Covid-19 roundup: No­vavax says vac­cine shows 'broad cross-re­ac­tiv­i­ty' against Omi­cron; France can­cels or­der on Mer­ck’s an­tivi­ral pill — re­port

No­vavax said Wednes­day that ini­tial da­ta sug­gest its Covid-19 vac­cine demon­strat­ed “broad cross-re­ac­tiv­i­ty against Omi­cron and oth­er cir­cu­lat­ing vari­ants” af­ter two dos­es — though neu­tral­iza­tion was around 4-fold low­er against Omi­cron com­pared to the orig­i­nal strain.

As a re­sult, the com­pa­ny says it’s work­ing on an Omi­cron-spe­cif­ic vac­cine and plans to launch clin­i­cal stud­ies in the first quar­ter of 2022.

“In the midst of an evolv­ing pan­dem­ic, NVX-CoV2373 showed strong im­mune re­spons­es against Omi­cron and oth­er cir­cu­lat­ing vari­ants,” R&D pres­i­dent Gre­go­ry Glenn said in a state­ment. “We are en­cour­aged that boost­ed re­spons­es against all vari­ants were com­pa­ra­ble to those as­so­ci­at­ed with high vac­cine ef­fi­ca­cy in our Phase 3 clin­i­cal tri­als, sug­gest­ing that NVX-CoV2373 can play an im­por­tant role in the on­go­ing fight against new vari­ants.”

Im­mune re­spons­es in­creased fol­low­ing a third dose at six months, with re­searchers not­ing a 9.3-fold boost in an­ti-spike IgG titers against Omi­cron com­pared to peak re­spons­es seen af­ter the two-dose reg­i­men.

Af­ter fac­ing mul­ti­ple de­lays in the US (for which the com­pa­ny at one point blamed sup­ply short­ages and a reg­u­la­to­ry man­u­fac­tur­ing is­sue re­lat­ed to one of their as­says), No­vavax fi­nal­ly won con­di­tion­al mar­ket­ing au­tho­riza­tion for its Covid-19 shot in Eu­rope ear­li­er this week.

CEO Stan­ley Er­ck told Ya­hoo Fi­nance Live on Tues­day that the com­pa­ny is ready to file for an EUA in the US, and would do so “with­in the next few days.”

France can­cels or­der on Mer­ck’s an­tivi­ral pill — re­port

A lit­tle over a week af­ter French reg­u­la­tors de­cid­ed against au­tho­riz­ing Mer­ck’s Covid-19 an­tivi­ral pill, the coun­try has can­celed its or­der, ac­cord­ing to mul­ti­ple re­ports.

A Mer­ck spokesper­son told Reuters that France’s planned pur­chase didn’t take place af­ter the coun­try’s health au­thor­i­ty re­ject­ed the pill over grow­ing con­cerns about ef­fi­ca­cy and the im­pact of the Omi­cron vari­ant. The coun­try had pre-or­dered enough dos­es to treat 50,000 pa­tients.

The FDA au­tho­rized the Ridge­back Bio­ther­a­peu­tics-part­nered drug, called mol­nupi­ravir, on Thurs­day. The US could have about 400,000 cours­es avail­able in the next few days, and by the end of Jan­u­ary, the US gov­ern­ment ex­pects to have about 3 mil­lion cours­es, which is the en­tire or­der that the US made.

Mer­ck had orig­i­nal­ly said mol­nupi­ravir, re­duced the risk of death and hos­pi­tal­iza­tions by 50%. Then in late No­vem­ber, the com­pa­ny came back with up­dat­ed da­ta that sug­gest­ed mol­nupi­ravir on­ly cut the risk by about 30% com­pared to place­bo.

Last month, the FDA’s An­timi­cro­bial Drugs Ad­vi­so­ry Com­mit­tee vot­ed 13-10 in fa­vor of the pill’s ben­e­fits out­weigh the risks for adults with­in 5 days of de­vel­op­ing Covid symp­toms.

Yes­ter­day, US reg­u­la­tors signed off on Pfiz­er’s Covid-19 pills, made up of nir­ma­trelvir tablets and ri­ton­avir tablets, co-pack­aged for oral use.

Pfiz­er’s pill, known as Paxlovid, proved to re­duce the rel­a­tive risk of hos­pi­tal­iza­tion or death by 89% (with­in three days of symp­tom on­set) and 88% (with­in five days of symp­tom on­set) com­pared to place­bo in a tri­al of more than 2,000 peo­ple.

“I don’t think you would find any­one who would pre­fer the Mer­ck pill to the Pfiz­er pill, giv­en the da­ta ev­i­dent so far,” Walid Gel­lad, a pro­fes­sor of med­i­cine at the Uni­ver­si­ty of Pitts­burgh, told End­points News.

New study sug­gests Sino­vac’s vac­cine does not pro­tect against Omi­cron 

A new study con­duct­ed in Chi­na found that two dos­es and a boost­er of Sino­vac’s vac­cine, dubbed Coro­n­aVac, did not pro­duce ad­e­quate lev­els of pro­tec­tive an­ti­bod­ies against the Omi­cron vari­ant.

