gr-cis.com

GigaGen is developing a recombinant polyclonal antibody therapy (rCIG) to treat COVID-19. First uses are envisioned as treatments for severely ill coronavirus patients and individuals at high risk of contracting the disease, including healthcare professionals.

“We are working toward an IND filing and expect to start clinical trials the first of next year,” David Johnson, Ph.D., co-founder and CEO of GigaGen, told BioSpace. That’s at least three months faster than normal, as manufacturing alone typically takes 12 months, he explained. “We’re hoping to do that in nine months by working in parallel rather than sequentially.”

GigaGen’s rCIG technology will deliver high concentrations of a comprehensive repertory of antibodies that combat the COVID-19 virus. That technology captures tens of thousands of antibodies to COVID-19 from the serum of scores of patients who have recovered from this virus. When replicated and developed into a vaccine, Dr. Johnson said the antibodies should coat the virus completely so it can’t replicate.

Although recombinant and plasma-based therapies both start with convalescent serum, GigaGen’s recombinant approach (unlike plasma-based vaccines) does not require steady supplies of donor plasma. Instead, GigaGen recreates complete libraries of the antibodies captured from donor serum. Those libraries, then, are used to generate recombinant therapeutics that have the potential to treat millions of patients.

Because rCIG is a recombinant – rather than a plasma – therapy, the risk of contamination is lower and batch-to-batch consistency is increased, allowing controlled doses. And, because it is polyclonal, rCIG offers hundreds-fold higher potency than plasma-derived equivalents and, therefore, potentially better clinical outcomes.

“rCIG is expected to confer passive immunity,” Johnson said. “Therefore, it will be used as a therapeutic rather than as a prophylactic vaccine.”

Dosing, at this early stage of development, isn’t yet known.

“Since it will be used in an emergency setting, its likely people may receive only one to two doses,” Johnson said.

To speed development, GigaGen already has discussed the manufacturing method with the U.S. Food and Drug Administration (FDA). Further discussions will be forthcoming as they seek ways to safely expedite development.

“Recombinant antibody manufacturing is a very defined path,” Dr. Johnson said. “We need to make a master cell bank, conduct engineering runs and GMP runs, dose primates for toxicology studies, etc. It all takes time.”

“Science must take many paths until a solution to the pandemic emerges,” he continued. We’re hoping an active vaccine will be developed to turn the pandemic around, but both an active and therapeutic vaccine are needed.”

Between 10 and 15 percent of people do not respond to vaccines, he explained. “Some people have immune deficiencies, or are older and lack the antibodies for their bodies to launch an immune response. Vaccines will help create herd immunity,” thus conferring some protection to those without immunity.

GigaGen has developed recombinant immunoglobulin technologies for therapeutics for several years. A few years ago, it launched this platform as a way to target primary immune deficiency and infectious pathogen. The platform already has been validated in mouse models, with recombinant polyclonal antibodies targeting Zika virus, Haemophilus influenza B, Influenza A, and Hepatitis B.

“When we developed the technology, experts advised us to also think about using it for rapid responses against emerging pathogen. For the past few years we’ve tried to secure government contracts to build out a rapid response capability.”

Nothing resulted from those discussions. Now GigaGen is in talks with the National Institutes of Health to determine financing mechanisms for various approaches. In the meantime, “We’re putting our own money into the COVID-19 fight.”

Yet, for commercial scale up, GigaGen needs partners. It’s working with its long-time CMO FujiFilm Diosynth Biotechnologies, as well as with Griffols, a plasma-derived therapeutic company that exclusively funded GigaGen.

GigaGen isn’t the only organization targeting convalescent plasma therapeutics. Johns Hopkins University announced a similar public-private initiative late Friday, receiving $4 million in funding from the State of Maryland and Bloomberg Philanthropies. The partnership, like GigaGen, aims to explore therapeutic uses of blood plasma from recovered COVID-19 patients.

The Johns Hopkins team, led by Arturo Casadevall, M.D., is planning randomized clinical trials for patients at all stages of disease progression and for high-risk patients who have been exposed, following a March 24 FDA  guidance that facilitates the use of experimental treatments against COVID-19.

