Answering this question that is on the minds of most is difficult because not all vaccine development programs are created equal. Comprehensive testing is needed to ensure that vaccines are safe and effective. Human trials of the “Oxford vaccine”, long regarded as a pioneer, have had to be stopped suddenly for safety reasons.
The Oxford-AstraZeneca trials were stopped after one participant had an adverse reaction in the UK.
While US President Donald Trump insists the vaccine will be ready by October-November, experts say early 2021 is a more likely period. And given the challenges of delivery, a vaccine may not be available to the masses until the end of next year, even if it is approved for use this year.
Here’s how the major vaccine projects are progressing:
Phase 3, released for use
1. Sputnik V
Russia launched its Covid vaccine, developed by the country’s Gamaleya Research Institute of Epidemiology and Microbiology, along with Russia’s Direct Investment Fund (RDIF), after a preliminary trial involving only 76 people, a far cry from those many thousands of volunteers who often participate in human trials. It is based on a common cold virus that cannot replicate in the body. While it has been shown to stimulate the immune system to produce antibodies, international experts are cautious as more studies are needed to measure the complete immune response.
On August 11, Russian President Putin said that a coronavirus vaccine had been registered for use in the country and that one of his daughters had been inoculated.
Russian authorities now say it is a conditional certification that will be reviewed after phase 3 trials. They have approached India to host larger human trials, as well as to manufacture the vaccine.
Phase 3, limited use
1. CanSino Biologics
The vaccine, Ad5-nCoV, was developed by the Chinese company CanSino Biologics and a military institute. The Chinese military approved its limited use in June after phase 1 human testing ended in May. Phase 2 trials in July showed a strong immune response. In August, Saudi Arabia and Pakistan said they would host their phase 3 trials.
CanSino Covid-19 Vaccine Candidate Vaccine Vials, Ad5-nCoV
2. Sinovac
CoronaVac, another Chinese vaccine, was approved by Beijing for limited use in July. Like the polio and flu vaccines, it uses an “inactivated” or killed virus to produce immunity. Its phase 3 trials are underway in Brazil and Indonesia. It has already been administered to thousands of people, including around 90% of Sinovac employees and their families, as part of China’s emergency vaccination plan to protect people facing high risk of infection.
Phase 2, Phase 3
1. AstraZeneca, University of Oxford
The pioneering Oxford vaccine, known as ChAdOx1 nCoV-19 or AZD1222, is undergoing multiple phases of testing simultaneously. Phase 1/2 trials showed that it did not cause serious side effects. Phase 2/3 trials were underway in England, India, Brazil, South Africa and the US when they were stopped internationally because a participant in the UK developed an ‘unexplained illness’. AstraZeneca said it is speeding up its review process and the participant is expected to make a quick recovery.
The vaccine uses a weakened and harmless adenovirus (carrier) derived from chimpanzees and loads into it a coronavirus gene that instructs cells to build spike proteins. When the vaccine is administered to a person, the gene is “expressed”, causing the accumulation of spike proteins. The body’s immune system recognizes this and begins to create the antibodies to defeat the foreign object.
2. BioNTech, Pfizer, Fosun Pharma
Manufactured by BioNTech of Germany, Fosun Pharma of China and Pfizer of the United States, it uses RNA (genetic material) from the virus to build immunity. Although no RNA vaccine has been approved for human use so far, the United States ordered 100 million doses by December and Japan another 120 million.
Phase 3
1. Modern, National Institutes of Health
Another RNA vaccine was the first to begin trials in March, but suffered a setback when Moderna lost a patent battle in July. Yet it has $ 1 billion in funding from the US government and the promise of a $ 1.5 billion order for 100 million doses if the vaccine is safe and effective.
A volunteer is injected with a possible Covid-19 vaccine, developed by the National Institutes of Health and Moderna Inc
2. Sinopharm
Sinopharm, owned by the Chinese government, is testing two inactivated virus vaccines, one of which has been developed by the Wuhan Institute of Biological Products and the other by the Beijing Institute of Biological Products. The Wuhan vaccine is undergoing phase 3 trials in the United Arab Emirates, Peru and Morocco and could be ready for use by the end of this year, Chinese officials say. The other vaccine is in phase 3 trials in the UAE. Sinopharm claims that one of its vaccines has been approved for limited use, but it is unclear which one.
