PLC, according to people familiar with the matter, in a takeover likely to be valued at well over $20 billion and mark the largest healthcare merger of the year.
The U.S. biotechnology company was the last of three suitors standing in an auction for Horizon, the people said, after French drugmaker
Sanofi SA
said Sunday it was out of the running.
A deal could be finalized by Monday assuming the talks with Amgen don’t fall apart, the people said.
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Horizon develops medicines to treat rare autoimmune and severe inflammatory diseases that are currently sold mostly in the U.S. Its biggest drug, Tepezza, is used to treat thyroid eye disease, an affliction characterized by progressive inflammation and damage to tissues around the eyes.
The company is Nasdaq-listed, but based in Ireland and has operations in Dublin, Deerfield, Ill., and a new facility in Rockville, Md.
Horizon said last month it was fielding takeover interest from Amgen, Sanofi and
Johnson & Johnson,
a disclosure prompted by a Wall Street Journal report.
Johnson & Johnson later said it had dropped out.
Last year, revenue from Tepezza more than doubled, driving Horizon’s overall net sales 47% higher to $3.23 billion. Horizon has said that annual global net sales of the drug are targeted to eventually peak at more than $4 billion as the company aims to win approval to sell it in Europe and Japan.
That type of growth is attractive to big drug companies—with many sitting on big piles of cash—that rely on acquisitions as a key strategy to expand sales. Many big drugmakers are looking for new sources of revenue to offset losses when some of their main products lose patent protection.
Analysts expect Amgen will lose sales when patents begin expiring on its big-selling osteoporosis drugs Prolia and Xgeva later this decade. The pair of drugs accounted for nearly $5.3 billion of Amgen’s $26 billion in revenue last year.
In October, Amgen completed a $3.7 billion deal for ChemoCentryx and its drug to treat a rare immune-system disease.
Adding Horizon would provide more rare immune-disease drugs to Amgen’s lineup, which also includes the biotech’s Enbrel and Otezla immune-disease therapies. Amgen could help sell more of Horizon’s products overseas, according to analysts.
Acquiring Horizon could add about $4 billion in new revenue for Amgen by 2024, according to Jefferies & Co.
Other big life-sciences companies have been inking deals in recent months.
Johnson & Johnson recently struck a $16.6 billion deal to acquire heart device maker Abiomed Inc. to bolster sales of its medical-gear division, which had been lagging behind those of its pharmaceutical unit.
Merck
& Co. followed with a deal of its own, agreeing to buy blood-cancer biotech
Imago BioSciences Inc.
for $1.35 billion, ahead of the patent expiration of its cancer immunotherapy Keytruda.
Pfizer Inc.,
meanwhile, agreed in August to buy Global Blood Therapeutics Inc. for $5.4 billion, in a deal that would give the big drugmaker a foothold in the treatment of sickle-cell disease.
A deal for Horizon would likely rank as the largest healthcare acquisition globally in 2022, ahead of the Johnson & Johnson-Abiomed tie-up. The selloff in stocks this year amid rising interest rates, while putting a damper on deal activity, has also made some companies more attractive targets. At the stock’s peak about a year ago, Horizon was valued at roughly $27 billion.
The shares, which fell sharply earlier this year, have surged since the possibility of a takeover surfaced, and the company now has a market value of about $22 billion.
Horizon’s other drugs include Krystexxa for treating gout, a form of inflammatory arthritis, and Ravicti for a rare, potentially life-threatening genetic disease known as urea cycle disorder that raises ammonia levels in the blood.
Drugs treating rare diseases have emerged as a large source of pharmaceutical sales because they can command high prices that health insurers have been willing to pay.
Write to Ben Dummett at ben.dummett@wsj.com, Dana Cimilluca at dana.cimilluca@wsj.com and Laura Cooper at laura.cooper@wsj.com
Pfizer’s CEO has been rapped by the UK’s pharmaceutical watchdog for making “misleading” statements about children’s vaccines, The Telegraph can disclose.
Dr Albert Bourla used an interview with the BBC last December to claim that “there is no doubt in my mind that the benefits, completely, are in favour of” vaccinating youngsters aged five to 11 against Covid-19.
He argued that “Covid in schools is thriving” adding: “This is disturbing, significantly, the educational system, and there are kids that will have severe symptoms.”
