Pharmaceutical Industry News

New Delhi: For every positive COVID-19 test more than 20 negative tests have been done, the ICMR has said, asserting there has been a 1,000-fold increase in the quantum of tests per day in the last two months.

A total of 25,12,388 samples had been tested by 9 am of May 20, and the testing capacity has been scaled up to 1 lakh tests per day, it said.

Starting with less than 100 COVID-19 tests per day just two months ago, a 1000-fold increase in just 60 days was made possible by dedicated teams from research institutions, medical colleges, testing laboratories, ministries, airlines and postal services working together, the Indian Council of Medical Research (ICMR) said in a statement.

In January, India had only one laboratory testing for COVID-19, at the Indian Council of Medical Research’s National Institute of Virology, Pune. “Today there are 555 laboratories across the country, performing molecular tests for diagnosis of COVID-19 – an unparalleled achievement in the history of the Indian health system,” the apex health research body said.

Faced with an unprecedented challenge, both in terms of technicalities and scale, Indian scientists had to innovate extensively, health workers had to train and learn on the job, administrators had to coordinate multiple actions round the clock amid the challenges of a nationwide lockdown.

In the absence of an effective treatment, prevention is the best strategy, which revolves around testing. In a diverse country like India, for inclusive and equitable access to testing, optimization of resources, based on the evolving epidemic was an essential part of sustainable scaling up.

“As the epidemic evolved, India’s testing strategy underwent iterative calibration to keep pace with the changing epidemiology and extent of infection. This ensured that access to tests was assured for risk groups that needed it the most; wasteful, unnecessary testing was avoided; and testing infrastructure was optimally scaled up without taking away resources from other key public health interventions,” the ICMR said.

This is evidenced by the fact that for every positive test more than 20 negative tests have been done throughout the course of the epidemic, it said.

“With its testing capabilities now matching the most advanced countries in the world, Indian institutions have risen to the occasion in an emergency situation. In the days ahead their contributions will be required even more as India continues to grapple with the clear and present danger still posed by COVID-19,” it said.

Wipro founder-chairman Azim Premji, among the world’s most generous billionaires, is an investor in Moderna, the US-based biotech company, that has emerged a front-runner to make a vaccine to fight the novel coronavirus, according to sources familiar with the development.

The investment happened via PremjiInvest, his private investment arm which manages billions of dollars in assets and is among the biggest family offices in India.

The investment was in the range of $25-$30 million and was done a few years ago. While the fund sold some of its holding, it still has some left.

“Premji Invest has been consciously looking at firms that work in the area of low-cost immunity, care and delivery. It has invested in 5 such firms in the US. They have a full-fledged team looking at this area. The investment in Moderna was done by their Boston team, which has a lot of technical expertise in this area,” a person familiar with the investment told ET now.

While PremjiInvest declined to comment, ET NOW is awaiting comments from Moderna.

Moderna has raised hopes globally after its experimental vaccine showed signs that it can create an immune system response to fight the coronavirus. Its vaccine works by using messenger RNA or mRNA. Unlike a normal vaccine, RNA vaccines work by introducing an mRNA molecule coded to produce disease-specific antigens.

An early human trial on 45 patients showed that eight people who were injected with the mRNA produced antibodies similar to those in recovered patients. Moderna said the mRNA-1273 was generally safe and well-tolerated.

At the same time, medical publication Stat News reported that vaccine experts were sceptical as the company is yet to release significant data to support its claim.

The company now plans to go ahead with phase 2 and a phase 3 stage. It also announced plans to raise $1.34 Billion through a public stock offering to make and distribute its mRNA-1273 vaccine. Sources said the fund has no plans for a follow on investment.

“More money won’t go into Moderna. The fund is now evaluating opportunities in China and Israel. What attracted the team to Moderna was the work it did on Zika and Nipah, building out a vaccine platform. The fact that MIT’s noted professor and inventor Robert Langer was an early investor was also a big factor,” a source said.

Robert Langer is one of the most cited researchers in biotechnology and his lab at MIT is the largest biomedical engineering lab in the world. He’s founded over 30 biotech companies and was one of the founding investors of Moderna in 2010, where he still holds over 3%.

While Azim Premji began the investment fund in 2006, to distinguish it from his philanthropy(Azim Premji Foundation) and core IT business Wipro, he merged his investment arm with the Foundation in 2018, in a move professor and inventor Robert Langer was an early investor was also a big factor,” a source said.

