More positive news on the COVID-19 vaccine front

The Oxford Covid-19 vaccine that is backed by AstraZeneca (NYSE:AZN) is generating the kind of antibody and T-cell (killer cell) response that the researchers would hope to see, reports Robert Peston, saying the first data is due to be published soon in The Lancet.

“That said, the efficacy will only be properly established in the large phase III programme that is under way in the viral epicentre of Brazil, to deliver a large database that assesses safety as well as efficacy. As I understand, not all of the many vaccines under development across the world increase both antibodies and T-cells. But the Oxford vaccine looks as though it has this twin effect. If proven effective, it could go into mass production as early as September.”

Moderna jumped 17% after the closing bell on Tuesday after the company released data that showed its potential coronavirus vaccine producing a “robust” immune response in all 45 patients in its early human trial.

Coronavirus vaccine names are moving on the latest news in premarket trade: AstraZeneca (AZN) +3.6%; Pfizer (NYSE:PFE) +1.3%, BioNTech (NASDAQ:BNTX) +4.9%. Novavax (NASDAQ:NVAX) and Inovio Pharmaceuticals (NASDAQ:INO) are unchanged.

https://seekingalpha.com/news/3591301-positive-news-on-covidminus-19-vaccine-front

OC Cal. School Board to Allow In-Person Classes in Fall, No Masks, No Distancing

The Orange County Board of Education voted 4-1 Monday evening to allow schools to reopen next month with in-person instruction.

Students and teachers can choose to attend classes without masks and no social distancing required.

A group of parents and teachers gathered outside of the Monday evening meeting protesting the idea of children returning to school without safety precautions.

Some parents, however, were at the meeting in support of the Board of Education’s decision to start school with in-person instruction.

Last month, the Board of Education held a meeting with experts who concluded in a white paper that requiring students to wear masks “is not only difficult but may even be harmful over time.”

It was also stated that “social distancing of children and reduction of classroom size and census may be considered, but not vital to implement for school-aged children,” and advised that parents “are in the best position to determine the education environment that best suits their children rather than government officials.”

If a school district “is unable or unwilling to reopen schools in a manner that resumes a typical classroom environment and school atmosphere, parents should be allowed to send their children to another school district or charter school that will provide that preferred education,” the experts wrote.

“In fact, many parents stated they will opt for private schools or homeschooling if their child does not have a typical interactive academic classroom environment.”

The experts advised regular temperature checks, encouraged “good hygiene with frequent hand washing and the use of hand sanitizer,” as well as the cleaning of classrooms, meeting rooms, buses and administrative offices nightly.

The panel also concluded that teachers are more at risk of getting sick from another teacher or staff member than they are from children.

The recommendations stand in contrast with guidelines backed by Orange County Department of Education Supt. Al Mijares.

“There has been some confusion, and understandably so, over the role of the OC Board of Education and our agency, the Orange County Department of Education,” Mijares said in a statement.

The board’s “recommendations are not binding,” the superintendent added.

“Locally elected school boards and superintendents will approve and implement plans specific to their districts based on the needs of their schools and communities,” Mijares said.

Meanwhile, LAUSD Superintendent Austin Beutner announced Monday that the district’s campuses will remain closed when classes resume Aug. 18. saying the “health and safety of all in the school community is not something we can compromise.”

San Diego Unified also announced Monday that campuses will remain closed when the district resumes classes Aug. 31, with all courses remaining online only.

OC School Board Votes To Allow In-Person Instruction This Fall Without Masks, Social Distancing

Nearly one-third of children tested for COVID in Florida are positive

Palm Beach County’s health director warns of risk of long-term damage

Nearly one-in-three children tested for the new coronavirus in Florida has been positive, and a South Florida health official is concerned the disease could cause lifelong damage even for children with mild illness.

Dr. Alina Alonso, Palm Beach County’s health department director, warned county commissioners Tuesday that much is unknown about the long-term health consequences for children who catch COVID-19.

X-rays have revealed the virus can cause lung damage even in people without severe symptoms, she said.

“They are seeing there is damage to the lungs in these asymptomatic children. … We don’t know how that is going to manifest a year from now or two years from now,” Alonso said. “Is that child going to have chronic pulmonary problems or not?”

Her comments stand in contrast to Gov. Ron DeSantis’ messaging that children are at low risk, and classrooms need to be reopened in the fall. DeSantis has said he would be comfortable sending his children to school if they were old enough to attend.

