Covid-19 roundup: Pfiz­er/BioN­Tech shot just as ef­fec­tive in re­al world, study says, as pair preps vari­ant boost­er shots

The first re­al-world ev­i­dence for Pfiz­er/BioN­Tech’s Covid-19 vac­cine is in, and there’s a lot for the com­pa­nies to like.

Two months in­to the vac­cine’s roll­out in Is­rael, re­searchers from the coun­try’s Clalit Re­search In­sti­tute have pub­lished the first study to be peer-re­viewed over whether or not the shot is ef­fec­tive out­side a con­trolled clin­i­cal tri­al set­ting. They have found the two-dose vac­cine reg­i­men cut symp­to­matic Covid-19 cas­es by 94% across all age groups and se­vere cas­es by al­most as much.

Those fig­ures al­most ex­act­ly match up with Pfiz­er’s Phase III study for the shot, which showed a 95% ef­fi­ca­cy rate. Full re­sults were pub­lished Wednes­day in the New Eng­land Jour­nal of Med­i­cine.

The study of near­ly 1.2 mil­lion peo­ple al­so showed a sin­gle shot was 57% ef­fec­tive in pro­tect­ing against symp­to­matic in­fec­tions af­ter two weeks.

Re­searchers told Reuters that they ex­pect­ed the fig­ures in the re­al-world study to be low­er than the clin­i­cal tri­al num­bers, large­ly due to the fact that it’s more dif­fi­cult to main­tain cold stor­age ca­pa­bil­i­ties out­side of con­trolled set­tings. But they end­ed up get­ting sim­i­lar fig­ures re­gard­less, which sur­prised se­nior au­thor Ran Bal­icer.

“We have shown the vac­cine to be as ef­fec­tive in very dif­fer­ent sub-groups, in the young and in the old, in those with no co­mor­bidi­ties and in those with few co­mor­bidi­ties,” he told Reuters.

The study ap­peared to sug­gest that the Pfiz­er/BioN­Tech shot is al­so ef­fec­tive at pro­tect­ing against the coro­n­avirus vari­ant that first ap­peared in the UK, which was the dom­i­nant strain in Is­rael at the time of the study. Re­searchers couldn’t pin down an ex­act lev­el of ef­fi­ca­cy, how­ev­er, and there was no in­for­ma­tion about how ef­fec­tive the shots are against the South Africa virus vari­ant.

Is­rael says more than half of its pop­u­la­tion of 9 mil­lion have re­ceived at least one shot, and a third have re­ceived both dos­es since roll­out start­ed last Dec. 19. The study ex­am­ined a group of 600,000 vac­ci­nat­ed in­di­vid­u­als ver­sus about the same num­ber of un­vac­ci­nat­ed peo­ple as a con­trol.

Wednes­day’s news al­so comes amid grow­ing in­ter­na­tion­al crit­i­cism that Is­rael has not done enough to vac­ci­nate the Pales­tin­ian pop­u­la­tion liv­ing in the ter­ri­to­ries un­der which it as­serts sov­er­eign­ty. Prime Min­is­ter Ben­jamin Ne­tanyahu ac­knowl­edged for the first time on Wednes­day that Is­rael has been shar­ing some of its Covid-19 vac­cines with coun­tries that have giv­en fa­vors to Is­rael in the past, ac­cord­ing to an As­so­ci­at­ed Press re­port.

Pfiz­er/BioN­Tech prep tri­als for boost­er and vari­ant-based shots

As coro­n­avirus vari­ants con­tin­ue to trig­ger con­cerns world­wide, Pfiz­er and BioN­Tech are prepar­ing a new tri­al to po­ten­tial­ly coun­ter­act their spread.

The com­pa­nies will launch a study in­volv­ing par­tic­i­pants from their Phase I tri­al to eval­u­ate the safe­ty and ef­fi­ca­cy of a third shot, they an­nounced Thurs­day morn­ing. In­di­vid­u­als who re­ceived their two shots 6 to 12 months ago will be of­fered a 30µg boost­er of the cur­rent vac­cine.

“While we have not seen any ev­i­dence that the cir­cu­lat­ing vari­ants re­sult in a loss of pro­tec­tion pro­vid­ed by our vac­cine, we are tak­ing mul­ti­ple steps to act de­ci­sive­ly and be ready in case a strain be­comes re­sis­tant to the pro­tec­tion af­ford­ed by the vac­cine,” Pfiz­er CEO Al­bert Bourla said in a state­ment.

