Coronavirus vaccine update: Importance of Covid-19 drug, current status

Large pharmaceutical companies globally, such as Gilead Sciences, Pfizer and Moderna, are racing to find a successful Covid-19 vaccine
Less than six months after the world first learnt about the novel coronavirus (SARS-CoV 2) in Wuhan, China, there currently are more than 110 teams in contention, speeding up efforts to produce a ready vaccine. A lot of vaccines are in the development phase in India as well, and medicinal trials are also going on for treatment. The reason behind the rush is a staggering number of Covid-19 cases (past 6 million) and death toll (more than 350,000 globally). In India alone, there are 151,876 corona cases as of May 27. Large pharmaceutical companies such as Gilead Sciences, Pfizer, Moderna, among others, are racing to find a successful vaccine. In India, Ramdev's Patanjali has also joined the race to develop coronavirus vaccine.

How soon can the world expect a Covid-19 vaccine?

A vaccine would normally take years, if not decades, to develop. But in this case, researchers hope to achieve the same amount of work in just a few months. Most experts think a vaccine is likely to become available by mid-2021.

Why is a coronavirus vaccine important?

The virus spreads easily and a majority of the world's population is still vulnerable to it. A vaccine would provide some protection by training people's immune systems to fight the virus so that they do not get sick.

This would allow lockdowns to be lifted more safely, and social distancing to be relaxed.

Here are some updates on coronavirus vaccine development:

1. Moderna's RNA vaccine status

Moderna's RNA vaccine is among the top front-runners in the race. It set to move into the second phase of the clinical trials in July. The company, which makes use of a novel mRNA sequence fights the infected proteins and carries instructions to the body to deploy necessary antibodies to fight against the infection. Doubts overt Moderna's vaccine emerged after a volunteer told a news channel that he started getting chills within hours of getting home from his second dose and had nausea and aching muscles. He said he had received the highest dose from the trials — one 10 times stronger than others. However, he maintained that as sick as he was, it was never “life-threatening”, according to report in The New York Post.

2. China's Sinovac 99% sure of vaccine efficacy

Chinese biopharmaceutical company Sinovac Biotech has said that it is 99% sure that their COVID-19 vaccine will work.

The company reached stage 2 of the coronavirus vaccine trial with more than 1000 volunteers participating. The company is in preliminary talks to hold stage 3 trials - the final part of the process in the UK.

3. Novavax Covid 19 vaccine status

Named NVX-CoV2373, Novavax’s vaccine is created using recombinant protein nanoparticle technology — a genetic-engineering technology. This technology is reportedly already being used against viruses that cause Hepatitis B and shingles.

On May 25, the US-based vaccine development company announced in a press release that it had begun Phase I/II trial of its Covid-19 vaccine candidate in Australia.

A total of 131 volunteers in the age group of 18-59 years will be enrolled in Phase-1 trial at two different sites in Australia. The trial will test two different doses (5 and 25 mcg) with and without the adjuvant. The placebo group will get a saline solution.

The preliminary results of Phase-1 trial are expected in July 2020, after which Phase-II trials will begin in multiple countries, including the US. In the meantime, Novavax has bought Czech Republic-based Praha Vaccines, a unit of India’s Cyrus Poonawalla Group, which also owns Serum Institute, for $167 million.

4. Lilly, Junshi Biosciences coronavirus vaccine update

Shanghai Junshi Biosciences Co Ltd plans to start clinical studies to test its experimental antibody against corona in the United States and China in the second quarter of the year, with partner Eli Lilly and Co. Junshi said the companies intended to file an application to begin human testing of one of their two antibodies — protective proteins produced in response to infection — tested first in rhesus monkeys.

Shanghai Junshi said results from the preclinical studies, published in the science journal Nature, revealed that both the tested antibodies, called CA1 and CB6, showed substantial neutralisation activity against the virus.

5. Oxford University Covid-19 vaccine status

ChAdOx1 nCoV-19 is made from a virus (ChAdOx1), which is a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees, that has been genetically changed so that it is impossible for it to replicate in humans.

The Phase-I trial in healthy adult volunteers began in April. More than 1,000 immunisations have been completed and follow-up is currently ongoing.

The next study will enrol up to 10,260 adults and children and will involve a number of partner institutions.

While explaining when the results of the trial will be available, the university said that to assess whether the vaccine worked to protect from Covid-19, the statisticians in the team would compare the number of infections in the control group with the number of infections in the vaccinated group.

For this purpose, it is necessary for a small number of study participants to develop Covid-19.

Drugmaker AstraZeneca has finalised its licence agreement with Oxford University for the recombinant adenovirus vaccine.

6. Pfizer-BNTECH vaccine update

Pfizer CEO claims coronavirus vaccine could be ready by October end

The pharmaceutical giant, which is co-producing the vaccine with the help of a German company, BNTECH has started the process of dosing patients. Four vaccine candidates devised out of messenger RNA (mRNA) format are being tested on volunteers to identify the most viable and suited vaccine of the four. The data is being shared with scientists in real-time. The tests are currently going on in Germany and parts of the USA.

