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NEW DELHI: With the aim to reduce dependence on China for import of chemicals, the government is planning a production linked incentive scheme to boost local manufacturing of some of the key chemicals used in pharmaceuticals, insecticides and in other critical industrial usage, sources said.

In a series of recent meetings, the department of chemicals has identified around 75 critical chemicals and more are likely to be added to the list. The proposal for the incentive scheme includes offering 10% of production value as incentive. According to the proposal, the scheme will have an outlay of Rs 25,000 crore over the next five years.

The proposed scheme assumes significance in the wake of the ongoing tension between the two countries — India and China. India imports chemicals worth over Rs 1.5 lakh crore, of which around 85-90% comes from China, an official said. These chemicals are used in manufacturing of active pharmaceutical ingredients, insecticides and other industrial processes.

“Chemicals are essential products used in many industries including medicines. While we have already started a PLI scheme for manufacturing pharma APIs, we realised that there are some key chemicals – which are still being imported from China – for use in manufacturing these APIs. Hence, the need for complete backward integration to ensure we are not dependent on imports,” a senior official said. The department of chemicals has also constituted a committee on the matter and the final proposal for the PLI scheme will be soon submitted to the department of expenditure before taking it to the Cabinet.

Biopharmaceutical company OPKO Health has launched a Phase II clinical trial to assess Rayaldee as a potential treatment for mild to moderate Covid-19.

The drug is an extended-release oral formulation of calcifediol, a prohormone of calcitriol, the active form of vitamin D₃.

Rayaldee is said to be the first and only drug approved by the US Food and Drug Administration (FDA) to increase serum total 25-hydroxyvitamin D (25D) and decrease intact parathyroid hormone (iPTH) levels in blood.

Named REsCue, the randomised, double-blind, placebo-controlled Phase II trial is designed to investigate the safety and efficacy of extended-release capsules of Rayaldee to treat symptomatic Covid-19 patients.

OPKO Health said that the initial sites are primarily in South Florida, the Central Gulf coast, the Midwest and the Southwest. The first participants are set to be enrolled within the coming weeks.

During the study, patients will receive Rayaldee or placebo for four weeks, with two weeks of follow-up. The drug will be given at a 300mcg dose per day on days one, two and three, followed by 60mcg per day on days four to 27.

The primary efficacy endpoints are raising and maintaining serum total 25D within the 50ng/mL to 100ng/mL range and time to the resolution of symptoms.

Secondary endpoints include incidence of emergency room or urgent care visits, oxygen saturation of less than 94%, the need for and duration of hospitalisation, and the need for mechanical ventilation.

In addition, the trial will track mortality rate and severity and duration of illness based on quality-of-life measures.

Eli Lilly has reported positive proof-of-concept results from the BLAZE-1 clinical trial, which assessed SARS-CoV-2 neutralising antibody candidate LY-CoV555, to treat symptomatic Covid-19 in outpatients.

An interim analysis found that the drug candidate decreased rate of hospitalisation.

The study involved recently diagnosed patients with mild to moderate Covid-19 across placebo, 700mg, 2800mg and 7000mg arms.

Lilly added that majority of patients, including those on placebo, had near complete viral clearance by day 11.

Meanwhile, the prespecified endpoint of Covid-19-related hospitalisation or ER visit was demonstrated in 1.7% of patients on Lilly’s drug across dose groups, versus 6% on placebo. This is said to indicate a 72% risk reduction in this population.

Most hospitalisations were in patients who had underlying risk factors such as age or BMI. The company expects to confirm this finding in ongoing studies.

No progression to mechanical ventilation or death was reported across treatment arms.

Furthermore, exploratory analyses revealed a more rapid symptoms improvement in participants treated with LY-CoV555 compared to placebo.

LY-CoV555 was well-tolerated, without any drug-related serious adverse events. Treatment emergent adverse events were observed to be similar across all dose groups and comparable to placebo.

Eli Lilly chief scientific officer Daniel Skovronsky said: “These interim data from the BLAZE-1 trial suggest that LY-CoV555, an antibody specifically directed against SARS-CoV-2, has a direct antiviral effect and may reduce Covid-related hospitalisation.”

