Covid-19 roundup: J&J boost­er shot da­ta show promise; CD­C's ACIP meet­ing this week to dis­cuss Pfiz­er boost­ers

J&J re­vealed a sum­ma­ry of new Covid-19 vac­cine da­ta to­day, in­clud­ing new re­sults show­ing boost­er shots may help with pro­tec­tion.

A Phase III study (EN­SEM­BLE 2) looked at boost­er shots at two dif­fer­ent points in time: a sec­ond shot 56 days af­ter the first shot, or a sec­ond shot six months af­ter the first. The eight-week shot showed in­creased pro­tec­tion against symp­to­matic Covid-19, with the fol­low­ing lev­els of pro­tec­tion:

  • 75% pro­tec­tion against mod­er­ate to se­vere Covid-19 glob­al­ly.
  • 94% per­cent pro­tec­tion against mod­er­ate to se­vere Covid-19 in the US alone.
  • 100% per­cent pro­tec­tion against se­vere Covid-19 at least 14 days post-fi­nal vac­ci­na­tion.

That boost­er al­so came with a four- to six­fold in­crease in an­ti­bod­ies. The six-month boost­er showed a nine- to twelve­fold in­crease in an­ti­bod­ies, re­gard­less of age. Full da­ta will be avail­able in the com­ing months, ac­cord­ing to J&J’s state­ment.

Oth­er re­sults that J&J re­leased in­clude full da­ta from a study on the ef­fec­tive­ness of a sin­gle dose and da­ta from a re­al world study look­ing at peo­ple who re­ceived the shot out­side a clin­i­cal tri­al — and how well they did.

On a sin­gle dose, da­ta showed 74% ef­fec­tive­ness for Covid-19-re­lat­ed in­fec­tions and 89% for Covid-re­lat­ed hos­pi­tal­iza­tions.

The re­al-world study com­pared 390,000 peo­ple who got the J&J shot to more than 1.5 mil­lion un­vac­ci­nat­ed peo­ple matched on age, lo­ca­tion and sex. Da­ta from this study showed the J&J shot was 79% ef­fec­tive for Covid-19-re­lat­ed in­fec­tions and 81% for hos­pi­tal­iza­tions.

J&J said in a state­ment that they have pro­vid­ed da­ta to the FDA and plan to sub­mit it to oth­er reg­u­la­tors. — Paul Schloess­er

CDC meet­ing to re­view Pfiz­er boost­er da­ta

The CDC’s Ad­vi­so­ry Com­mit­tee on Im­mu­niza­tion Prac­tices will meet to­mor­row and Thurs­day to dis­cuss a third dose of Pfiz­er/BioN­Tech’s Covid-19 vac­cine, ac­cord­ing to an agen­da post­ed late Mon­day.

Sev­er­al out­stand­ing ques­tions need to be re­solved pri­or to the meet­ing, in­clud­ing FDA’s is­suance of ei­ther an EUA or an ap­proval for the boost­er dose, and a de­ter­mi­na­tion on who ex­act­ly should re­ceive the boost­er.

FDA’s ad­comm of out­side vac­cine ex­perts last week round­ly re­ject­ed Pfiz­er/BioN­Tech boost­er shots for all in­di­vid­u­als old­er than 16, by a 16-2 vote Fri­day af­ter­noon. But then the com­mit­tee unan­i­mous­ly vot­ed for boost­ers for the 65-and-old­er pop­u­la­tion and in­di­vid­u­als at high risk of dis­ease due to oc­cu­pa­tion­al ex­po­sure or co­mor­bidi­ties. This pos­i­tive vote cen­tered on an EUA — not the sup­ple­men­tal BLA for which Pfiz­er had ap­plied.

