As pharmaceutical companies are inching towards the finish line, clinical trials are being conducted for multiple coronavirus vaccine candidates. Some countries are even mulling on emergency use authorisation for potential COVID-19 vaccines. Top physician and immunologist Dr Anthony Fauci said that rushing out a coronavirus vaccine before it has proven to be safe and efficient is a bad idea. He also said that doing so could hurt the development of other vaccine candidates. "The one thing that you would not want to see with a vaccine is getting an EUA before you have a signal of efficacy. One of the potential dangers if you prematurely let a vaccine out is that it would make it difficult, if not impossible, for the other vaccines to enrol people in their trial. To me, it's absolutely paramount that you definitively show that a vaccine is safe and effective," he said in an interview.
While many countries are mulling emergency authorisation for potential vaccine candidates, several coronavirus vaccine candidates are already under trial. Oxford University-AstraZeneca coronavirus vaccine candidate, one of the frontrunners, is conducting trials in multiple countries. It is scheduled to start in India on Tuesday. Novavax has also started enrolling volunteers for its trials.
Here are the latest developments from India and around the globe:
INDIA: Russian Ambassador Nikolai Kudashev reached out to India on Tuesday seeking a partnership in the production of coronavirus vaccine Sputnik V. As per reports, Russia is aiming to produce 6 million doses of coronavirus vaccine per month. This development comes after efforts from the Indian embassy to engage with Gamaleya National Centre of Epidemiology and Microbiology that developed Sputnik V. Kirill Dmitriev, CEO of Russian Direct Investment Fund (RDIF) that is funding the programme had hinted about a partnership between the countries earlier.
Meanwhile, the Serum Institute of India (SII) is set to begin the Phase 2 and 3 clinical trials of the Oxford University-AstraZeneca candidate in India. According to the Clinical Trials Registry of India, 17 sites have been identified for the clinical trials. Around 1,600 volunteers would undergo the clinical trials conducted by SII. The vaccine of 0.5 ml dose would be administered twice -- on Day 1 and Day 29. Placebo would be given similarly to other volunteers too. The trials would be observer-blind, randomised, and controlled.
US: Novavax on Monday said that it has begun enrolling volunteers for the second phase of an ongoing clinical trial of its COVID-19 vaccine candidate, with interim data expected in the fourth quarter of 2020. In the new phase, the age range has been expanded, with adults between 60 and 84 years accounting for nearly 50 per cent of the trial's population. Early-stage data has shown it produced high levels of virus-fighting antibodies, and the company aims to begin larger studies to obtain regulatory approvals as early as December. The vaccine candidate is one of nearly 30 being tested in human clinical trials globally and lags candidates from AstraZeneca, Pfizer and Moderna that are in late-stage studies. The US government in July awarded Novavax $1.6 billion to test and manufacture its vaccine in the United States, with the aim of delivering a 100 million doses by January.
President Donald Trump hailed FDA authorisation of a coronavirus treatment that uses blood plasma from recovered patients. The US Food & Drug Administration's (FDA) announcement of its "emergency use authorisation" of the treatment came on the eve of the Republican National Convention. "This is what I've been looking to do for a long time. Today I'm pleased to make a truly historic announcement in our battle against the China virus that will save countless lives," said Trump at a White House news conference.
CHINA: China has reportedly begun injecting people with a vaccine that is still under development. The COVID-19 vaccine, Sinopharm, is currently undergoing trials in UAE. Senior health official revealed that it is already being administered. The Washington Post quoted head of China's coronavirus vaccine development programme, Zheng Zongwei, who said that the vaccine is being given to medical workers and government employees. "In order to prevent the disease spread in the fall and winter, we are considering a moderate expansion in the programme... The purpose would be to first build and immunity barrier among special groups in the population," said Zheng.
ITALY: Italy started clinical trials of a COVID-19 vaccine candidate on Monday. Rome's Lazzaro Spallanzani institute, a hospital specialising in infectious diseases will conduct trials on 90 volunteers over the coming weeks. Francesco Vaia, health director of the Spallanzani hospital, said that the first patient will be monitored for four hours before being allowed to go home where he will be kept under observation for 12 weeks. "We will see if it produces any side effects and if it produces neutralizing antibodies," Vaia said, adding the second phase of testing will take place in countries with higher infection rates, like Mexico and Brazil.
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