CDC Approves COVID-19 Vaccines For Children Under 5

U.S. health advisers on Saturday recommended COVID-19 vaccines for infants, toddlers and preschoolers — the last group without the shots.The advisers to the Centers for Disease Control and Prevention unanimously decided that coronavirus vaccines should be opened to children as young as 6 months. On Saturday afternoon, CDC Director Rochelle Walensky signed off on the panel’s recommendation.

“Together, with science leading the charge, we have taken another important step forward in our nation’s fight against COVID-19,” Walensky said in a statement. “We know millions of parents and caregivers are eager to get their young children vaccinated, and with today’s decision, they can. I encourage parents and caregivers with questions to talk to their doctor, nurse, or local pharmacist to learn more about the benefits of vaccinations and the importance of protecting their children by getting them vaccinated.”

HHS Secretary Xavier Becerra released a statement calling the CDC’s move a “major milestone.”

“Thanks to the FDA and CDC’s rigorous, comprehensive, and independent review of the data, and their strict commitment to following the science, we are reaching another major milestone in our efforts to protect more children, their families, and our communities as we work to end the pandemic,” Becerra said. “We are following the data and science as we make sure all Americans are eligible and have access to COVID-19 vaccines and boosters to prevent severe disease and save lives. Based on CDC and FDA actions, we now know that vaccination for our children 6 months through 5 years old is safe and effective and we are ready to get millions of children vaccinated.”

The White House also weighed in on the decision in a statement calling the CDC’s decision a “monumental step forward in our nation’s fight against the virus.””For parents all over the country, this is a day of relief and celebration,” President Biden said in the statemente. “As the first country to protect our youngest children with COVID-19 vaccines, my Administration has been planning and preparing for this moment for months, effectively securing doses and offering safe and highly effective mRNA vaccines for all children as young as six months old.

“While the Food and Drug Administration OKs vaccines, it’s the CDC that decides who should get them. The government has been gearing up for the start of the shots early next week, with millions of doses ordered for distribution to doctors, hospitals and community health clinics around the country. Roughly 18 million kids will be eligible, but it remains to be seen how many will ultimately get the vaccines. Less than a third of children ages 5 to 11 have done so since vaccination opened up to them last November.

Two brands — Pfizer and Moderna — got the green light Friday from the FDA. The vaccines use the same technology but are being offered at different dose sizes and number of shots for the youngest kids.

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Pfizer’s vaccine is for 6 months through 4 years. The dose is one-tenth of the adult dose, and three shots are needed. The first two are given three weeks apart, and the last at least two months later. Moderna’s is two shots, each a quarter of its adult dose, given about four weeks apart for kids 6 months through 5. The FDA also approved a third dose, at least a month after the second shot, for kids with immune conditions that make them more vulnerable to serious illness.

Two doses of Moderna appeared to be only about 40% effective at preventing milder infections at a time when the omicron variant was causing most COVID-19 illnesses. Pfizer presented study information suggesting the company saw 80% with its three shots. But the Pfizer data was so limited — and based on such a small number of cases — that experts and federal officials say they don’t feel there is a reliable estimate yet.

Hospitalizations surged during the omicron wave. Since the start of the pandemic, about 480 children under age 5 are counted among the nation’s more than 1 million COVID-19 deaths, federal data show. “It is worth vaccinating, even though the number of deaths are relatively rare, because these deaths are preventable through vaccination,” said Dr. Matthew Daley, a Kaiser Permanente Colorado researcher who sits on the advisory committee.

U.S. officials expect most shots to take place at pediatricians’ offices. Many parents may be more comfortable getting the vaccine for their kids at their regular doctor, White House COVID-19 coordinator Dr. Ashish Jha said. He predicted the pace of vaccination to be far slower than it was for older populations.

