Spain to Test Mixing COVID Vaccines After Restricting AZ Shot

MADRID (Reuters) – Spain will study the effects of mixing different coronavirus vaccines, government researchers said on Monday, responding to shifting guidelines on the safety of the AstraZeneca’s shot.

Along with several other European countries, Spain restricted vaccines produced by the Anglo-Swedish drug maker to people over 60 after regulators linked it to a rare form of brain blood clots, mostly in younger women.

“After decisions by various European public health authorities to suspend use of the AstraZeneca vaccine in under 60 year olds, we are setting out to urgently find scientific evidence to support decision making around possible alternatives,” Raquel Yotti, director of the Carlos III Health Institute, told a news conference.

The trial will draw on a sample of 600 people of all ages from across Spain, said Jesus Frias Iniesta, clinical research coordinator at Carlos III.

“The study’s objective is…to determine within 28 days whether a second dose of the Pfizer vaccine can be given to patients who have received the AstraZeneca vaccine,” he said.

A UK study on mixing vaccines was expanded last week to include shots made by Moderna and Novavax, while France and Germany are considering giving an alternative to under 60s who received a first dose of AstraZeneca.

Separately, Spain’s El Mundo newspaper reported the health ministry was considering delaying second doses for under 80 year olds to maximise the number of people who received at least one injection.

Patients would receive a second shot of vaccines produced by Pfizer and Moderna eight weeks after the first, El Mundo said. The European Medicines agency recommends a 28-day gap between Moderna shots and 21 days between Pfizer.

The proposal would signal a sharp departure from the current national strategy, which favours giving vulnerable age groups a full course of two shots as quickly as possible.

The Health Ministry was not immediately available for comment.

Several real-world studies have shown a first dose of the Pfizer-BioNTech vaccine provides a high level of protection.

Despite delays to the deployment of the one-shot Johnson & Johnson vaccine and supply disruptions at AstraZeneca, Spain still expects to have half its 47-million population fully inoculated by late July.

Data released on Friday showed 7% of the population had received a full course, while 19% had received at least one dose.

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Hypothesis: Milk and Beef ‘Causally Linked’ to Colorectal Cancer

HEIDELBERG, Germany — Bovine meat and milk factors (BMMF), the recently discovered pathogenic agents found in milk products and beef, could play a role in the development of colorectal cancer, say German scientists.

The team is headed by Harald zur Hausen, MD, PhD, Division of Episomal-Persistent DNA in Cancer and Chronic Diseases, German Cancer Research Center, Heidelberg, Germany, who received the Nobel Prize in Physiology or Medicine in 2008 for his discovery of the role of human papilloma viruses in the development of cervical cancer.

The team has been researching the link between BMMF and colorectal cancer for some years, and the latest study was published by the Proceedings of the National Academy of Sciences of the United States of America on March 23.

“The results support our hypothesis that the consumption of milk and beef is causally linked to the development of colon cancer,” Hausen said in a related press statement.

Pathogenic Agents, Found in Vicinity of Tumors

BMMF are infectious agents that occur as circular single strands of DNA and have a notable similarity to the sequences of some bacterial plasmids.

A few years ago, Hausen and colleagues found these pathogenic agents in colon cancer patients, in the immediate vicinity of tumors.

They therefore put forward the hypothesis that BMMF could trigger chronic local inflammation, which in turn could cause genetic mutations via oxidative stress and lead to the development of cancer over the long term.

The German researchers were also able to show in in vitro models that BMMF multiply in human cells where the H1MSB.1 Rep protein, which is required for their replication, is synthesized.

In their latest study, the scientists analyzed tissue samples from colorectal cancer patients and from individuals without the disease.

They found that the BMMF could trigger chronic inflammation in the intestinal tissue of cancer patients, as demonstrated via the presence of pro-inflammatory macrophages.

