The COVID-19 Vaccine Global Race
|The COVID-19 Vaccine Global Race - Photo: KOAM|
WHO says that currently there are about 150 active projects on to find out COVID-19 vaccine, and there are four main types of vaccines in development, each of these have been effective in protecting against some major diseases in the past, as cited by Al Jazeera.
Virus vaccine: The report says that there are at least seven projects that are developing vaccines using the virus itself, which is in a weakened or inactivated form.
Viral-vector vaccines: As per the report, in this method, a virus is genetically engineered so that it can produce coronavirus proteins in the body. Since these viruses are weakened, they cannot cause the disease. This method is used in case of measles or the recently approved Ebola vaccination.
Around 25 groups are trying to develop viral-vector vaccines against the novel coronavirus.
Nucleic-acid vaccines: At least 20 teams are aiming to use genetic instructions, in the form of DNA or RNA, for a coronavirus protein that prompts an immune response, explains the report. In this type of vaccination, the nucleic acid is inserted into human cells, which then churn out copies of the virus protein.
Protein-based vaccines: 28 teams are trying protein-based vaccine against COVID-19. In this method, coronavirus proteins directly injected into the body. According to the Nature report, fragments of proteins or protein shells that mimic the coronavirus’s outer coat can also be used.
|Photo: Al Jazeera|
According to Gavi, when candidate vaccines make it to human clinical trials, they first go through phase 1 trials primarily to test the vaccine’s safety, determine dosages and identify any potential side effects in a small number of people.
Phase 2 trials further explore safety and start to investigate efficacy on larger groups.
The final stage, phase 3 trials, which few vaccines ever make it to, are much larger, involving thousands or tens of thousands of people, to confirm and assess the effectiveness of the vaccine and test whether there are any rare side effects that only show up in large groups.
The World Health Organization (WHO) lists candidates at various stages of clinical trials:
|Photo: Gavi - The Vaccine Alliance|
At this time, there are only 10 of 150 active projects have their COVID-19 vaccine test through phase 3; however, they are promising vaccines on the brink of going through regulatory approval to be rolled out:
The UK has just become the first country in the world to approve this vaccine and plans to roll the first 800,000 doses out next week. Older people in care homes, care home staff, over-80s and health workers will be first in line.
Since it is an RNA vaccine and will need to be kept at temperatures below -70 degrees Celsius, the first vaccinations are likely to be done in the hospital. BioNTech, working together with Pfizer, started testing its BNT162 vaccine in humans as part of global trials, initially in Germany, and more recently in the USA.
BioNTech has also entered into a € 100 million debt financing agreement with the European Investment Bank in order to scale-up the production of the vaccine in Europe.
On 27 July, it announced the launch of a phase 2/3 trial with 30,000 volunteers in the USA and other countries including Argentina, Brazil and Germany. In September, the company said it would expand its phase 3 US trial to 43,000 participants.
At the start of October, BioNTech and Pfizer started recruiting for a phase 3 trial in South Africa, and by early November had reported promising interim results. In their final efficacy analysis, Pfizer/BioNTech data showed a vaccine efficacy rate of 95% (even in adults over 65 years, efficacy was more than 94%, which is reassuring as older people don’t always have a strong immune response to vaccines).
The final trial results confirm this vaccine has a 94% efficacy, and the data has been sent to regulators in the US, Europe and UK for the emergency licence. As with the Pfizer vaccine, this RNA vaccine will also need to be kept in ultra-cold freezers.
The vaccine has been developed by Moderna, in Cambridge, Massachusetts, and funded by the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the US National Institutes of Health.
The vaccine was tested in phase 1 trials on volunteers at the Kaiser Permanente Washington Health Research Institute in Seattle. Moderna has run phase 2 trials on participants of a wide range of ages and started phase 3 trials in July. The final trial enrolled 30,000 healthy people from across the United States.