Pediatricians, other primary care physicians and children’s hospitals are planning to provide the vaccines. Limited drugstores will offer them for at least some of the under-5 group. U.S. officials expect most shots to take place at pediatricians’ offices. Many parents may be more comfortable getting the vaccine for their kids at their regular doctor, White House COVID-19 coordinator Dr. Ashish Jha said. He predicted the pace of vaccination to be far slower than it was for older populations.

“We’re going see vaccinations ramp up over weeks and even potentially over a couple of months,” Jha said. It’s common for little kids to get more than one vaccine during a doctor’s visit. In studies of the Moderna and Pfizer shots in infants and toddlers, other vaccinations were not given at the same time so there is no data on potential side effects when that happens. But problems have not been identified in older children or adults when COVID-19 shots and other vaccinations were given together, and the CDC is advising that it’s safe for younger children as well.

About three-quarters of children of all ages are estimated to have been infected at some point. For older ages, the CDC has recommended vaccination anyway to lower the chances of reinfection.Experts have noted re-infections among previously infected people and say the highest levels of protection occur in those who were both vaccinated and previously infected. The CDC has said people may consider waiting about three months after an infection to be vaccinated.

Source: CDC approves COVID-19 vaccines for children under 5 | Fox Business

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AstraZeneca Sees $4B In COVID-19 Vaccine Sales

AstraZeneca recorded a big jump in revenue on Thursday as it begins to take a profit from its coronavirus vaccine for the first time.

The company recorded full-year revenues of $37.4 billion, an increase of 38% from the year before at constant exchange rates. Part of the boost came from $4 billion in sales of its COVID-19 vaccine, developed with the University of Oxford.

Despite rising revenue, AstraZeneca reported a pre-tax loss of $265 million due to costs from its purchase of U.S. drug company Alexion Pharmaceuticals and new drug research.

The Anglo-Swedish drugmaker said in November it would begin to take a “modest” profit from the COVID-19 shot, which it had been providing “at cost” — around $2 to $3 —following an agreement with Oxford. Other COVID-19 vaccine producers, such as Pfizer and Moderna, have been booking hefty profits on their shots all along.

Dr Tamara Joffe administer a dose of the AstraZeneca COVID-19 vaccine to Mustafa Field of the Faiths Forum, during a pilot project of pop up vaccination drive called Vaxi Taxi in Kilburn, London, Sunday, Feb. 28, 2021.  (AP Photo/Alastair Grant)

In the three months to September, the company said revenue jumped by about 50%, to a record $9.9 billion. The increase was due to sales of more than $1 billion in COVID-19 vaccines and the inclusion for the first time of some $1.3 billion worth of revenue from its rare disease business unit following the recent acquisition of Alexion.

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AstraZeneca forecast total group sales to rise by a “high teens percentage” in 2022, but said COVID-19 revenues would decline by a “a low-to-mid twenties percentage.”

Chief executive Pascal Soriot said AstraZeneca had “delivered on our promise of broad and equitable access to our COVID-19 vaccine with 2.5 billion doses released for supply around the world.”

“AstraZeneca continued on its strong growth trajectory in 2021, with industry-leading R&D (research and development) productivity, five of our medicines crossing new blockbuster thresholds, and the acquisition and integration of Alexion,” he said.

Soriot said the company would raise the dividend to shareholders by 10 cents to $2.90, the first increase in a decade.

AstraZeneca shares were trading about 3% higher at 8.62 pounds ($11.68) on the London Stock Exchange on Thursday morning.

Source: AstraZeneca sees $4B in COVID-19 vaccine sales | Fox Business

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Critics:

AstraZeneca (AZN.L) said it would begin to earn a modest profit from its coronavirus vaccine as the world learns to live with the virus and the drugmaker is in talks with several countries about new orders for delivery next year.

AstraZeneca made a commitment to sell the shot developed with Oxford University at cost during the pandemic and in a press conference on Friday said low-income nations would continue to receive the vaccine on a no-profit basis, while a post-pandemic commercial approach would apply to other new orders even as infections in Europe rise again. read more

The Anglo-Swedish company’s third-quarter results showed the vaccine contributed one cent to core earnings per share of $1.08, a rise of 14%. Total product sales jumped 49% to $9.74 billion, as its vaccine sales topped $1 billion.

