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U.S. clears Moderna vaccine for COVID-19, 2nd shot in arsenal – CityNews Toronto

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The U.S. added a second COVID-19 vaccine to its arsenal Friday, boosting efforts to beat back an outbreak so dire that the nation is regularly recording more than 3,000 deaths a day.

Much-needed doses are set to arrive Monday after the Food and Drug Administration authorized an emergency rollout of the vaccine developed by Moderna Inc. and the National Institutes of Health.

The move marks the world’s first authorization for Moderna’s shots. The vaccine is very similar to one from Pfizer Inc. and Germany’s BioNTech that’s now being dispensed to millions of health care workers and nursing home residents as the biggest vaccination drive in U.S. history starts to ramp up.

The two work “better than we almost dared to hope,” NIH Director Dr. Francis Collins told The Associated Press. “Science is working here, science has done something amazing.”

Early results of large, still unfinished studies show both vaccines appear safe and strongly protective although Moderna’s is easier to handle since it doesn’t need to be stored at ultra-frozen temperatures.

A second vaccine represents a ray of hope amid despair as the virus continues to spread unabated even before holiday gatherings that are certain to further fuel the outbreak.

The scourge has claimed more than 312,000 U.S. lives and killed 1.7 million people worldwide. New cases in the U.S. are running at over 216,000 per day on average. Deaths per day have hit all-time highs, eclipsing 3,600 on Wednesday.

California has emerged as one of the most lethal hot spots, with hospitals running out of intensive care beds and ambulances lining up outside emergency rooms in scenes reminiscent of the calamity around New York City last spring. California on Friday reported over 41,000 new cases and 300 more deaths.

When New York’s hospitals were in crisis, health care workers from across the country came to help out. This time, “there’s no cavalry coming” because so many hospitals are swamped, said Dr. Marc Futernick, an emergency room physician in Los Angeles.

The nation is scrambling to expand vaccinations as rapidly as Moderna and Pfizer can churn out doses. Moderna’s is for people 18 and older, Pfizer’s starts at age 16.

It’s just the beginning of “what we hope will be a big push to get this terrible virus behind us, although it will take many more months to get to all Americans,” Collins said.

Even with additional candidates in the pipeline, there won’t be enough for the general population until spring, and shots will be rationed in the meantime. And while health workers are enthusiastically embracing vaccination, authorities worry the public may need more reassurance to ensure more people get in line when it’s their turn.

“Frankly if we don’t succeed in getting 80% or so of Americans immunized against COVID-19 by the middle of this 2021 year, we have the risk that this epidemic could go on and on and on,” Collins said.

He is especially concerned that accurate information about the shots’ value reaches communities of colour, which have been hard-hit by COVID-19 yet also are wary after years of health care disparities and research abuses.

To try to help instil confidence, Vice-President Mike Pence received the Pfizer-BioNTech shot on live TV Friday, along with Surgeon General Jerome Adams.

FDA’s decision could help pave the way for other countries that are considering the Moderna vaccine, the first-ever regulatory clearance for the small Cambridge, Massachusetts, company. European regulators could authorize its use as soon as Jan. 6. Britain, Canada and a few other countries already have cleared the Pfizer-BioNTech shot, with a European Union decision due Monday.

“What we want to always remember is one size does not fit all. We want to have options,” said Dr. Paul Duprex of the University of Pittsburgh.

Moderna has about 5.9 million doses ready for shipment set to begin over the weekend, according to Operation Warp Speed, the government’s vaccine development program. Injections of health workers and nursing home residents continue next week, before other essential workers and vulnerable groups are allowed to get in line.

Both Moderna’s and Pfizer-BioNTech’s shots are so-called mRNA vaccines, made with a groundbreaking new technology. They don’t contain any coronavirus – meaning they cannot cause infection. Instead, they use a piece of genetic code that trains the immune system to recognize the spike protein on the surface of the virus, ready to attack if the real thing comes along.

Their development less than a year after the coronavirus first emerged set a speed record, but Collins stressed that shouldn’t worry people. The speed was due to billions in company and government investments paired with years of earlier scientific research, not any cut corners.

“The rigour of the analysis of these vaccines is unprecedented,” Collins said. “We’re not done with this but hope is on the way, and the hope comes from this scientific brain trust that has pulled out all the stops.”

Experts are hoping the two vaccines together will “break the back of the pandemic” when combined with masks and other precautions, said Dr. Arnold Monto of the University of Michigan, who chaired an advisory committee that publicly debated the shots’ evidence ahead of FDA’s decisions.

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GameStop’s volatile rally smashes Wall St price targets – Aljazeera.com

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The video game retailer’s stock surged as much as 145 percent to $159.18 on Monday, triggering at least nine trading halts.

To see how far GameStop Corp. has outrun anyone’s ability to render sensible analysis, consider what its current dizzying rally has done to Wall Street’s best guesses of its value.

Now perched close to $75 a share, hoisted by a short squeeze ignited and arguably organized in chat rooms, the game retailer’s stock is about $60 above the average forecast of equity handicappers tracked by Bloomberg. The ratio between the two is by far the biggest in the Russell 3000 and jumped for a third day, as crazed trading capped a stretch in which the 37-year-old company burned bears who had shorted 139% of its shares.

It’s happening in a stock that before 2020 had fallen six straight years as earnings shrunk, and which isn’t projected to turn a profit before fiscal 2023. While fundamentals may one day matter again, GameStop has now become the latest show of force by newbie day traders in a market that seems more like their plaything each day.

