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Omega Diagnostics receives CE-Mark for its COVID antigen test for self-use

investing-new.pngStock MarketsFeb 03, 2022 
Omega Diagnostics receives CE-Mark for its COVID antigen test for self-use© Reuters

By Samuel Indyk

Investing.com – Omega Diagnostics (LON:ODX) has announced it has successfully CE-Marked is VISITECT COVID-19 antigen test for self-use.

The test will now allow consumers to accurately detect the nucleoprotein of the SARS-CoV-2 virus in nasal swabs only.

The AIM-listed company said it remains in discussions with commercial partners about how best to service the European market and other territories that recognise the CE-Mark. Omega said its commercial offering will be via B2B partners and distributors and not a direct-to-consumer strategy.

The CE-Mark certificate is conditional upon the submissions of additional data and follow-up reports by 31st March 2022. Omega said it is working closely with its external study centres to ensure this deadline is met.

On the UK front, the company confirmed it remains in the review process under the recently introduced CTDA regulations. Further field study data has been requested and the company is seeking the information from external parties, but this data may not be available before the current extended deadline for submission of 10th February.

“We are delighted to have reached this milestone, achieving CE Mark for our VISITECT COVID-19 antigen test for the home-use market,” said Omega Diagnostics CEO Jag Grewal. “It is frustrating that our test is still awaiting approval under CTDA regulations for sale of the professional-use test in the UK.”

At 08:40GMT, shares in Omega Diagnostics were trading higher by 16.6% at 11.07 pence per share.

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Pfizer Falls as Revenue Falls Short, Non-Covid Business Struggles

investing-new.pngStock MarketsFeb 08, 2022 
Pfizer Falls as Revenue Falls Short, Non-Covid Business Struggles© Reuters

By Dhirendra Tripathi

Investing.com Pfizer stock (NYSE:PFE) fell 3.5% in premarket trading Tuesday after the company’s fourth-quarter revenue fell short of expectations, revealing struggles in its non-Covid business.

Excluding contributions from Comirnaty and Paxlovid, revenue fell 2% on the year.

Sales of its pneumococcal conjugate vaccine Prevnar fell 27% in the U.S. as schedule of government purchases changed while Covid vaccinations were prioritized.

Shipments of its anti-smoking tablets Chantix remained suspended and weighed on the results. Tests had shown an unacceptably high level of a carcinogen in the medication. Sales of cancer drug Sutent were lower due to entry of competition on loss of exclusivity.

Fourth-quarter revenue more than doubled to nearly $24 billion as sales of its Covid vaccines exceeded expectations. Pfizer blamed the shortfall in revenue, excluding Covid treatments, to fewer selling days during the period compared to last year.

Comirnaty contributed $12.5 billion in direct sales and alliance revenue during the quarter. Germany’s BioNTech (NASDAQ:BNTX) is Pfizer’s partner in marketing the Covid vaccines and they split the profits from it equally.

The company’s record-high forecast of $100 billion in 2022 revenue at the midpoint of its guidance range failed to cover the disappointment of its fourth-quarter numbers. The annual outlook includes revenue of around $32 billion from Comirnaty and $22 billion from Paxlovid.

Pfizer aims to make more than 4 billion doses of the shot in 2022. That compares with last year's 3 billion doses. Pfizer forecast 2022 sales of $98 billion to $102 billion, also below estimates of $105.48 billion.

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The World Health Organization expects a more transmissible version of omicron to increase in circulation around the world, though it’s not yet clear if the subvariant can reinfect people who caught an earlier version of the omicron strain.

Maria Van Kerkhove, the WHO’s Covid-19 technical lead, said Tuesday the global health agency is tracking four different versions of omicron. Van Kerkhove said the BA.2 subvariant, which is more contagious than the currently dominant BA.1 version, will likely become more common.

“BA.2 is more transmissible than BA.1 so we expect to see BA.2 increasing in detection around the world,” Van Kerkhove said during a question and answer session livestreamed on WHO’s social media platforms Tuesday.

The WHO is monitoring BA.2 to see if the subvariant causes an increase of new infections in countries that saw a rapid increase and then a sharp decline in omicron cases, Van Kerkhove said.

Van Kerkhove emphasized that there’s no indication of a difference in the severity of infections caused by either subvariant, though she noted that research is ongoing. Omicron generally doesn’t make people as sick as the alpha and delta variants, though it does spread faster.

