A
A
A
As the COVID-19 continues to spread through the United States and other countries, the hard push to develop a vaccine to combat the virus has gone on a number of fronts. The biotech firm Moderna Therapeutics recently announced results of their Phase 1 trial of an experimental serum that appears to provide antibodies against COVID. A closer look offers hope for finding a vaccine that will allow the public health to be protected against this dangerous virus, so that the country can return to economic stability.
Impact of the Novel Coronavirus
Coronavirus encompasses a broad family of viruses, but this form of the virus has been particularly contagious and particularly deadly, having taken the lives of over 90,000 Americans in just a few months. Close contact with droplets from the nose and mouth appears to transmit the virus quickly. Any essential worker who must engage in frequent, close contact with others are at increased risk of acquiring the disease, bringing it back home to family and community.
Read More »
Stepped Up Efforts to Protect Against the Virus The recent lockdowns have been effective in halting the spread of the disease, but it has also damaged economic security for millions of people. The need for an effective immunization agent has become critical in order to re-open the economy across the nation, without experiencing numerous outbreaks that can threaten more lockdowns. As a result, companies involved in the development of immunization medicines have accelerated their efforts to bring a workable antibody serum to market as quickly as possible.
Challenges of Development
Developing a serum to stimulate an immune response in the human body is not a fast or easy process. There are no shortcuts for the clinical trials that will ensure that the drug is effective and will be safe to use. DNA technologies have facilitated the initial steps in developing an immunization, but the hard work of testing requires considerable time and care. President Donald Trump has encouraged pharmaceutical and biotech companies to step up their efforts to develop scalable methods to vaccinate the public against the virus by the end of the year.
How the Clinical Trial Was Conducted
Forty-five subjects were given the serum at three different doses to determine the antibody activity at a variety of dosage levels. An initial dose and a second booster dose were given. At the 25-milligram level, antibody levels reached that of 4 individuals who had experienced a COVID infection. At the 100-milligram level, the amount of antibodies in the 4 subjects exceeded that of individuals who had survived the disease. These are early results and are incomplete, but they offer some hope for fast development of an antibody medication.
Keeping A Close Eye on Adverse Effects
When developing new immunization medications, great care must be taken not only to ensure the effectiveness of the drug in a variety of populations. They must also be tested for safety in the young, the old and in those who may have underlying medical issues. Adverse effects of all kinds must be noted and investigated. In the Phase 1 study, mRNA-1273 was well tolerated in subjects at the lower dose level. Some side effects were observed, but they were considered to be slight and self-resolving.
Although the results of the first phase of the Moderna trial provide some grounds for optimism, further testing will be needed to ensure both the safety and effectiveness of the new immunization serum across a variety of demographic groups. However, the aggressive actions being taken by manufacturers to create and produce a scaleable product that can be widely distributed throughout the country suggest that a successful outcome may be on the horizon within a reasonably short period of time.