“We started this project to help … but we also said that at some stage in the future, we will transition to commercial orders,” Chief Executive Pascal Soriot told journalists.”It will never be high priced. Because we want the vaccine to remain affordable to everybody around the world,” he added.

Soriot, a French national, said the virus was becoming endemic, a term for a background level of infections that is part of everyday life.Talks about new orders with undisclosed countries were underway, mainly for delivery next year, with some prospective customers focusing on booster shots, Soriot said.

AstraZeneca unveiled plans this week to set up a separate unit to focus on its coronavirus efforts and other respiratory infections. It said on Friday the unit would independently manage production and distribution. read more

Shares of the FTSE 100 (.FTSE) drugmaker were down 3.4% at about 91.22 pounds at 1209 GMT as overall third-quarter profit fell short of analysts’ expectations.

There were strong performances of core products like kidney disease treatment Farxiga and established asthma drug Symbicort, and from the addition of rare-disease specialist Alexion from July 21, thanks to last year’s $39 billion takeover deal.

However, integration costs related to that deal ate into profits, as did a $1.2 billion writedown for an experimental kidney disease drug AstraZeneca acquired in 2012, with overall expenses also rising on investments into the drug pipeline.

Top selling drug Tagrisso for lung cancer also posted lower-than-expected growth in sales due to price cuts in China. AstraZeneca said a profit boost from the vaccine in the fourth quarter would make up for costs related to its antibody cocktail for preventing and treating COVID-19, as it stuck with its earnings forecast for the year.

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AstraZeneca’s COVID-19 vaccine gets the green light in the UK”. biopharma-reporter.com. Retrieved 30 December 2020.

“Registered office and corporate headquarters”. AstraZeneca. Retrieved 27 February 2020.

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“Key facts”. AstraZeneca. Archived from the original on 8 September 2010. Retrieved 1 September 2010.

 AstraZeneca to ax 1,600, relocate thousands in global R&D reshuffle”. fiercebiotech.com. FierceBiotech.

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AstraZeneca and Astex ally for anticancer agents Business Intelligence, 1 July 2005

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AstraZeneca agrees to buy Arrow Therapeutics for US$150M Marketwatch, 1 February 2007

AstraZeneca seeks a remedy for its patent pain The Telegraph, 21 April 2012

“AstraZeneca to pay $15.2B to purchase rival MedImmune; Deal sees London-based drugmaker take on debt for the first time in order to fill product line”. Bloomberg.

AstraZeneca Buys MedImmune for US$ 15.6 Billion The New York Times, 24 April 2007

“AstraZeneca To Acquire Infection Research Company Novexel And Expand Collaboration With Forest Laboratories”. 23 December 2009. Retrieved 20 February 2015.

“Novexel to be Acquired by AstraZeneca”. Retrieved 20 February 2015.

AstraZeneca to buy Chinese generics firm Healthcare News, 8 December 2011

AstraZeneca and Amgen collaborate on treatments for inflammatory diseases Medcity News, 4 February 2012

AstraZeneca Reaches $1.26 Billion Deal for Ardea Biosciences The New York Times, 23 April 2012

Peacock, Louisa (30 June 2012). “AstraZeneca to pay £2.2bn towards ‘joint venture’ diabetes deal”. The Daily Telegraph. London. Archived from the original on 4 August 2012. Retrieved 1 July 2012.

Moderna Stock Crash Intensifies: Losses Top $130 Billion After Scientists Find Covid Boosters Aren’t Halting Omicron Infections

Battered by a steep broad-market selloff this week, Moderna shares fell for a sixth straight day Friday as experts questioned whether Covid-19 vaccine sales alone will help justify the firm’s meteoric valuation, intensifying a crash that’s wiped out more than 60% of the value in one of last year’s top stocks and turned it into this year’s worst performer.

