The rising number of Covid-19 cases across the world, which has surpassed the 6.29 million mark, has paved the way for fast-tracking of clinical trials of vaccines, which are being seen as the only ray of hope in the battle against SARS-CoV-2 in the long run.

Coronavirus (Covid-19) vaccine: US Company’s Moderna’s clinical trial enters phase II; Sinovac 99% sure of vaccine efficacy drugmaker Sanofi, Novavax Inc and Inovio Pharmaceuticals Inc.

ChAdOx1 nCoV-19 vaccine being developed by Oxford University and AstraZeneca Plc received permission for third stage trial in Brazil.

Brazil, which reported a record number of Covid-19 deaths in the past two days, has approved human clinical trials for the ChAdOx1 nCoV-19 vaccine being developed by Oxford University and AstraZeneca Plc, Reuters reported. The development comes amid scientists turning to places like Brazil, where the infection is still rife, to test potential vaccines with transmission rates dropping in UK, mainland Europe and the US.

US Firm Moderna Is Ahead

US firm Moderna Inc recently said it had started dosing patients in a mid-stage study with its experimental coronavirus vaccine and eventually plans to enroll 600 patients for the trial. The move signals that the company’s mRNA vaccine has passed its initial safety checks. Moderna plans to begin late-stage trials in July, Reuters reported.

In a press statement, Moderna said the first participants in each age group of the trial — adults below and above age 55 — had received doses of the company’s candidate.

Earlier this month, Moderna had released early-stage data that showed the vaccine successfully produced protective antibodies in a small group of healthy volunteers.

Around 120 vaccines are in the works across the world, of which at least 10 are undergoing human trials.

US pharmaceutical giant Pfizer has said a Covid-19 vaccine, which is being jointly developed with German firm Biontech, could be ready by the end of October 2020.

“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,” Albert Bourla, the CEO of the firm, said at an event.

Pfizer is conducting clinical trials in the US and Europe for the BNT162 vaccine programme. The programme includes four vaccine candidates, each representing a different combination of mRNA format and target antigen.

“The short, less than four-month timeframe in which we’ve been able to move from pre-clinical studies to human testing is extraordinary,” he further said.

Brazil approves Oxford corona vaccine trials; Moderna to start final phase in July

Brazil, which reported a record number of Covid-19 deaths in the past two days, has approved human clinical trials for the ChAdOx1 nCoV-19 vaccine being developed by Oxford University and AstraZeneca Plc, Reuters reported. The development comes amid scientists turning to places like Brazil, where the infection is still rife, to test potential vaccines with transmission rates dropping in UK, mainland Europe and the US.

The Oxford University vaccine is among the first Covid-19 vaccines to move into Phase II, or mid-stage, trials, along with the one from the US biotech company Moderna Inc. To speed up development, researchers are carrying out at the same time both Phase II and Phase III trials, which involve a broader age group.

ChAdOx1 nCoV-19 vaccine,” Anvisa, Brazil’s health regulator, said in a statement. The Federal University of Sao Paulo said it would recruit 1,000 front-line volunteers who had not contracted the disease for trials.

Coronavirus (Covid-19) Vaccine Latest Update: US has selected five companies as the most likely candidates to produce a vaccine; Moderna is looking to start final phase of trials as early as July.

China In Race

Coronavirus (Covid-19) vaccine latest update: Sinovac Biotech says it is 99 per cent sure of its CoronaVac vaccine efficacy; Patanjali group joins efforts in developing a cure for Covid-19

A Chinese vaccine, being jointly developed by the Beijing Institute of Biological Products and China National Biotec Group Co, has completed phase II testing and may be ready for the market at the end of this year or early next year, according to a report published by the State-owned Assets Supervision and Administration Commission.

The report, quoted by Reuters, said the production line for the vaccine would be fully disinfected would have a full manufacturing capacity of 100 million-120 million vaccines each year. The vaccine candidate employs a killed version of the novel coronavirus that can still trigger an immune response.

In total, five vaccines developed by Chinese companies are being tested on humans, the most in any country.

