Search This Blog

Wednesday, July 29, 2020

Pfizer lays out Covid-19 vax commercial strategy for pandemic, beyond

With its trials and pricing set, Pfizer has pulled back the curtain on the long-range commercial strategy for its COVID-19 vaccine. During its earnings call Tuesday, execs laid out two phases, pandemic and seasonal, with some combination of the two likely to play out over the next several years.
The current pandemic phase, expected to continue through 2021 and even into 2022, means dose production in high volumes for mass vaccinations and pricing for broad access, said Angela Hwang, group president of Pfizer Biopharmaceuticals.
That broad access pricing is the $19.50-per-dose agreement with the U.S. for 100 million doses that will also be used as the benchmark price in developed countries around the world.

In the second, more seasonal phase for the vaccine, Pfizer anticipates a steady stream of repeat vaccinations over a number of years. During that time, Hwang said, Pfizer expects a return to regular supply channels and “a more value-based pricing approach.”
Chairman and CEO Albert Bourla added that that more normal seasonal pricing strategy would be based on the competition at the time and the value the Pfizer COVID-19 vaccine brings to the table.
Pfizer’s beyond-the-pandemic scenario casts COVID-19 as a prominent virus which will continue to circulate in society much like the flu. And while that means assessing societal needs and vaccination schedules for this particular novel coronavirus, Pfizer is also looking at the mRNA development platform it shares with BioNTech as “an important pillar,” not only against COVID-19 but also existing and future viruses.

The mRNA platform will also be able to “disrupt the flu market, novel vaccines against CMV and even to go into a novel age group of RSV. So we see a very large opportunity based on the leadership we have with this mRNA platform, particularly by being able to engage both neutralizing antibodies and antiviral CD8 cells,” Mikael Dolsten, Pfizer’s chief scientific officer, said on the call.

School closures in spring linked to drastic decrease in Covid-19 cases and deaths