ASTRAZENECA/UNIVERSITY OF OXFORD (UK)
Viral Vector Vaccine
The ChAdOx1 vaccine, developed by the University of Oxford, has a vaccine efficacy of up to 90%. Although the efficacy is slightly lower than the Moderna and Pfizer vaccines, it is fridge-stable meaning that it can be transported anywhere in the world.
At about US$ 4 per dose, it is also a fraction of the cost of others that are around US$ 26 per dose. It was tested in phase 3 clinical trials with more than 10,000 people from across the UK, including children and the elderly. The vaccine was also tested in Brazil, the United States and India, and South Africa started the first COVID-19 vaccine trial in Africa.
With support from the Coalition for Epidemic Preparedness Innovations (CEPI), AstraZeneca is manufacturing 300 million doses of this coronavirus vaccine candidate in anticipation of the vaccine proving to be both safe and effective. Production has begun, and 4 million doses have been supplied to the UK so far, though they can only be used once the vaccine is licensed.
Sinovac recently began phase 3 trials involving volunteers in Brazil, Bangladesh, Indonesia and Turkey. It might start trials in the Philippines by the end of this year. A report in July said that the Chinese government has given the Sinovac vaccine emergency approval for limited use. The city of Jiaxing has reportedly offered the vaccine to health workers and other high-risk groups for US$ 60.
WUHAN INSTITUTE OF BIOLOGICAL PRODUCTS (CHINA)
The Wuhan Institute launched phase 3 trials in July in the United Arab Emirates, and in Peru and Morocco in August. The state-owned Chinese company Sinopharm has been putting the vaccine through clinical tests. On 14 September, the U.A.E. gave emergency approval for the vaccine to be given to health care workers.
BEIJING INSTITUTE OF BIOLOGICAL PRODUCTS (CHINA)
Like the Wuhan Institute, the Beijing institute is also part of China’s state-run Sinopharm Group and is working on this vaccine with the Chinese Center for Disease Control and Prevention. In phase 3 trials in the United Arab Emirates, 5,000 people are receiving the Wuhan Institute version, while another 5,000 are receiving the Beijing Institute one.
CANSINO BIOLOGICS INC. (CHINA)
Viral Vector Vaccine
The Ad5-nCoV vaccine candidate uses a harmless non-replicating viral vector (essentially a sort of molecular transport) to carry vaccine antigens into the human body – this is the same platform that the vaccine developer CanSino Biologics Inc, based in Tianjin, used for its Ebola vaccine. The vaccine was jointly developed with the Institute of Biotechnology of the Academy of Military Medical Sciences. On 25 June, the Chinese military approved the vaccine for a year as a “specially needed drug”, which is unusual given that by then phase 2 results hadn’t been collated. On 9 August, the Saudi health ministry announced that CanSino would run a phase 3 trial in Saudi Arabia; later in the month the company also started a trial in Pakistan and Russia.
GAMALEYA RESEARCH INSTITUTE (RUSSIA)
Viral Vector Vaccine
Gamaleya has started a phase 1 clinical trial on this non-replicating viral vector vaccine candidate (Sputnik V) with two sets of volunteers receiving vaccination since mid-June. Before the trial went on to later trials, Russia had announced that the vaccine would be approved for use. A phase 3 trial of the vaccine began with more than 2,000 people in Russia, Latin America and the Middle East, and then expanded to 40,000. Volunteers were also recruited in Belarus, the United Arab Emirates and Venezuela.
Viral Vector Vaccine
J&J has developed vaccines for Ebola and other diseases with Recombinant Adenovirus Serotype 26 (Ad26) and has now made one for the coronavirus. It launched phase 1/2 trials in July and launched a phase 3 trial with 60,000 participants in September in Latin America. It hopes to make up to a billion doses in 2021.
Protein Subunt Vaccine
Novavax is using a nanoparticle technology platform to generate antigens from the protein found on the spikey outer shell of the coronavirus. The vaccine also received the highest funding from CEPI with a total of US$ 388 million. Phase 2 trials started in August in South Africa and phase 3 trials started in the UK in September, with plans for phase 3 trials in the USA this month.
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