Covid-19 vaccine - how far is the UK’s vaccine trial?
Vaccine development process: Normally it takes 5-8 years to develop a vaccine, but applying the newer technique, scientists are optimistic to develop a successful vaccine in September this year in the UK.
Oxford University Vaccine: The University of Oxford is at the forefront of developing a coronavirus vaccine. This trial vaccine named as ChAdox1 nCoV-19 is a vaccine trial being run by the Jenner Institute of Oxford Vaccine Group led by Professor Sarah Gilbert,, started their work on 9 January 2020.
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 modified. During this modification genetic materials have been added to ChadOx1 vaccine, which is used to make proteins from the COVID-19 coronavirus called Spike glycoprotein (S), normally this protein is usually found on the surface of the COVID-19 coronavirus and plays a pivotal role in the infection pathways of SARS-CoV2 virus. COVID-19 coronavirus uses its spike protein to bind to the ACE2 receptor of cells of human body organs and cause infection. If the trial is successful, vaccinated individuals' bodies can recognise and develop an immune response to the spike protein that will help stop the COVID-19 coronavirus from entering the human cell and potentially prevent infection.
Animal testing of oxford vaccine: Oxford University's vaccines collaborators at Rocky Mountain Laboratories, Montana, and USA have conducted rapid animal testing on one of the old monkey species rhesus macaque. Trial vaccine demonstrated good safety and immunogenicity, and progressed to human trial.
Human Phase I trial: Healthy volunteers aged between 18 and 55 years recruited for phase I human trial, total 1112, apart from 10 volunteers 551 of them received ChadOx1 nCov-19 vaccine and 551 of them received MenACWY vaccine (meningitis vaccine), in a total of 1102 volunteers received 1 dose of the trialled vaccine, 10 healthy volunteers were given the same vaccine given 2 doses instead of 1 vaccine. In phase I trial safety and immunogenicity were assessed, this phase is already completed, no adverse reaction was reported, detailed results will be published mid-July to the end of July 2020.
Human Phase II trial: For PhaseII clinical trials 10,260 adults and children were recruited in the UK. Higher risk volunteers were recruited for assessing efficacy
Aged between 56-69 years
Aged over 70
Aged between 5-12 years
Human phase III trial: This phase involves assessing vaccine efficacy in a larger number of volunteers over the age of 18. The main focus in this phase is an assessment of how well the vaccine works to prevent people from becoming infected with COVID-19 coronavirus. Both the Phase II and Phase III trial Oxford University collaborated internationally in Brazil and South Africa and testing has already begun in June.
Imperial College London's vaccine: Like computing programming, vaccines are programming for the human immune system. Professor Robin Shattock's team at Imperial College London started developing a COVID-19 coronavirus on 9th January 2020, different from other vaccines is, it is completely synthetic, self-amplifying RNA vaccine for the first time. Genetic code of the surface protein of the virus has taken for developing this vaccine, not the virus itself. The viral genetic code is inserted in fat droplets into the muscles of the arm. When the vaccine is injected in the muscle, the RNA self-amplifies - generates copies of itself and instructs body's cells to produce copies of a spike protein that found on the surface of COVID-19 coronavirus, allowing your immune system to learn to recognise the virus's surface spike and provide immunity to the vaccinated person when coming into contact with novel coronavirus for real. The unique characteristics of this vaccine, a litre water bottle of vaccine it is possible to vaccinate 2 million people.
Animal testing: This synthetic vaccine tested in mice, good news is antibodies developed in mice, and even antibodies were much higher level when it was compared with patients who recovered from COVID-19 coronavirus. The team started animal studies on 9 March, progressed to human phase I trial.
Phase I human trial: Team has started human phase I trial on 18 June 2020. What is different from oxford vaccine, Imperial has recruited 300 volunteers for phase I human trial, aged 18-45 years, volunteers will receive 2 vaccines 4 weeks apart instead of oxford volunteers received 1 vaccine. The number of volunteers increased very cautiously, every 48 hours, new volunteers was vaccinated. In this phase vaccines, safety and efficacy are assessed, due to be finished in September 2020.
Human phase II and III trial: If phase I human trials are successful, phase II and III due to start in October 2020. This vaccine will be tested in a few thousand healthy volunteers. The Imperial team is also exploring parallel trials internationally because vaccines need to be tested in countries where the infection rate is still higher.
If human trials in all phases are successful, the Imperial team is expecting to see a successful vaccine in December 2020 or the beginning of next year it would be the first successful vaccine developed by synthetic technology.
Why are both Oxford and Imperial Vaccines developing so fast?
The Oxford team is using Platform technology for developing this vaccine taking only one of the genes to make one of the proteins from the pathogen therefore, safety testing doesn't take a long time. Imperial vaccine team, applying a newer technique called Synthetic technique, genetic code of the virus has taken to develop the vaccine, therefore possible to fast-tracked safety test,
Oxford and Imperial Vaccine Marketing: AstraZeneca, a British pharmaceuticals company signed a contract with the University of Oxford for commercial manufacture of COVID-19 corona vaccine in September 2020 if the vaccine trial is successful. At least 30 million doses will be readied for Britain. AstraZeneca signed a contract of 1.2 Billion dollars for USA, France, Germany Netherland and Italy set up the Inclusive Vaccine alliances signed a contract with AstraZeneca to supply up to 400 million doses and agreed with a license to the Serum Institute of India for supplying 1 billion doses for low and middle-income countries.
Instead of partnering with any pharmaceutical company Imperial has set up social entrepreneurship for vaccines accessible to the world market. Imperial College London formed a social enterprise called Vac Equity Global Health to bring the vaccine to the world. Good news, royalties will be waived for low-income countries and higher prices for wealthy countries. An Imperial vaccine for poorer countries is going to be cheap, around £2 to £3, very cheap for a new vaccine.
For vaccinating 7 Billion people in the world, we need few successful vaccines. Many governments in developed countries are already far ahead of vaccine availability for their citizens if a successful vaccine is developed. Bangladesh government should take strategies to make the vaccine available for 170 million Bangladeshi people; it may be worth to form a national task force for COVID-19 coronavirus vaccine and engaging Bangladeshi diplomats working in the countries where vaccine trials in human phases are progressing faster to develop a successful COVID-19 coronavirus vaccine.
The writer is clinical lecturer, Faculty of Medicine, Imperial College London