When state officials were deciding whether to shutter their schools back in March, the evidence they had to work with was thin. They knew kids easily catch and spread influenza — and that school holidays and closures have helped slow its spread. But they weren’t sure if the same was true for Covid-19.
Now, a study published Wednesday in the Journal of the American Medical Association shows that closing all of a state’s schools was associated with a drastic decrease in both Covid-19 cases and deaths. And the point at which officials made that call mattered: Those states that adopted the policy while few people were testing positive saw a correlated flatter curve of cases.
“It’s a nice study. It’s clear that coincident with closing down schools, the numbers improved,” said Helen Boucher, chief of the division of geographic medicine and infectious diseases at Tufts Medical Center, who wasn’t involved in the research. But she noted that we have to be careful about drawing overly broad conclusions from a single sliver of a sweeping shutdown strategy: “School closing didn’t happen in a vacuum.”
It also still isn’t clear how likely kids of different ages are to get and pass on the virus, which makes it hard to tease out the reasons why school closures might have helped to shift the outbreak.
“It’s quite possible — and probable — that people changed their behavior because they thought, ‘Oh my goodness, there’s this new virus and it’s so scary they’re closing schools,’” said pediatrician Katherine Auger, associate chair of outcomes at Cincinnati Children’s Hospital Medical Center, and the first author of the new paper.
“One thing we can’t tease out is how much of the effect was related to the virus spreading within schools, and the larger change in the community because now parents aren’t going to work,” she added.
The findings arrive amid a furor over school reopenings. This spring, the Centers for Disease Control and Prevention released guidelines about preventing viral transmission within schools, recommending that students be physically distanced, by placing desks 6 feet apart, for instance. For some schools, that seemed impossible, given the number of kids enrolled and the architecture of classrooms. That meant that at least some teaching would take place online, which contradicted the president’s rosy — and to many public health experts, risky — ideas about reopening.
After both Trump and Vice President Mike Pence criticized the guidelines and encouraged schools to reopen fully, the CDC released revised guidelines, which sparked fears that federal public health experts were caving under political pressure.
The new study doesn’t show cause and effect, only an association between school closures and case counts in an area. The authors warned it also can’t provide a blanket prescription for the fall.
“Our study took place at a time when schools weren’t doing things like masking,” Auger explained. “It’s really impossible to project the old way of schools into the future of schools, assuming they’ll be following the expert guidelines.”
To her, the work supports the “flexible and nimble” approach backed by the American Academy of Pediatrics. Having kids physically present in schools doesn’t just spur academic learning and the essential cognitive and emotional development that comes from social interaction, the organization stated. It also allows them to receive a slew of services, from free meals to adult eyes that might pick up signs of abuse at home.
But those benefits have to be weighed against the risks of Covid-19 for kids, parents, grandparents, and teachers — a threat best kept in check with rapid testing that much of the country cannot provide.
In the new study, Auger and her team compared reality — in which all 50 states closed schools in March — to a computer model in which everything else stayed the same while schools remained open. They calculated the time it would’ve taken for infections acquired in schools to be transmitted, and for those patients to then show up in hospitals and for a certain fraction of them to die.
Their projection found that, if schools had stayed open, there could have been roughly 424 more coronavirus infections and 13 more deaths per 100,000 residents over the course of 26 days.
Extrapolate that to the American population, and the country might have seen as many as 1.37 million more cases and 40,600 more deaths, explained Samir Shah, the director of hospital medicine at Cincinnati Children’s Hospital Medical Center and one of the authors of the paper.
“These numbers seem ridiculously high and it’s mind-boggling to think that these numbers are only … in the first several weeks,” said Shah. “That’s bonkers.” He warned, though, that those numbers should be taken with a grain of salt. While their statistical model attempts to pinpoint the impact of schools staying open or being closed, the method can’t actually establish any sort of causal relationship.
The authors realized that their estimation of how long it might take an infection picked up in a school to turn into a symptomatic case of Covid-19 might be off, and wondered if that might influence their results. When they changed those time lags, though, they still found a significant correlation between closing schools and decreased caseload and mortality.
To Steffanie Strathdee, associate dean of global health at University of California, San Diego, that was what made this study convincing. “This study was taking imperfect data but doing a very elegant analysis,” she said. “If we were wrong, what’s the other extreme, would it change the results? If these kids infected parents, but it took a little longer or a little shorter, what then?”
The bottom line, she said, was that strategies such as school closures do seem to make a difference when it comes to the risks of Covid-19.
Auger’s team also analyzed whether the timing of school closures was correlated to a change in cases and deaths. “States who closed schools before their Covid numbers were high had the largest effect,” she said.
While kids seem to be less likely to get sick than adults, there is some evidence that schools can be important sites of coronavirus transmission. Younger children appear less likely to pass on the virus than tweens and teens, though more research is needed to fully understand the various risks.
Shah, meanwhile, warned that people reading the study should not forget about the risks of interruptions to schooling. “We can quantify the risk of Covid. It’s much harder to quantify the risk of being absent from school for a prolonged period of time,” he said.
Both he and Auger emphasized the importance of tailoring strategies to the needs and coronavirus risks within each family and community, and that better, quicker testing would allow for a safer back-to-school strategy. “It’s a real challenge, and I think that our study is one very important piece of the puzzle in how we think about this,” Shah said.

India’s Hetero wins approval to sell COVID-19 drug favipiravir

India’s Hetero Labs Ltd has received regulatory approval to sell its version of anti-viral drug favipiravir to treat COVID-19, the drugmaker said on Wednesday, as coronavirus infections in the world’s third worst-hit nation crossed 1.5 million.
The drug, priced at 59 rupees (79 cents) per tablet, is approved to treat mild to moderate COVID-19 and will be available at drug stores from Wednesday, privately held Hetero said in a statement.
Favipiravir and another anti-viral treatment, remdesivir, have emerged as the most sought after medicines to treat COVID-19 in India, which had already approved the drugs as emergency treatments to fight the outbreak.
India reported about 48,000 fresh cases on Wednesday. Globally, coronavirus cases have crossed 16.7 million, resulting in more than 659,000 deaths.
Favipiravir was originally developed by Japan’s Fujifilm Holdings Corp under the brand name Avigan for treating influenza.
Hetero is also among the drugmakers that have a license with U.S.-based Gilead Sciences Inc to make remdesivir.
Other Indian drugmakers developing or selling favipiravir include Glenmark Pharmaceuticals Ltd, Cipla Ltd, privately held Brinton Pharma and Jenburkt Pharmaceuticals Ltd.

