Roche Canada crowdsources COVID-19 ideas in quick-turn innovation challenge

Roche Canada is looking for a few good ideas to fight COVID-19, and it needs them soon.
The Swiss drugmaker recently launched a Canada-specific innovation challenge, asking for entries by April 10 in a contest that promises up to $100,000 in winnings to fund development.
The Roche Canada COVID-19 Innovation Challenge hopes to uncover any and all ideas that advance the fight against the novel coronavirus, but it does offer suggestions. How to address health system capacities, enhance real-time information-sharing, and manage remote and rural populations, for three. The contest is open only to legal residents of Canada.

“We are hoping to get a broad range of interest from all facets of society, including science-based experts such as biologists, data scientists, and healthcare providers, as well as entrepreneurs and technology developers, students, patients, and anyone with an innovative mind and wants to make a difference,” said a Roche spokesperson in an email.
While innovation challenges by pharma companies have proliferated over the past few years in specific diseases and technologies, the Roche Canada contest is one of the first to crowdsource for COVID-19 ideas.
Entries will be evaluated on five equality weighted criteria: clarity, design, innovativeness, impact and outcome, and feasibility and applicability. A Roche steering committee will choose and notify winners by April 15 and grant funding up to $50,000 for individual winners and $100,000 for team submissions.

“We are establishing this initiative in the hope that it can foster much needed solutions and create opportunities for people to get involved,” Michael Duong, head of personalized healthcare at Roche Canada, said in a news release. “Every Canadian is touched by this situation and it’s going to take the whole community coming together to get through it.”
https://www.fiercepharma.com/marketing/roche-canada-crowdsources-covid-19-ideas-new-quick-turn-innovation-challenge

UK seeks to end coronavirus lockdown with ‘immunity passports’

The UK is facing fresh questions over its coronavirus testing plan, as it emerged that the government is hoping to exit the lockdown through controversial “immunity passports” and antibody tests that are still not proven to work.
In the face of intense criticism, the health secretary, Matt Hancock, on Thursday admitted for the first time that mistakes had been made. “There will be criticisms made, and some of them will be justified,” he told the daily press briefing.
Hancock revealed that certificates to prove someone is immune to the virus could allow some of the population to go back to work, as he made a new pledge to complete 100,000 tests a day in England by the end of the month.
He attempted to relaunch the government’s strategy while Boris Johnson remains unwell in self-isolation, after a week of pressure about why so few tests are being carried out, especially on NHS workers.
Hancock promised that tests would be expanded from hospital patients and medics to more NHS staff, key workers and finally more people in the community. These will be a combination of tests for live cases of the virus and antibody tests to determine whether someone has previously been infected. Germany is carrying out around 70,000 tests a day, all for live cases of Covid-19.
However, the government was also forced to acknowledge it was not likely to have the capacity to embark on a programme of mass testing for live cases in the general public, as advocated by the World Health Organization and public experts.

Instead, No 10 and health department sources confirmed the general public would primarily have to rely on the potential for an antibody test – but these are “ideally” done 28 days after an infection, to give the clearest indication of whether someone has already had the virus, according to Prof John Newton, a senior Public Health England official.

Newton said the idea of testing all those that have symptoms in the country was “unrealistic” and the as yet unproven antibody test was more likely to be used by people at home.
Hancock said work was progressing with the antibody tests but that the results of many of the early tests had been “poor” and he was more hopeful about later ones that have been acquired. The government has bought options on up to 17.5m antibody tests of different types that are currently being tested, but cannot say definitively when they will be safe to use.
When the antibody tests are available, Hancock said, the government was looking at the possibility of issuing immunity certificates, so that some of the population “can get back to work as much as possible”.