ACIP’s meet­ings, which typ­i­cal­ly oc­cur af­ter an ap­proval or an EUA, will dis­cuss the safe­ty and im­muno­genic­i­ty for a 3rd Pfiz­er dose, as well as safe­ty mon­i­tor­ing for third dos­es of mR­NA vac­cines, and mod­el­ing the po­ten­tial im­pact of boost­er dos­es in nurs­ing home res­i­dents. — Zachary Bren­nan

First clin­i­cal da­ta for low-cost Covid vac­cine shows ac­cept­able safe­ty and po­tent im­muno­genic­i­ty

As part of a wider push to bring cheap­er Covid-19 vac­cines to low- and mid­dle-in­come coun­tries, re­searchers said yes­ter­day that a new vac­cine that can be cheap­ly made in chick­en eggs showed an ac­cept­able safe­ty pro­file and strong im­muno­genic­i­ty in a Phase I tri­al.

The re­sults, pub­lished in a pre-print and not yet avail­able in a peer-re­viewed jour­nal, could jump­start a way for flu vac­cine man­u­fac­tur­ers to man­u­fac­ture Covid-19 vac­cine dos­es.

The study from Thai­land en­rolled 210 peo­ple, find­ing that the vac­cine can­di­date, known as NDV-HXP-S, so­licit­ed pre­dom­i­nant­ly mild ad­verse events like in­jec­tion site pain, fa­tigue, and headache, and there were no vac­cine-re­lat­ed se­ri­ous ad­verse events.

The au­thors not­ed: “The vac­cine was strong­ly im­muno­genic in a for­mu­la­tion and dose de­pen­dent man­ner, in­duc­ing lev­els of vac­cine-ho­mol­o­gous an­ti-S IgG and virus neu­tral­is­ing an­ti­bod­ies that ex­ceed­ed by sev­er­al fold the lev­els mea­sured in 14-day con­va­les­cent sera from con­sec­u­tive cas­es of health care work­ers with mild to mod­er­ate COVID-19 ill­ness in 2020.” — Zachary Bren­nan

Poland rec­om­mends boost­er shot for those over 50

Poland will rec­om­mend a boost­er dose of the COVID-19 vac­cine for peo­ple over 50 as well as health­care work­ers, a deputy health min­is­ter said on Tues­day, ac­cord­ing to Reuters.

The UK al­so an­nounced plans last week for boost­er shots to be giv­en to health­care work­ers, those over 50 and those who are par­tic­u­lar­ly vul­ner­a­ble to the virus, which could to­tal about 30 mil­lion peo­ple. This push for boost­ers across the UK and Eu­rope comes as the Biden ad­min­is­tra­tion is ex­pect­ed to soon an­nounce that it’s pur­chas­ing hun­dreds of mil­lions more dos­es of the Pfiz­er/BioN­Tech vac­cine to do­nate to the world. — Zachary Bren­nan

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

No­var­tis' sec­ond at­tempt to repli­cate a stun­ning can­cer re­sult falls flat

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,700+ biopharma pros reading Endpoints daily — and it's free.

Credit: Shutterstock

How Chi­na turned the ta­bles on bio­phar­ma's glob­al deal­mak­ing

Fenlai Tan still gets chills thinking about the darkest day of his life.

Three out of eight lung cancer patients who received a tyrosine kinase inhibitor developed by his company, Betta Pharma, died in the span of a month. Tan, the chief medical officer, was summoned to Peking Union Medical College Hospital, where the head of the clinical trial department told him that the trial investigators would be conducting an autopsy to see if the patients had died of the disease — they were all very sick by the time they enrolled — or of interstitial lung disease, a deadly side effect tied to the TKI class that’s been reported in Japan.

Ugur Sahin, AP Images

As pres­sure to share tech­nol­o­gy mounts, BioN­Tech se­lects Rwan­da for lat­est vac­cine site

BioNTech’s first mRNA-based vaccine site in Africa will call Rwanda home, and construction is set to start in mid-2022, the company announced Tuesday at a public health forum.

The German company signed a memorandum of understanding, after a meeting between Rwanda’s Minister of Health, Daniel Ngamije, Senegal’s Minister of Foreign Affairs Aïssata Tall Sall, and senior BioNTech officials. Construction plans have been finalized, and assets have been ordered. The agreement will help bring end-to-end manufacturing to Africa, and as many as several hundred million doses of vaccines per year, though initial production will be more modest.

