Before a vaccine can reach the human trials stage, there are several prior phases that must be approved. Phase 1 involves safety tests to control the correct dosage amount, side effects that exist and confirmation of improving the immune system.
Phase 2 involves a larger test sample of different ages with a focus on the likelihood of producing a potential vaccine.
Most vaccines struggle to reach phase 3, which includes an even larger testing sample (thousands) that targets the effectiveness, side effects that were not picked up previously and introduction of a placebo. Countries are racing to develop a COVID-19 vaccine, with the USA, China, UK and Germany leading the way.
USA – Phase 3
Moderna was developed in Cambridge with funding from the National Institute of Allergy and Infectious Diseases. Phase 1 trials were conducted on volunteers at a health research institute in Seattle. Phase 2 extended testing onto a wider age range of participants. Phase 3 recently began in July.
Novavax is at Phase 2, attempting to use the nanoparticle technology platform to generate antigens from protein found on the spikey outer shell of coronavirus. The company is expecting preliminary data in July and has started testing on humans. Novavax received the highest amount of funding from CEPI with a total of US$388m.
China – Phase 3
China currently has 3 vaccines at Phase 3. Sinovac has been tested on primates and has so far protected them from contracting the virus three weeks after being injected with the vaccine. After this success, Sinovac launched phase 3 trails on 9,000 volunteers in Brazil. Similarly, in July, the Wuhan Institute of Biological Products has begun phase 3 trials on 15,000 people in the United Arab Emirates. This is a government run project. The Beijing institute is also a government run group, developing a vaccine with the Chinese Center for Disease and Control and Prevention.
UK – Phase 3
The University of Oxford is testing the ChAdOx1 vaccine in phase 3 trials on more than 10,000 people in the UK. This includes a wide range of ages, from children to the elderly. The vaccine has also been tested in Brazil and South Africa. South Africa recently started the first COVID-19 vaccine trial in Africa. AstraZeneca is planning to manufacture 300 million doses of this vaccine when it proves both safe and effective. If no delays occur, the first doses are expected to be available in late 2020.
Germany – Phase 2/3
With trials recently beginning in the USA, BioNTech is working with Pfizer to begin testing the BNT162 vaccine on humans in Germany. To fund this project, BioNTech entered a €100m debt financing agreement with a European Investment Bank to scale-up the production of the vaccine in Europe. On 27 July, phase 2/3 trial was announced on 30,000 volunteers in the US and other countries including Argentina, Brazil, and Germany.
In June, the FDA announced that a coronavirus vaccine would have to protect at least 50% of vaccinated people to be considered effective. To be approved, regulators from each country will review the results and decide whether to approve the vaccine. As a pandemic exists, a vaccine may receive emergency use before getting formal approval. After the vaccine is licensed, researchers will continue to monitor the results to ensure safety and effectiveness.