However, some critics fear that this could lead to resentment in the population who have not had the virus, and that people might even deliberately try to get infected in order to obtain an immunity certificate.
Paul Hunter, professor in medicine at the University of East Anglia, told the Guardian that immunity certificates for frontline medical workers would be crucial for allowing staff to return to work and allowing personal protective equipment to be rationed in the safest way.
However, in the wider population, fraud could be an issue, which could rule out home-based testing, and there were concerns about unintended consequences. “People going out to deliberately get infected so they could get back to work is a concern and I don’t know how you’d avoid that,” he said. “Those are big issues.”
After a week spent in isolation with coronavirus himself, Hancock was forced to defend the government on numerous fronts. He told the press briefing:

• Johnson’s ultimate target of 250,000 tests a day – first made on March 18 – was still valid.
• Premiership footballers should take a pay cut in solidarity with NHS workers who are putting their lives on the line.
• Shortages of swabs had been rectified, but the UK was “still tackling the reagents issue, which is a global challenge”.
• The UK was having to build its capacity from a “lower base” than the likes of Germany, which is testing around 70,000 people per day.
• More commercial laboratories, including universities and private businesses, would be used to accelerate testing after criticism that this “Dunkirk” approach had initially been ignored.
• The NHS will have £13.4bn of debt written off, as previously confirmed.

Tensions have bubbled in Whitehall over who is to blame for low testing numbers in the UK, with some political sources blaming Public Health England (PHE) for not placing enough emphasis on the issue in recent weeks.
However, PHE rejected criticism that it had been trying to do all the testing itself and was too inflexible in which chemicals were allowed to be used, suggesting that it was the responsibility of ministers to find private capacity for more tests.
Prof Paul Cosford, emeritus medical director of the public health body, said PHE’s role was to “make sure our labs are doing what they need to do” in terms of testing hospital patients with a clinical need, with NHS staff a second priority.
Conservative backbenchers voiced concern in private about the government’s failure to roll out testing faster, saying there was anxiety that the public mood could turn against the government if it appeared there was no end to the lockdown as a result.
A former supporter Johnson in the leadership contest said they were worried sentiment could turn rapidly: “I think the government could get blown away if people are still inside after Easter and there is no progress on testing.”
Concerns were voiced that Johnson and other ministers had appeared to allow PHE to lead on testing, without asking the independent researchers and the private sector to get involved until Hancock’s announcement. “The fact that there’s not mass testing now is inexcusable,” another Conservative MP complained.
One senior MP said the party would be watching the polls closely and that he was “frankly amazed” that Johnson’s popularity was holding up. A bit like the virus, there might be a two-week lag before the public comes to fully realise that the government is failing to get the testing issue under control, they said.
“There are some in my party who are trying to blame PHE, but ultimately, it will be the politicians who get the blame if the economy collapses because we can’t test NHS workers.
“The death toll will become totemic. If we get thousands of people dying every day for several days, who knows where this will go. It is frightening, and the prime minister looks like he doesn’t know what to do.”
Jeremy Corbyn, the outgoing Labour leader, said: “The fact that we are not yet even testing 10,000 people a day is very, very serious indeed. There are almost half a million [frontline] people working in the NHS and the care sector. Even they have not yet been tested. It is ludicrous. We have got to get on top of testing.”
https://www.theguardian.com/politics/2020/apr/02/no-10-seeks-to-end-covid-19-lockdown-with-immunity-passports

BioNTech, CureVac urge lower clinical trial bar for quick COVID-19 vaccine

Two German biotech companies at the start of a race to create new vaccines against the COVID-19 pandemic are warning the European Medicines Agency and the FDA they will need traditional clinical trial hurdles removed if governments want the inoculations as quickly as possible.
Speaking to the Financial Times, both companies said some of the bigger clinical trial regulations will need to be cut in order for hundreds of millions of doses to be available by the end of the year.
Both BioNTech and CureVac, the former now partnered with Pfizer and the latter recently embroiled in a weird tale that allegedly saw the U.S. government try to lure it over the pond, are in preclinical trials for potential vaccines and are set to start testing on humans within the coming weeks.