 

Some studies suggest that children are less likely to catch COVID-19 than adults. Children are also far less likely to die of the disease. About 17,000 of Florida’s roughly 287,800 cases have been people younger than 18. Of the 4,514 COVID-19 deaths reported by Florida as of Tuesday, four have been younger than 18.

Still, it’s possible COVID-19 could have long-term consequences that will take time to understand, Alonso said.

“This is not the virus you bring everybody together to make sure you catch it and get it over with,” she said. “This is something serious, and we are learning new information about this virus every day.”

State statistics also show the percentage of children testing positive is much higher than the population as a whole. Statewide, about 31% of 54,022 children tested have been positive. The state’s positivity rate for the entire population is about 11%.

Researchers have linked a serious and potentially deadly inflammatory condition with COVID-19 in children. The condition, called pediatric multisystem inflammatory syndrome, doesn’t appear to be widespread. The Florida Department of Health lists 13 confirmed cases of the syndrome.

Dr. Jorge Perez, co-founder of Kidz Medical Services, said it’s too early to say how common and severe long-term damage could be from COVID-19, but early evidence suggests some children infected with the virus could have lasting damage.

“We are learning something every day,” said Perez, who operates pediatric offices throughout South Florida. “We have to be knowledgeable about this and continue to monitor to see what effects it has in children.”

DeSantis told talk radio host Rush Limbaugh last week that the risk to children is “very low.”

“I’ve got a 3-year-old daughter, 2-year-old son, and a newborn daughter,” DeSantis said in the radio interview. “And I can tell you if they were school age, I would have zero concern sending them.”

https://www.sun-sentinel.com/coronavirus/fl-ne-pbc-health-director-covid-children-20200714-xcdall2tsrd4riim2nwokvmsxm-story.html

Has Italy Beaten COVID-19?

Nation adapts to “new normal” of masks and distancing; second wave now seen as unlikely

Three weeks ago, the hospital Policlinico San Donato in Milan, Italy, slowly started to get back to a semblance of “normal.”

In the early days of the coronavirus pandemic, this 500-bed hospital was caring for 600 patients with COVID-19.

Now, the hospital’s chief cardiac surgeon, Lorenzo Menicanti, MD, says his unit is operating at 40% to 50% of its normal volume — which may sound underwhelming, but at one point his entire cardiac ICU was dedicated to the care of COVID-19 patients.

“We are almost out of the nightmare,” Menicanti told MedPage Today, noting that the hospital has seen no new positive cases in the last three weeks.

Once seen as the world’s worst hotspot, Italy has managed to bring the virus to heel, as has much of the rest of Europe. Italy has had more than 34,000 deaths, with nearly half of them in the Lombardy region, of which Milan is the capital.

At one time, experts in the U.S. were worried that it would become “the next Italy” — a prospect that now seems welcome as America has nearly 100,000 more deaths than the European country.

Menicanti attributes Italy’s success to surprisingly high levels of compliance with social distancing measures from the Italian people.

“In the beginning, all of us were shocked by the rules. To be locked in, not being able to travel or meet people, that’s very strange for us. Italians love crowded places,” Menicanti said. “But the population, incredibly, has followed the rules.”

Even today, Italians continue to be frightened into compliance and are “afraid to restart their lives normally,” he said.

“I think the feeling of the U.S. population is not the same,” he said.

Living the Nightmare

Italy’s first case of coronavirus was identified in Codogno, a town of 16,000 people about an hour’s drive from Milan.

Annalisa Malara, MD, an intensivist and anesthesiologist at Codogno Hospital, diagnosed the first patient there on Feb. 20.

Local officials responded swiftly: “I called the chief of the hospital who declared it a crisis situation,” Malara wrote in a narrative for the European Society of Cardiology.” The chief in Lombardy was contacted as were the politicians, and a national emergency was announced. Codogno hospital was put in lockdown and emergencies were sent to Lodi Hospital, which is 30 km away.”

The town locked down immediately and largely averted a major crisis, according to news reports. An Associated Press report from mid-March said most Codogno residents were wearing masks when they went outside, handshakes were forsaken and people kept a social distance as they waited in lines at pharmacies and food stores.

Other towns that didn’t implement such a strict lockdown right away, such as Bergamo and Cremona, were hit harder, and scenes of coffins piling up in churches were burned into the national psyche.

Mario Carminati, a priest in Bergamo, told the BBC that the “sound of ambulance sirens was constant. This was a reminder to be on the lookout, that if you didn’t do as they said, you could be next.”