Takeda-led COVID-19 plasma treatment unlikely to meet July goal of trial start

A group led by Takeda Pharmaceutical Co have completed test supplies of a blood plasma treatment for COVID-19, but pending regulator approval will likely prevent clinical trials from meeting a July start date.
The CoVIg-19 Plasma Alliance is ready to start shipping vials to study sites once the trial is approved by regulators in the United States, said Julie Kim, president of the plasma-derived therapies unit of Takeda.
The group had originally aimed to begin clinical trials in July. The National Institutes of Health in the U.S. is the trial sponsor, and is looking at study sites around the world, according to Kim, who also serves as co-leader of the alliance.
The alliance, which also includes Biotest AG, CSL Behring, and Octapharma Plasma, is working on a hyperimmune globulin therapy derived from convalescent plasma. It offers a standardized dose of antibodies and doesn’t need to be limited to patients with matching blood types.
Clinical supplies of the treatment were produced at Takeda’s facility in the U.S. state of Georgia and at CSL Behring’s facility in Bern, Switzerland.
If the trials prove successful, the alliance expects to start submissions for regulatory authorization before the end of the year, Kim said.

Germany begins mass coronavirus testing at airports

Berlin’s Tegel airport began large scale coronavirus testing on Wednesday, as airports across Germany prepared for the advent of free, compulsory testing for many passengers from next week.
Two rooms were set aside for tests, but an airport spokeswoman said a larger space was being prepared, indicating that authorities are preparing for testing to remain a fixture for a long time to come.
“These rooms are of course a bit small, as you can see,” said spokeswoman Sabine Deckwerth. “That is why the large Terminal D in Tegel is being prepared to host a bigger one.”
An increase in the number of infections across Europe has dashed the hopes of airlines and tourist destinations such as Spain for a relatively quick return to mass tourism after months of lockdown.
Airports such as Frankfurt, Germany’s busiest, have been offering tests over the previous weeks, but now preparations are gearing up across the country for the testing of passengers arriving from countries deemed high risk that is due to begin next week.
On Tuesday, Germany’s top public health official scolded the public for their lack of discipline in adhering to social distancing practices and wearing masks that can slow the spread of the highly contagious disease in the absence of a vaccine.

The number of daily new cases almost doubled on Tuesday to 633, with 684 added on Wednesday, giving a total of around 207,000 with just over 9,100 deaths.
Earlier on Wednesday, research minister Anja Karliczek warned the public not to expect a vaccine that could be deployed on a broad scale before the middle of next year.