The interview was published on Dec 2 – before the vaccine had been approved by Britain’s medical regulator for this age group.
Shortly after the article’s publication, a complaint was submitted to the pharmaceutical watchdog – the Prescription Medicines Code of Practice Authority (PMCPA) – by UsForThem, a parent campaign group which was set up to promote the plight of children during the pandemic.
‘Extremely promotional in nature’
The complaint alleged that Dr Bourla’s remarks about the children’s vaccine were “disgracefully misleading” and “extremely promotional in nature”, arguing that it breached several clauses of the Association of the British Pharmaceutical Industry’s (ABPI) code of practice.
“There is simply no evidence that healthy schoolchildren in the UK are at significant risk from the SARS COV-2 virus and to imply that they are is disgracefully misleading,” they said.
In September 2021, the Joint Committee on Vaccination and Immunisation (JCVI), had advised against a mass roll-out for children aged 12-15, saying the “margin of benefit” was “considered too small” and citing the low risk to healthy children from the virus.
But less than a fortnight later, ministers gave the green light for youngsters to be given a single dose of the Pfizer-BioNTech jab with the UK’s chief medical officers arguing that this would help to keep schools open.
It was not until February 2022 that the JCVI ruled that children aged 5-11 could be offered the vaccine – but ministers said the decision should be left up to parents.
A code of practice panel, convened by the PMCPA, found that Pfizer had breached the code in a number of different ways, including by misleading the public, making unsubstantiated claims, and by failing to present information in a factual and balanced way.
‘Up-to-date scientific evidence’
Pfizer appealed against the findings, strongly refuting UsForThem’s claims that Dr Bourla had breached the code of practice. They argued that his remarks were based on “up-to-date scientific evidence” and could be substantiated by the “publicly available independent benefit-risk assessments”.
Earlier in November an appeal board met to consider their arguments. The breaches of the code relating to misleading the public, making unsubstantiated claims and the lack of balance were upheld.
Hope for long Covid sufferers as new study will trial Pfizer’s antiviral Paxlovid in patients left with lingering symptoms months later
100 people who have had long Covid symptoms for 3+ months will take Paxlovid
Researchers want to see if it will help with brain fog, fatigue and weakness
1 in 13 US adults suffer with long Covid, and trial results are expected next year
By Caitlin Tilley, Health Reporter For Dailymail.Com
Published: | Updated:
Paxlovid – an antiviral made by Pfizer – is now being looked at as a possible long Covid treatment.
The pharma giant’s flagship Covid drug gained emergency approval in the US last December to treat high-risk patients – slashing their risk of death by 90 per cent.
It is currently the only medication you can take at home to treat Covid and has been given to millions of vulnerable Americans with underlying health conditions.
Now, researchers at Stanford are about to launch the first clinical trial of the drug to see it may also provide relief to people who are still ill months and years after clearing the virus.
Prior research has indicated that people given the drug are a quarter less likely to suffer long Covid – which most commonly causes intense tiredness, brain fog and muscle weakness.
As of yet, there are no proven treatments for long Covid, and no one knows what causes the ongoing symptoms.
A popular theory is that there may be bits of leftover virus wreaking havoc in the body. A recent study suggested people with long Covid suffer physical alterations to their brain months after clearing the initial infection.
More than 15million Americans are officially estimated to have long Covid to varying degrees.
Trial participants will take the antiviral drug for ten days longer than people usually take it for, to see if it needs longer to work
What is long Covid?
Long Covid is an informal term, used to describe ongoing symptoms following a Covid infection that go on longer than four weeks, according to the ONS.
A dizzying array of symptoms have been attributed to long Covid, including:
extreme tiredness (fatigue)
shortness of breath
chest pain or tightness
problems with memory and concentration (‘brain fog’)
difficulty sleeping (insomnia)
heart palpitations
dizziness
pins and needles
joint pain
depression and anxiety
tinnitus, earaches
feeling sick, diarrhoea, stomach aches, loss of appetite
a high temperature, cough, headaches, sore throat, changes to sense of smell or taste
rashes
There is no cure for the condition though the NHS does recommend a number of treatments designed to help alleviate the symptoms.
The new study hopes to sign up 200 adults who have been negative for Covid for three months yet still suffer symptoms.
Half the participants will receive Paxlovid and half will take a placebo.