It is a large investor in publicly traded companies such as Jubilant Foodworks, Marico and HDFC. According to Venture Intelligence, PremjiInvest itself has made 5 publicly disclosed investments (17% of its overall portfolio) in the Healthcare space: cancer care chain HCG; Koye Pharmaceuticals; publicly listed Zydus Wellness (along with PE firm TrueNorth) and US-based health services firms Iora Health and Devoted Health.

New Delhi: The All India Institute of Medical Sciences (AIIMS) is set to study how long coronavirus can remain in the body and whether dead bodies of Covid-19 patients transmit infection, as it plans to conduct the first ever autopsy soon on the body of a person who died of coronavirus.

“We are coordinating for medical research autopsy. The clinical findings of the case along with various laboratory reports and imaginings will have to be studied before we conduct a autopsy,” said Dr Sudhir Gupta, head of department of forensic medicine and toxicology, AIIMS.

The findings are crucial as the paranoia that surrounds handling the body is disturbing and will clear the air, said Gupta. “There are restrictions for the relatives to abide. The dead body is given in a plastic bag.

Once we know the behaviour of Covid-19 infection in the body, we will be able to put to rest many such questions,” he said.

So far, the limited studies conducted around the world on patients who died due to Covid-19 indicate that the disease damages organs such as heart, liver, kidney, brain and blood vessels.

India has decided that invasive technique should not be adopted for forensic autopsy in Covid-19 death cases as mortuary staff are exposed to potentially dangerous health risks due to organ fluids and secretions even after taking the highest precautions, say the new Standard Guidelines for Medicolegal autopsy in Covid-19 deaths in India by the Indian Council of Medical Research (ICMR).

The guidelines suggest that a dedicated core research group be created comprising specialists from pathology, microbiology, biomedical research, anatomy, forensic medicine and other interested clinical departments to assess resources, feasibility, infrastructure, identifying research objectives, establishing biosafety laboratories and determining ethical aspect.

According to the guidelines, an informed consent and other ethical aspects such as confidentiality and religious sentiments should be addressed as per the specific objectives and methodology of the study while conducting the autopsy.

“The research study would be conducted after the proper ethical clearance from respective institute and as per the established research guidelines of ICMR and other health authorities,” say the guidelines. The guidelines recommend that autopsy dissection procedure be strictly limited to what is necessary for the research work concerned.

Washington: US biotech firm Moderna reported promising early results on Monday from the first clinical tests of an experimental vaccine against the novel coronavirus performed on a small number of volunteers.

The Cambridge, Massachusetts-based company said the vaccine candidate, mRNA-1273, appeared to produce an immune response in eight people who received it similar to that seen in people convalescing from the virus.

“These interim Phase 1 data, while early, demonstrate that vaccination with mRNA-1273 elicits an immune response of the magnitude caused by natural infection,” said Moderna’s chief medical officer Tal Zaks.

“These data substantiate our belief that mRNA-1273 has the potential to prevent COVID-19 disease and advance our ability to select a dose for pivotal trials,” Zaks said.

President Donald Trump welcomed the news saying “it’s incredible what they can do and I’ve seen results.

“And the results are staggeringly good,” Trump told reporters. “So I’m very happy and the market’s up very big.”

Wall Street stocks posted substantial gains on Monday with the Dow Jones Industrial Average adding 3.85 percent and the S&P 500 up 3.15 percent.

Moderna shares gained 19.96 percent to close at $80.00 in New York.

Moderna, which was founded nine years ago, said the vaccine “was generally safe and well tolerated” and that patients suffered no more than redness or soreness from the shots.

In a conference call, Moderna chief executive Stephane Bancel said the preliminary tests inspired confidence that mRNA-1273 has “a high probability to provide protection” against the virus.

The US government has invested nearly half a billion dollars in the development of Moderna’s vaccine candidate.

It is being developed in a partnership with the National Institute of Allergy and Infectious Disease headed by Anthony Fauci and the clinical test was carried out by the National Institutes of Health.

– ‘As fast as safely possible’ – Three groups of 15 patients aged 18 to 55 received three different doses of the vaccine in the Phase 1 test, the complete results of which are not yet known.

“We could not be happier about these interim data,” Bancel said of the Phase 1 test, the first of three in the development of a vaccine.

Separate tests performed on mice showed that the vaccine prevented the virus from replicating in their lungs, according to the company.

The Phase 2 trial, with 600 subjects, has already received the green light from the US Food and Drug Administration and Moderna said they should begin this quarter.

A Phase 3 trial, the largest and most important to validate the efficacy of a vaccine, should begin in July.

