Appearing to be a competent participant in the global race to produce a covid-19 vaccine, American company Innovio Pharmaceuticals is set to begin safety tests for a potential vaccine. The company announced on Monday that the US Food and Drug Administration (FDA) has accepted its Investigational New Drug application for its DNA vaccine candidate 1NO-4800. The second American company to attain approval from the FDA, Innovio will begin Phase-1 of clinical testing this week.
The trial will comprise of 40 volunteers, selected through screening conducted at Philadelphia and Kansas City. The first doses will be administered on Monday. Each participant will receive two doses of INO-4800 four weeks apart. Initial immune responses and safety data can be expected by late summer, although a broad clearance or approval for use is still a year to 18 months away. Parallel to the Phase-1 clinical trial, the company will continue additional preclinical trials and challenge studies. Moderna which was the first American company to have its drug approved began its tests in mid-march.
While the vaccine produced by Moderna used messenger RNA, the Innovio DNA vaccine candidate presents a part of the pathogen to the immune system. The vaccine candidate works by injecting a patient with a specifically engineered plasmid, a small independent genetic structure. As a response, the patient’s body cells will then produce an antibody to fight off the infection. Antibodies are a kind of immune memory which after being elicited once, can be mobilised again when the body is exposed to the virus. DNA vaccine candidates are widely used in the case of animals but have not been approved for human use. FDA’s approval of the vaccine candidate is also based on results from the Innovio’s pre-clinical studies performed on animals which recorded an increased immune response in the animals.
Measures such as social distancing have only slowed down the spread of COVID-19, a novel form of coronavirus that has already caused more than 70,000 deaths as of April 7th 2020. Any long-term success with regards to ultimately containing the pandemic will rely on the production of a vaccine. And even though human trials have come up at an impressively fastened timeline, actual vaccine is still at least a year away.
According to a statement by WHO on March 20th, 44 candidates were in the list of potential vaccines. We do however have a head start owing to the fact that the pathogen shares genetic material with the SARS and MERS outbreaks that were also caused by coronavirus. Due to the groundwork related to both diseases, a lot of research and studies is at the expense of organisations developing a covid-19 vaccine. Rolling out a vaccine also depends on how effective it actually is in a real world scenario. What may work in labs may not work in the real world. For vaccines to be approved for use, three long phases of clinical testing have to be conducted, each of which will be months long.