To treat an infection, Paxlovid is given as six pills a day for five days, but participants in the new study will take the drug for 15 days to test the theory that the drug needs more time to have its full effect.
Results of the trial are expected next year.
The first participant in the trial was 67-year-old Bill Fimbres from California, who has been suffering with long Covid symptoms for a year-and-a-half, including a loss of smell and taste, debilitating fatigue and brain fog.
He said: ‘It’s like you have somebody else’s brain.’
Mr Fimbres will take his first dose of either the drug or placebo on Monday.
He told NBC News: ‘If I could get rid of just one of my symptoms, that would be great. I’m just going on hope.’
A study by the Department of Veterans Affairs this month suggested those who received the drug immediately after their Covid diagnosis were 26 per cent less likely than those who did not take the antiviral to have lasting symptoms three months on.
However, the participants were all aged 60 or above with additional health issues, meaning the findings may not be applicable to everyone.
Long Covid has puzzled scientists and physicians since it first popped on their radar in 2020.
Its causes have not been figured out, but experts believe it could be tied to the body’s immune response to the virus.
There have also been previously known cases of people suffering long-term symptoms after suffering more common viruses like the flu.
The CDC estimates that around 7.5 per cent of American adults are suffering from long Covid symptoms.
Sufferers are generally under the age of 50, and are more likely to be women. Reports of long Covid are most common in southern states like Kentucky and Alabama.
Moderna’s COVID-19 shot may cause two to three times as many heart-related side effects as Pfizer’s, according to a new Canadian study.
The rates of myocarditis and pericarditis in individuals within 21 days of getting their second shot were 35.6 and 22.9 per million doses, respectively, for Moderna compared to 12.6 and 9.4 per million for Pfizer, the research found. The connection between the mRNA vaccines and heart complications was most pronounced in men and younger vaccine recipients.
“in whom minimizing risk of myocardial insult is crucial, these data give a strong argument to preferentially use the BNT162b2 [Pfizer] vaccine over mRNA-1273 [Moderna]” https://t.co/70nNikSsSv
— Amesh Adalja (@AmeshAA) November 9, 2022
The study’s authors were quick to caution that incidences of heart inflammation were still fairly rare and that catching COVID-19 appears to carry a greater risk of myocarditis or pericarditis than receiving an mRNA vaccine.
Potential recipients should “consider the self-limiting and mild nature of most myocarditis events, benefits provided by vaccination, higher effectiveness of the Moderna vaccine against infection and hospitalization [found in prior studies], and the apparent higher risk of myocarditis following COVID-19 infection than with mRNA vaccination,” lead study author Dr. Naveed Janjua said in the American College of Cardiology news release accompanying the findings.
The authors also said the research should help inform policymakers and individuals choose between Pfizer and Moderna. Those with a propensity for heart conditions may be better off choosing the former, they said.
A number of medical bodies and health professionals have raised concerns about the association between mRNA vaccines and heart conditions. Some have pulled back on recommending the mRNA vaccines for young men in particular due to the less favorable risk-reward balance compared to other demographic groups.
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SINGAPORE—Chinese leaders are considering steps toward reopening after nearly three years of tough pandemic restrictions but are proceeding slowly and have set no timeline, according to people familiar with the discussions.
Chinese officials have grown concerned about the costs of their zero-tolerance approach to smothering Covid outbreaks, which has resulted in lockdowns of cities and whole provinces, crushing business activity and confining hundreds of millions of people at home for weeks and sometimes months on end. But they are weighing those against the potential costs of reopening on public health and support for the Communist Party.
As a result, they are proceeding cautiously despite the deepening impact of the Covid policies, the people said, pointing to a long path to anything approaching pre-pandemic levels of activity, with the timeline stretching to sometime near the end of next year.
The uncertainty around China’s Covid-19 strategy has led to a guessing game in the financial markets, with some looking for any sign that China would begin easing its Covid policies. China’s Communist Party congress last month, when Chinese leader
Xi Jinping
claimed a third term, had once been viewed as a potential turning point in its battle against Covid, but little has changed in the country’s approach to containing Covid.
China’s leaders are worried that a surge in Covid infections, hospital admissions and deaths could undermine confidence in the ruling Communist Party’s legitimacy.
