It has been five months since the World Health Organisation (WHO) announced COVID-19 a global health crisis, and as teams around the world race to be the first to release a viable vaccine, the discussion of when we can expect one has increased exponentially.
Before we get into the who, where and when of it all, it’s important to understand the how. Usually, a new vaccine will undergo years of tests and trials before it is rolled out into public use. Each vaccine needs to go through and successfully pass four essential phases before reaching the final phase – approval for use in the general public.
The phases of vaccine testing
The phases of vaccine testing are as such:
- Pre-clinical – researchers give doses of the vaccine to animals to determine any kind of immune response from the animal.
- Phase 1 – the first stage of clinical trials. A small scale safety trial on a handful of human volunteers to determine that the vaccine is safe and to test the immune response in people.
- Phase 2 – clinical safety trials expand and the vaccine is given to hundreds of people to learn more about the safety of the vaccine and so scientists can determine the correct dosage.
- Phase 3 – the vaccine is given to thousands of people to confirm its safety, test for any rare side effects, and determine its efficiency. This phase also includes a placebo control group.
- Approved – once passing all four previous phases, the final phase sees the vaccine approved for general use.
Understandably, scientists are doing their best to fast track this process for a COVID vaccine. With over 170 vaccines being tracked by the WHO there are dozens in the animal testing phase, and even several vaccines in the later human trial phases. However, this doesn’t necessarily mean that we can expect a vaccine in the next few months.
Even if a vaccine reaches Phase 3, if it fails researchers will have to go back to the beginning and try again. Because a vaccine mimics the virus it is fighting in order for the body to build antibodies against it, it needs to be held to a higher standard of safety as it will be administered to millions of healthy people, not just those who are or have been infected.
Current Late Phase Vaccines
- BioNTech, a German company, in conjunction with New York based Pfizer and Chinese drug producer Fosun Pharma, entered combined Phases 1 and 2 back in May. The volunteers successfully developed antibodies and immune cells called T cells that respond to the virus. While there were some mild side effects like sleep disturbances and sore arms, on July 27th they moved into a combined Phase 2 and 3 trial, recruiting 30,000 volunteers from the US, Argentina, Brazil, Germany and other countries. Already, the US government has awarded a $1.9b contract for 100 million doses by December, with an option for another 500 million. Japan has also made a deal with the company for 120 million doses. If the vaccine reaches approval stage, Pfizer said they expect to manufacture over 1.3 billion doses worldwide by the end of 2021.
- US company Moderna, along with the National Institutes of Health, have found their vaccine to protect monkeys against the coronavirus, and in March they launched their first human trials which produced encouraging results. After successfully completing Phases 1 and 2, they launched Phase 3 on July 27th, enrolling 30,000 healthy people from around the US. They received almost $1b from the US government to bankroll their research, and as of August 11th, they received an additional $1.5b for 100 million doses if the vaccine passes into approval.
- Chinese company CanSino Biologics, in association with the Institute of Biology at the country’s Academy of Military Medical Sciences, has produced a vaccine which showed promising Phase 1 results. Moving through Phase 2, they reported that their vaccine produced a strong immune response back in July and as of August 9th, the Saudi health ministry announced that CanSino would run Phase 3 trials in Saudi Arabia. Currently in negotiations with other countries for more trials, the vaccine has already been approved by the Chinese military, however CanSino have not said whether the vaccine has been rolled out as mandatory or optional among Chinese soldiers.
- British-Swedish company AstraZeneca, along with the University of Oxford, have developed a vaccine that has provided protection against the virus in monkeys. After conducting Phase 1 and 2 trials, they found that the vaccine was safe, produced no negative side effects, and raised antibodies and other immune defences. Currently running Phase 2 and 3 trials in England and India, they are also running Phase 3 trials in Brazil and Argentina, and have received $1.2b in support from the US. According to AstraZeneca, if these final stage trials are approved, they would be able to manufacture emergency doses as soon as October, and their total manufacturing capacity would allow them to produce 2 billion doses once approved.
- Earlier this week, Russia announced that they have already pushed a vaccine into approval for early use. The Russian Ministry of Health launched Phase 1 testing only in June, and by July, the upper house of Russia’s Parliament announced that they would be able to produce the vaccine by the end of the year. On August 11th, President Vladimir Putin announced the vaccine had already been approved by a Russian health care regulator, well before it had even begun Phase 3 trials. The vaccine, which has been named Sputnik V, has been called “highly risky” by international vaccine experts.
- Australia currently has three notable vaccines in the works. Australian company Vaxine have already passed Phase 1, and expect to move into Phase 2 in early September. The University of Queensland launched their own vaccine research in July, and if it returns positive results will move into late stage clinical trials, and is expected to produce tens of millions of doses. Finally, the Murdoch Children’s Research Institute in Australia is studying a repurposed vaccine, the Bacillus Calmette-Guerin which was developed in the 1900s to fight tuberculosis. It is currently in Phase 3 and other clinical trials are underway to see if this vaccine is effective against the coronavirus.
This is just a handful of the great work being done by research centres around the world. However, while research companies and scientists are testing, trialing, and working hard to produce a viable vaccine against coronavirus, unfortunately it may still be some time before we are all getting that important jab in the arm. The WHO have stated that although there are some encouraging results coming out of several different trials, realistically it may be another 12-18 months before we see a global rollout of coronavirus vaccines.