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2021 m. gruodžio 1 d., trečiadienis

Omicron is a risk for vaccinated people to be infected


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"The Omicron variant of the Covid-19 virus could lead to more infections among vaccinated people, according to several scientists, but some said there were reasons to believe the shots would protect against severe disease.

While the new variant might evade the antibodies generated in reaction to the vaccines, the virus likely will remain vulnerable to immune cells that destroy it when it enters the body, said Ugur Sahin, co-founder of BioNTech SE, which sells a Covid-19 shot with partner Pfizer Inc.

"Our message is: Don't freak out, the plan remains the same: Speed up the administration of a third booster shot," Dr. Sahin said Tuesday.

It will take a couple of weeks for scientists working for the main vaccine makers to determine through laboratory tests whether antibodies generated by the existing shots are effective against the new variant. Later on, data collected from patients will reveal how often vaccinated people infected with Omicron go on to experience mild or severe Covid-19 cases.

So far, there are few confirmed infections involving the new variant, making it difficult to generalize findings from these cases, especially because it can take weeks for Covid-19 patients to develop severe symptoms after they become infected.

Still, based on current knowledge about the mechanisms behind the vaccines and the biology of variants, Dr. Sahin said he assumes that immunized people would have a high level of protection against severe disease even if infected by the Omicron variant.

Dr. Sahin said the shot, which he and his team invented in January 2020 and developed with Pfizer, has been proven to protect against severe illness from other coronavirus variants that infect vaccinated people.

The currently prevalent variant, Delta, has proven more adept at infecting vaccinated people than earlier variants but those people mostly experience only mild symptoms, Dr. Sahin said.

The vaccine developed by BioNTech and Pfizer, like most other vaccines, offers two distinct layers of protection against the virus. The first comprises antibodies, which may help prevent people from becoming infected in the first place by preventing viruses from colonizing healthy cells in the body.

Antibodies, however, start to wane around five months after the second dose, according to some studies. Due to the high number of mutations, Omicron is likely to be better at circumventing the antibodies generated after contact with the vaccine than Delta, Dr. Sahin said.

This characteristic of Omicron may explain why preliminary tests suggest that an antibody drug cocktail from Regeneron Pharmaceuticals Inc. isn't as effective against Omicron as against older variants, the company said Tuesday. Outside scientists said another antibody drug cocktail from Eli Lilly & Co. also appears to lose effectiveness.

 

Vaccines also provide a second layer of protection: Immune agents called T-cells, some of which mobilize to destroy infected cells after an infection has occurred.

 

"Even as an escape variant, the virus will hardly be able to completely evade the T-cells," Dr. Sahin said.

 

That means that, even if the vaccines are shown to be less effective at neutralizing the Omicron variant, they could still offer good protection against severe disease and death, Dr. Sahin said.

 

Some experts are more skeptical. Dr. Sahin's comments come after Moderna Inc. Chief Executive Stephane Bancel told the Financial Times that he expects the current Covid-19 vaccines would be less effective at tackling the Omicron variant.

Stanley Plotkin, a veteran scientist who developed a number of vaccines, including the shot against rubella, said Dr. Sahin's assumptions are "gratuitous and without any proof."

Dr. Plotkin said data so far indicates that antibodies play a key role in protecting from coronavirus, and that there is little evidence that T-cells would be fully protective against severe symptoms.

However, he said it would make evolutionary sense for mutations in the virus that make it more infectious but less deadly to human hosts to become dominant over time.

Other experts, however, agree with Dr. Sahin. Professor Luke O'Neill, an immunologist and chair of biochemistry at Trinity College Dublin in Ireland said Dr. Sahin's assumption make sense from an immunological point of view.

"There is optimism that the T-cells will hold the line -- they are very good at stopping severe disease," he said. Even so, he said the booster campaign must be accelerated, and added that the arrival of Omicron would most likely establish a three-shot vaccination as the optimal protocol for immunization against coronavirus.

So far, scientists and doctors in South Africa, in the region where the new variant was first detected, said that about three out of four people currently hospitalized in the country were unvaccinated, while others had received only one dose.

Experts cautioned that the overall number of patients so far remains too small -- and their infections too recent -- to draw firm conclusions on whether Omicron leads to milder or severe cases of Covid-19 than other variants.

Peter English, a retired consultant in communicable-disease control in the U.K., cautioned that researchers would also want to see data in their own countries because the South African population is younger on average than many Western countries and has a relatively low rate of vaccination." [1]


1. U.S. News: Omicron Risks Infecting Vaccinated People

Pancevski, Bojan.  Wall Street Journal, Eastern edition; New York, N.Y. [New York, N.Y]. 01 Dec 2021: A.6.

