The American pharmaceutical company Novarax has started in Australia the first human clinical trial of its possible vaccine against the new coronavirus. And he hopes to have the preliminary results of the study in July, before starting the second - and final - phase.
"Administer our vaccine in the first participants of this clinical trial It is a significant achievement, taking us one step closer to solving our fundamental need for a vaccine against the global pandemic of COVID-19.”Stanley C. Erck, Novavax President and CEO, said in a statement.
"We are looking forward to sharing the results in July and, if they are promising, to quickly start the second phase of this trial," added Erck.
Called NVX-CoV22373, the vaccine is being tested with some 130 healthy participants between the ages of 18-59 at two non-specified locations in Australia. In April, authorities had anticipated that they planned to use their Matrix-M adjuvant to improve the immune response.
Adjuvants are mainly used for vaccines to induce a strong immune response, even through increased antibody production, and provides longer-lasting protection against viral and bacterial infection.
Along these lines, the company, which has its headquarters in the state of Maryland, assured that preclinical trials predict that the vaccine "it will be highly immunogenetic in humans, potentially achieving protection from COVID-19 and helping to control the spread of the disease"
If this is the case, they announced, Phase 2 of the trial will be conducted in different countries, including the United States. This stage will assess immunity, safety and disease reduction over a broader age range, the company added..
Vaccine development is supported by the large global network of the Coalition for Innovations and Epidemic Preparedness (CEPI), working to find a vaccine to mitigate the effects of the current pandemic.
Currently, there are about 10 vaccines that are being tested in humans, including projects from the laboratories of the American company. Pfizer, which develops its project together with the German laboratory Biontech, and another from the British pharmacist AstraZeneca, which investigates with the Jenner Institute, Oxford University.
The latter, in fact, has already started phase 2 and expanded participation in vaccine tests to more than 10,000 people, including individuals over the age of 70 and children between the ages of 5 and 12.
Human clinical trials are also being conducted in four laboratories in China, two by the company. Sinopharm, one of Sinovac and another of the Chinese Academy of Medical Sciences and CanSino Biologics Company.
The prestigious medical journal The Lancet published last Friday an article in which he indicated that the latter, the first to reach the stage in question It was found to be safe, well tolerated and capable of generating an immune response against the disease..
"These results represent an important milestone. The trial shows that a single dose of the new COVID-19 vaccine vectorized by adenovirus type 5 (Ad5-nCoV) produces specific antibodies against the virus and T cells in 14 days, making it a potential candidate for further investigation.”Explains the person in charge of the work, Wei Chen, from the Institute of Biotechnology in Beijing, China.
The trial assessed the safety and ability to elicit an immune response from different doses of the new Ad5-nCoV vaccine in 108 healthy adults 18-60 years of age who were not infected with SARS-CoV-2. Volunteers from a center in Wuhan, China were enrolled and assigned a single intramuscular injection of the new Ad5 vaccine at a low, medium or high dose..
The vaccine candidate was well tolerated at all doses, no serious adverse events were reported in the 28 days after vaccination. Most adverse events were mild or moderate, with 83 percent (30/36) of those receiving low and medium doses of the vaccine and 75 percent (27/36) in the high-dose group reporting at least one adverse reaction within 7 days of vaccination.
Wei Chen clarified that the results should be "interpreted with caution", considering that "the challenges in developing a vaccine against the disease are unprecedented, and the ability to trigger these immune responses does not necessarily indicate that the vaccine will protect humans from it. ”. However, he emphasized that the result "shows a promising vision", but clarified that "we are still very far from making this vaccine available to everyone."
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