Coronavirus Vaccine Update
The race for a coronavirus vaccine is continuing at break neck pace as cases mount across the world.
According to the World Health Organisation (WHO), there are 16 vaccine candidates currently in late-stage clinical trials among the 140 vaccines in different stages of development to fight COVID-19.
Of these 16 vaccine candidates, five are being researched in China, three in the US, two in the UK, and one each in Australia, Germany, and Russia.
But the big question is how far away is coronavirus vaccine? And what's the status of trials?
While many scientists and researchers anticipate that a safe and effective vaccine may take 12-18 months to develop, several others believe that if a medicine is formulated before the end of the year, it would be the fastest vaccine development in the world.
With the news of the Oxford University-AstraZeneca vaccine in its last-stage trial, the world is hopeful of an earlier than expected arrival of a COVID-19 vaccine.
Here are the latest developments on COVID-19 vaccine trials:-
1. Oxford University-AstraZeneca vaccine
According to the latest reports, the Oxford University-AstraZeneca vaccine candidate has emerged as a frontrunner in the race to find an effective cure for coronavirus. The British drugmaker has already started conducting phase III human trials of its AZD1222 (formerly known as ChAdOx1 nCoV-19) vaccine candidate. Around 800 people will be administered the vaccine. The developers have inked a deal to manufacture 10 crore doses of the vaccine. Brazil announced on Saturday that it had signed a $127 million deal to locally produce the Oxford-AstraZeneca vaccine.
2. Moderna coronavirus vaccine
American biotech company Moderna, which has begun phase II trials for its vaccine candidate mRNA-1273, has collaborated with drugmaker Catalent Inc to manufacture 100 million doses starting in the third quarter of 2020. Final-stage trials of the Moderna vaccine are all set to begin in July, with tests slated to be conducted on 30,000 people.
3. CanSino vaccine
China's military has received greenlight to use a COVID-19 vaccine candidate developed by its research unit and CanSino Biologics after clinical trials proved it was safe and somewhat efficient, the company said on Monday. The Ad5-nCoV is one of the eight vaccine candidates being developed by Chinese companies and researchers approved to be moved into human trials. The shot also won approval for human testing in Canada. China's Central Military Commission approved the use of the vaccine by the military on June 25 for a period of one year, CanSino said in a filing. The vaccine candidate was developed jointly by CanSino and the Beijing Institute of Biotechnology in the Academy of Military Medical Sciences.
4. Sanofi-GSK coronavirus vaccine
French pharma major Sanofi, which has developed a COVID-19 vaccine candidate with GlaxoSmithKline (GSK), recently announced that it plans to start phase 1 of its clinical trial by the end of the year. If the first stage results turnout to be positive, the company will also get the approval for mass production in the second half of 2021. Sanofi is using one of GSK's proprietary additives, a compound that drives the immune response, with this vaccine. The French drugmaker plans to manufacture 10 crore doses in 2020 and another 100 crore in 2021.
Sanofi also announced that it will invest $425 million in US start-up Translate Bio to broaden its vaccine development venture.
5. BNTECH-Pfizer vaccine
German company BNTECH has tied up with US-based drugmaker Pfizer for developing a COVID-19 vaccine. Their vaccine candidate is based on messenger RNA technology, similar to Moderna. Tests for the same are being conducted on volunteers in Germany and the US. The vaccine is in phase one of its clinical trials with the first set of results likely in the coming weeks. Pfizer expects to start commercial production of vaccine by October 2020.
6. Novavax vaccine
American vaccine development company Novavax is carrying out human trials of its protein-based NVX-CoV2373 candidate vaccine in Australia. The results are expected by July. Novavax plans to manufacture 10 crore doses by this year and 150 crore in 2021.
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Rs 2,000 crore from PM CARES Fund to be spent on 50,0000 ventilators for COVID-19 patients
The centre has allocated Rs 2,000 crore from the PM CARES Fund for manufacturing and supplying 50,000 'Made-in-India' ventilators to government-run COVID-19 hospitals. The order has been divided among several manufacturers across India. The government has also announced that Rs 1,000 crore have been allocated for the welfare of migrant labourers who had suffered immensely during the COVID-19 lockdown.
According to a government statement, "Out of the 50,000 ventilators, 30,000 ventilators are being manufactured by M/s Bharat Electronics Limited. The remaining 20,000 ventilators are being manufactured by AgVa Healthcare (10000), AMTZ Basic (5650), AMTZ High End (4000) and Allied Medical (350)."