JAV naujienos: teigiama, kad vaistų kokteiliai praranda veiksmingumą prieš omikrono variantą

„Preliminarūs tyrimai rodo, kad Covid-19 antikūnų kokteilis iš Regeneron Pharmaceuticals Inc. praranda veiksmingumą prieš omicroną“, antradienį pranešė bendrovė, o tai yra ženklas, kad kai kuriuos svarbios terapijos klasės produktus gali prireikti modifikuoti, jei nauja padermė plačiai išplis.

 

    Atskiras kito autorizuoto Covid-19 antikūnų vaistų kokteilio iš Eli Lilly & Co tyrimas rodo, kad jis taip pat nėra toks veiksmingas prieš omicroną, teigia išorės mokslininkai. Lilly teigė, kad bando naująjį variantą prieš gydymą antikūnais ir nespėlioja, kokie bus rezultatai.

 

    Šios išvados yra ankstyvieji tyrėjų lenktynių rezultatai, siekiant įvertinti naujojo omicrono varianto poveikį Covid-19 gydymui, kuriuo pasitikėjo pacientai, gydytojai ir ligoninės, taip pat kuriamoms tabletėms, kurios žadėjo apsaugoti žmones nuo ligoninės.

 

    Tyrėjai teigia, kad kai kurios antikūnų terapijos gali būti ypač pažeidžiamos omicrono, nes jame yra smailių baltymų mutacijų, į kurias nukreipiami vaistai Regeneron ir Lilly, o kiti vaistai turėtų gerai išsilaikyti, nes atakuoja nepakitusius viruso elementus.

 

    Monokloniniai antikūnai yra laboratorijoje pagamintos molekulės, gautos iš Covid-19 išgyvenusių žmonių arba pelių, sukurtų turėti žmogaus imuninę sistemą. Sušvirkštus netrukus po užsikrėtimo, vaistai prisitvirtina prie koronaviruso paviršiaus ir neleidžia jam daugintis naujose ląstelėse.

 

    Tai yra vieninteliai vaistai, leidžiami gydyti pacientus, kuriems gresia didelė rizika susirgti sunkiais atvejais, kol jiems nereikia hospitalizuotis.

 

    Vaistai skiriasi nuo vakcinų, kurios treniruoja imuninę sistemą, kaip apsiginti nuo viruso, įskaitant antikūnų gamybą. Praėjusiais metais buvęs prezidentas Donaldas Trumpas įvertino Regenerono vaistą už greitą pasveikimą nuo COVID-19.

 

    „Regeneron“ teigė, kad per ateinančias savaites galės kiekybiškai įvertinti varianto poveikį, kai bus atlikti tolesni bandymai.

 

    Jei galutinis tyrimas rodo, kad jos antikūnų vaistai yra mažiau veiksmingi prieš omicroną, Regeneron sukūrė alternatyvius antikūnus, kuriuos ji gali panaudoti, atliekant klinikinius tyrimus ir kurie, jos nuomone, išliks veiksmingi prieš variantą, sakė bendrovės prezidentas ir vyriausiasis mokslo darbuotojas George'as Yancopoulosas.

 

    Vienas iš alternatyvių Regeneron antikūnų jau yra klinikiniuose tyrimuose, kuriuos bendrovė pradėjo, tikėdamasi, kad laikui bėgant atsiras naujų variantų.

 

    Praėjusią savaitę Pietų Afrikos mokslininkai nustatė omicrono variantą, todėl vaistų tyrėjai pradėjo grumtis ir išsiaiškinti, ar palyginti nedidelė Covid-19 gydymo vaistų dėžutė vis dar veiks prieš naują padermę.

 

    „Turime pripažinti, kad per pastarąsias šešias dienas mūsų skubumas išaugo“, – sakė daktaras Yancopoulosas. „Tai, kas prasidėjo, kaip atsarginis planas, dabar tapo daug skubesnis.

 

    Fredo Hutchinsono vėžio tyrimų centro Sietle mokslininkai nustatė, kad atskiros omicrono mutacijos sumažino arba pašalino Regenerono ir Lilly vaistų gebėjimą prisijungti prie viruso, sakė mokslų daktarė Allie Greaney.

 

    Ji sakė, kad norint visiškai suprasti poveikį, reikia atlikti išsamesnius vaistų testus prieš visą variantą.

 

    Lilly šiuo metu bando naują variantą prieš savo vaistą, dviejų antikūnų, vadinamų bamlanivimabu ir etesevimabu, derinį, sakė Nicole Kallewaard, Lilly virusologė ir tyrimų patarėja. Ji atsisakė komentuoti rezultatus, rodančius sumažėjusį veiksmingumą prieš atskiras omicrono mutacijas, nes rezultatai gali skirtis, kai derinamos visos mutacijos.