Pfizer believes that a Covid-19 vaccine could be ready by the end of October 2020, reported The Times of Israel, citing Albert Bourla, the CEO of the firm.

“If things go well, and the stars are aligned, we will have enough evidence of safety and efficacy so that we can… have a vaccine around the end of October,” Bourla was quoted as saying in the report.

Coronavirus vaccine progress in India

7. Ramdev's Patanjali joins the coronavirus race

The Patanjali group, whose flagship unit sells consumer products and ayurvedic remedies, said it has launched clinical trials on humans to find a cure for COVID-19 after receiving regulatory approvals.

"We are not talking about an immunity booster.  We are talking about a cure," said Acharya Balkrishna, managing director of Patanjali.

The clinical trials have begun in Indore and in Jaipur after Patanjali secured permission last week.

8. ICMR-Bharat Biotech vaccine status

Vaccine maker Bharat Biotech and Thomas Jefferson University of Philadelphia signed an exclusive deal to develop a new vaccine candidate for Covid-19.

The novel vaccine was developed using an existing deactivated rabies vaccine as a vehicle for coronavirus proteins, according to Bharat Biotech. Recently tested on animals, the vaccine showed a strong antibody response in mice, according to the company.

9. Serum Institute of India (SII) vaccine update

Pune-based Serum Institute of India (SII) is a leading contender for vaccine development. The company, which is known to produce over 10 million doses of vaccines in a year used for treating other diseases has partnered with the University of Oxford to speed up the development of a safe and affordable coronavirus vaccine. While the Oxford University vaccine shows good success rates (and has reached the human clinical trial stage), SII is speeding up efforts to produce the vaccine and making sure that vaccine doses are available as early as October 2020.

10. Zydus Cadila vaccine update

The Council of Scientific & Industrial Research (CSIR), which is currently testing a "repurposed" vaccine against Covid-19 in a Phase-2 trial, is hoping to seek approval from the drug controller for its wider use against the pandemic in as early as 30 days from now, according to the scientist coordinating the effort.

CSIR is currently testing Cadila Pharmaceuticals' "Sepsivac" against Covid-19.

Coronavirus drug update

1. Russia to roll out its first approved Covid-19 drug (Avifavir) next week

Russia will start giving its first drug approved to treat Covid-19 to patients next week. Avifavir, known generically as favipiravir, was first developed in the late 1990s by a Japanese company later bought by Fujifilm as it moved into healthcare.

RDIF head Kirill Dmitriev said Russian scientists had modified the drug to enhance it, and said Moscow would be ready to share the details of those modifications within two weeks.

Dmitriev said clinical trials of the drug had been conducted involving 330 people, and had shown that it successfully treated the virus in most cases within four days.

2. GSK's coronavirus vaccine booster

GlaxoSmithKline Plc will expand production of vaccine efficacy boosters, or adjuvants, to produce 1 billion doses in 2021 for use in shots for Covid-19. Adjuvants have been shown to create a stronger and longer-lasting immunity against infections. GSK's adjuvant can reduce the amount of vaccine protein required per dose, which would allow for more vaccines to be made, the British drugmaker said.

The company in talks with governments on backing for the programme, which would effectively allow for a scaling up of production of future successful vaccines for the disease caused by the novel coronavirus.

3. Roche mixes Actemra with Gilead's remdesivir in Covid-19 trial

Roche plans to test if mixing its anti-inflammation drug Actemra with Gilead Sciences Inc's anti-viral treatment remdesivir works better against severe covornavirus pneumonia than remdesivir alone.

Actemra and remdesivir are being used separately in some settings and clinical trials, with the former drug used to tackle massive immune reactions that sometimes occur in patients stricken with the new coronavirus and the latter aimed at interfering with viral replication.

The Swiss drugmaker is hoping that by combining the two in a global study of 450 hospitalised patients worldwide, it will be able to offer doctors a one-two punch against the disease. The cocktail will be compared against remdesivir and a placebo.

4. Sun Pharma gets approval for clinical trial with Nafamostat

Sun Pharmaceutical, India's top pharmaceutical company has received approval from the DCGI to initiate clinical trial with Nafamostat Mesilate in Covid-19 patients.

Nafamostat is approved in Japan for improvement of acute symptoms of pancreatitis and treatment of disseminated intravascular coagulation (DIC).

A group of scientists from the University of Tokyo in Japan and Leibniz Institute for Primate Research in Germany recently demonstrated that Nafamostat at very low concentrations suppresses a protein (TMPRSS2) that the Covid-19 virus uses to enter human lung cells.

5. Gilead Sciences gets permission for marketing authorisation for remdesivir in India
India's drug regulator has granted US pharma giant Gilead Sciences marketing authorisation for its anti-viral drug remdesivir for "restricted emergency use" on hospitalised Covid-19 patients in view of the crisis posed by the pandemic.

The approval process for remdesivir was accelerated in view of the emergency situation and the unmet need for medicines in light of the coronavirus outbreak

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