The BLAZE-1 trial is ongoing to evaluate LY-CoV555 in combination with LY-CoV016, a second Lilly antibody that binds a different epitope in the SARS-CoV-2 spike region.

Last month, Lilly launched the Phase III BLAZE-2 trial of LY-CoV555 to prevent Covid-19 in residents and staff at long-term care facilities.

Biotechnology firm Vaxart has received clearance from the US Food and Drug Administration (FDA) to conduct a Phase I clinical trial of its Covid-19 vaccine candidate.

The company is developing an oral vaccine to prevent Covid-19. Based on the company’s oral tablet vaccine platform, the candidate is expected to elicit mucosal and systemic immune responses.

Vaxart submitted an investigational new drug (IND) application last month seeking approval for a Phase I trial of the vaccine candidate.

Primary objective is to assess the safety and reactogenicity of two-doses of the vaccine candidate, while secondary objectives include immunogenicity, immune response duration and occurrence of symptomatic Covid-19.

“The IND clearance and the initiation of our Phase I clinical trial moves us a step closer to proving the superiority of our convenient oral Covid-19 solution in the clinic.”

Last month, the company started a SARS-CoV-2 challenge study in hamsters to capture efficacy data and insights into the optimal dose regimen of the Covid-19 vaccine candidate. Results are set to be reported next month.

The company will also report data from a non-human primate (NHP) challenge study, which is being conducted in a harmonized protocol under the US Government’s Operation Warp Speed programme.

Vaxart is performing this preclinical programme in alliance with the Biomedical Advanced Research and Development Authority (BARDA) and other entities that are part of Operation Warp Speed.

Vaxart chief scientific officer Sean Tucker said: “Both hamsters and monkeys are susceptible to SARS-CoV-2 infection and these models may be capable of providing a deeper understanding of the immune responses and correlates of protection elicited by our oral vaccine candidate.”

The company expects that its room-temperature stable vaccine tablet will be easier and cheaper to store and distribute in the US and other international markets.

Imperial College London is set to conduct small clinical trials of inhaled versions of Covid-19 vaccines developed by researchers and the University of Oxford.

The trials, funded by UKRI-NIHR, will test the safety and efficacy of giving the vaccines as airborne droplets inhaled by a participant through the mouth.

The vaccines are currently undergoing clinical trials as intramuscular formulations.

With the inhaled vaccines, direct action on the cells lining the airways is expected to elicit a more effective immune response against the virus. The aim is to stimulate a localised and more specialised immune response.

A total of 30 participants are expected to be enrolled for the trials, with low, medium and high doses of the vaccine being evaluated.

Blood samples will be tested for the presence of neutralising antibodies and T cells, while nasal samples will be checked for the presence of IgA antibodies found in the nose and throat.

Project lead Dr Chris Chiu said: “We have evidence that delivering influenza vaccines via a nasal spray can protect people against flu as well as help to reduce the transmission of the disease.

“We are keen to explore if this may also be the case for SARS-CoV-2 and whether delivering Covid-19 vaccines to the respiratory tract is safe and produces an effective immune response.”

In a separate development, a large-scale randomised clinical trial, RECOVERY, which is led by the University of Oxford in the UK, is set to test Regeneron Pharmaceuticals’ anti-viral antibody cocktail, REGN-COV2, to treat hospitalised Covid-19 patients.

The trial will assess REGN-COV2 plus usual standard-of-care compared to standard-of-care alone in a total of around 4,000 patients. REGN-COV2 is said to be the first specifically designed Covid-19 treatment evaluated by RECOVERY.

In a private call with investors from J.P. Morgan late Wednesday, AstraZeneca Chief Executive Officer Pascal Soriot confirmed that a woman injected with the company’s experimental COVID-19 vaccine candidate developed a serious spinal inflammatory disorder called transverse myelitis.

The trial was paused by the U.K.-based pharma company to assess the illness and determine whether or not the vaccine was the cause. However, during that same call with investors, Soriot said this was not the first time the Phase II/III study had been halted. In July, the study was paused after another patient experienced neurological issues. According to STAT News, which first reported the call, that patients was diagnosed with multiple sclerosis and it was determined the issue had nothing to do with the company’s experimental vaccine treatment. Although STAT did not participate in the call, some who did spoke to the news outlet on condition of anonymity. The sources told the outlet that Soriot wanted to reassure the investors that AstraZeneca is taking every precaution regarding safety with the vaccine candidate.