They also used anti-Rep antibodies to show that the Rep protein was present around and inside the macrophages. In cancer patients, 7.3% of all the intestinal cells in the tumor environment were positive for Rep vs just 1.7% of those in the control group.

In addition, the researchers reported increased levels of reactive oxygen species close to Rep-positive cells.

“These oxygen radicals promote the development of genetic changes,” Hausen said.

The inflammation was particularly localized to the immediate vicinity of the intestinal crypts, where the intestinal stem cells, which are responsible for the constant regeneration of the intestinal mucosa, are found.

“We therefore think of the BMMF as indirect carcinogens, some of which will probably have an impact on dividing cells in the intestinal mucosa for decades,” Hausen explained.

He assumes that infection with BMMF typically occurs early in life. This “opens up the possibility of early intervention,” he suggested.

The early detection of BMMF could allow the identification of individuals particularly at risk, and for these patients to be offered timely colon cancer screening.

The researchers stress, however, that further study will be required to confirm the results.

They nevertheless believe that BMMF could help explain the link between the consumption of red meat and dairy products and other cancers and diseases, in particular breast, prostate, and lung cancers.

Finally, the pathogenic agents could partially explain the preventive effect of anti-inflammatory dugs such as aspirin and ibuprofen on the incidence of colon cancer and other cancers, via the reduction of chronic inflammation.

This work was supported by an unrestricted grant from ORYX Alpha (Munich) (to Hausen). Mathias Heikenwalder was supported by the EOS Foundation (Flundern), the SFBTR-179 and 209, and a European Research Council consolidator grant. The authors have disclosed no relevant financial relationships.

PNAS. Published online March 23, 2021. Full text

Translated and adapted from Medscape’s French edition.

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Magic mushroom compound at least as good as antidepressant in UK study

LONDON (Reuters) – Psilocybin, the psychedelic active compound in magic mushrooms, may be at least as effective as a leading antidepressant drug and could help more patients into remission from severe depression, a small study by British scientists has found.

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The findings, in the first-of-a-kind head-to-head comparison of psilocybin therapy and the antidepressant escitalopram, suggests the psychoactive ingredient has promise as a potential mental health treatment, the researchers said.

“Remission rates were twice as high in the psilocybin group than the escitalopram group,” Robin Carhart-Harris, who designed and led the study as head of the centre for psychedelic research at Imperial College London, told a briefing.

“One of the most important aspects of this work is that people can clearly see the promise of properly delivered psilocybin therapy by viewing it compared with a more familiar, established treatment,” he said. “Psilocybin performed very favourably in this head-to-head.”

Depression is one of the leading causes of ill health worldwide, and existing treatments are often ineffective or have adverse side effects that lead patients to stop taking them.

Carhart-Harris warned that while these findings – published in the New England Journal of Medicine – were encouraging, patients with depression should not try to self-medicate with magic mushrooms. “That would be an error of judgment,” he said.

The research involved 59 patients with moderate to severe depression who got either a high dose of psilocybin and a placebo, or escitalopram plus a dose of psilocybin so low as to be classed as non-active and unlikely to have an effect.

This design was aimed at ensuring the two arms of the trial were as alike as possible for those taking part.

Treatment response, defined as a reduction of at least 50% in depression scores from baseline, was seen in 70% of people in the psilocybin group and 48% in the escitalopram group.

Results also showed that remission of symptoms – measured as a score of 0 to 5 at week six – was seen in 57% of the psilocybin group compared with 28% in the escitalopram group.

Carhart-Harris said participants’ reports suggested the psilocybin had a more “fundamental” effect than antidepressants.

“I think it’s getting more at the root causes of suffering,” he said. “There’s a kind of epistemic quality to the treatment, a revelatory quality, where people report feeling that they understand more fully why they’re depressed.”

The Imperial team, co-led by David Nutt, a professor of neuropsychopharmacology, has been exploring the potential of psilocybin for many years.

In 2016 they published a small study showing psilocybin could help ease a severe condition known as treatment-resistant depression.

