Covid-19 roundup: Old test samples suggest Omicron has been in Europe for weeks; US to tighten travel restrictions — report

Look­ing at past test sam­ples, Dutch of­fi­cials have de­tect­ed the Omi­cron vari­ant in cas­es dat­ing back as far as Nov. 19, adding fur­ther ev­i­dence that the vari­ant ar­rived in Eu­rope well be­fore the first cas­es were de­tect­ed in South Africa.

The sam­ples in ques­tion were tak­en on Nov. 19 and 23, ac­cord­ing to the coun­try’s health in­sti­tute, RIVM.

‘It is not yet clear whether these peo­ple had al­so vis­it­ed south­ern Africa,’ the RIVM said in a state­ment.

On Nov. 26, the coun­try test­ed 624 peo­ple re­turn­ing from South Africa, 61 of whom were pos­i­tive for Covid-19, and 14 of whom had the Omi­cron vari­ant. Lab tests con­firmed dif­fer­ent strains of the vari­ant among the 14 trav­el­ers, mean­ing they were like­ly in­fect­ed in­de­pen­dent­ly of each oth­er.

‘RIVM will be retroac­tive­ly ex­am­in­ing old­er sam­ples from lab­o­ra­to­ries that rou­tine­ly per­form the spe­cial PCR test,’ to look for ear­li­er cas­es of the vari­ant, the in­sti­tute said.

Mean­while, Nige­ria has de­tect­ed the con­cern­ing vari­ant in cas­es dat­ing back to Oc­to­ber, ac­cord­ing to a Reuters re­port. And Bel­gium and Ger­many have al­so con­firmed cas­es in their coun­tries be­fore South Africa alert­ed the world last week, CBS News re­port­ed. On Tues­day, EMA di­rec­tor Emer Cooke said the vari­ant was found in at least 10 Eu­ro­pean coun­tries, per Reuters.

The WHO says it’s not yet clear whether the new vari­ant is more trans­mis­si­ble or if it can cause more se­vere dis­ease than oth­er vari­ants like Delta — and un­der­stand­ing the lev­el of risk could take days to sev­er­al weeks.

‘All vari­ants of Covid-19, in­clud­ing the Delta vari­ant that is dom­i­nant world­wide, can cause se­vere dis­ease or death, in par­tic­u­lar for the most vul­ner­a­ble peo­ple, and thus pre­ven­tion is al­ways key,’ the or­ga­ni­za­tion said in a state­ment.

While Mod­er­na CEO Stéphane Ban­cel warned of a ‘ma­te­r­i­al drop’ in vac­cine ef­fi­ca­cy, BioN­Tech CEO Uğur Şahin said he ex­pects that the com­pa­ny’s Pfiz­er-part­nered shot will con­tin­ue to of­fer pro­tec­tion against se­vere dis­ease. Both Mod­er­na and Pfiz­er have said they will be­gin de­vel­op­ing boost­er shots specif­i­cal­ly tai­lored to the Omi­cron vari­ant.

US to tight­en trav­el re­stric­tions  — re­port

As more and more coun­tries be­gin de­tect­ing cas­es of the Omi­cron vari­ant, the US is re­port­ed­ly con­sid­er­ing tighter trav­el re­stric­tions.

CDC of­fi­cials told Reuters the agency is look­ing to re­quire that all air trav­el­ers com­ing in­to the coun­try pro­vide proof of a neg­a­tive Covid-19 test per­formed with­in one day of de­par­ture. Cur­rent­ly, vac­ci­nat­ed trav­el­ers can take up to three days to get a neg­a­tive test.

Of­fi­cials al­so told Reuters that they’re con­sid­er­ing re­quir­ing air trav­el­ers to get an­oth­er Covid test three to five days af­ter ar­rival.

On Mon­day, the US banned trav­el for non-US cit­i­zens from South Africa, which was the first to re­port cas­es of the Omi­cron vari­ant, and sev­en oth­er south­ern African coun­tries. The fol­low­ing day, the CDC added Niger, Papua New Guinea, Poland, Trinidad and To­ba­go, to its list of 80 dis­cour­aged trav­el lo­ca­tions.

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Stéphane Bancel, Moderna CEO

Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.

Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?

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The nonprofit Institute for Clinical and Economic Review on Wednesday released a new report highlighting the ways in which payers are generally ensuring fair access to prescription drugs, even when based on a set of criteria set by the nonprofit.

While noting the lack of transparency hindered the report’s results, ICER said that the ‘great majority’ of payer policies in the formularies evaluated are structured in a way to support many key elements of how ICER defines ‘fair access.’

Reshma Kewalramani, Vertex CEO (Vertex via YouTube)

Vertex claimed its second early-stage win of the fall Wednesday, announcing positive results in a small study on a genetically defined form of kidney disease.

The 16-patient, Phase II trial focused on patients with focal segmental glomerulosclerosis, a rare disease where kidneys are unable to filter blood properly. Over 13 weeks on an experimental pill, the level of protein in the patients’ urine fell by an average of 47.6%.

Ugur Sahin, BioNTech CEO (Frank Rumpenhorst/dpa via AP Images)

Whereas some public health officials and biopharma leaders — including Moderna CEO Stéphane Bancel — are sounding the alarm over the new Omicron coronavirus variant, BioNTech chief Ugur Sahin is pressing a more cautious approach.

In interviews Tuesday with the Wall Street Journal and Reuters, Sahin cautioned that little is yet known of the variant’s ability to cause severe Covid-19, and T cell responses among the vaccinated would likely remain strong. Though the biotech is still conducting lab tests to determine whether antibody protection will be diminished, Sahin isn’t pressing the panic button.

Paul Hudson, Sanofi CEO (Cyril Marcilhacy/Bloomberg via Getty Images)

Paul Hudson has spotlighted vaccines, immunology and dermatology as some of the top R&D focuses at Sanofi. His latest deal brings all of them together.

The French pharma giant isn’t sharing any financial details about the buyout of Origimm, a low-profile, private Austrian biotech whose technology promises to identify antigens causing skin disease and build vaccines against them. Their lead candidate targets acne vulgaris.

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Philip Dormitzer, new GSK global head of vaccines R&D

GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.

Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.

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With little explanation for why Merck’s potential Covid-19 antiviral was less effective in reducing Covid hospitalizations and deaths in a full analysis of a Phase III trial versus an interim look, the FDA’s antimicrobial drugs advisory committee on Tuesday voted 13-10 in favor of the pill’s benefits outweighing the risks for adults within 5 days of developing Covid symptoms.

Molnupiravir will likely be authorized by FDA in the coming days for adults with mild or moderate Covid-19. While Pfizer’s antiviral may prove to be more effective, Merck’s pill will be another weapon in the armamentarium of Covid-19 treatments for countries around the world, adding to the mAb treatments already in use in the outpatient space from Regeneron, Eli Lilly and Vir/GlaxoSmithKline.
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