Albert Bourla (Evan Vucci, AP Images)

Covid-19 roundup: Pfiz­er/BioN­Tech say boost­er is 95.6% ef­fec­tive; Eu­ro­pean Par­lia­ment calls for more vac­cine trans­paren­cy

A month af­ter the FDA au­tho­rized a boost­er dose of Pfiz­er and BioN­Tech’s Covid-19 shot for cer­tain at-risk in­di­vid­u­als, the com­pa­nies are re­leas­ing new da­ta that sug­gest the ex­tra shot has a 95.6% ef­fi­ca­cy com­pared to the two-dose se­ries.

The re­sults come from a Phase III tri­al that test­ed a third 30 µg dose of the vac­cine giv­en at a me­di­an of 11 months, com­pared to a place­bo on top of Pfiz­er’s two-dose se­ries. A thou­sand par­tic­i­pants 16 years and old­er par­tic­i­pat­ed, just over 23% of whom were 65 or old­er.

Af­ter a me­di­an fol­low-up of 2.5 months, five cas­es were re­port­ed in the boost­er group, com­pared to 109 cas­es in the place­bo group. No safe­ty con­cerns were iden­ti­fied, and side ef­fects were con­sis­tent with the two-dose se­ries, ac­cord­ing to Pfiz­er.

“In ad­di­tion to our ef­forts to in­crease glob­al ac­cess and up­take among the un­vac­ci­nat­ed, we be­lieve boost­ers have a crit­i­cal role to play in ad­dress­ing the on­go­ing pub­lic health threat of this pan­dem­ic,” CEO Al­bert Bourla said in a state­ment. “We look for­ward to shar­ing these da­ta with health au­thor­i­ties and work­ing to­geth­er to de­ter­mine how they can be used to sup­port the roll­out of boost­er dos­es around the world.”

When US reg­u­la­tors au­tho­rized a third jab of the Pfiz­er/BioN­Tech on Sept. 22, they re­lied on an analy­sis from Pfiz­er show­ing that over the last two months, the in­ci­dence of Covid-19 was high­er among tri­al par­tic­i­pants who com­plet­ed their pri­ma­ry vac­cine se­ries ear­li­er, com­pared to par­tic­i­pants who com­plet­ed it lat­er.

While the FDA’s ad­comm first re­ject­ed the boost­ers for all in­di­vid­u­als old­er than 16 by a 16-2 vote, they end­ed up sup­port­ing an ex­tra shot for cer­tain com­mu­ni­ty mem­bers, in­clud­ing the 65-and-old­er pop­u­la­tion and those with co­mor­bidi­ties. Those at high risk due to oc­cu­pa­tion­al haz­ards, like health­care work­ers, are al­so el­i­gi­ble for an­oth­er shot.

Late on Wednes­day, the FDA moved to au­tho­rize boost­ers of the J&J and Mod­er­na vac­cines, as well as “mix-and-match” boost­ers, al­low­ing in­di­vid­u­als who got the pri­ma­ry se­ries of one vac­cine to re­ceive a boost­er of an­oth­er.

A half-dose of the Mod­er­na vac­cine is now avail­able for the same pop­u­la­tions as Pfiz­er’s boost­er at least six months af­ter pri­ma­ry vac­ci­na­tion, and all those 18 years and old­er who re­ceived a sin­gle-dose J&J shot are now el­i­gi­ble for a sec­ond dose of that vac­cine at least two months lat­er.

Eu­ro­pean Par­lia­ment calls for more vac­cine trans­paren­cy

The EU Par­lia­ment has called for more trans­par­ent vac­cine poli­cies, ac­cord­ing to a state­ment re­leased on Thurs­day.

Rep­re­sen­ta­tives vot­ed 458-149 (with 86 ab­sten­tions) in fa­vor of leg­is­la­tion to make the process of re­search­ing, pur­chas­ing, and dis­trib­ut­ing Covid-19 vac­cines more trans­par­ent. It would al­so open the door for mem­bers of par­lia­ment to more ef­fec­tive­ly scru­ti­nize vac­cine poli­cies.

Par­lia­ment called for the Eu­ro­pean Com­mis­sion to pub­lish vac­cine pur­chase agree­ments, in­clud­ing vac­cine costs and any po­ten­tial breach­es of con­tract. It al­so called for phar­ma com­pa­nies to be more trans­par­ent about clin­i­cal tri­al da­ta and re­ports.