The latest study was conducted under specific controlled conditions with two therapists and a regulated dose formulated in laboratory conditions, Nutt told the briefing, and taking magic mushrooms without such safeguards could be dangerous.

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Pandemic hits ‘critical point’ as Europe deaths top one million

coronavirus

Europe passed the grim milestone of one million coronavirus deaths on Monday, as the World Health Organization warned that infections are rising exponentially despite widespread efforts aimed at stopping them.

The death toll across Europe’s 52 countries, compiled by AFP from official sources, totalled at least 1,000,288 by 1830 GMT.

“We are in a critical point of the pandemic right now,” said Maria Van Kerkhove, the WHO’s technical lead on COVID-19.

“The trajectory of this pandemic is growing… exponentially.

“This is not the situation we want to be in 16 months into a pandemic, when we have proven control measures,” she told reporters.

The coronavirus has already killed more than 2.9 million people and infected nearly 136 million across the world.

But despite the sombre news in Europe—the world’s worst-hit region—Britain eased curbs for the first time in months on Monday, allowing Britons to enjoy a taste of freedom with a pint and a haircut.

The changes illustrate how fast-vaccinating countries are leaving other—mostly poorer—nations behind.

In South Africa, the president called for African-made vaccines as the continent lags behind, struggling with inadequate supplies as well as a lack of financing and logistical problems.

“Africa needs to harness its own continental capabilities and identify opportunities for collaboration,” Cyril Ramaphosa said.

Ramaphosa suggested India or Brazil could help after successfully developing their own generic pharmaceutical industries.

But both giants are battling severe COVID outbreaks, with India overtaking Brazil on Monday as the country with the second-highest number of infections after logging more than 168,000 new cases in a day.

Muslims prepare for second COVID Ramadan

Experts have warned that huge, mostly maskless crowds at political rallies and religious festivals have fuelled India’s caseload.

In the Himalayan city Haridwar, maskless Hindu pilgrims on Monday squeezed shoulder-to-shoulder on the banks of the Ganges River for a dip during the Kumbh Mela ritual.

Several Indian regions have tightened their coronavirus measures, with Maharashtra—India’s wealthiest state and current epicentre of its epidemic—imposing a weekend lockdown and night curfew.

Neighbouring Bangladesh has announced it will virtually seal itself off, shutting down both international and domestic transport starting Wednesday while shutting offices in an attempt to staunch its own spiralling outbreak.

Across the Muslim world, worshippers are gearing up for the start of their second Ramadan of the pandemic, with the holy fasting month due to kick off in many countries on Tuesday.

In Egypt, the Arab world’s most populous nation, the sanitary measures are less strict than a year ago when mosques were shut completely and a curfew was in force.

The mood in Cairo was relatively cheerful as the city prepared for special prayers on Monday night, with bright lights festooning the streets. Many of those rushing around the city shopping for last-minute supplies were maskless, however.

Saudi authorities have meanwhile said that only people immunised against COVID-19 will be allowed to perform the year-round umrah pilgrimage from the start of Ramadan.

Glimmers of hope

In Britain, despite one of the world’s highest COVID-19 death tolls, there were glimmers of hope Monday as pubs and restaurants were allowed to serve people outside—a move welcomed by the hard-hit hospitality sector, despite wintry temperatures.

“It’ll be great to see everybody again and see all the locals,” Louise Porter, landlady of The Crown Inn in Askrigg, northern England, told AFP.

“Our lives have just been turned upside down, just like everybody else’s,” she said, adding: “We’re still here to tell the tale.”

England’s hairdressers, indoor gyms and swimming pools also got the green light to reopen.

Once the worst-affected country in Europe, Britain launched a successful vaccination campaign coupled with lockdown measures that cut deaths by 95 percent and cases by 90 percent from January.

Italy has also been one of Europe’s hardest-hit countries, and on Monday, Rome saw the latest in a series of anti-lockdown demonstrations, with several hundred people turning out in protest against weeks of restaurant closures.