Dive Brief:

• FDA on Friday issued a policy to facilitate greater use of remote patient monitoring technologies to cut back on hospital visits and thereby minimize risk of exposure to COVID-19 while also reducing the burden on providers during the current crisis.
• The guidance document, effective immediately, is limited to the duration of the public health emergency and outlines modifications to the indications, claims, functionality, hardware and software of FDA-cleared non-invasive devices for tracking vital signs including body temperature, blood pressure, and respiratory and heart rates. One example of a change OK’ed under the policy might be allowing devices originally only cleared for healthcare settings in the home setting, FDA said.
• The data gathered via the devices can be used when healthcare providers diagnose or treat COVID-19 or co-existing conditions, FDA said.

Dive Insight:

The guidance document is one of several FDA has issued responding to COVID-19 in recent weeks. Others this week covered hand sanitizerpreparation, conducting clinical trials during the pandemic, and new parameters for rapidly increasing diagnostic testing capacity.

The remote patient monitoring device guidance applies to non-invasive devices that can be connected to a wireless network through Bluetooth, Wi-Fi or cellular connection to transmit a patient’s measurements directly to their healthcare provider or other monitoring entity. Some of the devices have the potential to apply algorithms to turn a patient’s physiological data into an index or alarm that may aid in diagnosing or assessing the severity of a condition.

In making way for an increase in remote monitoring, FDA is waiving a limitation on clinical decision support (CDS) software to now allow for the development of products that can provide advice on diagnosing and treating the coronavirus, Epstein Becker & Green attorney Bradley Thompson said in comments shared with MedTech Dive.

In September, the agency published a revised draft guidance detailing plans for regulating CDS software that reflected industry feedback seeking a risk-based approach for the software, but which some argued did not go far enough. At the time, FDA indicated it would exempt from regulation software that is low risk, and focus oversight on technology that supports clinical management for serious conditions in which a healthcare professional cannot independently evaluate the basis of software recommendations.

“What FDA is doing in this emergency guidance is basically waving that September 2019 objection that CDS can only escape FDA regulation if it is both low risk and transparent. FDA is saying in this context, even though the risk is arguably higher, they will accept transparency. That’s a really good thing,” Thompson said in an email. Thompson is also part of the CDS Coalition, which advocates against over-regulation of clinical decision support software.

BBC News reports that the firm has designed a new ventilator which still needs to get regulatory clearance and is set to be built at its plant in Wiltshire. Dyson is working with Cambridge-based The Technology Partnership.

The Guardian has reported that Airbus – which plans to scale up production of existing ventilator models – is expected to receive the go-ahead to build ventilators too while manufacturers in the car industry – including UK-based constructors in Formula One – are also exploring switching their production to focus on the government’s request for more ventilators.

Dive Brief:

• The European Commission is working on a proposal to delay enforcement of the EU Medical Device Regulation by one year, a spokesperson saidWednesday.
• Policymakers are aiming to submit the proposal in early April, and are imploring the European Parliament and Council to quickly adopt the postponement ahead of the May 26 go-live date for the regulatory overhaul. “This will relieve pressure from national authorities and industry and it will allow them to focus fully on urgent priorities related to the coronavirus crisis,” EC spokesperson Stefan de Keersmaecker read in a statement.
• The announcement was preceded by numerous calls to push back MDR’s previously unshakeable start date in light of challenges introduced by the ongoing COVID-19 pandemic, including from trade association MedTech Europe and from Socialists and Democrats (S&D) in Parliament.

Dive Insight:

Formal reassurance for industry that MDR will not take force in two months as originally planned appears to be on the horizon.

Despite regulators hardly budging the past year as industry worried a notified body shortage would render MDR implementation in 2020 unrealistic, a one-year postponement would recognize the burden medtechs face in trying to supply healthcare workers with necessary medical technologies to fight COVID-19 and maintain business operations while countries are shut down.

The European Commission has faced increasing pressure to implement a delay as the novel coronavirus has taken hold of Europe and much of the rest of the world.

“Although the regulation contains very important elements to improve patient safety, in these unprecedented times, the priority should be on meeting the demand for medical devices and equipment,” Croatian Parliament member and S&D medical devices spokesperson Biljana Borzan said in a statement Tuesday.

“This should be seen as just a temporary measure. An extraordinary measure for extraordinary times. Therefore, we demand the Commission to postpone its implementation until after the fight against Coronavirus has been won.”

In a letter Tuesday to EC President Ursula von der Leyen and Commissioner for Health and Food Safety Stella Kyriakides, the group of S&D members of Parliament said they are also open to proposals by the Commission to make changes to the current directives.

