The coronavirus pandemic continues to affect millions of people around the world.
Globally, over 27 million people have been infected, claiming the lives of almost 900,000 people. In the U.S., the number of cases has already topped the 6 Million mark, with the death count nearing 190,000.
The virus has also drastically changed everyday life as we know it – from lockdowns and quarantines to staying home and practicing safety measures in an effort to slow the spread of the virus.
The race to find a vaccine against the SARS-CoV-2 virus – the virus that causes COVID-19 – continues at an unprecedented rate. There are over 100 vaccines in development around the world – several are in various phases of human trials.
Three companies are beginning Phase 3 of clinical trials in the U.S. – AstraZeneca, Moderna, and Pfizer/BioNTech.
AstraZeneca announced last Monday (August 31) that they have started the late-stage trial of their experimental vaccine in the U.S., which would involve “recruiting up to 30,000 adults aged 18 years or over from diverse racial, ethnic and geographic groups who are healthy or have stable underlying medical conditions, including those living with HIV, and who are at increased risk of infection from the SARS-CoV-2 virus.”
On Tuesday (September 8), however, the company announced that they have paused global trials for a safety review, following an “unexplained illness” in a volunteer.
“As part of the ongoing randomized, controlled global trials of the Oxford coronavirus vaccine, our standard review process triggered a pause to vaccination to allow review of safety data,” the company said in a statement.
“This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials,” the statement added.
“In large trials, illnesses will happen by chance but must be independently reviewed to check this carefully. We are working to expedite the review of the single event to minimize any potential impact on the trial timeline. We are committed to the safety of our participants and the highest standards of conduct in our trials.”
Meanwhile, both Moderna and Pfizer/BioNTech are still in the midst of recruiting their stated goals of 30,000 volunteers each.
Last week, the Center for Disease Control and Prevention sent out documents asking states to prepare for a possible distribution of a potential coronavirus vaccine as early as late October. Per The New York Times, the documents sent to public health officials in all states and territories noted in its guidance that “limited Covid-19 vaccine doses may be available by early November 2020,”
However, the agency also said that it’s still hypothetical. “The Covid-19 vaccine landscape is evolving and uncertain, and these scenarios may evolve as more information is available.”
In an interview with ABC News on Friday (September 4), U.S. Surgeon General Dr. Jerome Adams said that the guidance is “just in case.”
“We’ve always said that we are hopeful for a vaccine by the end of this year or beginning of next year,” Dr. Adams said, adding, “That said, it’s not just about having a vaccine that is safe and effective — it’s about being ready to distribute it.”
The World Health Organization has already cautioned governments against rushing the development of coronavirus vaccines and advised taking great care in granting emergency use authorization, which fast tracks getting a vaccine in wide use earlier – full approval, which involves going through all proper channels, can take months.
Nine of the world’s leading drug manufacturers – Moderna, AstraZeneca, Pfizer, BioNTech, Merck, GlaxoSmithKline, Johnson & Johnson, Sanofi, and Novavax – signed a pledge on Tuesday (September 8) to seek approval only after their potential COVID-19 vaccines are demonstrated to be safe and effective.
“We, the undersigned biopharmaceutical companies, want to make clear our on-going commitment to developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles,” the statement read, which also pledged to “make the safety and well-being of vaccinated individuals our top priority” and apply for government authorizations only “after demonstrating safety and efficacy through a Phase 3 clinical study.”
“We believe this pledge will help ensure public confidence in the rigorous scientific and regulatory process by which COVID-19 vaccines are evaluated and may ultimately be approved,” they added.