Bayer sends private investigator to U.S. farm, appeals weed-killer case

Bayer AG sent a private investigator this month to evaluate the business of a U.S. peach grower who won a $265 million court verdict against the company and rival BASF SE, in a bid to overturn the decision, according to court filings.
A jury in U.S. District Court for the Eastern District of Missouri in February awarded Bill Bader, Missouri’s largest peach farmer, $15 million in actual and $250 million in punitive damages. Bader sued Bayer and BASF, saying his 1,000-acre orchard was irreparably harmed by herbicides drifting onto its trees from nearby farms.
Bayer’s private investigator found Bader’s retail store was selling peaches and his trees were growing fruit, according to a court filing on Tuesday that argued the dicamba-based herbicides did not ruin the farm. Bayer also cited advertisements promoting Bader peaches as evidence.
Bayer is battling a slew of lawsuits stemming from its $63 billion takeover of seed and chemical company Monsanto in 2018.
“The new evidence provided to the court clearly demonstrates that Bader Farm’s $15 million compensatory damages award was based on the false premise that the farm would be completely out of the peach business by 2019,” Bayer said in a statement on Wednesday.
Attorney Billy Randles, whose firm represented Bader, told Reuters: “We find it ridiculous that Monsanto persists in raising in the media matters that they either lost in front of the jury or did not raise before the jury,” said
“Bader Farms sells some peaches, even though it has been devastated by dicamba.” Bayer agreed last month to pay as much as $10.9 billion to settle U.S. lawsuits claiming that Monsanto’s Roundup weed-killer caused cancer.
Bayer also said it will pay up to $400 million to resolve lawsuits, not including Bader’s, that were brought by landowners who say their crops were damaged by neighbors using Monsanto’s dicamba-based weed-killer. The product is alleged to and waft away from the target field.

FDA Nears Decision Authorizing Covid-19 Treatment With Convalescent Plasma

The Food and Drug Administration is nearing a decision to authorize emergency use of antibody-rich blood plasma from recovered Covid-19 patients for treating people infected with the coronavirus, people familiar with the matter said.
The authorization could come as early as next week, according to the people, though the agency could also decide to delay a decision.
The designation could open the way for faster and wider access to one of the most promising treatments for Covid-19 patients. Only a Gilead Sciences Inc. antiviral drug known as remdesivir carries the designation.
The FDA can authorize a drug’s use in an emergency such as a pandemic after finding the treatment is safe and there is evidence of probable benefit. The designation might also prompt federal health officials to approve payment for the treatment under Medicare and Medicaid.
The FDA didn’t immediately respond to a request for comment.
There is a long history of using convalescent plasma to treat people during past outbreaks, including Ebola and influenza.
Because of a lack of proven drugs, some doctors and hospitals have been treating hospitalized Covid-19 patients with convalescent plasma under compassionate use and as part of studies.
More than 48,000 Covid-19 patients have received convalescent plasma through an expanded-access program sponsored by the FDA and led by the Mayo Clinic in Rochester, Minn., which is also studying whether the treatment works safely.
Michael Joyner of the Mayo Clinic, the principal investigator of the expanded-access study, said in an interview earlier this month that hospitals in virus hot spots giving convalescent plasma are struggling to treat patients while filing case reports and keeping up with data reporting.
An FDA emergency-use authorization could cut red tape for the hospitals and allow faster access to the therapy.
Preliminary studies have found convalescent plasma is generally safe to use and appears to improve the survival of hospitalized patients.
Researchers are also exploring whether earlier use of convalescent plasma could reduce the severity of illness and cut the number of hospitalizations.
This week researchers at the University of Pittsburgh, Michigan Medicine, Medical University of South Carolina and Stanford Medicine said they received federal funding for a 600-subject study that will in part look at such earlier use in patients starting to show symptoms.
As part of the trial, Covid-19 patients who showed up at a hospital with milder cases will be sent home after receiving either convalescent plasma or saline, then monitored to see whether the plasma prevented people from getting sicker or needing to return to the hospital.
If the plasma’s outpatient use proves effective, “We may rely on this while we wait for a vaccine,” said Clifton Callaway, executive vice chair of emergency medicine at the University of Pittsburgh and one of the principal investigators on the trial.
William Hartman, a doctor at the University of Wisconsin, Madison, who is treating hospitalized Covid-19 patients with convalescent plasma, said FDA emergency-use authorization may prompt more hospitals to give the treatment earlier.
“I think the data are pretty clear that using it as early as possible has advantages, and we should explore that possibility,” he said.
Dr. Hartman and colleagues studied 31 severely ill Covid-19 patients who were hospitalized and received convalescent plasma as part of the expanded access study.
The study’s results, which were posted on a public server but haven’t yet undergone peer review, indicated that most of the transfused patients with severe disease didn’t have to go to the intensive-care unit or receive mechanical ventilation.