In any normal time, and we’re far from that now, this would kick-start a long and laborious process that can take years to complete.
This is to accurately and thoroughly assess safety and efficacy. But given the ongoing spread of the pandemic, which at the start of April had infected at least 1 million people and killed more than 35,000, the pair said it wants to “abbreviate” these rules to speed up development.
This would include not having to do the final phase large-scale test, an expensive and time-consuming element, as well as making changes to how data are gathered.

Speaking to the FT, a spokesman for CureVac, which intends to start trials on humans in June, said that, if the company were forced to go through all three clinical stages, “It would take too much time to get a vaccine to market to fight against the current pandemic on time.” He added, “To speed this process up, authorities would have to allow us to abbreviate the approval process.”
Ugur Sahin, the founder of BioNTech, also told the financial newspaper: “Governmental organizations, experts and regulators need to work together to identify potential ways of accelerating the approval and availability of the vaccine.” BioNTech intends to begin testing its prototype on 150 healthy volunteers this month.
Other ways companies want to cut down on time are by sidelining on-site visits for side effects data gathering, using phone interviews instead, and perhaps lowering the level on just how comprehensive clinical reports will have to be.
It’s not clear whether they will or can be granted these “abbreviations” nor whether a regulator would be happy passing vaccines that had foregone the normal path to approval.(Although they will likely be under major political pressure to do so.) It also opens the door to potentially unsafe or nonefficacious medicines flooding a global market, with billions of people being inoculated with medicines that had not been tested to the same rigorous standards as all other vaccines have been.
But in a pandemic, which is also turning into an economic crisis, risk-benefit analysis starts to become a much harder proposition. The EMA, FDA and the U.K.’s MHRA have all already said they are willing to help speed up COVID-19 trials using a variety of methods.
Alongside U.S. biotech Moderna, the pair are using messenger RNA to develop these vaccines, which has the potential to speed up normal R&D lead times. There are, however, no mRNA vaccines on the market, making it more of an unknown. Both will also massively need to ramp up manufacturing capabilities.
CureVac told the FT it could produce 1 billion vaccines in one run, depending on the dose, once it completed its fourth manufacturing facility, which is being built.
BioNTech will manufacture BNT162 at its European mRNA manufacturing facilities with the support of its CDMO partner Polymun. However, global demand for an authorized SARS-CoV-2 vaccine could be huge, necessitating the coordination of other facilities to ensure fast access to the product.
https://www.fiercebiotech.com/biotech/biontech-curevac-tell-regulators-to-lower-clinical-trial-bar-if-they-want-a-covid-19

Hospital workers to be first up for Johnson & Johnson vaccine

Johnson & Johnson will offer its in-development coronavirus vaccine around the world, making it first available to front-line medical workers, Chief Scientific Officer Paul Stoffels told Nikkei.
The company will work with all governments around the globe — not just in Europe and the U.S., but also countries including Japan, China and South Korea — to “find ways to provide vaccines in every country,” including poor nations, Stoffels said. New Jersey-based Johnson & Johnson, the world’s largest health care company, has a presence nearly everywhere in the world, he noted.
In Stoffels’ view,  the focus is less on where the vaccine goes than on who gets it. “The first people who need to get access are the people at the highest risk,” such as “the health care workers who work in hospitals — the nurses, the doctors and all the people who work with the patients,” he said.
As for the price, Stoffels said it is “too early” in the development process to say, but he stressed that it will be as low as possible and that Johnson & Johnson considers the vaccine a not-for-profit project. “We are committed to make it affordable [and] accessible,” he said.
Asked how the drugmaker plans to produce its promised 1 billion doses, Stoffels expressed confidence that the company can quickly find peers to help. “We will do capital investment as well as collaborating with partners,” he said, adding that the company has begun building a new plant in the U.S. and has capacity in Europe that it can expand.
“We hope we will be able to get four plants in total to start with,” he said, adding “Two plants are already in line and two more to come, and we’ll work in the next few weeks and months to make sure two more plants will come online.”
Clinical trials on the vaccine are slated to begin in early September, and the company is working on scaling up production to make it available early next year, Stoffels said.
https://asia.nikkei.com/Editor-s-Picks/Interview/Hospital-workers-to-be-first-up-for-Johnson-Johnson-vaccine

UK ramps up coronavirus trials but results ‘a few months away’

Britain said on Friday it was launching the biggest clinical trial of possible treatments for coronavirus in the world but a leading health official cautioned that the results were likely a few months away.