Photo:
TINGSHU WANG/REUTERS
On Saturday, officials from China’s National Health Commission again reaffirmed their commitment to a firm “zero-Covid” strategy, which they described as essential to “protect people’s lives.”
Some progress is being made on relaxing border controls for inbound travelers from abroad. Beijing is likely to further cut the number of hotel quarantine days required of incoming travelers by early next year, to a total of seven days, say people involved in discussions, from a current policy of seven days in a quarantine facility followed by three days of home monitoring.
Domestically, officials have informed retail businesses that the frequency of PCR testing—a staple of China’s Covid regime—could be reduced as soon as this month, in part because of the high cost of mass testing, according to people familiar with the matter. The people said the government is planning to reduce the thousands of PCR testing stations that have been set up across the country as part of the campaign to institutionalize testing, citing the cost.
ECONOMIC IMPACT OF COVID IN CHINA AND CHINA’S ZERO-TOLERANCE APPROACH
Still, the leadership has found it difficult to enact broader relaxation measures this year, the people said. Many of the measures will remain. The country will still move aggressively to stamp out even small outbreaks, through mass testing and lockdowns. People will still need to use health codes on their phones to access public spaces, and travelers entering the country will face quarantines and rounds of Covid tests.
A combination of new viral variants, an underequipped public healthcare system and the impending approach of winter has left Beijing worried that a potential surge in Covid infections, hospital admissions and deaths could undermine confidence in the ruling Communist Party’s legitimacy.
Chinese health officials have been closely monitoring the fatality rates and public reactions in Hong Kong, Japan and South Korea, which share cultural roots with China and where governments had until recently imposed similar measures, the people said.
“The reopening in China will be carried out in an orderly manner. It will start gradually depending on the geographic areas and sectors, and it will be different from what we’ve seen in the West,” said one of the people involved in discussions. For example, the government could decide to implement less stringent measures in cities that are major business hubs.
Workers at the world’s biggest assembly site for Apple’s iPhones walked out as Foxconn has struggled to contain a Covid-19 outbreak. The chaos highlights the tension between Beijing’s rigid pandemic controls and the urge to keep production on track. Photo: Hangpai Xinyang/Associated Press
While some have questioned the accuracy of China’s official figures, health experts say the country’s Covid fatality rate has been much lower than in much of the West due to its strict measures. Officially, China has recorded roughly 5,000 Covid-19 deaths, a fraction of the U.S.’s more than 1 million deaths. China’s Communist Party has celebrated its lower official death count as evidence of the superiority of its governance model.
In recent months, Chinese officials have maintained close contact with the World Health Organization, focusing on the alert level that the Geneva-based body has assigned for the Covid-19 pandemic, according to people familiar with the matter.
The WHO’s emergency committee meets once every three months to assess whether the pandemic still constitutes a “public health emergency of international concern.”
A WHO shift in declaration would give China more wiggle room for policy changes. Beijing could start to push for more aggressive easing measures and adjust the domestic narrative on Covid, effectively declaring victory in containing the virus, according to people familiar with the matter.
The WHO first declared a public health emergency of international concern in January 2020, and decided during its latest meeting, held in October, that it is still too early to lift the status. The next meeting is slated for January.
A WHO official said the agency doesn’t comment on private discussions with member states.
One plan under consideration in Beijing, the people said, would be to begin treating Covid-19 as a “Class B” infectious disease following any change in the WHO’s designation. China has been treating it as a Class A disease, which calls for stricter public-health measures.
Even with such a move, it could take China a much longer time—perhaps a year, the people said—to return to pre-pandemic levels of activity. The government wants to continue to monitor new variants closely to ensure that they don’t become more dangerous, they said.
Any further loosening of measures would be contingent on a boost in the elderly vaccination rate. Beijing is planning to launch a vaccination campaign later this year for vulnerable groups, aiming for 95% of people aged 60 or above to receive two doses, some of the people said. The latest government data, from early November, shows 86% of the elderly population had received two vaccine doses, compared with 90% for the broader population.
Another condition for a full reopening of its economy is to boost access to oral antivirals to treat Covid, the people said. Earlier this year, China’s drug regulator granted approval for Azvudine, an HIV drug developed by Chinese drugmaker Henan Genuine Biotech Co., to be used for treating Covid. Drug regulators have also approved
Pfizer Inc.’s
Paxlovid drug.