As per the statement, 2,923 ventilators have already been manufactured out of which 1,340 have already been shipped out to different government hospitals in different states and Union Territories. "The prominent recipients include Maharashtra (275), Delhi (275),
Gujarat (175), Bihar (100), Karnataka (90), Rajasthan (75). By the end of June 2020, additional 14,000 ventilators will be delivered to all States/UTs.", according to the government statement.
The government also says that it has already distributed Rs 1,000 crore amongst all states and UTs for the welfare of migrant labourers. The funds have been distributed based on the formula "of 50% weightage for the population as per 2011 census, 40% weightage
for the number of positive COVID-19 cases and 10% for equal distribution among all the States/UTs."
The funds provided to the states/UTs will be used for arranging accommodation, food, medical treatment if required and transportation for the migrant labourers. "The main recipients of the grant are Maharashtra (Rs 181 cr), Uttar Pradesh (Rs 103 cr), Tamil Nadu (Rs 83 cr), Gujarat ( Rs 66 cr), Delhi (Rs 55 cr), West Bengal (Rs 53 cr), Bihar (Rs 51 cr), Madhya Pradesh (Rs 50 cr), Rajasthan (Rs 50 cr) and Karnataka (Rs 34 cr)", according to the government statement.
Baba Ramdev's Patanjali launches India's 'first Ayurvedic' medicine for coronavirus, Coronil
Baba Ramdev's herbal medicine company Patanjali Ayurved, on Tuesday, launched 'Coronil and Swasari' medicine to treat coronavirus patients. "We are launching COVID medicines Coronil and Swasari today", the yoga guru said in a press conference in Haridwar today.
Baba Ramdev claimed that his ayurvedic drugs have shown 100 per cent favourable results during the clinical trial. During the launch, Baba Ramdev said, " The whole country and the world was waiting for the medicine or vaccine of coronavirus. We are proud to announce that the first ayurvedic, clinically controlled trial based evidence and research-based medicine has been prepared by the combined efforts Patanjali Research Centre and National Institute of Medical Sciences (NIMS)".
Baba Ramdev added that his company Patanjali had conducted two trials of Coronil and Swasari. First, a clinical-controlled study, which took place in different cities, including Delhi, and Ahmedabad. "We conducted a clinical case study and clinical controlled trial, and found 69 per cent patients recovered in 3 days and 100 patients recovered in 7 days," Ramdev added.
During the press conference on Tuesday, Baba Ramdev thanked the director of NIMS, Dr Balbir Singh Tomar and all the doctors and scientists who were part of this project in creating anti-corona drug.
In India, drugs like Dexamethasone, Remdesivir, Fabiflu, and Hydroxychloroquine are some of the known drugs that doctors are using in the treatment of coronavirus patients.
Coronavirus: Glenmark conducts Fabiflu trial on 1,000 patients; to compete with Gilead's Remdesivir
Drug major Glenmark Pharmaceuticals, the first Indian company to commercially launch antiviral drug Favipiravir with brand name FabiFlu, is conducting a large study involving 1,000 patients to prove the drug's efficacy in coronavirus treatment.
"We are not in a hurry to rollout and want to doubly ensure its safety and efficacy before big launch. We are conducting a 1,000 patient study across India and the results will be available in the next two--three weeks. Trial batch production was started last week and big rollout will happen depending on the results," a top level Glenmark executive told Business Today on condition of anonymity.
The company is also hopeful of supplying the drug globally after the survey. The executive said the company has created adequate end to end domestic manufacturing capacity from raw materials to finished formulations. Capacity will not be a constraint to supplying the drug globally, according to the executive.
Currently, the US-based Gilead Life Sciences' Remedesivir is the only other drug allowed as emergency drug in many countries for coronavirus treatment. Glenmark is planning to take on Remdesivir with FabiFlu. While Glenmark has priced FabiFlu at Rs 3,500 for a pack of 34 tablets (Rs 103 per tablet), Glilead's injection is likely to be priced in the range of Rs 3,000 to Rs 5,000 per dose by licensed Indian manufacturers like Cipla and Hetero Drugs. The patient requires 5 to 6 doses. So the total treatment could cost anywhere between Rs 15,000 to Rs 36,000 in India with Remdesivir, say sources.