Kyriakides flagged the Commission’s response on social media Wednesday.

MedTech Europe said Wednesday that while it welcomes the EC’s plans, as well as “the support that the European Parliament has expressed for this,” the trade association remains convinced “a similar solution is needed” regarding implementation of the In Vitro Diagnostic Regulation (IVDR).

The group argued that although IVDR’s start date isn’t until 2022, diagnostic makers’ preparations that would have happened this year is being equally disrupted by coronavirus response.

“Right now, their capacity is focused on the critical task of keeping diagnostic tests available, despite the challenges the pandemic is creating for their production and distribution,” MedTech Europe wrote in a statement Wednesday. “By providing the same solution for the in vitro diagnostics and medical devices sectors, the EU would be doing even more to keep health systems up running effectively in times of the COVID19 pandemic.”

MedTech Europe had on Monday requested that implementation of both MDR and IVDR be paused and not resumed until six months after the crisis passes, which the group said could be defined by the World Health Organization declaring the pandemic over.

This story has been updated with a statement from MedTech Europe.

Dive Brief:

• As ventilator manufacturers scale up production across the U.S. to address a critical need for the breathing machines, AdvaMed on Tuesday sent a letter to the Federal Emergency Management Agency asking for designation of a single agency to make allocation decisions to ensure the devices get to those who need them most.
• Device manufacturers across the country are racing against time to increase ventilator production to meet demand as the number of coronavirus cases continues to rise nationwide. In response to the COVID-19 outbreak, FDA on Sunday issued guidance permitting ventilator manufacturers to modify hardware and software without first submitting a premarket notification.
• AdvaMed said it believes the most effective way to distribute the devices is under the direction of a lead agency, such as FEMA, with input from clinical experts including the CDC and other stakeholders in the face of “unprecedented demand” for the equipment.

Dive Insight: 

A major effort is underway to ramp up production of ventilators as the spread of COVID-19 accelerates across the country amid warnings of a looming shortage. In an article published Monday in the New England Journal of Medicine, Robert Truog, director of the Harvard Center for Bioethics and a professor of anesthesia, and colleagues said the U.S. is not yet facing a shortage of the devices, but whether rationing of ventilators becomes necessary in this country will depend on the pace of the pandemic’s spread.

The authors point to a limited window in which a patient can be saved once breathing deteriorates to the point where a ventilator is needed. “The decision about initiating or terminating mechanical ventilation is often truly a life-or-death choice,” they said.

The NEJM article cites numbers from the Johns Hopkins Bloomberg School of Public Health indicating U.S. hospitals have about 62,000 full-function ventilators and 98,000 basic ventilators, with an additional 8,900 in the Strategic National Stockpile. CDC estimates that 2.4 million to 21 million Americans will be hospitalized during the pandemic. Italy’s experience suggests 10% to 25% of hospitalized patients will require ventilation, the authors wrote.

U.S. manufacturers are racing to produce enough ventilators for those who need them, but face a challenge in determining how to allocate supplies among purchasers, according to AdvaMed. “Many healthcare providers, as well as state and local governments, are trying to buy ventilators. Some of these potential purchasers should have a higher priority than others based on the acuity of patient needs in their areas. It is difficult for manufacturers to establish these priorities,” the industry group said.

A single federal agency would be in the best position to assess individual users’ needs and determine whether a particular manufacturer or the Strategic National Stockpile should be the supplier, AdvaMed said in its letter to FEMA.

A number of medtechs are stepping up to boost supplies of ventilators to meet the increased demand. On Tuesday, Zoll Medical said it is gearing up to produce 10,000 ventilators per month, a 25-fold increase in its production volume. The company said it is prepared to expand its supply base as necessary. “We have received many unsolicited offers of help from not just medical companies, but industries including aerospace, automotive, and information technology,” CEO Jon Rennert said.

Ventec Life Systems is collaborating with GM to expand its ventilator production, with the device maker tapping into GM’s logistics, purchasing and manufacturing expertise, the companies said. ResMed said it is working to double or triple its ventilator output and scale up ventilation mask production more than tenfold.Medtronic said it is aiming to more than double its ventilator manufacturing workforce and production capacity in response to the crisis. GE Healthcare has added manufacturing lines and relocated employees to ventilator production sites, while Philips said its Chinese manufacturing capacity is rebounding as it also works to boost ventilator production.

