Russia to try out 'Sputnik-Light' COVID vaccine to make it go further

 Russia will conduct a clinical trial of a one-dose “Sputnik-Light” version of its coronavirus vaccine, authorities said on Monday, describing it as a possible “temporary” solution to help countries with high infection rates make it go further.

The slimmed-down vaccine will be tested on 150 people in Moscow and St Petersburg, a government clinical trials register showed.

According to authorities, over a million Russians have so far been inoculated with the original two-dose version of Sputnik V, named after the Soviet-era satellite that triggered the space race in a nod to the project’s geopolitical importance for Moscow.

The two-dose vaccine will remain the main version used in Russia, Kirill Dmitriev, the head of Russia’s sovereign wealth fund, which is responsible for marketing Sputnik V abroad, said on Monday.

The one-dose version could, however, be used for export.

“‘Sputnik-Light’ can serve as an effective temporary solution for many countries, which are experiencing a peak of coronavirus infection,” Dmitriev, head of the Russian Direct Investment Fund (RDIF), which is covering the costs of the Sputnik-Light trial, said.

Several governments are considering ways to stretch scarce supplies of COVID-19 vaccines, including by delaying second doses and reducing dose sizes.

The aim is to maximise the number of people who have at least partial immunity, thereby potentially reducing the number of severe cases and lessening the burden on healthcare systems.

The two Sputnik doses are delivered using different inactive viruses, known as vectors, and some Russian manufacturers are finding the second less stable to produce, leading to a surplus of the first component.

Last month, Russia shipped 300,000 vials of the Sputnik V vaccine to Argentina, its first major international vaccine delivery. The shipment was made up only of the first component, drawn from this surplus batch, Reuters reported.

President Vladimir Putin has said the single dose will provide less protection than the two doses but “will still reach 85%”.

The Gamaleya Institute that developed the vaccine says it is more than 91% effective after the two-dose course.

Gamaleya Institute director Alexander Gintsburg has said that protective immunity after just the first shot of Sputnik V lasts around 3-4 months, the TASS news agency reported.

https://www.reuters.com/article/us-health-coronavirus-russia-vaccine/russia-to-try-out-sputnik-light-covid-vaccine-to-make-it-go-further-idUSKBN29G17Y

Lilly says Alzheimer's drug slows clinical decline in mid-stage trial

 Eli Lilly and Co said on Monday a trial of its experimental Alzheimer’s drug donanemab showed it slowed by about a third the rate of decline in a combined measure of cognition and function in early-stage victims of the disease.

The drug is an antibody designed to remove clumps of the Alzheimer’s-related protein beta amyloid from the brain.

Lilly said the mid-stage trial of 272 patients met its main goal of showing a statistically significant change in clinical decline over 18 months.

Donanemab targets a type of beta amyloid known as N3pG which Lilly believes can be rapidly cleared, enabling short-term, but durable, treatment.

Patients in the study stopped receiving donanemab and were switched to placebo once their brain plaques reached levels seen in healthy people - a process that took just a few months for some patients.

“This study shows that the presence of amyloid is an important accelerant of Alzheimer’s disease,” Daniel Skovronsky, Lilly’s chief scientific officer, told Reuters.

The results also “tell us that there are other things at play,” he added, saying additional strategies were needed to fully combat Alzheimer’s.

A brain swelling side effect, known as ARIA-E, occurred in 27% of patients treated with donanemab, the company said.

“Alzheimer’s disease is uniformly fatal ... I think this safety profile matched with this efficacy profile is something that we can be excited about,” Skovronsky said.

Lilly said donanemab also showed positive results in the trial’s secondary endpoints measuring cognition and function, but did not reach statistical significance on all of them.

The company is continuing to study the drug in a second, 500-patient trial.

Lilly, along with companies like Biogen Inc and Eisai Co Ltd, is one of the last large drugmakers pursuing treatments for Alzheimer’s - a disease that afflicts nearly 6 million Americans and millions more worldwide.

The U.S. Food and Drug Administration is reviewing Biogen’s application for aducanumab, which also targets amyloid plaques.

Biogen said one of its two pivotal aducanumab studies showed a statistically significant benefit in slowing cognitive and functional decline, but a second trial missed that goal, showing benefit only for some patients who got a high dose for at least 10 months.