Up to 144 vol­un­teers from the orig­i­nal Phase I study will be re­cruit­ed from two age co­horts — those aged 18-55 and those be­tween 65 and 85 years old. The com­pa­nies said the study will mea­sure the safe­ty and tol­er­a­bil­i­ty of a third vac­ci­na­tion ir­re­spec­tive of the lev­el of an­ti­body titers of the tri­al par­tic­i­pant.

Re­searchers will as­sess par­tic­i­pants at the time they re­ceive the dose, one week lat­er and one month lat­er. Pfiz­er and BioN­Tech then plan to study the abil­i­ty of the serum from those par­tic­i­pants to neu­tral­ize strains of in­ter­est.

The pair are al­so talk­ing with reg­u­la­to­ry bod­ies to plan an ad­di­tion­al piv­otal tri­al for a vari­ant-based vac­cine based on the mu­ta­tion first dis­cov­ered in South Africa. They say they are fol­low­ing es­tab­lished reg­u­la­to­ry path­ways sim­i­lar to what is used for flu vac­cines.

As­traZeneca, EU ten­sion flares again

The tit-for-tat be­tween As­traZeneca and the Eu­ro­pean Union con­tin­ued Thurs­day, as con­cerns among EU of­fi­cials linger over whether the British drug­mak­er can come through on its Covid-19 vac­cine sup­ply promis­es.

As­traZeneca is aim­ing to de­liv­er 180 mil­lion dos­es in the sec­ond quar­ter, in­clud­ing 20 mil­lion shots to Italy, the head of the com­pa­ny’s Ital­ian unit told an Ital­ian news­pa­per Thurs­day, ac­cord­ing to Reuters. But per a sep­a­rate Reuters re­port ear­li­er this week, that num­ber still falls well short of what the con­ti­nent was promised.

An EU of­fi­cial on Tues­day said the com­pa­ny would miss its sup­ply tar­get by half, prompt­ing some ug­ly com­par­isons from politi­cians.

“As­traZeneca is be­hav­ing like an un­re­li­able sec­ond-hand car sales­man. Get­ting re­li­able da­ta from this com­pa­ny is still a chal­lenge,” said EU law­mak­er Es­ther de Lange, VP of the largest par­ty in the bloc’s par­lia­ment.

The com­pa­ny’s con­tract had called for 300 mil­lion shots to be de­liv­ered by the end of June, but CEO Pas­cal So­ri­ot has said the con­tracts are not legal­ly bind­ing due to a “best ef­fort” clause in the text.

EU of­fi­cials had been skep­ti­cal of that claim, but af­ter the bloc pub­lished the con­tract in an ef­fort to boost trans­paren­cy ear­li­er this month and mis­tak­en­ly left some por­tions unredact­ed, ea­gle-eyed in­ter­net sleuths and Ger­man jour­nal­ists dis­cov­ered text ap­pear­ing to back So­ri­ot’s as­ser­tion. The mis­take prompt­ed the EU to pub­licly apol­o­gize.

Thurs­day is just the lat­est round in an on­go­ing spat be­tween the bloc and the vac­cine mak­er. Things start­ed heat­ing up late last month when As­traZeneca no­ti­fied the bloc that it would de­liv­er rough­ly 60% few­er dos­es than orig­i­nal­ly promised, blam­ing pro­duc­tion prob­lems at a Bel­gian fac­to­ry. That trig­gered fiery back­lash from the EU, which was al­ready deal­ing with de­lays of the Pfiz­er/BioN­Tech vac­cine and lags in vac­ci­na­tion.

The news al­so comes as re­ports emerge of Eu­ro­pean in­di­vid­u­als, as well as health care work­ers, re­fus­ing to take the As­traZeneca vac­cine at all. Bloomberg re­port­ed last week that front­line health work­ers in Ger­many and France are push­ing to get shots from Mod­er­na and Pfiz­er/BioN­Tech.

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

Bio­mark­er 'roadmap­s' and the fu­ture of can­cer R&D; Cur­tain rais­es on #AS­CO22; Pfiz­er, No­var­tis tack­le drug ac­cess; 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.

While this was not a week for earth-shattering news, there were certainly a lot of interesting tidbits. If you found this recap helpful, please recommend it to your friends and colleagues. We’ll see you on the other side of the long weekend.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,800+ biopharma pros reading Endpoints daily — and it's free.

