The latest vaccine developments
The world is looking at the thousands of researchers currently working hard to develop a cure or treatment for Covid-19. As we are entering September, and therefore the 9th month of this global pandemic, more than 165 vaccines are being developed against the coronavirus, and 32 vaccines are in human trials. But what are the most promising research studies and what can we expect from the next couple of months? Will there be a vaccine as early as next year? We have mapped out the latest vaccine developments in clinical trials for you.
The race for a vaccine in clinical research
Even though vaccines typically require years of research and testing before being put out to the public, current research studies are pushing hard to produce a safe and effective vaccine against Covid-19. Researchers are currently testing different vaccines for their safety and efficiency, with trials having to run through different phases to be approved:
Preclinical testing - before vaccines are being tested on humans, scientists are testing on animals (such as mice or monkeys) whether the treatment is able to produce an immune response.
Phase 1 - This phase is the so-called safety trial - researchers are testing the vaccine on a few people to see whether the vaccine is safe and determine the right dosage and the stimulation for the immune system.
Phase 2 - In this expanded trial, researchers are widening the test group to hundreds of people and divide them into subgroups, for example, children or elderly, to see whether different groups respond differently to the vaccine.
Phase 3 - In this phase, researchers are expanding the group of people again, this time to an even bigger group (thousands of people) to compare how many people become infected, compared to the placebo group. This phase shows whether a vaccine can actually protect people from the virus or not. According to the FDA, at least 50% of vaccinated people have to be protected in order to consider a vaccine effective.
After the 3rd phase, regulators in each country are looking and reviewing results of these clinical trials to see whether the vaccine can be approved or not. During a pandemic, vaccines may receive emergency authorization before receiving formal approval.
Current developments in vaccine trials
There are a variety of different vaccines tested at the moment - while some organizations are focusing on genetic vaccines, others are looking more into viral vector vaccines, protein-based vaccines, whole-virus vaccines, or repurposed vaccines. Current clinical trials who are in their final phases of testing are the following:
Phase 3 clinical trial for a genetic vaccine
Moderna, in partnership with the National Institutes of Health, are developing a vaccine that is based on messenger RNA (mRNA) to produce viral proteins in the body. The trial is currently going in phase 3, where over 30,000 healthy people will be enrolled in over 89 sites around the United States. So far, the vaccine has proven to protect monkeys from the coronavirus and was put into human trials for a Covid-19 vaccine back in March of this year.
BioNTech collaboration with Pfizer and Fosun Pharma
The German company BioNTech in collaboration with New York-based Pfizer, and Chinese drugmaker Fosun Pharma are currently working on developing an mRNA vaccine for the coronavirus. The trial has been launched in May for a phase 1/ 2 trial, testing two versions of the vaccine. Both versions have been found to cause volunteers to develop antibodies against the virus, and immune cells called T cells, which respond to the virus as well. In July, one of the two versions (BNT162b2) was moved forward into phase 2/ 3 due to fewer side effects and has been entering a clinical trial with 30,000 volunteers in a variety of different countries such as the United States, Germany, Argentina, and Brazil.
Vaccine approved for limited use in China
The chinese company CanSino Biologics developed a vaccine based on an adenoverius called Ad5 in partnership with the Institute of Biology. Their phase 1 safety trial showed very promising results back in May, and their phase 2 results underlined that the vaccine might be able to produce strong immune responses. In June, the Chinese military approved the vaccine for one year as an especially needed drug. Apparently, the company is moving on to a phase 3 trial in Saudi Arabia and is in discussions with other countries about more clinical trials.
Russia approval of early use of vaccine
Based on a phase 1 clinical trial of the Gamaleya Research Institute, the Russian government has announced that they are planning to start vaccine production by the end of the year. The vaccine that was tested is called Gam-Covid-Vac lyo (now renamed Sputnik V) and is a combination of two adenoviruses, Ad5 and Ad26. Both are engineered with a coronavirus gene. The announcement of production and approval came even before Phase 3 trials had begun and health experts worldwide have expressed criticism for a premature vaccine. Ever since Russia has been clarifying that approval would only take place after positive results from phase 3 clinical trials with around 40,000 volunteers.
These are just some examples of clinical trial developments in the race of finding a vaccine for Covid-19. Multiple other organizations are working hard to develop new results at the moment with more promising results. Follow along for more updates on the clinical trial developments for Covid-19 and other health conditions.
Making a difference for medical innovation
Now more than ever, we see how essential clinical research is in order to drive clinical innovation and to save the lives of millions of people. Do you want to be part of medical history and make a difference for your community? Clinical trials need volunteers in order to test new treatments effectively and bring them to the mass market. If you want to learn more about clinical trials, the benefits, and risks and see if this would be something for you, please visit our clinical trial education website here.