Moderna stock fell 4.4% Friday to an eight-month low of $160, pushing shares down more than 20% over the past week amid growing research suggesting Moderna’s Covid-19 booster, while very effective against previous strains, has been less effective against the rapidly spreading omicron variant.

Though the number of Covid infections has spiked amid the omicron-spurred wave of the pandemic, the Centers for Disease Control and Prevention said Friday that Moderna and Pfizer boosters were 90% effective at preventing people infected with the new variant from being hospitalized.

Speaking to Yahoo Finance on Thursday, Jefferies analyst Michael Yee said the “overly high expectations” set last year, as Moderna’s Covid-19 vaccine became widely available to the public, will “lead to challenges . . . as people digest” what’s next for the firm beyond Covid vaccines.

Yee said the recent stock drawback has helped put Moderna’s valuation in line with other biotechnology competitors, but he warned analysts increasingly expect Covid vaccine sales—currently Moderna’s sole revenue source from a commercialized product—will fall over the next few years as the pandemic becomes endemic and competition heats up among treatment and prevention options.

Moderna’s stock plunge has pulled prices down so much that Bank of America analyst Geoff Meacham told investors in a Friday note that its valuation is now “back to earth” after its meteoric rise during the pandemic.

Meacham said he’s now focused on the company’s pipeline beyond Covid (Moderna is also developing a flu vaccine), pointing to the firm’s massive $17 billion in cash as a source of “strategic” opportunity.

In a Friday note, UBS analyst Eliana Merle was more optimistic about Moderna’s prospects, calling its mRNA technology a disruptive force in the $35 billion annual vaccine market and saying its success with Covid-19 suggests a high likelihood of success for other vaccine targets.

Shares of Moderna have plunged 67% from an all-time closing high of $484 on August 9, wiping out about $133 billion from the firm’s market capitalization, which now stands at roughly $65 billion.

Though it skyrocketed 143% to land the S&P 500’s third-best gain in 2021, Moderna stock has plummeted 35% this year—even worse than Netflix, which is down 32% after a steep 20% plunge Friday following a disappointing earnings report. To compare, Devon Energy and Marathon Oil, last year’s top- and second-best-performing stocks in the S&P, have climbed 7% and 11% this year, respectively.

$5.3 billion. That’s how much Moderna CEO Stéphane Bancel, who joined the firm in 2011, is worth Friday, according to Forbes. The French native owns a roughly 8% stake in Moderna and was at one point worth more than $12 billion.

Founded in 2010, Cambridge, Massachusetts-based Moderna spent nearly a decade developing the technology for its messenger RNA vaccines, which tell the body to produce part of a pathogen to trigger an immune response—unlike traditional vaccines that instead use a piece of the pathogen.

Once the pandemic hit, the company doubled down on the efforts and filed for an emergency use authorization for its Covid-19 vaccine in November 2020. The shots have proven to be a massive boon for businesses heading up their development, but Moderna shares have struggled in recent months as critics increasingly question whether or not sales of Covid-19 vaccines alone will prove a viable revenue stream in years to come.

In November, the company reported third-quarter sales and earnings that failed to meet analysts’ expectations, with revenue falling short of $5 billion, despite average analyst projections calling for $6.2 billion. In addition to lower sales projections, supply chain constraints and the development of antiviral Covid-19 treatments have also dented investor sentiment—and triggered Moderna stock selloffs.

Moderna is expected to report fourth-quarter earnings by the end of February.

Shares of Moderna plunged 17% shortly after the market opened Thursday, wiping out more than $24 billion in market value and pushing prices to a three-month low of $287.

Triggering the morning crash, Moderna on Thursday reported third-quarter sales and earnings that failed to meet analysts’ expectations, with revenue falling short of $5 billion despite average analyst projections calling for $6.2 billion.

In a conference call, Moderna CEO Stéphane Bancel blamed a “more complex” supply-chain environment for the disappointing performance, adding that longer delivery times for international shipments may shift some deliveries to early 2022, instead of 2021’s fourth quarter.