Any further loosening of measures would be contingent on a boost in the elderly vaccination rate.
Photo:
CHINA DAILY/VIA REUTERS
The National Health Commission responded to a request for comment by referring to remarks made during its Saturday press conference.
There have been some signs of a shift in China’s posture on Covid in recent months. In September, Mr. Xi visited Central Asia, making his first trip outside the country since Covid began spreading in the central Chinese city of Wuhan in early 2020. The Chinese leader has also begun receiving foreign heads of state in Beijing and is expected to attend a summit of leaders from the Group of 20 nations in Indonesia next week.
Still, Beijing has been careful to rein in expectations of a rapid shift, including in the Saturday press conference. In a string of pointed commentaries last month, Communist Party mouthpiece the People’s Daily called for confidence and patience with Beijing’s zero-Covid strategy. Health officials have urged local governments to build quarantine hospitals to prepare for rebounding infections. Shanghai, for example, is building a quarantine facility that can house more than 3,000 people at a cost of just under $200 million, state media reported.
“All the signs are pointing to the beginning of preparation for an eventual reopening, especially given the rising cost of the ‘dynamic zero-Covid’ policy for the economy,”
Goldman Sachs
economists said in a Monday note. “The actual reopening is still months away as elderly vaccination rates remain low and case fatality rates appear high among those unvaccinated based on Hong Kong official data.”
Twitter Inc. has suffered “a massive drop in revenue” because of advertisers cutting back on using the social-media platform, new owner
Elon Musk
said Friday, as the company started sweeping layoffs just over a week after the billionaire took it over.
Mr. Musk, in a tweet Friday, blamed the cutback in advertising on “activist groups pressuring advertisers.” He said that the company hadn’t changed content moderation and had tried to address activists’ concerns. “Extremely messed up!” he said, casting the pullback as an assault on free speech.
Mr. Musk’s remarks came after several big-name advertisers, including food company
General Mills Inc.,
GIS -0.63%
Oreo maker
Mondelez International Inc.,
MDLZ 0.44%
and
Pfizer Inc.
PFE 0.74%
and others have temporarily paused their Twitter advertising in the wake of the takeover of the company by Mr. Musk, The Wall Street Journal has reported. German car-making giant
Volkswagen AG
said it had recommended to its various brands they pause advertising on Twitter to assess any revisions the company makes to its brand safety guidelines.
Mr. Musk’s tweet comes after Twitter, in a message sent to staff Thursday, said staffers would be notified by 9 a.m. Friday if they had lost their position or were still employed, the Journal reported.
Twitter by early Friday began notifying employees who had been laid off, according to documents viewed by the Journal.
Roughly 50% of Twitter’s workforce has been hit with layoffs, according to an email sent overnight to one of those affected in the U.S. that was viewed by the Journal. It didn’t specify what departments the terminated employees worked in.
Twitter had more than 7,500 employees at the start of this year, according to a regulatory filing.
The staff reductions were intended “to place Twitter on a healthy path,” according to the company’s Thursday email. “We recognize that this will impact a number of individuals who have made valuable contributions to Twitter, but this action is unfortunately necessary to ensure the company’s success moving forward,” the company added.
In the layoff emails, Twitter said employees assigned “nonworking” status would continue to receive compensation and benefits through a separation date, which for one person was designated as early February and for another early January. It said to expect to receive one month’s base pay in severance approximately 45 days after the termination date, in addition to providing instructions for returning company property such as laptops.
Twitter didn’t say whether employees should expect to receive year-end bonuses, which historically have been based on individual and company performance. The company also didn’t mention whether employees would receive equity payments during the nonworking period.
Some employees said they had lost access to Twitter communication tools overnight. An email sent to an employee in Canada and seen by the Journal said that suspended access to the company’s systems didn’t mean the person’s employment has been terminated.
The layoffs cap a tumultuous period for Twitter staff that began in April, when the company disclosed Mr. Musk had become its largest individual shareholder. Mr. Musk then agreed to join Twitter’s board, before deciding not to. He launched a bid for the company that Twitter eventually accepted. Weeks later Mr. Musk raised questions about the deal, then tried to abandon it, before reversing course again last month and saying he would go ahead with the transaction. Along the way, he at times criticized the company and its executives.