The study, con­duct­ed by the Uni­ver­si­ty of Hong Kong and the Chi­nese Uni­ver­si­ty of Hong Kong, al­so found that two dos­es of the Pfiz­er/BioN­Tech vac­cine, Comir­naty, pro­duced poor an­ti­body re­spons­es against Omi­cron. How­ev­er, a third dose of Comir­naty giv­en to those who re­ceived two dos­es of ei­ther Comir­naty or Coro­n­aVac did pro­duce pro­tec­tive lev­els, ac­cord­ing to a news re­lease by the Uni­ver­si­ty of Hong Kong.

“Those who had re­ceived two dos­es of ei­ther Comir­naty or Coro­n­aVac should get a third dose of Comir­naty vac­cine around six months af­ter their sec­ond dose of vac­cine to achieve op­ti­mal pro­tec­tion against Omi­cron vari­ant,” pro­fes­sor Ma­lik Peiris said in a state­ment.

Just a week ago, Sino­vac claimed that a third shot of Coro­n­aVac was 94% ef­fec­tive against Omi­cron, ac­cord­ing to a re­port by Nikkei Asia.

Coro­n­aVac was one of the first vac­cines au­tho­rized for emer­gency use by the Chi­nese gov­ern­ment, snag­ging an OK back in Ju­ly 2020, an un­named of­fi­cial told Reuters. 

Sino­vac has tout­ed mixed re­sults in the past, with Brazil’s Bu­tan­tan In­sti­tute an­nounc­ing a 78% ef­fi­ca­cy rate back in Jan­u­ary, then cor­rect­ing that fig­ure to 50.4% less than a week lat­er. In Feb­ru­ary, tri­al re­sults from Brazil and Turkey sug­gest­ed Coro­n­aVac pre­vent­ed 50.65% of all Covid-19 cas­es, 83.70% of cas­es re­quir­ing med­ical treat­ment, and 100% of hos­pi­tal­iza­tions, and se­vere or fa­tal cas­es 14 days af­ter the sec­ond dose was ad­min­is­tered.

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

Alexander Lefterov/Endpoints News

A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

In a set­back, FDA or­ders Gilead to hit the brakes on their late-stage, $5B can­cer play

Gilead’s $5 billion drug magrolimab has run into a serious setback.

The FDA ordered Gilead to halt enrollment on their studies of the drug in combination with azacitidine after investigators reports revealed an “apparent imbalance” in the suspected unexpected serious adverse reactions between study arms. And the halt is raising questions about Gilead’s plans for a quick pitch to regulators.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 129,700+ biopharma pros reading Endpoints daily — and it's free.

Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 129,700+ biopharma pros reading Endpoints daily — and it's free.

Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 129,700+ biopharma pros reading Endpoints daily — and it's free.

Roy Baynes, Merck

FDA bats back Mer­ck’s ‘pipeline in a prod­uct,’ de­mands more ef­fi­ca­cy da­ta

Despite some heavy blowback from analysts, Merck execs maintained an upbeat attitude about the market potential of its chronic cough drug gefapixant. But the confidence may be fading somewhat today as Merck puts out news that the FDA is handing back its application with a CRL.

Dubbed by Merck’s development chief Roy Baynes as a “pipeline in a product” with a variety of potential uses, Merck had fielded positive late-stage data demonstrating the drug’s ability to combat chronic cough. The drug dramatically reduced chronic cough in Phase III, but so did placebo, leaving Merck’s research team with a marginal success on the p-value side of the equation.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 129,700+ biopharma pros reading Endpoints daily — and it's free.

Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 129,700+ biopharma pros reading Endpoints daily — and it's free.

Covid-19 roundup: Pfiz­er/BioN­Tech launch Omi­cron-spe­cif­ic vac­cine tri­al; UK to re­cruit thou­sands more for mol­nupi­ravir study

Pfizer and BioNTech announced Tuesday that they’ve initiated a clinical study to evaluate the safety, tolerability and immunogenicity of an Omicron-targeted vaccine candidate in healthy adults 18 through 55 years of age, although it remains unclear when, if ever, that vaccine might be necessary.

Drawing on some of the participants from the companies’ Phase III booster study, the trial will enroll up to 1,420 participants and evaluate three groups of healthy adults up to the age of 55, including one group who received 2 doses of the Pfizer vaccine and will get one shot of the Omicron-specific booster, one group that received three doses of the Pfizer vaccine and will get one of the Omicron-based vaccines, and then a third group receiving three doses of the Omicron-based vaccine.

Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.

Not cheap­er by the dozen: Bris­tol My­ers be­comes the 12th phar­ma com­pa­ny to re­strict 340B sales

Bristol Myers Squibb recently joined 11 of its peer pharma companies in limiting how many contract pharmacies can access certain drugs discounted by a federal program known as 340B.

Bristol Myers is just the latest in a series of high-profile pharma companies moving in their own direction as the Biden administration’s Health Resources and Services Administration struggles to rein in the drug discount program for the neediest Americans.