Moderna said it now expects to deliver between 700 million and 800 million Covid-19 vaccine doses this year, down from previous projections calling for between 800 million and 1 billion doses; sales should now fall between $15 billion and $18 billion, instead of the $20 billion originally projected, the company said.

Covid-19 vaccines, which are Moderna’s only commercialized product, have proven to be highly effective in preventing serious illness and the market’s best defense against the virus—making them a massive boon to a slew of businesses heading up their development.However, Moderna shares have struggled in recent months as critics increasingly question whether or not sales of Covid-19 vaccines will prove a viable revenue stream in years to come.

In August, Bank of America sparked one of the biggest selloffs in Moderna’s history after saying future sales expectations don’t justify the company’s current valuation. The analysts warned that lower-than-expected vaccine sales and more intense competition as Covid-19 research advances marked the biggest risks to Moderna stock prices.

Despite its recent weakness, Moderna is still the S&P’s best-performing component this year, with shares skyrocketing about 200% thanks to the company’s Covid-19 vaccine becoming widely available across the world. Still, shares have crashed nearly 40% from an all-time closing high of $484 on August 9.

$9.5 billion. That’s how much Bancel, who joined Moderna in 2011, is worth as of 10:00 a.m. EDT Thursday, according to Forbes. The French native, who owns a roughly 8% stake in Moderna, has seen his fortune plunge by about $1.6 billion as a result of the stock’s rout on Thursday.

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I’m a senior reporter at Forbes focusing on markets and finance. I graduated from the University of North Carolina at Chapel Hill, where I double-majored

Source: Moderna Stock Crash Intensifies: Losses Top $130 Billion After Scientists Find Covid Boosters Aren’t Halting Omicron Infections

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Moderna Data Shows mRNA Isn’t a Quick Fix For The Flu Vaccine

The first data from clinical trials of Moderna’s mRNA-based seasonal flu vaccine, released by the company Friday morning, were underwhelming — a finding that shows gene-based vaccines might not be a fix for all the problems with vaccine development.

The overwhelming success of the mRNA COVID-19 vaccines, made by Moderna and Pfizer / BioNTech, supercharged interest in that strategy for developing shots. The shots inject people with tiny snippets of the gene for a virus, which the body builds and then uses to learn how to fight the virus.

Current flu shots contain inactivated copies of the influenza virus. mRNA vaccines are faster to design and produce because manufacturers don’t have to grow copies of the virus, which is why experts have for years seen them as the future of vaccines.

Moderna launched a clinical trial of an mRNA seasonal flu vaccine this summer, hoping to capture the same success as it did with its COVID-19 vaccine. Typically, seasonal flu shots are around 40 to 60 percent effective, and pharmaceutical companies want to make that better. Three other companies are also working on mRNA flu shots.

Moderna released its first results during an investor phone call and presented slides showing that the mRNA flu shots did generate antibodies — but the levels of those antibodies weren’t higher than those for other flu shots already on the market. They also had more side effects than existing shots.

The findings don’t necessarily mean that mRNA flu shots aren’t any better than what we have now. Because mRNA vaccines are faster to design and make, the shots don’t have to be developed as far in advance. Companies may not have to do as much guesswork around what strain of the flu to target them against each year because they can wait to make the shots until they see what strains are circulating.

And as far as efficacy goes, there’s still a lot more data to collect: Moderna is preparing to conduct larger trials that would test how well the shots actually keep people from getting sick in the real world (not just testing antibody levels)..

Still, this early data shows that the immune system is tricky and that mRNA vaccines probably aren’t an easy shortcut for stopping a virus as persistent as the flu. More studies will be needed to figure out if there is a specific benefit to using mRNA vaccines to fight the flu, wrote chemist and writer Derek Lowe in Science. But it’s not a sure thing.

Nicole Wetsman

Source: Moderna data shows mRNA isn’t a quick fix for the flu vaccine – The Verge

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