And it sug­gest­ed poli­cies to ad­dress eq­ui­table vac­cine dis­tri­b­u­tion:

The EU should help non-EU coun­tries fight COVID-19 and speed up vac­ci­na­tion by over­com­ing pro­duc­tion bot­tle­necks. Com­pa­nies could, for ex­am­ple, trans­fer their tech­nol­o­gy (through the World Health Or­ga­ni­za­tion’s COVID-19 Tech­nol­o­gy Ac­cess Pool, or C-TAP), and coun­tries could con­tribute more to the CO­V­AX scheme.

The news fol­lows a lengthy le­gal saga that the EU launched against As­traZeneca for not de­liv­er­ing the amount of vac­cine dos­es laid out in a con­tract. At one point the EU pub­lished a heav­i­ly redact­ed ver­sion of the com­pa­ny’s con­tract in an ef­fort to fos­ter trans­paren­cy. But when in­ter­net sleuths and Ger­man jour­nal­ists found the blacked-out sec­tions could be eas­i­ly re­moved, the EU was forced to apol­o­gize.

“Pe­ti­tions show that some cit­i­zens are re­luc­tant about vac­ci­na­tions. This is why we need to be trans­par­ent about how COVID-19 vac­cines are de­vel­oped, pur­chased and dis­trib­uted,” pe­ti­tions com­mit­tee chair Do­lors Montser­rat said in a state­ment on Thurs­day.

Serum In­sti­tute boosts vac­cine ca­pac­i­ty ahead of pos­si­ble third wave

Things are look­ing up at the Serum In­sti­tute of In­dia, which has re­sumed vac­cine ex­ports for the first time since April and just about quadru­pled its month­ly out­put of As­traZeneca shots, ac­cord­ing to a Reuters re­port.

The vac­cine gi­ant now has the ca­pac­i­ty to pro­duce 240 mil­lion dos­es of As­traZeneca’s vac­cine per month, and is lin­ing up “large vol­umes” for ex­port start­ing in Jan­u­ary, CEO Adar Poon­awal­la told Reuters.

The news comes as In­dia pre­pares for a po­ten­tial third wave of Covid-19 in­fec­tions, af­ter the last two waves took the lives of more than 453,000 peo­ple.

“In­dia may need boost­er shots and oth­er things al­so, so ex­ports in Jan­u­ary won’t reach as high as 200 mil­lion dos­es. But cer­tain­ly, it will be large vol­umes,” Poon­awal­la said, adding that the Serum In­sti­tute might be able to send out 30 mil­lion dos­es in No­vem­ber and De­cem­ber.

Spe­cial re­port: Meet 20 ex­tra­or­di­nary women who are su­per­charg­ing bio­phar­ma R&D

Even though many biopharma leaders have come together in recent years to address its gender gap, the consensus is clear: We still have a long way to go.

Companies this year were 2.5 times more likely than last year to have a diversity and inclusion program in place, according to a recent BIO survey, but women are still largely absent from executive roles. Getting women to enter the industry isn’t the problem — studies show that they represent just under half of all biotech employees around the world. But climbing through the ranks can be challenging, as women still report facing stereotypes, and, unfortunately, harassment.

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Op­ti­miz­ing Oral Drug De­liv­ery us­ing Zy­dis® Oral­ly Dis­in­te­grat­ing Tablet Tech­nol­o­gy to Ad­dress Pa­tient Chal­lenges

KEY POINTS

Patients prefer oral dosing, but swallowing tablets can be a challenge for many patients.
The Zydis® orally disintegrating tablet (ODT) platform addresses challenges associated with oral dosing, expanding benefits for patients and options for healthcare providers.
A strong growth trajectory is expected for ODTs given therapeutic innovation and continued technology development.

Many patients prefer conventional tablets for the administration of medications, but some geriatric and pediatric patients and those with altered mental status and physical impairments find swallowing tablets to be difficult. Orally disintegrating tablets (ODTs), which dissolve completely without chewing or sucking, offer a patient-friendly dosage form for the administration of small-molecule drugs, peptides and proteins. With the potential for multiple sites of drug absorption, often faster onset action for the active pharmaceutical ingredient (API), and potentially greater bioavailability, ODTs are an attractive option for drug developers considering first-to-market formulations or product line extensions of existing drugs with compatible API. In this report, we look at how innovation in the industry-leading Zydis ODT platform is expanding oral formulation options and bringing benefits to patients.

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Geoffrey Porges (SVB Leerink)

The 2022 wave com­ing? Top an­a­lyst says Big Phar­ma will have more than $1T avail­able to sat­is­fy its grow­ing ap­petite for biotech M&A

All through this year you could practically feel the frustration of the biotech investor class as M&A activity continued to drag behind expectations — or desires. Buyouts of public companies provide the essential juice for keeping stocks lively, and there’s been a notable lack of juice in 2021.