Almost 1,000 patients from 132 hospitals had been recruited in 15 days and thousands more were expected to join in the coming weeks, the health department said.
The trial is testing medicines more commonly used to treat malaria and HIV, and is designed so that when further medicines are identified, they can be added to the study within days.
England’s Deputy Chief Medical Officer Jonathan Van-Tam said the next round of clinical trials should include new medicines, including those that might be in development for other diseases and might “have a role to play”.
But he was cautious on the timeline for results of the trials.
“I know that there’ll be a question about when are we going to get some results from these clinical trials, and my straight answer to you is: ‘I don’t know.’ I think it’s going to be a few months,” he told a news conference.
Health Minister Matt Hancock said that until possible treatments for COVID-19, the disease caused by the coronavirus, were shown to be effective, the only protection against it was to stay at home.
He said that so far clinical trials had been focused on repurposing existing drugs and steroids for treatment of COVID-19.

“We’ve also set up an expert therapeutics taskforce to search for and shortlist other candidate medicines for trials,” Hancock said.
“We need more patients to volunteer to be part of these trials because the bigger the trials, the better the data and the faster we can roll out the treatments, if – and only if -it’s proven to work.”
https://www.reuters.com/article/us-health-coronavirus-britain-trials/uk-ramps-up-coronavirus-trials-but-results-a-few-months-away-idUSKBN21L2KQ

Emergent BioSolutions, Feds Partner to Speed Plasma Therapy for COVID-19

• BARDA to provide $14.5 million in funding to support development of COVID-Human Immune Globulin (COVID-HIG), a human plasma-derived therapy candidate being developed as a potential treatment for COVID-19 in severe hospitalized and high-risk patients
• NIAID to include COVID-HIG product candidate in one of its clinical studies for assessment of treatments for COVID-19 upon availability of clinical material
• Emergent will seek a path forward with the FDA for the development of COVID-HIG and possible use under Emergency Use Authorization (EUA)

Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has entered into a formal partnership with the U.S. government to expedite development of a plasma-derived therapy for patients with coronavirus disease 2019 (COVID-19). Emergent has received $14.5 million from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health & Human Services (HHS), in support of its COVID-HIG program, one of two hyperimmune development programs announced by Emergent in March.
COVID-HIG is a candidate human hyperimmune product being developed as a potential treatment for COVID-19 in severe hospitalized patients and high-risk, acute symptomatic patients to prevent progression to severe symptoms. COVID-HIG will be manufactured using plasma donations from people who have recovered from COVID-19 with antibodies to SARS-CoV-2.
https://investors.emergentbiosolutions.com/news-releases/news-release-details/emergent-biosolutions-partners-us-government-comprehensive

NY insurers to defer premiums until June for individuals, small biz in money woes

New York’s state government has required insurers to not collect premiums for the next two months from the state’s individuals and small businesses experiencing financial hardship due to COVID-19.
The plans will still be required to pay claims for the individual and small group plans through June 1. Health plans also cannot report late payments to credit rating agencies during this period, according to the announcement made Thursday.
The government added it is prohibited under state law for insurers to impose late payment fees.

New York also announced a one-month extension of the special enrollment period for Affordable Care Act plans through May 15. If someone lost employer coverage, they have within 60 days of losing coverage to apply.
The state’s Department of Financial Services will consider “any liquidity or solvency concerns of the health plans in giving effect to this directive.”
Major insurers have started to waive cost-sharing for COVID-19-related costs and tests.
https://www.fiercehealthcare.com/payer/new-york-requires-insurers-to-defer-premium-payments-till-june-for-individuals-small