On Saturday, Glenmark announced the launch of the drug in India at Rs 103 a tablet, following the approval from Drug Controller General of India (DCGI) through a fast track approval process. The approval was based on a 150 patient clinical trial in India and 18 global clinical trials involving 3,000 subjects in India, US, Canada, Italy, China, France, UK and other countries.
Favipiravir, sold under the brand name Avigan by Fujifilm Toyama Chemical, has been used in Japan since 2014 for influenza treatment. It is already commercially used in therapeutic management of coronavirus in Bangladesh and UAE. Russia launched it on Saturday and Japan is awaiting a large trial data result. A Russian study on 390 patients found 80 percent plus success rate, while a trial among 2,141 patients in Japan saw 88 percent success rate. The trials so far claim the drug has a success rate of 80 to 88 percent.
Meanwhile, patent experts say Favipiravir main compound has no patent protection in India and Indian companies are free to make it. Favipiravir 200 mg patent in India (IN/PCT/2001/144/KOL) and its use as antiviral for the main compound expired on 18 August 2019. Another patent application for Favipiravir tablet or granulated powder compositions in India (IN6955/DELNP/2011) was filed in 2011 and the application was rejected later by the Indian patent office. "Its patent is not enforceable in India and the company Fujifilm Toyama Chemical is not a full fledged drug maker to aggressively pursue even if it had the rights," said Gopakumar G Nair, founder and CEO of Patent Gurukul and Gopakumar Nair Associates.
Companies like Strides Pharma, Mangalam Drugs, Brinton Pharmaceuticals, Lasa Supergenerics and Optimus Pharma are among the companies preparing for launch in India. "While Glenmark and Strides have both manufacturing and marketing scale to make and distribute the drug globally, rest of the companies are either API makers or lack marketing network to take the formulations globally", say sources.
Coronavirus vaccine: When will it be ready? Moderna, AstraZeneca offer answers
The search for a coronavirus vaccine has reached its zenith. While some researchers have progressed to advanced stages of trials, some have already put out a time frame for the release of the corona vaccine. World Health Organisation expects nearly 2 billion doses of COVID-19 vaccine to be ready by the end of next year. Moderna, one of the leading contenders for the coronavirus vaccine said that there's a high probability of their candidate reaching the distribution stage in 2021. Germany's CureVac AG is also aiming for mid-2021 release of its coronavirus vaccine candidate.
Here's the latest updates on coronavirus vaccine research and development:
WHO Chief Scientist Dr Soumya Swaminathan said that she expects nearly 2 billion doses of a COVID vaccine by the end of next year. "At the moment we do not have a proven vaccine but if we are lucky, there will be one of two successful candidates before the end of this year and 2 billion doses by the end of next year," she said while addressing the media from Geneva. There are currently over 100 vaccines under trial.
Moderna is preparing to launch Phase 3 of the trials in July. CEO Stephane Bancel said that there was a high probability that the company's product could reach the distribution stage in 2021. Bancel said that they are anticipating the efficacy data to be out by Thanksgiving. Moderna is aiming to recruit 30,000 people for its Phase 3 of trials. "We are very, very interested in knowing as much as we can about this vaccine and to ensure it is safe," he said. Bancel said that the company has worked upon several vaccines over the years that helped in speeding up their process. "This was actually the 10th vaccine that we put in clinical trial. We've learned a lot over the years: how to optimise the manufacturing process, how to optimise your chemistry, to get the best vaccine we could," said the CEO.
AstraZeneca that is producing the corona vaccine candidate developed by Oxford University said that they could deliver the candidate by October if everything goes well. AstraZeneca CEO Pascal Soriot said that their potential COVID-19 vaccine candidate is likely to provide protection for a year. "We think that it will protect for about a year," Soriot said. The company has already started human trials.
Germany's CureVac AG has said that if approved, their coronavirus vaccine candidate could be on the market by mid-2021. Klaus Cichutek, President of German vaccine regulator PEI said that the company might be able to apply for approval by early 2021. The company has received approval from the government to conduct trials on 168 health people.
Imperial College London that is conducting human clinical trials of the coronavirus vaccine hopes to have a viable candidate by April 2021. The human trials of the corona vaccine candidate will reveal its efficacy and safety. "From a scientific perspective, new technologies mean we have been able to get moving on a potential vaccine with unprecedented speed. We've been able to produce a vaccine from scratch and take it to human trials in just a few months - from code to candidate - which has never been done before with this type of vaccine," said Professor Robin Shattock from the Department of Infectious Disease at Imperial College.