So is all that about to change, big time?

SVB Leerink’s Geoffrey Porges, a longtime student of biotech M&A, thinks so. In a lengthy analysis he put out last week, Porges totted up the cash flow of the major pharmas and determined that there was a good long list of industry buyers who would have around a half trillion dollars of cash to play with in 2022. Leverage that up with added debt and you could get that deal cache to $1.6 trillion.

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Covid-19 roundup: Plant-based shot proves safe, 71% ef­fi­ca­cious in PhI­II; Bourla ex­pects an­tivi­ral to launch this month

Quebec-based Medicago and its adjuvant partner GlaxoSmithKline said Tuesday that their plant-based Covid-19 vaccine candidate proved to be 71% efficacious against all variants of SARS-CoV-2 in a Phase III trial of more than 24,000 adults in Canada, the US, UK, Mexico, Argentina and Brazil.

In addition to showing 75% efficacy against the Delta variant specifically, the companies also said the vaccine proved to be generally safe, with no serious adverse events reported and reactogenicity generally being mild to moderate. The results mean that a regulatory submission will be filed with Health Canada imminently, they said.

Tedros Adhanom Ghebreyesus (Denis Balibouse/Pool Photo via AP Images)

WHO rec­om­mends against the use of con­va­les­cent plas­ma for Covid-19

The World Health Organization said late today that it’s not recommending the use of convalescent plasma as a treatment for Covid-19 for mild or severe cases, but some U.S. experts disagree with the recommendations and say there are patients who can benefit from the plasma of those who’ve recovered from Covid-19.

The recommendation is informed by a review of 16 RCTs and a “meta-analysis on antibodies and cellular therapies for covid-19,” the WHO said, adding in a statement:

Gilead re­calls 2 lots of Vek­lury af­ter in­ves­ti­ga­tion con­firms com­plaint of glass par­tic­u­lates

Two lots of the Covid-19 treatment Veklury have been recalled by Gilead, the company said last week, after the appearance of glass particulates. A customer complaint was confirmed by Gilead’s investigation.

Veklury, also known as remdesivir 100 mg for injection, is used in more than half of hospitalized patients with Covid-19, according to Gilead. It raked in around $2.8 billion last year, and was the only drug approved by the FDA for this setting. But a study out of Europe dubbed DisCoVeRy found that no clinical benefit was observed in patients who received the drug over those who got standard of care alone. And while previous studies have linked remdesivir to a faster time to recovery, that result was not seen in the DisCoVeRy trial.

Mar­ket­ingRx Matchup: How Ab­b­Vie and Bio­haven ads rank in head-to-head mi­graine chal­lenge

Are you ready to rumble? DTC brands that is. MarketingRx is launching a new monthly feature today called MarketingRx Matchup. We’re pitting two pharma brands’ DTC advertising in the same therapeutic category against each other to find out what consumers and patients really think.

Market research company Leger is handling the polling and analysis each month, and I’ll be writing up the results — along with my own take — inside MRx on the first Tuesday of the month.

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Wendy Lund, Organon chief communications officer

Q&A: Organon chief com­mu­ni­ca­tions of­fi­cer Wendy Lund talks about the Mer­ck spin­off, women’s health and why it mat­ters

One of Wendy Lund’s earliest jobs was head of marketing at Planned Parenthood. As the youngest person on its management team, she introduced them to emerging new technologies, and in return, she learned the importance of fighting for what you believe in.

Now as chief communications officer at Organon, the women’s health company recently spun off by Merck, Lund is keeping that point top of mind. That’s in part because women’s health hasn’t been a spotlight therapy area for Big Pharma in years. Several companies have spun off, sold or at least considered selling women’s health assets to focus on “core” products.

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Mar­ket­ingRx roundup: Pfiz­er re-ups pneu­mo­nia ads as Mer­ck threat looms; Re­al Chem­istry founder CEO Jim Weiss steps back

Every autumn, leaves fall from the trees and people start holiday shopping – and for the last few years Pfizer debuts a new “Know Pneumonia” awareness TV ad. This year the commercial, launched a week ago, features different people who talk about why they got vaccinated against pneumococcal pneumonia. Actors portray a young female firefighter with asthma, a mechanic with heart disease and an older woman with her grandchild. A Pfizer spokesperson declined comment on the latest iteration of the long-running campaign.

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