In France, now the European country with the most infections, an expansion of the vaccine rollout has buoyed optimism among lockdown-weary residents. Everyone aged over 55 years old is now eligible for a COVID vaccination.

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EU Seeks New Contract With Pfizer/BioNTech for Up to 1.8 Bln Vaccines From 2022: EU Source

BRUSSELS (Reuters) – The European Commission is seeking EU governments’ approval to launch talks with Pfizer and BioNTech for the purchase of up to 1.8 billion doses of their COVID-19 vaccines to be delivered in 2022 and 2023, an EU official told Reuters.

Earlier on Friday, German daily Die Welt reported that the Commission was shortly to sign contracts to buy up to 1.8 billion doses, but did not say with which company.

The EU official, who asked not to be named because the matter is confidential, said the EU executive had already decided to approach Pfizer-BioNTech and that EU governments backed the plan, though there was not yet a definitive approval.

A Commission spokesman confirmed plans to buy the additional doses, of which half would be optional.

He also confirmed that the EU executive had already identified one supplier, a manufacturer of mRNA vaccines, but declined to comment on which company would be approached to negotiate the contract.

“If provided the opportunity Pfizer and BioNTech are prepared to supply Europe with hundreds of millions of doses of COVID vaccines in 2022 and 2023 produced in our manufacturing facilities in Europe,” a Pfizer spokesman said.

The two companies have the capacity to produce more than 3 billion doses of vaccine in 2022, he added.

Pfizer-BioNTech and Moderna are already supplying the EU with mRNA vaccines and German biotech firm CureVac is seeking EU approval for its mRNA shot.

The vaccines would be delivered under monthly timetables and with clauses obliging the supplier to deliver, the EU official said.

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Italy reports 296 coronavirus deaths on Monday, 10,680 new cases

A Venice resident receives a coronavirus disease (COVID-19) vaccine on board a traditional ‘vaporetto’, a ferry normally used for public transportation in Venice, Italy, April 5, 2021. REUTERS/Manuel Silvestri

MILAN (Reuters) – Italy reported 296 coronavirus-related deaths on Monday against 326 the previous day, the health ministry said, while the daily tally of new infections decreased to 10,680 from 18,025.

Italy has registered 111,326 deaths linked to COVID-19 since its outbreak emerged in February last year, the second-highest toll in Europe after Britain and the seventh-highest in the world.

The country has reported about 3.6 million cases to date.

Patients in hospital with COVID-19 – not including those in intensive care – totalled 28,785 on Monday, slightly up from 28,432 a day earlier.

There were 192 new admissions to intensive care units, from 195 on Sunday. The total number of intensive care patients rose to 3,737 from a previous 3,703.

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Novartis says Kesimpta gets EU approval in multiple sclerosis

FILE PHOTO: The logo of Swiss drugmaker Novartis is pictured at the French company’s headquarters in Rueil-Malmaison near Paris, France, April 22, 2020. REUTERS/Charles Platiau

ZURICH (Reuters) – Novartis AG said on Tuesday Kesimpta (ofatumumab) has won European Union approval as the first and only self-administered, targeted B-cell therapy for adult patients with relapsing multiple sclerosis.

The Swiss drugmaker is developing and marketing the product under a license agreement with Genmab.

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Novartis closes U.S. gene therapy site as Zolgensma sales fell from Q3 to Q4

FILE PHOTO: The logo of Swiss drugmaker Novartis is pictured at the French company’s headquarters in Rueil-Malmaison near Paris, France, April 22, 2020. REUTERS/Charles Platiau

ZURICH (Reuters) – Novartis is laying off 400 people and closing a U.S. gene therapy location that it bought only two years ago to make its $2.1 million per patient treatment Zolgensma as sales momentum for the most expensive one-time treatment stalled last year.