Lilly said full trial results would be presented at a future medical meeting and submitted for publication in a peer-reviewed clinical journal.

https://www.reuters.com/article/us-elililly-alzheimers/lilly-says-alzheimers-drug-slows-clinical-decline-in-mid-stage-trial-idUSKBN29G161

Indonesia approves China's Sinovac vaccine as infections surge

 Indonesia gave Sinovac Biotech’s COVID-19 vaccine its first emergency use approval outside China on Monday as the world’s fourth most populous country launches nationwide inoculations to stem surging infections and deaths.

A lack of data and varying efficacy rates reported for the vaccine from different countries could undermine public trust in the rollout, according to public health experts.

Interim data from a late-stage human test of CoronaVac showed it is 65.3% effective, Indonesia’s food and drugs authority BPOM said - lower than figures in Brazil and Turkey which have yet to launch mass vaccinations.

BPOM head Penny K. Lukito said the results met the requirements of the World Health Organization’s minimum efficacy of 50%.

“Let’s support the COVID-19 vaccination program, because the success of COVID-19 handling belongs to us as a nation,” she said.

President Joko Widodo is set to get his first dose on Wednesday in a sign of the priority placed on immunisation in a country of 270 million people that has done far less than Southeast Asian neighbours to contain the virus.

But some public health specialists question how effective the rollout will be given the limited number of doses available, logistical challenges across thousands of islands and scepticism over the vaccine.

A BPOM official said 25 infections were found to get the efficacy rate, but without giving further details.

Dale Fisher of the National University of Singapore told the Reuters Next conference on Monday that not releasing detailed data could be problematic for a fast rollout.

“Messaging is more important than ever,” he said.

Indonesia has suffered more than 24,343 deaths from 836,700 cases. Over a tenth of deaths were in the last two weeks.

A Brazil-based study last week showed Sinovac’s vaccine is 78% effective. Turkish researchers said in December it showed 91.25% efficacy based on interim analysis.

To start, only three million doses of CoronaVac will be available in Indonesia. Some 1.2 million doses have been dispatched to 34 provinces, which span an area wider than the continental United States.

Indonesian authorities say they have also secured a total of nearly 330 million doses of vaccine from Sinovac and other companies for a campaign they expect to take 15 months to reach herd immunity once two-thirds of Indonesians are vaccinated.

Siti Nadia Tarmizi, a health ministry official, told Reuters that the approval “would greatly help medical workers as frontliners against COVID-19. This would protect them and reduce deaths among them.”

She said over 500 medical workers have died.

Sinovac has been overseeing late-stage clinical trials in Indonesia along with local state-owned drugmaker Bio Farma.

Some 1.3 million frontline workers are due to be among the first to receive the vaccines. But as it seeks to revive its economy, Indonesia then plans to prioritise younger workers rather than the vulnerable elderly as many countries have done.

In a possible boost for acceptance in the world’s largest Muslim majority nation, the vaccine was declared “holy and halal” last week by the Indonesian Ulema Council.

But public health workers report scepticism, particularly given it is the first major international campaign using the Sinovac vaccine.

Irma Hidayana, co-founder of Indonesia’s LaporCOVID-19, an independent coronavirus data initiative, said at the Reuters Next conference on Monday public trust in vaccines was a major issue. [L1N2JM0GR]

A recent survey by the group found 69% were uncertain about getting vaccinated.

Based on traditional vaccine technology that uses inactivated coronavirus, CoronaVac can be stored at normal fridge temperatures of 2-8 degrees Celsius (36°-46°F) and may remain stable for up to three years.

Vaccines offered by Pfizer/BioNTech and Moderna use the novel synthetic messenger RNA (mRNA) technology but require more demanding temperature control for storage and transportation.

https://www.reuters.com/article/us-health-coronavirus-indonesia/indonesia-approves-chinas-sinovac-vaccine-as-infections-surge-idUSKBN29G0RP

Bluebird bio plans to spin off cancer drugs unit

 Bluebird bio Inc plans to spin off its cancer drugs unit into a new, publicly traded company later this year to focus on rare genetic diseases, the company said on Monday.