Another Chinese biopharmaceutical company Sinovac Biotech has pinned hope on its inactivated vaccine, dubbed CoronaVac, and said it was 99 per cent sure of its efficacy. As per a Sky News report, Luo Baishan, a researcher at Sinovac, said, “It must be successful…99 per cent sure.”

The company has reached stage 2 of its 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.

In a report in the academic journal Science last month, Sinovac said its vaccine protected monkeys from infection by the coronavirus.

Sinovac’s research and development subsidiary has received $15 million from private equity firms Advantech Capital and Vivo Capital to fund the development of the vaccine. Besides, the company has also been assigned a large factory to produce its coronavirus vaccine, with an aim of being able to produce 100 million doses.

India’s Vaccine In Monkey Trial

Along with other countries, India is also in race to develop vaccine for COVID-19. Indian government has already given permission to go for trial.

India, where about 30 vaccines are being developed, Bharat Biotech International Limited (BBIL) said the development of its candidate was moving in a positive direction and the next one month would be very crucial. BBIL is developing a vaccine jointly with Indian Council of Medical Research (ICMR).

“We are at a very crucial stage. The vaccine development is moving in a positive direction. The next one month is very crucial. I am a scientist and I believe in science,” Krishna Mohan Ella, chief executive officer at Bharat Biotech, told IANS.

Meanwhile, in a separate development, Pune-based National Institute of Virology (NIV) has been given permission by the government to do clinical trials for a vaccine on 30 female monkeys. According to a media report, the NIV scientists will be doing clinical trials on monkeys aged 3-4 years.

The US is planning massive clinical trials involving 100,000 to 150,000 volunteers. The government aims to start mid-stage testing in July. The first two vaccines to start mid-stage trials would likely be from Moderna and the AstraZeneca/Oxford University combination, Reuters reported.

Massachusetts-based biotechnology giant Moderna Inc, which last week started Stage II trials for its vaccine candidate mRNA-1273, is looking to start the final phase of trials as early as July.

For Phase III trials, the final stage of vaccine development, about 30,000 people will be enrolled, mostly from the age group of 18-55 years, but also the elderly and people who are at risk of severe Covid-19.

Dr Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, has told media the results of the Phase-III trial would be available by November or December this year. He further said by that time, Moderna would have already produced about 100 million doses of the vaccine.

Earlier this month, Moderna had released early-stage data that showed the vaccine successfully produced protective antibodies in a small group of healthy volunteers.

Russia In Race

Russia, which has the world’s third-highest Covid-19 toll after the United States and Brazil, has said it planned to start clinical trials within two weeks on a vaccine. Moreover, authorities also approved the country’s first anti-Covid-19 drug, a Reuters report said.

Kremlin officials said the nation’s researchers were working on almost 50 different vaccine projects. “The tests are under way and we plan to start clinical trials in the next two weeks,” Health Minister Mikhail Murashko was quoted as saying by the TASS news agency. He said volunteers had been selected to take part in the trials.

One of the vaccines is being developed by the state-run Vektor Institute in Siberia. On Saturday, its director general Rinat Maksyutov said he hoped to complete clinical trials in mid-September. Maksyutov said vaccine trials on animals had been successful.

Meanwhile, the Russian Direct Investment Fund said the Health Ministry had approved Avifavir for the treatment of Covid-19. It was developed on the basis of a drug known generically as favipiravir. The drug has proved highly effective in treating patients in the first phase of its clinical trials. The final stage of clinical trials is under way, with the participation of 330 patients.

South Korea Is In Trial

South Korea’s first clinical trials of a vaccine for COVID-19 are slated to begin this month, a report in The Korea Herald said. The International Vaccine Institute and Seoul National University Hospital said Thursday they were partnering for phase 1 and 2 trials of pharmaceutical company Inovio’s vaccine candidate INO-4800.

The study will proceed in two stages. The first of which will include 40 healthy adults aged 19-50 years to assess the vaccine candidate’s safety. An additional 120 people aged 19-64 will be enrolled in the next stage for examining its tolerability and immunogenicity, the report said.

Preliminary data from the phase 1 trial is estimated to be available by early September.

Source: The Indian Express