“A vaccine that nobody wants to take is not very useful,” Soriot was reported as saying during the call.

In a statement released publicly Wednesday, Soriot said the company is putting “science, safety and the interests of society” at the center of its work. He said the temporary pause to the late-stage study is “living proof” the company is following those principles while the Independent Data Monitoring Committee assesses the patient and the potential relationship between the vaccine candidate and the development of transverse myelitis.

“We will be guided by this committee as to when the trials could restart, so that we can continue our work at the earliest opportunity to provide this vaccine broadly, equitably and at no profit during this pandemic,” Soriot said in a statement.

Transverse myelitis is an inflammation of a part of the spinal cord that can lead to pain, muscle weakness, paralysis, sensory problems, or bladder and bowel dysfunction. According to the Mayo Clinic, transverse myelitis can be caused by infections and immune system disorders. The patient who contracted the rare condition, a woman in the United Kingdom, was hospitalized for the illness, but was expected to be released this week, STAT reported.

AstraZeneca launched its Phase III trial in the United States last month. The company hopes to include up to 30,000 patients in the trial. AstraZeneca said it will expedite the review of the patient’s illness to minimize any potential impact on the timeline of the trial.

AstraZeneca’s COVID-19 vaccine candidate AZD1222 is a viral vector-based, weakened version of adenovirus containing the genetic material of SARS-CoV-2 spike protein. It was co-developed with the Jenner Institute at Oxford University. In July, the company published positive Phase I data from its vaccine candidate that showed the preventative medication generated both neutralizing antibodies and immune T-cells that target the virus that causes COVID-19.

If the vaccine makes it through regulatory trials, AstraZeneca plans to manufacture two billion doses of its vaccine, with 400 million slated for the U.S. and UK, and one billion allotted for low- and middle-income countries.

The trial was paused the same day AstraZeneca joined eight other vaccine makers in a pledge to allow science and not political expediency drive the development and potential regulatory authorization of the medication. AstraZeneca, Pfizer, BioNTech, Moderna, GlaxoSmithKline, Sanofi, Novavax, Merck and Johnson & Johnson all agreed to the promise that any vaccine candidate put forward for approval will meet the rigorous standards set forth by regulatory agencies for approval.

The advertising campaign and packaging of the HUL-owned hygiene product, claiming an immunity boosting effect, are misleading and false as a topical application product.

The Drug Controller General of India has issued a show-cause notice to Serum Institute of India for not informing it about pharma giant AstraZeneca pausing the clinical trials of the Oxford Covid vaccine candidate in other countries.

The Drug Controller General of India (DGCI)has issued a showcause notice to vaccine maker Serum Institute of India (SII) after trials of the AstraZeneca Covid vaccine were halted in the UK as a participant felt sick.

Sources confirmed to India Today that the showcause notice was issued to SII as they had not revealed to DGCI the trial outcomes that have led to one participant falling ill in the UK trials of the AstraZeneca vaccine.

SII is the Indian manufacturer of the Covid vaccine developed by the Jenner Institute of Oxford University in collaboration with the British-Swedish pharmaceutical company AstraZeneca. The Oxford Covid vaccine is considered to be the most promising Covid-19 vaccine candidate globally.

The DCGI notice states, SII “has not informed the central licensing authority regarding the pausing of the clinical trial carried out by AstraZeneca in other countries” adding that SII “has not submitted the causal analysis of the reported serious adverse event with the investigational vaccine for the continuation of the Phase 2/3 trial of the subject vaccine in the country in the light of safety concerns”.

The Drugs Controller General of India in the showcause notice has asked SII as to why the permission granted for conducting phase 2 and 3 clinical trials of the vaccine candidate in India should be not suspended till patient safety is established.

Last month, the DCGI had granted permission to the Pune-based SII to conduct Phase 2 and 3 human clinical trials of the coronavirus vaccine candidate with 1,000 participants across 17 hospitals in the country.

“In view of the above, the Drugs Controller General of India and central licensing authority hereby give you an opportunity to show cause as per provided under rule 30 Of the new drugs and clinical trial rules 2019 — Why the permission granted to you on August 2 should not be suspended till patient safety is established,” states the notice accessed by India Today TV.