The gene therapy developer’s Chief Executive Officer Nick Leschly will helm the new cancer company and take up new role as executive chair of bluebird bio.

The president of bluebird bio’s severe genetic diseases business, Andrew Obenshain, will become its CEO.

The move comes as bluebird suffered multiple regulatory setbacks last year for both its rare disease and cancer drug candidates.

In November, the submission of a marketing application for its blood disorder treatment, LentiGlobin, was pushed to 2022 from 2021 after the U.S. health regulator set additional requirements.

LentiGlobin or Zynteglo is approved in Europe for treating beta thalassemia and is priced there at 1.58 million euros ($1.92 million) over five years.

The company and partner Bristol Myers Squibb Co also suffered a regulatory setback for their multiple myeloma therapy, ide-cel, in May. The drug still awaits the FDA’s decision by March.

The split is an interesting strategic development but how this plays out is largely to be determined, J.P.Morgan analyst Cory Kasimov said in a client note.

“On one hand, segmenting the company by oncology and severe genetic diseases makes sense so that each individual entity can focus on their designated expertise. On the other, this removes diversification that comes with having both cell therapy and gene therapies programs,” Kasimov said.

The separation is expected to close in the fourth quarter, the company said.

On Monday, the Wall Street Journal first reported the move and said Leschly had cited the need for increased specialization as the reason for the split.

Goldman Sachs & Co LLC is the exclusive financial adviser to bluebird bio for the spinoff.

https://www.reuters.com/article/us-bluebird-bio-spinoff/bluebird-bio-plans-to-spin-off-cancer-drugs-unit-idUSKBN29G15L

Travel body rejects compulsory COVID-19 shots, although herd immunity called distant

 The head of a global travel organisation on Monday opposed making COVID-19 vaccinations a requirement for travellers in the fight against the pandemic, despite scepticism about reaching herd immunity this year.

Several health experts said during the Reuters Next conference that the mass roll-out of coronavirus vaccines would not result in enough people having immunity to be able to effectively stop COVID-19 from spreading.

Some policymakers have proposed immunisation should be compulsory for air travel as the world steps up the battle to curb the spread of COVID-19, and Australia’s Qantas Airways has said it plans to introduce such a requirement.

But Gloria Guevara, chief executive of the World Travel and Tourism Council, said such moves would be similar to workplace discrimination.

“We should never require the vaccination to get a job or to travel,” Guevara, whose organisation represents a sector accounting for as much as 10% of global employment, told a panel at Reuters Next.

“If you require the vaccination before travel, that takes us to discrimination.”

She was supported by AirAsia Group CEO Tony Fernandes, who said global testing protocols remained key to unlocking travel.

Their comments contrasted with a majority of online panel viewers in a snap poll who supported a vaccine requirement.

The contrasting views highlighted the difficulties reaching agreement on ways to defeat COVID-19 as the death toll from the virus and its economic fallout mount.

More than 90 million people are reported to have been infected by the novel coronavirus globally and about 1.9 million have died from the disease since it first emerged in China in December 2019, according to a Reuters tally.

Countries including the United States, Singapore and European states have begun rolling out vaccines such as those developed by Pfizer and its partner BioNTech, by Moderna and by drugmaker AstraZeneca alongside Oxford University.

Indonesia and India plan to start mass inoculations later this week.

But Dale Fisher, chairman of the World Health Organization’s (WHO) Outbreak Alert and Response Network, said: “We won’t get back to normal quickly.”

He was cautious about the chances of countries quickly reaching herd immunity.

“We know we need to get to herd immunity and we need that in a majority of countries, so we are not going to see that in 2021,” Fisher told Reuters Next. “There might be some countries that might achieve it but even then that will not create ‘normal’ especially in terms of border controls.”

That was a best-case scenario, based on current knowledge of the vaccines being rolled out, Fisher said.

Pandu Riono, an epidemiologist at the University of Indonesia, told the conference some governments were over-reliant on the coming vaccines and this meant herd immunity could not be achieved in the near term.

Irma Hidayana, the Indonesia-based co-founder of LaporCOVID-19, an independent coronavirus data initiative, said public trust in vaccines could have an impact on the roll-out.