Researchers in Denmark have found found that BA.2 is about 1.5 times more transmissible than BA.1 and it is more adept at infecting people who are vaccinated and even boosted. However, people who are fully vaccinated are less likely to spread it than the unvaccinated.

Van Kerkhove said the shots remain highly effective at preventing severe disease and death, though they don’t prevent all infections. She called on people to get vaccinated and wear masks indoors.

Dr. Abdi Mahamud, the WHO’s Covid incident manager, said it’s unclear whether BA.2 can reinfect people who previously had BA.1.

That could have a significant impact on how much the virus is able to spread. A study in the U.K. found that two-thirds of people who caught omicron said they had Covid before.

Most states in the U.S. have confirmed the presence of BA.2, though it’s circulating at a low level with 460 total cases confirmed so far, according to an international data base that tracks Covid variants. CNBC

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Aside from the obvious physical impacts of the Covid-19 pandemic, health professionals have told CNBC that many people are struggling with the immense emotional and societal changes it has brought and, what’s more, are finding it hard to adapt to a “new normal” now that lockdowns are starting to ease. 

Many psychologists and psychiatrists have reported an influx in people seeking mental health support during the pandemic, with the unprecedented global health crisis causing an increase in anxiety and depression as well as exacerbating existing mental health conditions. Full article CNBC

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AstraZeneca sees 2022 growth, but COVID boost to drop

Reuters.pngStock MarketsFeb 10, 2022 
AstraZeneca sees 2022 growth, but COVID boost to drop© Reuters. FILE PHOTO: The logo for AstraZeneca is seen outside its North America headquarters in Wilmington, Delaware, U.S., March 22, 2021. REUTERS/Rachel Wisniewski


(Reuters) - AstraZeneca (NASDAQ:AZN) on Thursday forecast higher 2022 sales after the drugmaker posted better-than-expected fourth-quarter profit as it gets a lift from its COVID-19 antibody treatment.

The drugmaker, however, like rival GSK, warned that its gross profit margin from coronavirus products is expected to be lower than the company average for this year, while sales are expected to decline by a low-to-mid twenties percentage.


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Omicron hit to UK economy less sharp than feared in December

Reuters.pngEconomyFeb 11, 2022 
Omicron hit to UK economy less sharp than feared in December© Reuters. FILE PHOTO: A woman wearing a face mask shops in Cambridge Market Square, amid the coronavirus disease (COVID-19) outbreak, in Cambridge, Britain, January 14, 2022. REUTERS/Andrew Couldridge

LONDON (Reuters) -Britain's economy shrank by a less-than-expected 0.2% in December when the rapid spread of the Omicron variant of COVID-19 prompted many Britons to work from home and avoid their usual Christmas socialising which hit many services businesses.

Gross domestic product in December was 6.0% higher than a year earlier, the Office for National Statistics said.

Economists polled by Reuters had forecast a 0.6% monthly fall in GDP and for output to be 6.3% higher than a year earlier.

"Despite December's setback, GDP grew robustly across the fourth quarter as a whole with the NHS (National Health Service), couriers and employment agencies all helping to support the economy," ONS economist Darren Morgan said.

"Overall, GDP in December was in line with its level in February 2020, before COVID-19 struck, while in the fourth quarter as a whole, it was slightly below that of Quarter 4 2019," he said.


November's GDP month-on-month growth rate was revised down to 0.7% from a previous estimate of 0.9%.

The Bank of England has said it expects to keep on raising interest rates to slow demand as Britain's inflation rate heads above 7%, more than three times the BoE's target rate.

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Shares of the major Covid vaccine makers fell on Monday, as the unprecedented wave of omicron infections eased, with new cases rapidly dropping across the country.

Moderna plunged more than 11%, the biggest decline in the S&P 500 Monday. Pfizer tumbled nearly 2% and its partner BioNTech slid more than 9%, while Novavax was off more than 11% and Johnson & Johnson fell over 1%.

White House chief medical advisor Dr. Anthony Fauci told The Financial Times last week that the U.S. is exiting the “full-blown pandemic phase of Covid-19.”