No­var­tis dumps AveX­is pro­gram for Rett syn­drome af­ter fail­ing re­peat round of pre­clin­i­cal test­ing

Say goodbye to AVXS-201.

The Rett syndrome gene therapy drug made by AveXis — the biotech that was bought, kept separate, then renamed and finally absorbed by Novartis into its R&D division — has been dropped by the biopharma.

In Novartis’ third quarter financial report, the pharma had found that preclinical data did not support development of the gene therapy into IND-enabling trials and beyond. The announcement comes a year after Novartis told the Rett Society how excited it was by the drug — and its potential benefits and uses.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,700+ biopharma pros reading Endpoints daily — and it's free.

Aaron Siri, Siri & Glimstad

FDA shuts down an­ti-vax lawyer's pe­ti­tion to end Mod­er­na and J&J EUAs

Despite the efforts of a law firm leading the charge on the anti-vaccination movement, the emergency use authorization for Moderna and J&J’s Covid-19 vaccines will not be revoked, the agency said in a response letter Monday.

The FDA said so in a letter to an anti-vax lawyer based in New York City. Aaron Siri, from Siri & Glimstad, requested in a formal petition that the EUAs granted to Moderna and J&J be revoked after weeks of back-and-forth email correspondence with Peter Marks, Lorrie McNeill and others at the FDA.

Vas Narasimhan, Novartis CEO (Simon Dawson/Bloomberg via Getty Images)

With San­doz con­tin­u­ing to drag on No­var­tis, Vas Narasimhan says he may fi­nal­ly be ready for a sale or spin­off

After years of rehab work aimed at getting Sandoz in fighting trim to compete in a market overshadowed by declining prices, CEO Vas Narasimhan took a big step toward possibly selling or spinning off the giant generic drug player.

The pharma giant flagged plans to launch a strategic review of the business in its Q3 update, noting that “options range from retaining the business to separation.”

Analysts have been poking and prodding Novartis execs for years now as Narasimhan attempted to remodel a business that has been a drag on its performance during most of his reign in the CEO suite. The former R&D chief has made it well known that he’s devoted to the innovative meds side of the business, where they see the greatest potential for growth.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,700+ biopharma pros reading Endpoints daily — and it's free.

FDA is much worse than its reg­u­la­to­ry peers at proac­tive­ly dis­clos­ing da­ta, re­searchers find

The European Medicines Agency and Health Canada continue to outpace the FDA when it comes to proactively releasing data on drugs and biologics the agency has reviewed, leading to further questions of why the American agency can’t be more transparent.

In a study published recently in the Journal of Law, Medicine, & Ethics, Yale and other academic lawyers and researchers found that between 2016 and April 2021, the EMA proactively released data for 123 unique medical products, while Health Canada proactively released data for 73 unique medical products between 2019 and April 2021. What’s more, the EMA and Health Canada didn’t proactively release the same data on the same drugs. In stark contrast, the FDA in 2018 only proactively disclosed data supporting one drug that was approved that year.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,700+ biopharma pros reading Endpoints daily — and it's free.

James Peyer, Cambrian CEO

Brent Saun­ders joins $100M Se­ries C for a com­pa­ny out to be the Bridge­Bio of ag­ing

About a year ago, James Peyer, a CEO and co-founder of the little known longevity biotech Cambrian Biopharma, was trying to find some R&D talent last year when he met with more than a bit of experience in that department: David Nicholson, the former R&D chief of the erstwhile pharma giant Allergan.

It turned out Nicholson already had an interest in Peyer’s field. In their Allergan days, he and COO Brent Saunders held weekly meetups where they tried to figure out how to take the company’s dominance in aesthetics — which, until recently, was often what people meant by anti-aging science — and expertise with more traditional drug development, and use it to make drugs that extend people’s lifespan.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,700+ biopharma pros reading Endpoints daily — and it's free.