With trials of the Oxford vaccine trial being halted first in the UK and then in other countries, things are not looking good for the SII in India as well. In the show-cause notice, the drug regulator also mentioned that the clinical trials have been put on hold across countries where it is conducted i.e. USA, UK, Brazil and South Africa.

“The halting of trial in the UK is likely to have an impact on phase 3 trials of the Oxford vaccine in India as well,” said a source in the government.

Therefore, the DGCI is seeking an explanation from the vaccine manufacturing company.

SII SAYS NOT ASKED TO STOP TRIALS, WILL FOLLOW PROTOCOL

Meanwhile, Serum Institute of India (SII), which has partnered with AstraZeneca for manufacturing the Oxford vaccine candidate for Covid-19, on Wednesday said it is continuing with the trials in India.

Releasing a statement on the notice, the Serum Institute of India said, “We are going by DCGI’s direction and so far were not told to pause the trials. If DCGI has any safety concerns, we will follow their instructions and abide by the standard protocols.”

Commenting on the recent reports on AstraZeneca halting the trials in the UK, SII said in a statement: “We can’t comment much on the UK trials, but they have been paused for further review and they hope to restart soon.”

It further said: “As far as Indian trials are concerned, it is continuing and we have faced no issues at all”.

ASTRAZENECA STOPS GLOBAL TRIALS AFTER PATIENT FALLS ILL

AstraZeneca has suspended global trials of its experimental coronavirus vaccine after an unexplained illness in a participant in Britain, casting doubt on prospects for an early rollout.

AstraZeneca said on Tuesday it had paused trials, including late-stage ones, to allow an independent committee to review safety data, and it was working to minimise any potential impact on the timeline.

“It is obviously a challenge to this particular vaccine trial,” Britain’s Health Secretary Matt Hancock told Sky News.

AstraZeneca said a woman in the United Kingdom had symptoms consistent with a rare but serious spinal inflammatory disorder, which led to the British drugmaker’s decision to stop its clinical study of the new coronavirus vaccine, Stat News reported on Wednesday.

“This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials,” the AstraZeneca said in an emailed statement.

A separate report from the Financial Times noted that AstraZeneca could resume trials of its experimental coronavirus vaccine next week.

The stakes are high because AstraZeneca, Britain’s largest drugmaker by market value, has already agreed to supply close to three billion doses to governments across the globe.

he government of Russia has approved a vaccine for COVID-19, marking the first preventative treatment for the novel coronavirus. Despite the approval announcement, there is wide skepticism over how effective the Russian vaccine could be due to its early approval.

Scott Gottlieb, the former commissioner of the U.S. Food and Drug Administration, said on his Twitter account that the Russian medication was approved on what essentially amounts to Phase I data. Gottlieb said it appears the Russian vaccine has only been tested in a few hundred people, as opposed to the tens of thousands of people western pharmaceutical companies, such as AstraZeneca, Pfizer, BioNTech, Moderna and others are including in their ongoing Phase III vaccine programs. Russia said it intends to continue clinical testing, but will go ahead and make the vaccine available.

“I wouldn’t take it, certainly not outside a clinical trial right now,” Gottlieb said on CNBC’s Squawk Box, which he linked to on Twitter. “It’s not clear how efficacious the vaccine will be.”

He likened the Russian vaccine to one under development by China’s CanSino, which he said has not been shown to be effective in clinical studies.

Russia’s vaccine is an adenoviral vector vaccine developed by Moscow’s Gamaleya Institute. The vaccine has been genetically modified to infect cells than make those cells manufacture spike proteins of SARS-CoV-2, the novel virus that causes COVID-19.

Russia’s approval of a vaccine comes less than a month after The New York Timesreported Russia-based hackers were attempting to steal COVID-19 vaccine research from universities, pharmaceutical companies and other healthcare organizations. U.S. intelligence officials said the Russians were aiming to steal research to develop their own vaccine more quickly, the Times reported.

Russia had its vaccine in clinical testing for about two months before it approved the medication, Reuters reported this morning. The news wire said the Russian government hailed that rapid approval as “evidence of its scientific prowess.” The vaccine has been dubbed Sputnik V and will be available for global markets later this year. The Russian government said it has already received requests from foreign governments for 1 billion doses.