Another problem, Fisher said, was uncertainty about the ability of the virus to mutate further.

https://www.reuters.com/article/us-health-coronavirus-global-vaccines/travel-body-rejects-compulsory-covid-19-shots-experts-say-herd-immunity-distant-idUSKBN29G0TY

Trial of COVID-19 blood plasma finds no benefit in severely ill patients

 An international trial testing convalescent blood plasma on COVID-19 patients with moderate and severe illness has halted enrolment of severely ill COVID-19 patients requiring intensive care after it found no benefit, trial investigators said on Monday.

The decision by the REMAP-CAP trial leaders came after an initial analysis of more than 900 severely ill trial participants in intensive care showed that treatment with the product - an antibody-rich plasma taken from people who have recovered from the pandemic disease - did not improve outcomes.

“There was no evidence of harm associated with the administration of convalescent plasma” (and) the trial is continuing to recruit hospitalised COVID-19 patients who are moderately ill but not in intensive care, scientists leading the trial said in a statement.

“It is biologically plausible that patients who are not producing antibodies at the time of convalescent plasma therapy and those patients with excess virus may benefit more than others. Our additional analyses will explore this,” said Manu Shankar-Hari, a clinician and professor of critical care medicine at Britain’s Guy’s and St Thomas’ hospital, who is co-leading the trial.

He added that the initial analysis did not assess plasma’s effects in hospitalised patients with less severe disease. This “remains a very important question” and would continue to be explored in the ongoing trial, he said.

The underlying hypothesis for using convalescent plasma as a potential treatment for COVID-19 patients is that the antibodies it contains could neutralize the virus, stopping it from replicating and halting tissue damage.

But this initial analysis leading to the REMAP-CAP pause in enrolment of critically ill patients showed there was a very low probability - 2.2% - that it reduced death rates or decreased the number of days patients needed intensive care.

“Why convalescent plasma does not seem to improve outcome in severely ill COVID-19 patients admitted to the ICU is not yet known. However, it may be because the lung damage is too advanced for convalescent plasma to make a difference,” said Alexis Turgeon, a critical care doctor and professor at Université Laval in Canada, who is also working on the trial.

REMAP-CAP is an international clinical trial exploring potential treatments for COVID-19. It has already recruited 4,100 COVID-19 patients at more than 290 clinical sites across Europe, the Americas, Asia, Africa and Australasia.

Separate findings from REMAP-CAP showed last week that treating critically ill COVID-19 patients with Roche’s Actemra or Sanofi’s Kevzara arthritis drugs significantly improved survival rates and reduced the amount of time patients need intensive care.

The trial is also looking at potential effects of a range of other existing therapies, including anticoagulation medicines, antiplatelet agents, antibiotics, statins and vitamin C.

https://www.reuters.com/article/us-health-coronavirus-plasma/trial-of-covid-19-blood-plasma-finds-no-benefit-in-severely-ill-patients-idUSKBN29G1JZ

BioNTech lifts 2021 COVID-19 vaccine output target to 2 billion doses

 Pfizer’s partner BioNTech boosted the 2021 delivery target for their COVID-19 vaccine to 2 billion doses, up from 1.3 billion previously, as they bring new production lines on stream and as more doses can be extracted per vial.

Special syringes known as low dead space syringes were instrumental in the increase, which would result in 1 billion people getting the designated two-dose regimen, BioNTech said in a presentation posted on Monday.

The syringes allow the extraction of six doses from a standard vial, instead of the usual five, by avoiding unused liquid left in a syringe.

“We now believe that we can potentially deliver approximately 2 billion doses in total by the end of 2021, which incorporates the updated six-dose label,” BioNTech said.

A new site in Marburg, Germany, acquired from Novartis in September, would boost annual capacity by up to 750 million doses when it becomes operational by end-February, it added.

Additional capacity by contractors, who supply ingredients and fill the finished substance into vials, had also helped to lift the target.

The Biotech firm added on its slides that 32.9 million doses had been shipped as per Sunday.

A spokeswoman said that 50 million doses had been produced at the end of 2020, as previously planned, but that deliveries had been held until specific orders are placed to avoid excess storage time.

https://www.reuters.com/article/us-health-coronavirus-vaccine-biontech/biontech-lifts-2021-covid-19-vaccine-output-target-to-2-billion-doses-idUSKBN29G1DM