A day after it was announced remdesivir had received Orphan Drug designation for treatment of COVID-19 from the U.S. Food and Drug Administration, Gilead Sciences submitted a request for the regulatory agency to rescind that offer after an outcry was raised over the potential for exclusivity for the experimental pandemic treatment.

In addition to the request to rescind the designation, which would have granted the company market exclusivity for seven years, Gilead said it is waiving all benefits that accompany the designation. Gilead is confident that it can maintain an expedited timeline in seeking regulatory review of remdesivir, without the orphan drug designation. Recent engagement with regulatory agencies has demonstrated that submissions and review relating to remdesivir for the treatment of COVID-19 are being expedited, the company said in a brief statement. Stock prices have fallen more than 4% since the announcement.

Remdesivir is an antiviral drug that is currently in two late-stage trials for the treatment of COVID-19. The medication has been studied as a potential treatment for Ebola, Marburg, MERS and SARS. MERS and SARS are both caused by coronaviruses that have at least some similarities to the coronavirus causing COVID-19.

The company initially sought the designation earlier this month, a standard practice among drugmakers focused on the development of a drug that will treat a disease with fewer than 200,000 patients in the United States. Globally, there are more than 400,000 cases of COVID-19, the disease caused by the novel coronavirus that was declared a pandemic by the World Health Organization and about 55,000 in the United States.  In its announcement, Gilead said it recognizes the “urgent public health needs” posed by the pandemic and is working to advance the development of remdesivir as quickly as possible for this indication.

The award of Orphan Drug status for the experimental remdesivir was met with some outrage as much of the nation continues to remain in self-quarantine as part of an effort to “flatten the curve” of infection rates. Sen. Bernie Sanders, an outspoken opponent of high-priced prescription drugs, called it “outrageous” that the FDA would grant the status to Gilead Sciences. He said millions of dollars of taxpayer money have gone into the development of the anti-viral drug and added that while the pandemic rages, “now is not the time for profiteering in the pharmaceutical industry.”

“The Trump Administration must rescind this corporate giveaway to Gilead and make any treatment and vaccine free for everybody,” Sanders said in a statement. “When Jonas Salk developed the polio vaccine 65 years ago, he understood the tremendous value it would have for all of humanity, and he refused to patent it. Right now, we must put human life above corporate profit. We cannot give pharmaceutical corporations a monopoly on treatments that could save millions of people during this crisis.”

The receipt of and sudden request to rescind the Orphan Drug designation followed the company’s announcement over the weekend that Gilead Sciences planned to temporarily suspend individual compassionate use requests for remdesivir due to “overwhelming demand.” Gilead said it is in the process of transitioning from individual compassionate use requests to expanded access programs. Doing so will “both accelerate access to remdesivir for severely ill patients and enable the collection of data from all participating patients,” the company said. Gilead said it is attempting to rapidly assess the safety and efficacy of remdesivir as a potential treatment for COVID-19 through multiple ongoing clinical trials.

DUBLIN, Ireland, March 25, 2020 (GLOBE NEWSWIRE) — Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy, announced today that it has completed the REST-ON Phase 3 clinical trial for FT218. The REST-ON study enrolled a total of 212 patients, and the last patient last visit occurred earlier this week. The Company currently expects to announce topline data from the study in the second quarter of 2020.

“We’re excited to complete our pivotal Phase 3 REST-ON study of FT218 and look forward to announcing the topline data from the study as we move closer toward potentially bringing this new drug to narcolepsy patients. I want to thank our investigators, study staff and patients for their participation in this study, as well as the Avadel team for their continued dedication,” stated Dr. Jordan Dubow, Chief Medical Officer of Avadel.

The REST-ON study is a double-blind, randomized, placebo-controlled Phase 3 trial to assess the efficacy and safety of FT218, a once-nightly formulation of sodium oxybate using Avadel’s proprietary Micropump™ technology for extended-release oral suspension, for the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy. The REST-ON study is under a Special Protocol Assessment agreement with FDA.

Based on the Company’s industry research, it believes FT218, if approved by the FDA, has the potential to provide a valuable advancement in the treatment of both excessive daytime sleepiness and cataplexy for patients with narcolepsy. Currently, the twice-nightly sodium oxybate market is valued at an estimated annualized rate of $1.7 billion¹.

