ves­ti­gat­ing how the clots form say that there’s hope that the As­traZeneca vac­cine can be re-en­gi­neered by next year, but it’s too ear­ly to see whether that is pos­si­ble, or if it would make sense, com­mer­cial­ly, the WSJ re­ports. Along with sci­en­tif­ic chal­lenges, a mod­i­fi­ca­tion could re­quire own­er­ship or reg­u­la­to­ry up­dates.

On Mon­day, J&J’s jab was linked to a slight in­crease of risk to Guil­lain-Bar­ré syn­drome, which can cause hos­pi­tal­iza­tion and nerve dam­age.

WTO lists crit­i­cal in­put list for vac­cine man­u­fac­tur­ing

The World Trade Or­ga­ni­za­tion has joined forces with the Asian De­vel­op­ment Bank, the Or­ga­ni­za­tion for Eco­nom­ic Co­op­er­a­tion and De­vel­op­ment, and drug man­u­fac­tur­ers among oth­ers, to com­pile a work­ing doc­u­ment for man­u­fac­tur­ers to clar­i­fy the steps need­ed to prop­er­ly man­u­fac­ture Covid-19 vac­cines.

Com­prised of 83 line items, the list en­com­pass­es vac­cine man­u­fac­tur­ing, stor­age and dis­tri­b­u­tion and ad­min­is­tra­tion. It emerged out of dis­cus­sions the WTO held last month in an ef­fort to scale up vac­cines around the globe and ad­dress mount­ing con­cerns about vac­cine in­equity: Out of the 3.41 bil­lion dos­es ad­min­is­tered worl­wide, 22% have gone to 27 coun­tries that have just 10.4% of the world pop­u­la­tion, ac­cord­ing to Bloomberg’s track­er. Many African coun­tries have vac­ci­nat­ed less than 1% of their pop­u­la­tions.

The new in­ven­to­ry of in­gre­di­ents is one of sev­er­al in­for­ma­tion-shar­ing ef­forts WHO and WTO have tak­en to try to help coun­tries scale vac­cines, even as many Eu­ro­pean coun­tries re­sist broad­er calls for a tem­po­rary waiv­er on com­pa­nies’ in­tel­lec­tu­al prop­er­ty.

The list has no le­gal sta­tus, the agency said. It in­cludes ac­tive in­gre­di­ents, in­ac­tive in­gre­di­ents, con­sum­ables, equip­ment and pack­ag­ing.

Tawain am­bas­sador ex­plains crum­ble of BioN­Tech deal

A deal for BioN­Tech to send 5 mil­lion dos­es of its vac­cine to Tai­wan fell apart in Jan­u­ary, a diplo­mat said Tues­day to Reuters.

Tai­wan had still tried to get the vac­cine from the Ger­man com­pa­ny that col­lab­o­rat­ed with Pfiz­er for months, but blamed Chi­na for the col­lapse of the deal, the re­port said.

Two tech com­pa­nies had es­tab­lished with the gov­ern­ment the rights to ne­go­ti­ate for 10 mil­lion dos­es. But Tai­wan’s am­bas­sador to Berlin, Shieh Jhy-wey, said that a change in con­tact at the BioN­Tech and what he called “po­lit­i­cal in­ter­fer­ence” led to the crum­bling of the deal.

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.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 119,800+ biopharma pros reading Endpoints daily — and it's free.

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?

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

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.

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

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

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.

Tillman Gerngross, Adagio CEO

Q&A: Till­man Gern­gross ex­plains why his Covid mAb will have an edge over an al­ready crowd­ed field

If anyone knows about monoclonal antibodies, it’s serial entrepreneur, Adimab CEO, and Dartmouth professor of bioengineering Tillman Gerngross.

Even the name of Gerngross’ new antibody startup Adagio Therapeutics is meant to reflect his vision behind the development of his Covid-19 mAb: slowly, he said, explaining that “everyone else, whether it’s Regeneron, Lilly, or AstraZeneca, Vir, they all valued speed over everything.”

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

FDA's vac­cine ad­comm unan­i­mous­ly sup­ports Mod­er­na's boost­er in same pop­u­la­tions as Pfiz­er's boost­er

The FDA’s vaccine advisory committee on Thursday voted 19-0 in support of expanding Moderna’s Covid-19 vaccine EUA for booster doses for certain high-risk individuals. FDA is expected to authorize the Moderna booster shortly.

Similarly to the Pfizer booster shot, Moderna’s will likely be authorized for those older than 65, adults at high risk of severe Covid-19, and adults whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of Covid-19. But unlike the Pfizer adcomm, where FDA had to scramble to get the committee to vote in favor of a booster, this committee was unanimous with the Moderna shot.

David Kessler testifies during a Senate hearing in May (Jim Lo Scalzo/Pool via AP Images)

Biden's fight with Mod­er­na over pro­vid­ing vac­cines for the poor­est coun­tries in­ten­si­fies

With about $10 billion in taxpayer funds invested in Moderna so far, it would seem that the company would be more understanding of pleas from President Joe Biden and the federal government to provide more vaccine doses to low- and middle-income countries.

But the Biden-Moderna feud over supplying the world with doses of mRNA vaccines is now spilling into the public, with Biden’s chief science officer of the government’s Covid-19 response David Kessler explaining the details in an online panel discussion moderated by Yale law professor Amy Kapczynski on Wednesday.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 119,800+ biopharma pros reading Endpoints daily — and it's free.