“We don’t want to forget what happened,” Carminati said. “We want it to be a reminder of how to live in a certain way.”

That fear has produced compliance that made control of the virus possible, Menicanti said. The entire region of Lombardy now only has 41 COVID-19 patients in intensive care, down from a peak of 1,800. Only 277 people in the region are hospitalized with the disease.

“It’s another world, because in other times we had 12,000 patients hospitalized,” Menicanti told MedPage Today.

About 7% of staff at Policlinico San Donato became infected with the virus, a result Menicanti called lower than expected given that testing was limited at the beginning of the outbreak. “The PPE worked very well,” he said. “The incidence of infection in our hospital was low.”

However, more than 150 Italian doctors are said to have died from the virus.

Back to Business

Now in Lombardy, masks must be worn at all times while in public. Schools and universities remain closed. Bars and restaurants are open, but with social distancing rules in place. Some even place glass shields between tables. It’s the “new normal” that many Americans refuse to accept.

“It’s not nice to go to restaurants and see people inside cages, but it was a good way to start again, and people have accepted it,” Menicanti said.

While it was relatively easy to stop normal hospital operations and push all resources to COVID care, it’s “much more complicated to restart,” he said.

The layout of Policlinico San Donato has been changed so that there are new routes for COVID-free patients to enter and be transported through the hospital. All patients who enter the hospital must be screened for COVID and must have two negative swabs to be admitted to the surgical ward. An entire floor is devoted solely to screening.

Staff on the COVID wards are tested more frequently than those assigned to non-COVID areas. Menicanti said he’s tested about once a week.

A third of hospital beds must remain free in case there’s a new wave of infections, but “all the data we have in Italy are against this idea,” Menicanti said. “So probably in another couple of weeks, we will consider occupying all beds for normal operation.”

No Second Wave?

Like much of the rest of Europe, Italians have become so confident in their ability to control the virus that many experts believe there won’t be a massive “second wave” of infections and deaths.

Enrico Bucci, PhD, a molecular biologist and statistician who runs a company aimed at detecting research fraud, wrote in a widely shared Facebook commentary that the probability of having a second wave that produces as much mortality as the first is “pretty low.”

However, “the sooner we abandon spacing, masks, hand hygiene, tracking, isolation and containment measures in hospitals, the more we increase the likelihood of high-intensity epidemic waves,” Bucci noted.

Health officials have gotten better at identifying sources of infection and reacting quickly to contain them, Menicanti said. For instance, as soon as a hot spot at a company in Bologna was identified, it was shut down: “Now we know what to do” to prevent local outbreaks from growing into a large second wave, he said.

While he’s concerned about the winter and a double-whammy of flu and COVID cases, he noted that there’s a large campaign for flu vaccination that may help moderate that burden.

“Of course it’s not over, we know that,” he said. “But the population is very prudent and being very attentive to the rules.”

“Summer will be perfect, we hope,” Menicanti said. “We shall see what happens in October.”

https://www.medpagetoday.com/infectiousdisease/covid19/87446

Moderna’s COVID-19 vaccine could cruise to $5B in sales—or more, analysts say

Moderna has never scored a commercial approval for any of its drugs or vaccines, but analysts with Jefferies think the company has a winner in its COVID-19 shot. And not just any winner—a multibillion-dollar blockbuster.

The company, a frontrunner in the global vaccine race, will likely win an emergency approval or full approval early next year and earn billions of dollars in sales, Jefferies analysts wrote in a Monday note initiating coverage on the company.

Based on discussions with opinion leaders and public disclosures by the company, the analysts see a “good probability Moderna’s vaccine will work and get at least emergency use authorization in 2021,” Jefferies’ Michael Yee wrote in the note to clients. A safe and effective vaccine “can generate billions in sales, which we see as reasonable given there would be high demand over the first 1-2 years.”

The analysts predict 50 million people will be vaccinated in 2021 at $50 per dose. Under that scenario, Moderna could earn about $2 billion in 2021 and $5 billion over the next few years.

But if 100 million or 200 million people get vaccines at a higher price point, “this can quickly get to big numbers of $10-20B+ in theory,” Yee wrote. Aside from revenues in COVID-19, success would unlock “platform value” as the company is advancing other drugs and vaccines against various diseases.

Of course, there is a chance the vaccine doesn’t work, Yee acknowledged. In that case, the stock would be “hit hard,” along with others, as the pandemic drags on.