The U.S. reported a seven-day average of about 175,000 new Covid cases per day as of Sunday, according to data compiled by Johns Hopkins University, down 42% over the past week. Reported cases hit a pandemic high of more than 800,000 per day, on average, on Jan. 15.

Moderna’s Covid vaccine is the company’s only commercial product, so its stock could be exposed to further declines as demand for vaccines ebbs.

About 64% of the U.S. population is fully vaccinated with two shots of the Pfizer or Moderna vaccines or one dose of Johnson & Johnson, Centers for Disease Control and Prevention data shows.

While shots are still going into Americans’ arms, the national vaccination rate itself is rising much more slowly than earlier in the pandemic.

It took just over two months for the share of fully vaccinated Americans to go from 40% to 50% last summer and then another four months to reach the 60% level. It has gone up only four percentage points since Dec. 6.

Covid vaccinations spiked in December as states confirmed their first cases of the omicron variant, but have since fallen off. The U.S. administered an average of 443,000 shots per day over the last week, according to the latest CDC data available as of Feb. 8, down from a December high of more than 1.7 million shots per day and peak levels of nearly 3.5 million shots per day in April.

The Food and Drug Administration on Friday delayed plans to fast track authorization of the Pfizer and BioNTech’s Covid vaccine for children under 5 year old. The FDA had originally planned to authorize the first two doses of what will ultimately be a three-dose vaccine as soon as this month. However, Pfizer and the FDA said they now plan to wait until data is submitted on the third dose in April.

Pfizer and BioNTech also are developing a Covid vaccine that targets the omicron variant. CEO Albert Bourla has said the omicron shot will be ready in March, though its unclear whether a new vaccine will be needed if cases continue to decline. Moderna also has started clinical trials on an omicron-specific booster shot.

Novavax’s vaccine has not received FDA authorization. In the event that public health conditions continue to improve, it’s unclear how much demand there will be in the U.S. for the company’s vaccine after Novavax receives the regulatory green light.

In related news, Moderna CEO Stephane Bancel sold 19,000 company shares last week, totaling $2.9 million and deleted his Twitter account after two years of inactivity, raising questions on the social media platform. Bancel sells the same amount of shares on a weekly basis, according to securities filings. CNBC

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Pfizer and BioNTech’s two-dose Covid vaccine provided very little protection for children aged 5 to 11 during the wave of omicron infection in New York, according to a study published Monday.

The New York State Department of Health found that the effectiveness of Pfizer’s vaccine against Covid infection plummeted from 68% to 12% for kids in that age group during the omicron surge from Dec. 13 through Jan 24. Protection against hospitalization dropped from 100% to 48% during the same period.

The study has not yet undergone peer review, the academic gold standard. Due to the public health urgency of the pandemic, scientists have been publishing the results of their studies before such review.

The team of public health officials who conducted the study said the dramatic drop in vaccine effectiveness among children 5 to 11 years old was likely due to the lower dosage they received. Kids in this age group are given two 10-microgram shots, while children aged 12 to 17 receive 30-microgram shots.

The researchers also compared 11 and 12 year olds during the weekend ended Jan. 30. They found the vaccine effectiveness plunged to 11% for the low-dosage group but offered 67% protection to the group that received the higher dose.

“Given rapid loss of protection against infections, these results highlight the continued importance of layered protections, including mask wearing, for children to prevent infection and transmission,” the public health officials wrote in the study.

For children aged 12 to 17 years old, vaccine effectiveness against infection dropped from 66% to 51% from December through the end of January. Protection against hospitalization dropped from 85% to 73% for teenagers during the same period.

The data comes as New York City plans to end its school mask mandate by March 7, with California doing the same four days later. State governments are easing mandates and restrictions as Covid infections decline dramatically after the omicron variant swept the nation in December and January

Covid infections are down 91% from a pandemic high in January. The U.S. reported a daily average of nearly 66,000 new infections on Sunday, compared to the more than 802,000 on Jan. 15, according to a CNBC analysis of data from Johns Hopkins University.

The U.S. suffered a spike in hospitalizations of children with Covid during the omicron wave. The Food and Drug Administration sought to fast track Pfizer’s vaccine for kids aged six months through 4 years old this month in response to the number of children hospitalized with Covid.