The Thursday email said Twitter’s offices would be temporarily closed to ensure the safety of employees, the company’s systems and customer data. Employees who were in an office or on their way to one were asked to go home, according to the email.
Twitter employees have been bracing for job cuts. The Journal previously reported that the company was drafting plans for broad layoffs, with one investor saying up to 50% of staff could be cut and that employees would be evaluated to determine the scope of the firings.
Elon Musk has purchased Twitter, ending a monthslong saga over whether or not he would go through with his offer to acquire the social media platform. WSJ takes an inside look at the tweets, texts and filings to see exactly how the battle played out. Illustration: Jordan Kranse
Signs of pushback against Twitter’s actions emerged in the wake of the apparent dismissals. In a federal lawsuit dated Thursday, a handful of Twitter employees accused the company of violating federal and California law in failing to provide enough warning of a mass layoff.
The lawsuit, filed in California federal court by five former employees of Twitter who said they were terminated this week, said the company’s layoffs violated the federal Worker Adjustment and Retraining Notification Act and its California equivalent, which require giving 60 days of advance written warning of dismissing a large number of employees of a company at once. The lawsuit asked the court to issue an order blocking Twitter from its alleged violations of the acts. Twitter didn’t immediately respond to a request for comment.
In April, as Mr. Musk was moving to buy Twitter, entrepreneur
Jason Calacanis,
a close ally, suggested cutting the number of Twitter employees to roughly 3,000, according to messages between the two, which were released as part of litigation around the transaction.
A staff of 3,000 would represent the lowest level since 2013, the year Twitter went public, when the platform had about 2,700 employees and its revenue was roughly 13% of its level last year.
Twitter’s employee numbers began climbing in 2019, after ranging between approximately 3,000 and 4,000 for several years. Twitter has said that the increase in recent years was driven by investments in engineering, product, design and research.
Even before officially taking control at Twitter, Mr. Musk had indicated that he was concerned about the company’s expenses. Twitter has posted a loss in eight of its past 10 fiscal years, according to FactSet.
Mr. Musk moved quickly to make personnel changes at the top of the company. Last week, on the same day he closed the deal, he fired Twitter Chief Executive
Parag Agrawal
and three other top executives. Mr. Musk fired the executives for cause and is saying he isn’t required to pay them multimillion-dollar severance packages, the Journal reported. Other executives have departed since.
Mr. Musk has leveraged other parts of his business empire to try to put his imprint on Twitter. He brought in some
Tesla
engineers to begin working on reshaping the social-media platform, the Journal reported. Also added to an internal company directory were some people who appeared to work for the Boring Co., a tunneling business Mr. Musk founded.
Broadly, the social-media industry is struggling with weaker revenue from digital advertisers. Such advertising has slowed due to several factors, including rising inflation, the war in Ukraine, and
Apple
privacy changes that have made it harder to track the performance of ads. Twitter rival Snap Inc. this year said it was letting 20% of staff go.
Facebook
parent Meta Platforms Inc. also has indicated it was trimming ranks.
Tech companies beyond social media also have embarked on belt tightening that is leading to job losses and hiring freezes. On Thursday, ride-hailing company
Lyft Inc.
and payments company Stripe Inc. announced major layoffs, and
Amazon.com Inc.
said it would freeze corporate hiring for months.
Write to Sarah E. Needleman at sarah.needleman@wsj.com and Alexa Corse at alexa.corse@wsj.com
Pfizer and BioNTech have launched a clinical trial on a vaccine targeting both COVID-19 and influenza, the companies announced Thursday.
The phase 1 trial is being done in the United States with 180 participants between the ages of 18 and 64, with the first participant dosed this week, the companies said. The follow-up period for each participant will be six months.
In this Sept. 8, 2022, file photo, a teenager receives the Pfizer-BioNTech COVID-19 booster vaccine targeting BA.4 and BA.5 Omicron sub variants at Skippack Pharmacy in Schwenksville, Penn.
Hannah Beier/Reuters
“By combining both indications in one vaccine approach, we aim to provide individuals with an efficient way to receive immunization against two severe respiratory diseases with evolving viruses that require vaccine adaptation,” Dr. Ugur Sahin, CEO and co-founder of BioNTech, said in a statement.
The combination vaccine is based on the currently available bivalent COVID-19 booster and a quadrivalent mRNA flu vaccine, which is designed to protect against four different flu viruses.