The stock surged as much as 145% to $159.18 on Monday, at one point triggering at least nine trading halts. It briefly turned negative before bouncing back to trade up 22% to $79.56 at 2 p.m. in New York. The shares have advanced more than 320% since the start of the year.

“It doesn’t make business sense,” said Doug Clinton, co-founder of Loup Ventures. “It makes sense from an investor psychology standpoint. I think there’s a tendency where there is heavy retail interest for those types of traders to think about stocks differently than institutional investors in terms of what they’re willing to pay.”

Right now, they’re willing to pay 471% more than what analysts consider reasonable, on average. While perhaps fairly priced relative to its annual sales of about $5.2 billion in the 12 months through October, those sales are down 40% in just two years. The company is expected to report a per-share loss in both fiscal 2021 and 2022. To get a price-earnings multiple it’s necessary to look two years into the future, where the P/E is around 58.

Bears have seen more than $6.1 billion mark-to-market losses this year, according to financial analytics firm S3 Partners.

While Wall Street may have no clue what GameStop shares are worth, it does have ideas on what the company should do with them: sell.

“GameStop can issue equity and should sell stock to pay down debt,” said Wedbush Securities Inc. analyst Michael Pachter, who had a price target of $16 for GameStop as of Jan. 11. Doing so would involve “minimal dilution at these levels” and provide protection against an economic downturn. “They should do as much as the market will absorb,” he said.

Separately, Telsey Advisory Group analyst Joseph Feldman double-downgraded the stock to underperform from outperform on Monday, removing GameStop’s only buy-or-equivalent recommendation.

Bullish Options

Whatever the future holds, the recent past has been a bonanza for anyone who dared own the stock — or, even better, bullish options. Calls expiring Jan. 29 with a strike price of $115 were the most-traded GameStop contract early Monday. Other similar wagers had correspondingly heady gains as contracts once seen as long-shot upward bets suddenly were in the money.

At investment research firm Hedgeye, analysts advised clients to not go short the stock, despite removing it from their “best idea long list” to reanalyze fundamentals. “Wouldn’t dare do that given the positive catalysts we think will be coming down the pike as the year progresses” with a very bullish calendar on the horizon, Brian McGough and Jeremy McLean wrote.

GameStop “has become a cult stock because of Ryan Cohen’s success with Chewy,” Wedbush’s Pachter said, referring to the activist investor and co-founder of online pet retailer Chewy Inc., who joined GameStop’s board this month. “I cannot discount Mr. Cohen’s past successes and don’t know what he has in mind going forward, but I need to see their strategy before I give them credit for materially higher earnings power.”

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Canadian provinces push back vaccination plans as Pfizer deliveries grind to a halt – Canada News – Castanet.net

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Some Canadian health-care workers are being told they’ll have to wait longer to receive their first doses of COVID-19 vaccines as deliveries from a major manufacturer grind to a temporary halt.

Canada is not expected to receive any Pfizer-BioNTech vaccines this week as the company revamps its operations, and deliveries are expected to be slow for the next few weeks.

Ontario announced today that it was pausing COVID-19 vaccinations of long-term care staff and essential caregivers so that it can focus on giving the shots to all nursing home residents.

Several provinces have used up nearly all their vaccine supply and have been forced to push back their vaccination schedules.

Saskatchewan announced Sunday that it had exhausted all the doses it has received so far, while Quebec has used up more than 90 per cent of its supply.

Prime Minister Justin Trudeau has said the delay is only temporary and that Canada is expected to receive 4 million doses of the Pfizer vaccine by the end of March.

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Merck Gives Up on Coronavirus Vaccines – The Motley Fool

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Pharmaceutical giant Merck (NYSE:MRK) officially threw in the towel on its efforts to develop a COVID-19 vaccine. The company said it’s discontinuing the development of two candidates, V590 and V591, after a review of results from phase 1 studies indicated that they were unlikely to provide adequate protection against the coronavirus. It will instead focus its COVID-19 research and production capabilities on two therapeutic drugs for the disease.

Merck had hinted at a conference last month that the efficacy rates of Moderna‘s mRNA vaccine and the one developed by collaboration partners Pfizer and BioNTech were better than it had expected, and set a high bar for its efforts. As it turned out, V590 and V591 produced immune responses that were inferior not only to those produced by other vaccines, but to those seen in patients who have recovered from COVID-19 infections.

Syringe and torn paper with "Coronavirus" written on it.

Image source: Getty Images.

Merck is the second-largest vaccine seller in the world, but had hesitated to develop one for COVID-19, falling months behind in the race. Eventually, it launched programs to develop single-dose vaccine candidates based on proven technology, one using the viral vector Merck uses in its approved Ebola vaccine, and one from a company it acquired last year in the hope of getting multiple shots on the COVID-19 goal. Instead, Merck will take a non-cash charge to its fourth-quarter earnings for the programs.

However, the pharma company still has high hopes for two COVID-19 treatment candidates. MK-7110 is an anti-inflammatory drug that appears to reduce the risk of death or respiratory failure in moderately to severely ill COVID-19 patients by as much as 50%. Phase 3 trial results for it are expected in the first quarter. Molnupiravir (MK-4482) is an oral antiviral being evaluated in trials that are expected to be complete in May. If successful, that drug could compete with Gilead‘s remdesivir, which faces some skepticism over its efficacy.

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