About FT218
FT218 is an investigational, once-nightly formulation of Micropump™ controlled-release (CR) sodium oxybate. The company is currently conducting the REST-ON study, a double-blind, randomized, placebo-controlled Phase 3 trial, to assess the efficacy and safety of FT218 in the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy. FT218 has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of narcolepsy. The designation was granted on the plausible hypothesis that FT218 may be clinically superior to the twice-nightly formulation of sodium oxybate already approved by the FDA for the same indication. In particular, FT218 may be safer due to ramifications associated with the dosing regimen of the previously approved product.

About Avadel Pharmaceuticals plc:
Avadel Pharmaceuticals plc (Nasdaq: AVDL) is an emerging biopharmaceutical company. The Company’s primary focus is the development and potential FDA approval of FT218, which is in a Phase 3 clinical trial for the treatment of narcolepsy patients suffering from excessive daytime sleepiness and cataplexy. In addition, Avadel markets a portfolio of sterile injectable drugs used in the hospital setting. For more information, please visit www.avadel.com.

Gaithersburg, Maryland-based Novavax announced positive topline data from its pivotal Phase III clinical trial of NanoFlu, its seasonal flu vaccine. The primary objectives were non-inferior immunogenicity of NanoFlu compared to Sanofi’s Fluzone Quadrivalent based on several 28-day metrics. Company shares spiked29% at the news.

NanoFlu is a recombinant hemagglutinin (HA) protein nanoparticle flu vaccine. Novavax manufactures it using its Sf9 insect cell baculovirus system. The vaccine nanoparticles are produced in cells originally isolated in the 1970s from the ovaries of the fall armyworm (Spodoptera frugiperda). The Sf9 insect cell line can grow apparently forever when infected with a baculovirus (BV), a virus that only infects insects. And the baculovirus can be engineered to carry one or more foreign genes of interest. As a result, it can be programmed to make the Sf9 cells produced whatever protein or proteins intended that are both folded properly and biologically active.

The vaccine is also developed with the company’s Matrix-M adjuvant, which boosts the immune response of the vaccine, requiring less vaccine to be effective.

The primary objective was non-inferior immune response compared to Fluzone Quadrivalent using a day 28 ratio of geometric mean titers (GMT) and the difference in seroconversion rates (SCR) in addition to the overall safety profile of the vaccine. These are both epidemiological and statistical methods of determining an immune response. Immunogenicity was tested by hemagglutination inhibition (HAI) tests using egg-derived reagents.

NanoFlu hit the primary endpoints, both GMT and SCR, for all four strains used in the vaccine. It was well-tolerated and had a safety profile similar to Fluzone Quadrivalent with what the company calls “a modest increase in local adverse events.”

“With these data, we now have a clear path forward to licensure with our differentiated recombinant influenza vaccine,” said Stanley C. Erck, president and chief executive officer of Novavax. “These strong Phase III results align with and validate our previous clinical trials, in which NanoFlu showed higher HAI antibody responses than the leading flu vaccine for older adults. We expect that both Fast Track designation and the accelerated approval pathway from the FDA will help Novavax bring NanoFlu to market as quickly as possible to address the serious public health threat of influenza.”

Gregory Glenn, president of Novavax’s Research and Development, noted that the company was also happy that the vaccine met or exceeded the secondary endpoints for all four strains used. “NanoFlu demonstrated significant improvement against four drifted H3N2 strains that are co-circulating this year. These data, similar to what was shown in our Phase II clinical trial, demonstrate that NanoFlu overcomes issues related to egg-adaptation and antigenic drift. We extend our sincere appreciation to those who volunteered for this important study and to our clinical partners who worked so quickly and diligently on this trial.”

The trial studied 2,652 older adults at 19 clinical sites in the U.S. The patients received either NanoFlu or the Fluzone Quadrivalent. Both of the vaccines were developed with the four flu strains recommended for the 2019-2020 Northern hemisphere flu season. The patients will be followed for about one year after injection. The primary analysis was at Day 28.

Gilead has said it has stopped accepting “compassionate use” requests for its potential coronavirus antiviral remdesivir because it cannot keep pace with demand as health systems become overwhelmed.

Remdesivir is seen as the best hope in the fight against the COVID-19 coronavirus, at least until a vaccine comes along and several trials are already under way.

But the US pharma said that it is facing huge demand for compassionate use requests for the drug, where the drug is given to severely ill patients as there are no approved treatment options that are effective.

California-based Gilead said there has been an “exponential increase” in compassionate use requests as the SARS-CoV-2 virus spreads across Europe and the US.