The phase 1 trial will test for safety, immune response and optimal dose level of the combination vaccine, before moving on to larger trials. The data will also provide insight into the potential of mRNA vaccines to address more than one pathogen, Sahin said.
Annaliesa Anderson, senior vice president and chief scientific officer of vaccine research and development for Pfizer, called this an “exciting step in our ongoing journey with BioNTech as we collectively look to transform the prevention of infectious diseases around the world.”
“Even with existing seasonal influenza vaccines, the burden of this virus is severe across the world causing thousands of deaths and hospitalizations every year,” she said in a statement.
In this Sept. 9, 2022, file photo, a man gets an influenza vaccine from a pharmacist during an event hosted by the Chicago Department of Public Health at the Southwest Senior Center in Chicago.
Scott Olson/Getty Images
Studies indicate COVID-19 vaccine efficacy fades over time, though it’s not clear if every American will need an annual COVID-19 booster. As scientists continue to assess the need, several companies are at work on creating a single injection each fall that protects against both seasonal flu and COVID-19.
In addition to Pfizer, pharmaceutical companies Moderna and Novavax have announced plans to work on a combo shot.
Moderna said it anticipates starting clinical trials on a single-dose vaccine that combines a booster against COVID-19 and a booster against flu by the end of the year, with hopes of the vaccine being available for the 2023 season.
“We believe this is a very large opportunity that is ahead of us, if we could bring to market a high efficacy pan-respiratory annual booster,” Moderna COE Stéphane Bancel said during the Sept. 9 investor meeting.
Last year, Novavax enrolled people in a Phase 1/2 study to evaluate the safety, tolerability and immune response of a combination vaccine using the company’s seasonal influenza and COVID-19 vaccines. A phase 2 confirmation trial is expected to begin later this year, the company said in October.
Orange County has declared a health emergency over what officials call rapidly spreading viral infections that are leading to a record number of pediatric hospitalizations.
The OC Health Care Agency on Monday said daily emergency room visits are also on the rise in the county. There is no vaccine against RSV, a common respiratory virus that creates cold-like symptoms, but the county wants people to be up to date on COVID-19 and flu shots.
“Following preventive measures, including remaining up to date with other vaccinations such as flu and COVID-19, can help reduce the severity of disease and can help reduce the burden on hospitals this fall and winter,” Dr. Regina Chinsio-Kwong, County Health Officer and HCA’s Chief Medical Officer, said in a statement. “Our best shot at protecting ourselves and our children from respiratory illnesses continues to be the same things we practiced throughout the pandemic including the use of masks when indoors around others and staying home when you are sick.”
Additionally, a Proclamation of Local Emergency was declared, which allows Orange County to access state and federal resources to combat the spread.
Health officials are warning parents to look out for symptoms such as rapid breathing, head-bopping, lips turning blue or kids tugging at their rib cage. They also say parents and caregivers should keep young children with respiratory illnesses out of childcare, even if they have tested negative for COVID.
One local doctor told Eyewitness News younger children are more at risk for the respiratory illness.
“Their lungs aren’t as developed as our older children’s lungs are and that’s why we worry about these viruses and this inflammation affecting their lungs moreso. And that’s why they have the symptoms such as wheezing and breathing fast and respiratory stress,” said Dr. Rishma Chand with Dignity Health and Northridge Hospital.
New research shows vaccinating pregnant women helped protect their newborns from RSV, raising hopes that vaccines against the virus may finally be getting close after decades of failure.
Pfizer announced Tuesday that a large international study found vaccinating moms-to-be was nearly 82% effective at preventing severe cases of RSV in their babies’ most vulnerable first 90 days of life. At age 6 months, the vaccine still was proving 69% effective against serious illness – and there were no signs of safety problems in mothers or babies.
The vaccine quest isn’t just to protect infants. RSV is dangerous for older adults, too, and both Pfizer and rival GSK recently announced that their competing shots also proved protective for seniors.
None of the findings will help this year when an early RSV surge already is crowding children’s hospitals. But they raise the prospect that one or more vaccines might become available before next fall’s RSV season.
