Covid-19 roundup: EMA starts rolling re­view of Rus­si­a's Sput­nik V; No­vavax says shot is 51% ef­fec­tive against vari­ant in South Africa 

The EMA has start­ed a rolling re­view of Sput­nik V, the Russ­ian vac­cine that holds the du­bi­ous ti­tle of the world’s first reg­is­tered jab for Covid-19.

Sev­en months af­ter the con­tro­ver­sial clear­ance in Rus­sia, Eu­rope’s hu­man med­i­cines com­mit­tee says it’s con­vinced to start look­ing at the ap­pli­ca­tion by da­ta in­di­cat­ing that the ade­n­ovirus-based vac­cine trig­gers the pro­duc­tion of an­ti­bod­ies and im­mune cells against the SARS-CoV-2 coro­n­avirus.

As with pre­vi­ous rolling re­views of the Pfiz­er/BioN­Tech and As­traZeneca/Ox­ford vac­cines, a mar­ket­ing au­tho­riza­tion ap­pli­ca­tion has not yet been for­mal­ly sub­mit­ted. R-Pharm Ger­many — the Gama­leya Na­tion­al Cen­tre of Epi­demi­ol­o­gy and Mi­cro­bi­ol­o­gy’s part­ner in Eu­rope — is tasked with the fil­ing.

While Sput­nik V uti­lizes the same tech­nol­o­gy plat­form as As­traZeneca and J&J, the two-dose reg­i­men us­es two dif­fer­ent virus­es for the prime and boost­er shots: Ad26 for the first and Ad5 for the sec­ond. Sci­en­tists re­port­ed ef­fi­ca­cy of 92% in a Phase III tri­al, sur­pass­ing oth­er ade­n­ovirus-based vac­cines and ri­val­ing its mR­NA coun­ter­parts, al­though the ev­i­dence of­fered was no­tably slim­mer.

As EU lead­ers in Brus­sels strug­gle with de­lays in vac­cine sup­ply and roll­out, two mem­ber states have in­di­vid­u­al­ly turned to Rus­sia for their own vac­ci­na­tion cam­paigns.

Hun­gary was the first to by­pass the EMA, au­tho­riz­ing and pur­chas­ing not the Russ­ian vac­cine but al­so an in­ac­ti­vat­ed virus vac­cine from Chi­na’s Sinopharm.

Ear­li­er this week, Slo­va­kia an­nounced that it’s pur­chased 2 mil­lion dos­es of Sput­nik V, al­though its drug reg­u­la­tor has yet to give a green light. — Am­ber Tong

No­vavax says shot is 51% ef­fec­tive against vari­ant in South Africa 

No­vavax’s vac­cine can­di­date was 51% ef­fec­tive against the B.1.351 vari­ant in HIV-neg­a­tive pa­tients, ac­cord­ing to re­sults from a study con­duct­ed in South Africa.

A to­tal of 4,387 vol­un­teers were en­rolled in the Phase IIa/b study tri­al, in­clud­ing HIV-pos­i­tive pa­tients. The vac­cine group in­clud­ed 2,199 par­tic­i­pants who got two dos­es of No­vavax’s jab 21 days apart, ac­cord­ing to a preprint in medRx­iv. Near­ly 93% of cas­es in the study were dis­cov­ered to be caused by the B.1.351 vari­ant.

Over­all ef­fi­ca­cy in HIV-neg­a­tive pa­tients who were seroneg­a­tive at base­line was 60.1%, re­searchers re­port­ed. Ef­fi­ca­cy in­clud­ing HIV-pos­i­tive pa­tients was 49.4%.

About 30% of the par­tic­i­pants were seropos­i­tive at base­line, in­di­cat­ing pri­or Covid-19 in­fec­tion. How­ev­er, re­searchers found no sig­nif­i­cant dif­fer­ence in pro­tec­tion for that group com­pared to those who were seroneg­a­tive at base­line.

“The NVX-CoV2373 vac­cine was ef­fi­ca­cious in pre­vent­ing Covid-19, which was pre­dom­i­nant­ly mild to mod­er­ate and due to the B.1.351 vari­ant, while ev­i­dence of pri­or in­fec­tion with the pre­sump­tive orig­i­nal SARS CoV-2 did not con­fer pro­tec­tion against prob­a­ble B.1.351 dis­ease,” the preprint states.

The news comes just over a month af­ter No­vavax an­nounced its vac­cine was 89.3% ef­fec­tive at stop­ping symp­to­matic Covid-19 in its Phase III study in the UK, as of the first in­ter­im analy­sis. The read­out was based on 62 con­firmed cas­es of symp­to­matic Covid-19, 56 of which came in the place­bo group.

Al­ready run­ning be­hind oth­ers in the vac­cine race, No­vavax de­layed the start of its US/Mex­i­co Phase III tri­al a sec­ond time back in No­vem­ber. Man­u­fac­tur­ing is­sues, which were to blame for the first de­lay, ap­peared to be at play in the sec­ond holdup as well. — Nicole De­Feud­is 

UK to fast-track vac­cines for Covid-19 vari­ants — re­port

The UK’s reg­u­la­to­ry agency says it will fast-track vac­cines for Covid-19 vari­ants, us­ing an ac­cel­er­at­ed process sim­i­lar to the one used for sea­son­al flu vac­cines, ac­cord­ing to a Reuters re­port. 

The Med­i­cines & Health­care prod­ucts Reg­u­la­to­ry Agency (MHRA) said re­searchers will be al­lowed to mea­sure pro­tec­tion by an­ti­bod­ies pro­duced in the blood, rather than con­duct­ing lengthy clin­i­cal tri­als, Reuters re­port­ed on Thurs­day morn­ing. They’ll still need safe­ty da­ta, and da­ta from orig­i­nal clin­i­cal tri­als and re­al-world in­oc­u­la­tions are fair game.

“Our pri­or­i­ty is to get ef­fec­tive vac­cines to the pub­lic in as short a time as pos­si­ble, with­out com­pro­mis­ing on safe­ty,” said Chris­t­ian Schnei­der, the MHRA’s CSO, per the news agency.

As­traZeneca, Pfiz­er and Mod­er­na, which have shots OK’d for use in the UK, are all work­ing to ad­dress new vari­ants. Last week, Mod­er­na’s Stéphane Ban­cel told End­points News that vials con­tain­ing vari­ants of their vac­cine to beat new vari­ants of the virus had ar­rived at the NIH head­quar­ters in Bethes­da, where they will be­gin rapid clin­i­cal test­ing. — Nicole De­Feud­is 

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.

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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.

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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.

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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.

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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.

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