India to become a major vaccine manufacturer
Indian vaccine manufacturers supply 60% of the developing world’s vaccines and are now also involved in the development, testing and manufacturing of Covid vaccines.
Serum Institute of India (SII): The world’s largest vaccine manufacturer by volume has partnered in collaboration with the University of Oxford-AstraZeneca, Novavax, and US-based Condagenix to develop and manufacture vaccines. The Oxford vaccine is the most promising yet, despite the recent setback. It is in phase 3 trials in various countries and in phase 2 trials at 17 sites in India. Trials are expected to end in early 2021.
SII is also working with the international Gavi vaccine coalition and the Bill and Melinda Gates Foundation to distribute vaccines in India and 57 low- and middle-income countries at $ 3, or Rs 225, per dose.
The IBS has already produced 2 million doses for regulatory and testing purposes and the company said it could produce between 60 million and 70 million doses a month at full capacity.
Work is underway on a vaccine assembly line at the Serum Institute of India in Pune
Zydus Cadila: The Ahmedabad-based company has developed the ZyCov-D vaccine using a genetically engineered molecule that contains coronavirus DNA. It is now in phase 2 trials with 1,000 participants and if the results are satisfactory, it says it is ready to manufacture 100 million doses.
Bharat Biotech: It has developed a vaccine called Covaxin in collaboration with the Indian Council for Medical Research, the University of Wisconsin-Madison, and FluGen, based in the United States. Phase 2 trials of this inactivated virus vaccine are scheduled to begin this month. The Hyderabad-based company says it can produce 300 million doses.
E biological: Another Hyderabad-based firm signed an agreement with the Baylor College of Medicine in the United States to manufacture and test a protein-based vaccine in India. Trials are expected to begin this month and the firm says it can produce 1 billion doses.
Gennova Biopharmaceuticals: Pune’s mRNA vaccine will begin human trials in October, in India, the United States, Brazil and South Africa. It can produce around 200 million doses a year, but it can scale up to a billion doses.
Indian Immunos: The Hyderabad firm reached an agreement with Griffith University in Brisbane, Australia, to test and manufacture its vaccine that uses a weakened form of the virus to generate an immune response. But trials are not expected to begin until next year.
Vaccine makers won’t rush
After Trump claimed that the United States “might even have (a vaccine) during the month of October,” on September 8, the heads of nine major American and European pharmaceutical companies: AstraZeneca, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna , Novavax, Sanofi, BioNTech and Pfizer – pledged to “support the science” and said they would not seek clearance for coronavirus vaccine candidates until rigorous Phase 3 testing shows they are safe and effective. The companies issued what they called a “historic compromise” after heightened concern that safety standards could fail in the face of political pressure to launch a vaccine.
Steroid therapies emerge as the most promising treatment
Without a vaccine, some inexpensive steroids are the only treatment so far that can reduce the risk of death in severe cases of Covid, unlike Remdesivir, a promising early drug that primarily reduces recovery time.
A recent study looking at data from 1,700 seriously ill patients, most on ventilators, concluded that steroid therapies reduced the risk of death by 34%. Based on this analysis, the World Health Organization designated steroids as the “standard of care” for critically ill patients, although it did not recommend the use of steroids in less severe cases so as not to “exhaust global resources and deprive patients who could benefit. ” of it the majority “.
Steroid treatments do not directly attack the coronavirus. Instead, they prevent acute respiratory distress syndrome (ARDS), which can be a fatal condition, by preventing the patient’s immune system from racing over and attacking the lungs.
Some researchers are beginning to explore the possibility of using steroids in conjunction with antivirals to simultaneously lower viral load and prevent an immune system overreaction.
Dexamethasone, one of the steroids in the study, was approved for use in India in June after early studies showed promising results.
Source: NYT, covid-19vaccinetracker.org, Lancet, WHO, Nature, Journal of the American Medical Association, Stat News, media reports
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