However, the FDA and Pfizer decided to put those plans on hold after data on the first two doses did not meet expectations. The FDA is now waiting to see clinical trial data on a third dose for the youngest kids, which is expected in April. CNBC

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China's capital in race to detect COVID cases, avoid Shanghai's distress

Reuters.pngEconomyApr 27, 2022 
China's capital in race to detect COVID cases, avoid Shanghai's distress© Reuters. Medical workers in protective suits collect swabs samples from residents at a makeshift nucleic acid testing site amid a mass testing for the coronavirus disease (COVID-19) in Chaoyang district of Beijing, China April 27, 2022. REUTERS/Carlos Garcia Rawli

By Eduardo Baptista and Brenda Goh

BEIJING/SHANGHAI (Reuters) -Millions of people in Beijing took their second COVID-19 tests of the week on Wednesday as the Chinese capital tried to keep an outbreak numbering in the dozens from spiralling into a crisis like the one the locked-down city of Shanghai is enduring.

Evidence that Shanghai's month-long isolation has become almost unbearable for many of the city's 25 million people is emerging on an almost daily basis on the country's heavily censored internet.

A widely circulated video - since taken down - showed a foreigner trying to break through metal barriers onto a Shanghai street, before being pulled back and dragged to the ground by four people in protective hazmat suits.

"I want to die," the man shouted repeatedly in Chinese and English. One of the people holding him down responded: "You came to China, you need to respect the laws and regulations here."

"Calm down, calm down," says another. Reuters was unable to immediately verify the authenticity of the video.

Such distressing scenes are being watched with apprehension in Beijing, where officials hope early mass testing will spare them the anguish of Shanghai, where officials waited for about a month as cases surged before ordering city-wide screening.

In Beijing, supermarkets have kept supplies well-stocked under orders from authorities. Shi Wei, 53, a retiree, said he was encouraged by the capital's low caseload but still nervous.

"These past two days every time I go to the supermarket there are lots of people, so I just turn around and leave, as I feel slightly unsafe," he said. "I can understand the panic, given what happened in Shanghai."

Geng, 31, who works in finance and only gave his surname, said he worried about being a close contact of a COVID case and being forced into quarantine with his whole family.

Beijing was testing the more than 3.5 million residents of its Chaoyang district on Wednesday, all of whom were screened on Monday. On Tuesday, 16 million from other districts were tested and are due for another round on Thursday.

In total, 20 million of Beijing's 22 million will be tested three times this week.

Results for almost all samples from the first round came through on Wednesday afternoon, with 12 tubes of mixed samples showing positive, a Beijing health official said. Some 46 new cases have been identified since 4 p.m. on Tuesday, a second Beijing official said.

In mass testing in China, multiple samples are tested together in a single tube for speed and efficiency.


The coronavirus first emerged in the Chinese city of Wuhan in late 2019 and authorities managed to keep outbreaks largely under control with lockdowns and travel bans. But the fast-spreading Omicron variant has tested China's "zero-COVID" policy.

Shanghai has been offered a glimmer of hope with officials reiterating that they would soon begin easing restrictions in districts that have stamped out infections, without giving a time frame or other details.

In the meantime, most people are confined to their homes. Even those who can go out have few options, with most shops and other venues closed.

Data showed six of Shanghai's 16 districts had zero cases outside quarantined areas, with numbers in seven others in the single digits. In total, Shanghai detected 171 such cases on Tuesday, down from Monday's 217.

Shanghai reported 48 new deaths on Tuesday, down from 52 the day before, taking the city's official death tally since April 17 to 238.


China's zero tolerance policy has provoked rare public anger in an important year for President Xi Jinping, over measures that look increasingly bizarre to much of the outside world that has chosen "live with COVID", even as infections spread.

Xi is widely expected to seek a third leadership term this year.

Research by Gavekal Dragonomics estimated that 57 of China's 100 biggest cities were under some form of COVID curbs as of last week.

The measures have hurt consumption, disrupted industry and prompted official efforts to stimulate the world’s second largest economy, including stepping up infrastructure investment, state television reported, citing a meeting chaired by Xi.

Hundreds of factories have been allowed to resume operations, with state media giving plenty of coverage of the reopening of Tesla's Shanghai plant last week.


But industry associations say most factories are struggling to get back to work with staff stuck at home, trucks parked in lots, and orders of components from contractors in the same situation unfilled.

Many frustrated bankers, traders and investors confined to their homes say they are considering moving to other financial centres.

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