As a result this has “flooded” an emergency treatment access system set for very limited access to investigational drugs, and was never intended for use in response to a pandemic.

In response Gilead said it is moving existing individual compassionate use requests to an “expanded access” programme.

This will ensure these requests are met with a similar 72-hour timeframe to the compassionate use requests.

But the company will not accept new compassionate use requests, except for pregnant women and children aged under 18 with confirmed COVID-19 and severe symptoms.

Latest figures from the World Health Organization show the virus is still spreading rapidly throughout Europe and the US.

The data published on Sunday show 53,578 new cases in Italy, with 6,557 new cases, 4,827 deaths, and 795 new deaths.

Spain is badly hit with nearly 25,000 cases, 1,326 deaths, and 324 new deaths. In the US there are 15,219 cases, 201 deaths, but figures show no new cases or new deaths.

In China there are more than 81,000 confirmed cases, with 82 confirmed new cases and six new deaths, with 3,267 total deaths.

Gilead’s share price was down in premarket trading following the news, falling by more than $5, almost 7%, following the announcement.

Medical authorities in China last week said that a similar drug, favipiravir, developed to treat new strains of influenza appeared to be effective in coronavirus patients.

The Guardian reported that Zhang Xinmin, an official at China’s science and technology ministry said favipiravir had produced encouraging outcomes in clinical trials in Wuhan and Shenzhen involving 340 patients.

With the coronavirus pandemic gathering momentum outside China, AstraZeneca has said it will donate 9 million face masks to healthcare workers around the world.

The first shipments of the face masks are already en route to Italy, according to AZ, and other countries will get supplies shortly, with those at greatest need prioritised. The masks will be produced in China, where AZ has a sizeable presence.

The company also says it is making lab resources available to government programmes for screening and diagnosing people, and is testing all employees working in manufacturing and supply chain to make sure access to its medicines continues throughout the crisis.   

Merck & Co meanwhile has agreed to donate half a million masks to front-line responders in New York City – which is fast emerging as the epicentre for the outbreak in the US with almost 15,000 cases at last count and 157 deaths – and Amgen is making $12.5 million in funding available to support COVID-19 relief efforts.

Swiss drugmaker Roche has also said it is ramping up production of its COVID-19 tests, and is also boosting supplies of Actemra (tocilizumab), a drug which has just started phase 3 testing as a treatment for pneumonia in people with the new coronavirus.

New containment measures

A sharp increase in cases to more than 400,000 – and another big rise in Italy which previously appeared to have seen new cases level off – is driving countries to implement more stringent restrictions on the public.

The rapid acceleration of the pandemic is apparent from the fact that it took 67 days for the first 100,000 cases of COVID-19 to be recorded, 11 days for the next 100,000, and four days to reach 300,000.

The latest milestone took just two days to be passed, and 85% of new cases are in Europe and the US.

In the UK – which has just seen its biggest rise in cases and deaths since the start of the outbreak to more than 8,100 and 422, respectively – the government has issued instructions to people not to leave home unless it is absolutely necessary.

The exceptions are to shop for essentials like food, to get exercise (once a day only), for medical reasons and to go to work – only if it is impossible to work from home. Non-essential shops, libraries and other public places will be closed, extending the shutdown of pubs and restaurants last week.

Prime Minister Boris Johnson has intimated that police may be asked to enforce social distancing if the public doesn’t act responsibly, and so far the country hasn’t followed the lead of Italy and France and imposed fines on those who don’t comply.

The UK has also announced a new temporary field hospital based at London’s ExCeL conference centre that will be ready to treat COVID-19 cases from next week.

The NHS Nightingale Hospital, as it will be known, will have two wards, each able to house 2,000 people, and will be operated with the help of the military. Another 250,000 volunteers are being sought to help the NHS cope with the crisis.

The government is however taking some flak from critics – including former Health Secretary Jeremy Hunt – who say the country isn’t carrying out enough diagnostic tests to keep a lid on the spread of coronavirus, and is falling behind other countries like Germany on screening.

Elsewhere, India has imposed a three-week total lockdown on its entire 1.3 billion population after a spike in cases, while Japan has finally decided to formally postpone the Tokyo Olympics until next year, after Canada and Australia both said they would not send athletes if the games went ahead.

Meanwhile, France has said 40% of its intensive care beds are now occupied, and doctors are warning that the healthcare system is at risk of being overwhelmed unless the population adheres strictly to containment measures.