It may seem like an eternity since the COVID-19 pandemic began, but in reality just four months ago the World Health Organization (WHO) activated the plan to accelerate the development of diagnostic tests, vaccines and therapies for the novel coronavirus, of which there are already several promising immunizations in its final stages of testing in thousands of volunteers around the world.
Recently President Vladimir V. Putin declared that Russia was the first country to approve a coronavirus vaccine, however, many global health authorities would point out of not having completed critical clinical trials of the latest stages of development, which are important for determining its safety and efficacy. Despite these questions, it is true that, with more than a hundred vaccines being tested, the world had never seen this rapid pharmacological response to a disease.
There is still no guarantee that the most advanced experimental vaccines – from the National Institutes of Health and Moderna Inc., as well as those in China, the University of Oxford of Great Britain and one in Brazil – will actually protect against infection, until they complete their tests, but the progress has been extraordinary and promising.
Under WHO coordination, it was on April 13 that a group of diverse experts stated that they were working on the development of COVID-19 vaccines. Those 128 scientists, doctors, funders, and manufacturers signed an international collaborative statement to help accelerate the availability of a vaccine to control this pandemic. Their call to the world population to follow the prevention and protection recommendations against the virus would give them time “while a vaccine is developed as quickly as possible.”
Under U.S. CDC standards, the process requires basic research, clinical studies, determination of side effects, and adverse reactions, prior to approval of any vaccine. The general phases are exploratory stage, preclinical stage, clinical development, regulatory review and approval, manufacturing, and quality control.
During Phase I, small groups of people receive the trial vaccine. In Phase II, the clinical study is expanded, and the vaccine is administered to people who have characteristics (such as age and physical health) like those destined for the new vaccination. In Phase III, the vaccine is given to thousands of people and efficacy and safety are tested. In addition, many vaccines undergo formal and ongoing phase IV studies after it is approved.
According to the Pan American Health Organization, the first decade of the 21st century was the most productive in the development of new vaccines thanks to innovative manufacturing technologies, support from public-private partnerships and other resources and financing mechanisms. New vaccines that are helping to save lives include those that fight the rotavirus, pneumococcal and papillomavirus.
To approve a vaccine in the United States, the process is regulated by the Food and Drug Administration’s (FDA) Center for Biological Assessment and Research. The sponsor of the new product usually follows these steps: submit application for new drugs under investigation; clinical trials of the pre-license vaccine, biological license application (BLA), inspection of the manufacturing plant, submission of the findings to the FDA Advisory Committee on Vaccines and Related Biological Products (VRBPAC), and usability testing of product labeling.
After approval, the FDA will continue to monitor the production of the vaccine to ensure continued safety. The follow-up of side effects is done through a surveillance system co-sponsored by the FDA and the CDC in which reports of patients, parents, medical providers, pharmacists, and manufacturers are accepted.
“We are optimistic, cautiously optimistic,” said Dr. Stephen Hoge, president of Moderna, based in Massachusetts, to a federal House subcommittee. The vaccine could be ready by the end of this year. The goal is to have 300 million doses of vaccine by January 2021.