As the COVID-19 pandemic rages on in the United States and other countries throughout the world, the race for a vaccine has amped up as well. While early phases of several clinical trials have shown promising results, the larger, third phase of trials is what measures their overall effectiveness and safety.
Vaccines are difficult to produce and adverse side-effects can derail a medical trial for months. With so many hiccups and information floating out there on the Internet, it is hard to keep up. Here is what you need to know about the current status of COVID-19 clinical trials.
The Major Players
The U.S. Food and Drug Administration (FDA) has said that, due to the severity of the COVID-19 pandemic, an approved vaccine would only need to be effective in 50 percent of people who receive it. The reasoning is that some protection is better than nothing. Currently, there are five companies that have completed two phases of esting that meet these FDA standards.
At the end of October, Pfizer and its partner, BioNTech, announced that they are fewer than 2,000 medical-trail participants away from completing phase three. They have administered the double-dose vaccine to approximately 36,000 people at this point, making it the most promising trial to date.
The treatment uses an RNA genetic code that causes human cells to produce a coronavirus protein. This prompts the body’s immune system to generate a defensive response.
Pfizer could file for an Emergency Use Authorization with the FDA as early as late November. This would make the vaccine available to vulnerable groups, such as first responders and the elderly, by the end of the year. Broader distribution to the public could be expected by spring.
Moderna Therapeutics is in the middle of phase-three testing of its COVID-19 vaccine, which also uses the same genetic code technology. They currently have 30,000 participants enrolled in the study.
AstraZeneca, working with the University of Oxford, saw a trial paused during the summer after a patient suffered a serious reaction to the vaccine. The condition, known as traverse myelitis, an inflammation in the spinal cord, put the medical trial on hold for several weeks. But it has resumed and is in the final phase.
Johnson & Johnson
The only major drug company testing a single-dose vaccine is Jonhson & Johnson. Their phase-three trial was also put on hold for a few weeks after a participant in his 20s suffered a stroke. After an FDA investigation, they were allowed to resume testing.
Novavax is the fifth company to complete the second phase of clinical trial testing. They plan to begin phase-three testing in late November.
Other Medical Trials
There are other clinical trials in the early testing phase. CureVac has seen promising results in a small, 250-person study with participants developing neutralizing antibodies at the same levels seen in people who had contracted COVID-19.
There are other trials focusing on treating the symptoms of COVID-19. Roivant Sciences is attempting to address one of the main complications of COVID-19: acute respiratory distress syndrome (ARDS), and overactivation of inflammatory myeloid cells in the lungs.
Roivant has developed a therapeutic called Gimsilumab, an antibody that attacks the factor that causes inflammation. They have completed phase one with more than 200 patients and have moved on to phase two.
Which Medical Trial Will Prevail
It is impossible to say with certainty when a vaccine will be available to the public, but optimism about one being approved in the next sixth months continues to grow.
And all the companies working on them have been ramping up their distribution capacity. So, in the event that a vaccine gains approval, they will be “sitting on go.”
We hope you found this information about the status of COVID-19 medical trial testing helpful. Be sure to check out some of our other posts on everything from digital marketing and technology to health and lifestyle.