Take a look at some of the biggest movers in the premarket:
Abiomed (ABMD) – Abiomed stock soared 51.6% in premarket trading after agreeing to be acquired by Johnson & Johnson (JNJ) in a nearly $16.6 billion deal. J&J will pay $380 per share for the maker of heart, lung and kidney treatments, and will add a contingent value right worth up to $35 per share if certain milestones are achieved. J&J shares fell 0.7%.
Uber Technologies (UBER) – Uber rallied 8.8% in the premarket after it reported better-than-expected quarterly revenue as gross bookings surged compared to a year ago. Uber did report a quarterly loss, but that was largely due to unrealized losses on equity investments such as its stake in Didi Global.
SoFi Technologies (SOFI) – SoFi surged 14.3% in premarket trading, following a smaller-than-expected quarterly loss and revenue that exceeded analysts’ forecasts. The fintech company also lifted its outlook after adding nearly 424,000 new members during the quarter, bringing its total to more than 4.7 million.
Pfizer (PFE) – Pfizer jumped 4% in premarket trading following a better-than-expected quarter and an improved financial outlook. Strong demand for Pfizer’s older drugs helped offset a drop in sales of its Covid-19-related products.
Goodyear Tire (GT) – Goodyear tumbled 8.3% in the premarket following a third-quarter earnings miss. The tire maker said its results were impacted by higher costs and a stronger U.S. dollar, although that was partially offset by higher prices.
Eli Lilly (LLY) – Eli Lilly beat top and bottom line estimates for its latest quarter, but the drugmaker’s stock fell 2.2% in the premarket as it cut its full-year forecast. Lilly is seeing a negative impact from a stronger dollar, increased cancer drug competition and lower insulin prices.
Hologic (HOLX) – Hologic rallied 7.6% in the premarket after the medical equipment maker reported better-than-expected quarterly profit and issued an upbeat outlook. Hologic said it saw “unprecedented strength” across its core businesses.
Stryker (SYK) – Stryker lost 4.9% in premarket action after the surgical equipment and medical device maker cut its financial outlook, citing the impact of inflation and a stronger U.S. dollar.
Avis Budget (CAR) – Avis Budget shares gained 3.7% in the premarket following better-than-expected quarterly earnings from the rental car giant amid continued strong travel demand.
Trex (TREX) – Trex shares tumbled 7.5% in premarket trading after the maker of decking and railing materials missed both top and bottom line estimates for its latest quarter. Trex said it reduced production levels and implemented layoffs during the quarter as it adjusted to falling sales.
NEW YORK, Oct 20 (Reuters) – Pfizer Inc expects to roughly quadruple the price of its COVID-19 vaccine to about $110 to $130 per dose after the United States government’s current purchase program expires, Pfizer executive Angela Lukin said on Thursday.
Lukin said she expects the vaccine – currently provided for free to all by the government – will be made available at no cost to people who have private insurance or government paid insurance.
Reuters earlier on Thursday reported that Wall Street was expecting such price hikes due to weak demand for COVID vaccines, which meant vaccine makers would need to hike prices to meet revenue forecasts for 2023 and beyond.
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The U.S. government currently pays around $30 per dose to Pfizer and German partner BioNTech SE (22UAy.DE). In 2023, the market is expected to move to private insurance after the U.S. public health emergency expires.
“We are confident that the U.S. price point of the COVID-19 vaccine reflects its overall cost effectiveness and ensures the price will not be a barrier for access for patients,” Lukin said.
It is not yet clear what kind of access people without health insurance will have to the vaccine.
Pfizer said it expects the COVID-19 market to be about the size of the flu shot market on an annual basis for adults, but that the pediatric market would take longer to build based on shots given so far.
So far the U.S. rollout of updated COVID-19 booster shots which target both the original coronavirus strain and the Omicron strain has lagged last year’s rate despite more people being eligible for the shots.
Around 14.8 million people in the U.S. received a booster shot over the first six weeks of the rollout of the new shots. In the first six weeks of the 2021 revaccination campaign, over 22 million people received their third shot even though only older and immunocompromised people were eligible at that point.
Lukin said she does not expect purchasing of the vaccines to transfer to the private sector until the first quarter of 2023 “at the earliest.” The move is dependent on the government contracted supply being depleted.
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Reporting by Michael Erman; Writing by Caroline Humer; Editing by Bill Berkrot and Richard Pullin
Our Standards: The Thomson Reuters Trust Principles.
