Boris Johnson at a press conference Dec. 8, after discussions on restrictions as a result of the Omicron variant (Adrian Dennis/Pool via AP Images)

Covid-19 roundup: UK preps for a wave of Omi­cron cas­es; Bourla sug­gests a fourth dose might be nec­es­sary

With re­ports of Omi­cron cas­es in over 50 coun­tries, and at least 19 US states, some re­gions like the UK are now ex­pect­ing a rapid rise of Omi­cron as com­mu­ni­ty spread takes off.

While the UK has on­ly seen about 800 Omi­cron cas­es so far, the gov­ern­ment’s Health Se­cu­ri­ty Agency warned that if the re­cent growth rate con­tin­ues, “we ex­pect to see at least 50 per­cent of Covid-19 cas­es to be caused by the Omi­cron vari­ant in the next two to four weeks,” ac­cord­ing to the New York Times.

John Ed­munds, an epi­demi­ol­o­gist at the Lon­don School of Hy­giene & Trop­i­cal Med­i­cine, said that plan B mea­sures an­nounced by PM Boris John­son were “ab­solute­ly not an over­re­ac­tion” even if Omi­cron turned out to be milder than the cur­rent dom­i­nant vari­ant, ac­cord­ing to The Guardian.

Ed­munds told a Roy­al So­ci­ety of Med­i­cine we­bi­nar Thurs­day that it was “ex­treme­ly like­ly” there’s more Omi­cron in com­mu­ni­ties, adding, “With the speed of spread of this virus, we may well have re­al­ly sig­nif­i­cant num­bers of cas­es by Christ­mas.”

Mean­while, CDC di­rec­tor Rochelle Walen­sky said Wednes­day that her staff is “avail­able 24/7, as they have been through­out this en­tire pan­dem­ic, to pro­vide in-per­son and re­mote tech­ni­cal sup­port for the pub­lic health re­sponse to the Omi­cron vari­ant, in­clud­ing in­ves­ti­ga­tions of the epi­demi­o­log­ic and clin­i­cal char­ac­ter­is­tics of Omi­cron or oth­er SARS-CoV-2 in­fec­tions.”

An­tho­ny Fau­ci, Pres­i­dent Biden’s top in­fec­tious dis­ease ex­pert, added at the brief­ing, “We are do­ing live virus and pseu­do virus as­says that might be ready for in­ter­pre­ta­tion in the mid­dle of next week for the pseu­do virus and prob­a­bly the end of next week for the live virus­es. We’ll be able to de­ter­mine whether or not an­ti­bod­ies in­duced by our vac­cines lose their ca­pa­bil­i­ty of ef­fec­tive­ness with Omi­cron.”

Be­tween Nov. 26 and Dec. 6, CDC has worked with with more than 25 ju­ris­dic­tions on sus­pect­ed and con­firmed cas­es of the Omi­cron vari­ant, Walen­sky said.

Pfiz­er CEO Bourla sug­gests the need for a fourth vac­cine dose to fight Omi­cron

Da­ta on the Omi­cron vari­ant that are com­ing in the next two weeks will of­fer an ac­cu­rate look at whether Pfiz­er’s vac­cine can stand up to the new, more in­fec­tious vari­ant, Pfiz­er CEO Al­bert Bourla told CN­BC yes­ter­day.

“When we see re­al-world da­ta, will de­ter­mine if the Omi­cron is well cov­ered by the third dose and for how long. And the sec­ond point, I think we will need a fourth dose,” Bourla said. Al­though, Bourla’s opin­ion is con­flict­ed by his po­si­tion and ob­vi­ous in­ter­est in sell­ing as many vac­cine dos­es as pos­si­ble.

Bourla pre­vi­ous­ly said that a fourth dose like­ly wouldn’t be need­ed un­til a year af­ter the third, but he said this new, faster time­line is be­cause of Omi­cron.

The push comes as Fau­ci has al­so now in­di­cat­ed that an Omi­cron-tar­get­ed vac­cine might not be nec­es­sary.

While stress­ing that he was hy­poth­e­siz­ing, Fau­ci sug­gest­ed in an in­ter­view with STAT News that it’s pos­si­ble the cur­rent vac­cines will pro­vide enough pro­tec­tion against Omi­cron.

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.