Without large-scale clinical testing there are safety concerns alongside efficacy concerns regarding the Russian vaccine. This morning, Russian President Vladimir Putin dismissed those concerns. Speaking on Russian television, he said the vaccine was safe and had been given to one of his daughters, Reuters reported. As BioSpace previously reported, the Gamaleya Institute’s director, Aleksandr Gintsberg, announced on television in May that he had been dosed by the vaccine before announcing the completion of monkey trials. The Russian government has not shared clinical data from its vaccine program, so there is little proof of its efficacy.

“I know that it works quite effectively, forms strong immunity, and I repeat, it has passed all the needed checks,” Putin said, according to the report.

Mass production of the vaccine will begin soon, the Russian government said.

Despite Putin’s assurances, Russia’s Association of Clinical Trials Organizations, a trade organization representing pharmaceutical companies conducting business in that country, raised concerns about the rapid approval of the vaccine. The association urged a delay of approval until a Phase III trial could be completed.

“It is during this phase that the main evidence of a vaccine’s efficacy is collected, as well as information on adverse reactions that could appear in certain groups of patients: people with weakened immunity, people with concomitant diseases and so forth,” the organization said, according to Reuters.

As we head into cold and flu season, the question arises: Can you get COVID-19 and the flu at the same time?

The short answer is: maybe.

There have been some cases reported around the world of people who tested positive for both COVID-19 and an influenza virus, but the reports are in the dozens, whereas more than 26 million people globally have tested positive for SARS-CoV-2, the virus that causes COVID-19.

“It is quite possible and likely that the two viruses could infect a patient at the same time or, for that matter, sequentially: one month, one virus, and the next month, the other virus,” Michael Matthway, professor of medicine at the University of California, San Francisco, told NPR. “It’s likely with both viruses at the same time, the severity of respiratory failure would be greater. Or, of course, having two illnesses in a row that affected the lungs would make the respiratory failure more severe.”

But, in fact, nobody really knows. Co-infections are common in respiratory viruses, but the research into co-infections around SARS-CoV-2 is only beginning. However, one study published in JAMA evaluated positive COVID-19 patients and found that about 20% also tested positive for at least one other respiratory virus. Those viruses include rhinovirus, which causes the common cold, and respiratory syncytial virus (RSV), a more serious infection.

But it’s not as simple as having two viral infections at the same time—although sometimes it can be. In some cases, a second virus may not do anything, or it could make the illness more severe. It might also have a short-term protective effect.

Helen Chu, an associate professor of medicine at the University of Washington in Seattle, told NPR it wasn’t clear if rhinovirus makes the flu worse. “But for a lot of the other viruses that are known causes of disease like parainfluenza virus and human metapneumovirus and human coronavirus, those can work with flu and cause you to have more severe disease.”

But Sarah Meskill, an assistant professor of pediatrics and emergency medicine atBaylor College of Medicine in Houston, notes that “There are many studies all over the map.” But her gut feeling is that “we’re going to see co-infections; we are going to see patients positive for both” flu virus and the coronavirus.

As it turns out, Swiss-based Roche announced today that the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for a diagnostic test to quickly identify whether a patient has COVID-19 or one or two flu viruses.

“With the approaching flu season, this new test is particularly important as SARS-COV-2 and influenza infections can hardly be differentiated by symptoms alone,” said Roche’s diagnostic head, Thomas Schinecker. “Now, with a single test, healthcare professionals can confidently provide the right diagnosis and most effective treatment plan for their patients.”

On the positive side, while flu season is just beginning in the Northern Hemisphere, it is just ending in the Southern Hemisphere. Public health authorities observed fairly little influenza in the Southern Hemisphere this year, probably, they say, because of travel restrictions, social distancing and mask-wearing.

And Chu, who has been tracking viral infections in Seattle, noted that, “There’s really no transmission of these other viruses going on in the community right now. That is what we are seeing in Seattle.”

Which doesn’t mean the flu isn’t there or won’t be. The flu vaccinations are already available and are generally recommended, particularly to avoid the double-threat of flu and COVID-19.