Keep­ing pres­sure on Am­gen, Mi­rati draws mixed re­views on lat­est cut of KRAS da­ta

As the close runner-up to Amgen’s Lumakras in the KRAS race, any data cut from Mirati’s adagrasib continues to draw scrutiny from analysts. And the latest batch of numbers from ASCO is a decidedly mixed bag.

While a quick comparison suggests that adagrasib spurred slightly more responses and led to a longer overall survival than Lumakras among a group of non-small cell lung cancer patients, its duration of response appears shorter and the safety profile continues to spark concern.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,800+ biopharma pros reading Endpoints daily — and it's free.

Switzer­land to de­stroy over 600,000 ex­pired dos­es of Mod­er­na Covid vac­cine

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

Ann is one of ViiV Healthcare's newest spokespeople as the retired school administrator speaks up about her HIV status.

GSK's Vi­iV de­buts next evo­lu­tion in HIV med Dova­to cam­paign with new spokes­peo­ple and new mes­sage

When Ann saw the first TV commercials for HIV medicine Dovato, she didn’t see herself represented. So the 74-year-old retired school administrator who’s been living with HIV since 1998, reached out to GSK’s ViiV Healthcare and asked why not?

Now Ann is one of three people starring in ViiV’s latest Dovato campaign called “Detect This.” The next-step evolution in the branded campaign plays on the word “detect” — often used in describing HIV status under control as undetectable — but in this case, uses the word as a directive for people to understand they can use fewer medicines.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,800+ biopharma pros reading Endpoints daily — and it's free.

Tran­si­tion to new Eu­ro­pean clin­i­cal tri­als in­fo sys­tem starts slow­ly

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

Covid-19 roundup: CDC study shows good pro­tec­tion from mR­NA boost­er plus J&J's sin­gle-dose vac­cine; White House launch­es test-to-treat Paxlovid site

Concerns about rare but life-threatening blood clots have limited the use of J&J’s Covid-19 vaccine — once pitched as the only one-shot option in the mix — with the FDA cutting it off except in limited circumstances. Yet there’s some good news for those who did receive it: A single booster dose of an mRNA vaccine for recipients of a single priming dose of Ad26.COV2.S (the J&J vaccine) provided protection close to that of a three-dose mRNA vaccine regimen.

Nassim Usman, Catalyst Biosciences CEO

Af­ter $60M Ver­tex deal, group of Cat­a­lyst share­hold­ers claims biotech could’ve sold as­sets three years ago

Catalyst Biosciences was down to five employees in March, and the biotech needed to do something after two rounds of layoffs, a nixed collaboration and a culling of its hemophilia program.

In came Vertex, with $60 million to buy up the South San Francisco biotech’s preclinical complement drugs, which target the system that bridges the body’s innate and adaptive immune response and a class most known for Ultomiris and Soliris. The deal includes CB 2782-PEG, the dry AMD drug that Biogen no longer wanted in March.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,800+ biopharma pros reading Endpoints daily — and it's free.

Lina Khan, FTC chair (Graeme Jennings/Pool via AP Images)

Pile-on over PBMs con­tin­ues with FTC com­ments and a new bi­par­ti­san Sen­ate bill

More than 500 stakeholders sent comments to the FTC on whether the commission should look further into pharma middlemen, known as PBMs, with many of the commenters calling for more federal oversight.

Similar to the critical open comment period in a deadlocked FTC session last February, pharmacies and pharmacy groups are continuing to call out the lack of transparency among the top 3 PBMs, which control about 80% of the market.

Pharma brands are losing their shine with US consumers who are now thinking about the economy and inflation instead of Covid. (Credit: Shutterstock)

Phar­ma brands fade in an­nu­al Har­ris con­sumer vis­i­bil­i­ty poll: Mod­er­na drops off and Pfiz­er dips

As Covid-19 concerns are fading in the US, so is biopharma visibility. The annual Axios Harris Poll survey to determine and rank the 100 most top-of-mind brands in the US finds Moderna, which was No. 3 last year, not on the list at all for 2022, and Pfizer sinking 37 spots.

However, it’s not that Moderna or Pfizer did anything wrong, it’s just that Americans have moved on to other worries beyond Covid.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,800+ biopharma pros reading Endpoints daily — and it's free.