Moderna, which is advancing an mRNA vaccine candidate, entered human testing for its vaccine in record time this spring and is kicking off a phase 3 trial this month.

But some of the world’s largest pharma companies are also pursuing COVID-19 vaccines. On Monday, partners Pfizer and BioNTech won FDA Fast Track Designations for two of their candidates. Last week, the CEOs for those companies said in separate interviews they expect to be ready to submit them to the FDA in the fall and winter, respectively. Experts have said it’ll likely take multiple vaccines to defeat COVID-19.

AstraZeneca, Sanofi and Johnson & Johnson are among the other pharma giants involved in the work.

https://www.fiercepharma.com/vaccines/analysts-see-5-billion-potential-for-moderna-covid-19-vaccine

Trump readying drug pricing executive orders, official says

Multiple crises might be roiling the U.S. these days, but drug pricing is still on President Donald Trump’s mind.

After a bipartisan drug pricing effort fell apart in Congress, Trump is getting ready to sign three executive orders on drug pricing, White House chief of staff Mark Meadows told “Lou Dobbs Tonight” last week. Meadows didn’t offer details, but he said the orders will “substantially make sure that the average American gets to pay less for their prescription drugs.”

Trump campaigned to shake up drug pricing before the 2016 election, and, after winning, he said drug companies were “getting away with murder”—and he’d make sure that stopped.

But enacting changes to the drug pricing system has proven tough for the Trump administration. In May 2018, officials rolled out a drug-pricing blueprint that aimed to boost competition and price negotiations, plus crack down on anticompetitive behavior in the industry. Officials have also sought to take on rebates and implement drug importation, but they scrapped the rebate proposal after a review from the Congressional Budget Office.

Another administration effort to force drug prices into TV ads faced legal pushback from the drug and advertising industries. Last month, several companies prevailed in their lawsuit against the measure.

Pharma companies still enjoy broad pricing freedoms in the U.S. despite those efforts, but the scrutiny itself has put a damper on price increases in recent years. Though pharma companies continue to hike prices, they’re marking up stickers on fewer drugs and by lower margins.

Now, though, after Congress couldn’t come to an agreement on the issue, Trump is reportedly readying those executive orders.

Meadows’ comments come after a drug pricing effort by Sen. Charles Grassley lost steam. In a Wall Street Journal op-ed last month, Grassley wrote that Democrats “have left the negotiating table” in pursuit of “political gain.” Republicans, meanwhile, are “sitting on their hands” and “throwing the taxpayers we claim to champion under the bus.”

Meanwhile, some pharma companies are moving forward with midyear price hikes even amid the pandemic. AstraZeneca, Eli Lilly and Sanofi were among companies that have raised dozens of prices by low single-digit percentages in July, according to GoodRx.

https://www.fiercepharma.com/pharma/fiercepharmapolitics-trump-readying-drug-pricing-executive-orders-official-says

Merck KGaA’s manufacturing group could see billions from COVID-19 work: analyst

COVID-19 vaccines are moving forward at record speeds, but market watchers have cautioned about the looming manufacturing challenges. Merck KGaA, with its manufacturing services outfit, could see billions of dollars in revenue as it assists certain players with their scale-up, an analyst says.

The company is working with more than 200 groups developing COVID-19 vaccines and drugs, Jefferies analyst Brandon Couillard wrote to investors after speaking with Merck KGaA’s process solutions division head, Andrew Bulpin. Among them are Baylor University and Oxford University, two groups advancing COVID-19 vaccines.

Couillard’s team figures the market opportunity could be worth $4 billion to $5 billion. Still, it’s “hard to quantify … until we know which vaccines actually work and what type of production processes each will use,” he pointed out.

Merck KGaA’s process solutions outfit aims to help groups take their programs from R&D scale to “pilot scale” and eventually industrial production. That’s a “very complex” process, the analyst wrote, “but Merck is aiming to help shorten the timelines, given its expertise and breadth of up/downstream solutions.”

The company is already a “market leader” in process solutions and is on track to generate nearly $4 billion in revenues this year, the analyst wrote. Meanwhile, amid the COVID-19 crisis, more than 160 vaccines are in development, many of them from academic groups and small biopharma companies that could use manufacturing assistance.

As Merck KGaA expands in life sciences, the company recently opened a campus in Shanghai with 13 labs spanning drug discovery, development and manufacturing, according to SHINE.

https://www.fiercepharma.com/pharma/merck-kgaa-s-contract-manufacturing-group-could-see-billions-from-covid-19-work-analyst