Novartis is closing the Longmont, Colo., plant after buying it from AstraZeneca in 2019, , U.S. media including the Denver Business Journal reported. Sales of Zolgensma, a one-time treatment for spinal muscular atrophy, were $254 million in the fourth quarter from about $291 million in the third quarter, company data show.

Novartis now plans to make gene therapy at two other commercial production locations in Illinois and North Carolina.

“We now know that we can fulfill our long-term demand, including for patients who may benefit from our next wave of gene therapies, with two commercial sites coupled with the technical development capabilities at our San Diego site, as well as our extensive network of external partners,” Novartis said in a statement to media.

Zolgensma’s sales have been hurt, in part, by stalled efforts to expand its use in older patients after safety concerns prompted Novartis to pause a trial in order to collect more data for the U.S. Food and Drug Administration.

Novartis, which bought Zolgensma in 2018 with its $8.7 billion purchase of AveXis, has faced delays and trial failures on other drugs as well. These snags have muted revenue expectations, including for its cholesterol drug Leqvio that is awaiting regulatory sign-off on a European production facility and failure of an inflammation drug to boost lung cancer survival.

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Canada recommends AstraZeneca vaccine despite U.S. criticism of trial data

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OTTAWA (Reuters) – Canada on Tuesday said the AstraZeneca COVID-19 vaccine is safe and will continue to be recommended for use despite criticism from U.S. health officials of the drugmaker’s analysis of the shot’s efficacy, health officials said.

“The message is that the efficacy and the safety of the vaccine have been shown,” senior Health Canada official Marc Berthiaume told reporters. “It continues to be beneficial for Canadians to prevent COVID-19.”

Deliveries of coronavirus vaccines are ramping up in Canada, with some 2 million doses of the Pfizer Inc and Moderna Inc vaccines coming in this week. The United States has said it is sharing 1.5 million doses of the AstraZeneca vaccine with Canada as early as this week.

The U.S. National Institute for Allergy and Infectious Diseases said on Monday that the board charged with ensuring the accuracy of AstraZeneca’s latest trial said the company may have given an incomplete view of the shot’s effectiveness. The company has since said it will publish up-to-date results here from its latest trial within 48 hours.

“We will look at the complete data package (from the U.S.) sometime in April, and will assess and communicate the results,” said Supriya Sharma, chief medical adviser at Health Canada, the federal health ministry. “The bottom line is: that doesn’t change recommendations on the AstraZeneca vaccine at this time.”

There will be a delay of a day or two of the delivery of the Moderna vaccines this week, Alberta’s Chief Medical Officer of Health said on Twitter on Tuesday, adding that bookings for shots will not be affected.

Also on Tuesday, Canada said it would give C$23.7 million ($18.9 million) to the province of Ontario to open more voluntary isolation sites for those who catch the virus and need a place to quarantine as cases surge during a third wave.

Canada has recorded about 940,000 virus infections and more than 22,700 deaths from COVID-19.

($1 = 1.2561 Canadian dollars)

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Number of COVID patients in intensive care in France at highest level this year

Medical staff members work in the COVID Care Unit where patients suffering from the coronavirus disease (COVID-19) are treated at the private Polyclinique Saint Jean in Cagnes-Sur-Mer, France, March 23, 2021. REUTERS/Eric Gaillard

PARIS (Reuters) – The number of people with COVID-19 in French intensive care units rose by 84 on Tuesday to a new 2021 high of 4,634, health ministry data showed.

But the number of new infections, at 14,678, was the lowest since Jan. 3, excluding Mondays, when case numbers dip because fewer tests are done over the weekend.

A third of France’s population, including the Paris region, has since Friday been under a lockdown that is due to last four weeks. Experts generally say it takes two weeks for restrictive measures to take effect.

The total number of people in hospital for COVID-19 rose by 268 to at 26,756, the highest since Feb. 11.

The COVID-19 death toll rose by 287 to 92,908, the seventh-highest in the world.

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