 

    Padidėjęs omicrono paplitimas gali sudaryti galimybę konkurentams, kurie teigia, kad jų vaistai neatrodė, kad preliminariuose tyrimuose gali būti paveikti šio varianto, įskaitant Vir Biotechnology Inc. ir GlaxoSmithKline PLC, kurių vaistas sotrovimabas buvo leistas naudoti skubiu atveju anksčiau.

 

    Fredo Hutchinsono mokslininkai taip pat teigė, kad jų pradiniai tyrimai parodė, kad Vir-GSK antikūnų vaistas išlaikė savo veiksmingumą. 

 

Adagio Therapeutics Inc., biotechnologija su Covid-19 antikūnų klinikiniais tyrimais, teigė, kad naujasis variantas taip pat neturi įtakos jos antikūnams. Viras, Glaxo ir Adagio teigė, kad atlieka tolesnius bandymus. [1]

1. U.S. News: Drug Cocktails Said to Lose Effectiveness Against Strain

Walker, Joseph.  Wall Street Journal, Eastern edition; New York, N.Y. [New York, N.Y]. 01 Dec 2021: A.7.

U.S. News: Drug Cocktails Said to Lose Effectiveness Against Strain


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"Preliminary tests indicate the Covid-19 antibody drug cocktail from Regeneron Pharmaceuticals Inc. loses effectiveness against Omicron, the company said Tuesday, a sign that some products in an important class of therapies might need modifying if the new strain becomes widespread.

Separate testing of another authorized Covid-19 antibody drug cocktail, from Eli Lilly & Co., indicates it also isn't as effective against Omicron, outside scientists said. Lilly said it is testing the new variant against its antibody treatment and wouldn't speculate on what the results will be.

The findings are the early results of researchers' race to assess the impact of the new Omicron variant on Covid-19 treatments that patients, doctors and hospitals have been relying on, as well as pills in development that have promised to keep people out of the hospital.

Researchers say some antibody therapies are likely to be especially vulnerable to Omicron because it contains mutations to the spike protein that the Regeneron and Lilly drugs target, while other drugs should hold up well because they attack elements of the virus unchanged in the variant.

Monoclonal antibodies are lab-made molecules derived from survivors of Covid-19 or mice engineered to have human immune systems. When given soon after infection, the drugs attach to the surface of the coronavirus and prevent it from replicating itself in new cells.

They are the only drugs authorized to treat patients, before they require hospitalization, who are at high risk of developing severe cases.

The drugs differ from vaccines, which train the immune system how to defend against the virus, including with the production of antibodies. Last year, former President Donald Trump credited Regeneron's drug with his speedy recovery from Covid-19.

Regeneron said it would be able to quantify the impact of the variant in coming weeks, after further testing is done.

If final testing shows that its antibody drugs are less effective against Omicron, Regeneron has developed alternative antibodies that it can push into clinical testing and that it thinks will retain effectiveness against the variant, said George Yancopoulos, the company's president and chief scientific officer.

One of Regeneron's alternative antibodies is already in clinical testing, which the company began in anticipation of new variants emerging over time.

The Omicron variant was identified last week by scientists in South Africa, prompting drug researchers to scramble to see if the relatively small medicine chest of Covid-19 treatments would still work against the new strain.

"What we have to admit is, in the course of the past six days, our urgency has increased," Dr. Yancopoulos said. "What started out as a backup plan has now been made a lot more urgent."

Scientists at the Fred Hutchinson Cancer Research Center in Seattle found that individual mutations from Omicron reduced or eliminated the ability of Regeneron's and Lilly's drugs to attach to the virus, said Allie Greaney, a Ph.D. candidate at the center and the University of Washington in Seattle.

More comprehensive tests of the drugs against the entire variant are needed to fully understand the impact, she said.

Lilly is in the process of testing the new variant against its drug, a combination of two antibodies called bamlanivimab and etesevimab, said Nicole Kallewaard, a Lilly virologist and research adviser. She declined to comment on the results showing reduced effectiveness against individual Omicron mutations, because the results may differ when all of the mutations are combined.

 

A rise in the prevalence of Omicron could present an opportunity for competitors who say their drugs don't appear in preliminary testing to be affected by the variant, including Vir Biotechnology Inc. and GlaxoSmithKline PLC, whose drug sotrovimab was authorized for emergency use earlier this year.

 

Fred Hutchinson researchers also said their initial testing indicated the Vir-GSK antibody drug retained its effectiveness. Adagio Therapeutics Inc., a biotech with a Covid-19 antibody drug in clinical trials, said its antibody also appears to be unaffected by the new variant. Vir, Glaxo and Adagio said they are conducting further tests.” [1]

1. U.S. News: Drug Cocktails Said to Lose Effectiveness Against Strain

Walker, Joseph.  Wall Street Journal, Eastern edition; New York, N.Y. [New York, N.Y]. 01 Dec 2021: A.7.