“The Moderna team continues to focus on moving as fast as safely possible to start our pivotal Phase 3 study in July,” said Bancel, Moderna’s CEO.

Based on the Phase 1 partial results, Moderna said they would no longer study the highest dose since the lower doses appeared to provide some effect.

“The lower the dose, the more people we expect to be able to protect,” said Moderna president Stephen Hoge.

Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine, said that while it was difficult to be sure of the results “from a press release,” there was reason for optimism.

“It must be noted that this is a Phase 1 study which has an object of showing the vaccine is able to induce an antibody response and that the dose range is appropriate,” Evans said.

“It will not be until the Phase 3 trial is completed that it will be known whether the vaccine actually prevents COVID-19 disease,” he added.

Trump has said he wants 300 million vaccine doses by January 2021 to protect the US population and his administration has provided funding to Moderna, Johnson & Johnson, and France’s Sanofi.

NEW DELHI: Industrial and automotive supplier Schaeffler IndiaNSE 0.11 % on Monday shared details of the company’s contribution towards fighting the ongoing COVID-19 pandemic. Schaeffler India took two initiatives in joining the support – procurement of emergency health equipment for a government run hospital in Pune and voluntary donation of a part of salaries by employees, with the company matching an equivalent amount, according to a release.

Schaeffler procured and donated emergency medical equipment and essentials for a government run hospital (Aundh hospital) in Pune city. The Aundh Hospital that specializes in treating of diseases related to the respiratory system has been identified as a dedicated COVID-19 hospital by the ministry. It is a 300-bed facility, with allocation of 50-beds to their isolation ward to treat COVID 19 patients and 10 beds to the ICU facility. The equipment and essentials provided by Schaeffler India have improved its capacity to fight against COVID 19 pandemic and treatment of patients.

In addition, employees voluntarily donated a part of their April salaries, while the company matched the amount to contribute to PM Cares fund set up by the government. The total amount contributed by employees and the company was Rs 12.70 million.

Santanu Ghoshal, VP – HR and CSR, Schaeffler India said, “These are difficult times and its heart wrenching to think of the daily wage earners and their plight. We were determined to contribute to the PM Care Fund as an organization. I am happy to see that each and every employee of Schaeffler India has come forward to contribute to the fund and together as an organization we have been able to support the government initiative.”

Schaeffler India has been reaching out far and wide to contribute to human progress and positively touch the lives of the surrounding communities through their flagship CSR initiative called HOPE, which stands for Healthcare, Occupation Skills for Employability, Preservation of National Heritage, Art and Culture and Empowerment of Society.

Revising its strategy for COVID-19 testing, ICMR said on Monday that returnees and migrants who show symptoms for influenza-like illness will be tested for coronavirus infection within seven days of ailment and stressed that no emergency clinical procedure, including deliveries, should be delayed for lack of testing. The Indian Council of Medical Research (ICMR) in its revised strategy for coronavirus testing in India also added that all hospitalised patients who develop symptoms for influenza-like illness (ILI) and frontline workers involved in containment and mitigation of COVID-19 having such signs will also be tested for coronavirus infection through RT-PCR test.

Besides, asymptomatic direct and high-risk contacts of a confirmed case are to be tested once between day five and day 10 of coming in contact, the new document stated. Asymptomatic contacts of a confirmed case were being tested once between day five and day 14.

An official said, “The apex body for health research revised its strategy in view of a spurt in coronavirus cases in the country. The new strategy aims to contain the spread of infection more effectively and to provide reliable diagnosis to all individuals meeting the inclusion criteria of COVID-19 testing.”

The death toll due to COVID-19 rose to 3,029 and the number of cases climbed to 96,169 on Monday, registering an increase of 157 deaths and a record jump of 5,242 cases in 24 hours since sunday 8 am.

“ILI case is defined as one with acute respiratory infection with fever more than or equal to 38 degrees Celsius and cough while a SARI case is defined as one with acute respiratory infection with fever more than or equal to 38 degrees Celsius and cough and requiring hospitalisation,” the ICMR stated.

Till now, people with ILI symptoms living within hotspots or containment zones, patients of severe acute respiratory infection (SARI) and symptomatic healthcare workers were being tested for coronavirus infection as per the guidelines.

All asymptomatic individuals with a history of international travel in the last 14 days and all symptomatic contacts of laboratory-confirmed case were also being tested.

“No emergency procedure (including deliveries) should be delayed for lack of test,” the ICMR said, adding all testing in the categories is recommended by real time RT-PCR test only.