The FINANCIAL -- The outcome of vaccine trials is being closely watched around the world. Pharmaceutical company AstaZeneca said Tuesday that it had paused global trials of its coronavirus vaccine in America as it is investigating one of the volunteers in United Kingdom who had a serious side effect – unexplained illness. It's a standard precaution in vaccine trials that is meant to ensure experimental vaccines don't cause serious reactions among participants. AstraZeneca described it as a routine pause in the case of an unexplained illness.
The AstraZeneca vaccine, known as AZD1222, was invented by the University of Oxford and an associated company, Vaccitech. The company said that monoclonal antibodies are created in the lab, mimic natural antibodies, and their treatment may prevent disease progression. The monoclonal antibodies are derived from the convalescent plasma of COVID-19 patients. The company pointed to a recent study published in Nature where researchers at Vanderbilt University Medical Center showed the monoclonal antibodies blocked the SARS-CoV-2 virus from binding to host cells and shielded “against infection in cell and animal models of disease,” as reported by FOX News.
A spokesperson for AstraZeneca, a frontrunner in the race for a Covid-19 vaccine, said in a statement that the company’s standard review process triggered a pause to vaccination to allow review of safety data. In a follow-up statement, AstraZeneca said it initiated the study hold. The nature of the adverse reaction and when it happened were not immediately known, though the participant is expected to recover, according to an individual familiar with the matter. The spokesperson described the pause as 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 spokesperson also said that the company is working to expedite the review of the single event to minimize any potential impact on the trial timeline, according to StatNews.
Earlier Tuesday, AstraZeneca joined eight other companies in signing a pledge promising they would not seek premature government approval for any coronavirus vaccine. They promised they would wait until they had adequate data showing any potential vaccine worked safely. The AstraZeneca vaccine is one of three coronavirus vaccines in late-stage, Phase 3 trials in the US. A Data and Safety Monitoring Board usually monitors trials for adverse events and can order a pause or halt a trial, but AstraZeneca did not say who had stopped the trial. Common adverse events in vaccine trials include fever, headache, soreness at the injection site and muscle pain. Regulators and companies alike have been working to ensure people trust in the vaccine authorization process. The US Food and Drug Administration must give either emergency use authorization or full approval to any vaccine before it can be distributed in the US, CNN reported.
"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. It was signed by the CEOs of AstraZeneca, BioNTech GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer and Sanofi. They also added that they 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.
The trial’s halt will allow the British-Swedish company to conduct a safety review. How long the hold will last is unclear. In a statement, the company described the halt as 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. In large trials like the ones AstraZeneca is overseeing, the company said, participants do sometimes become sick by chance, but such illnesses must be independently reviewed to check this carefully, THe New York Times wrote.
It is interesting to note that a recent retrospective study published in JAMA Network Open found that people with untreated vitamin D deficiency, measured as less than 20 nanograms per milliliter, may be almost twice as likely to contract coronavirus compared to people who get sufficient doses of the sunshine vitamin. The study, out of UChicago Medicine, looked at 489 patients whose vitamin D levels were measured within the year before being tested for novel coronavirus. Those patients with levels categorized as deficient were found to be more likely to have a positive COVID-19 test result.
Obesity makes it more difficult to vaccinate adults against influenza. Will this be the case for COVID-19 too? Evidence that obese people have a blunted response to common vaccines was first observed in 1985. Moreover, having obesity, defined as a body mass index (BMI) of 30 or above, increases your risk of severe illness from COVID-19. The researchers found that 22 percent of obese patients were intubated, 25 percent died, and 2 percent remained hospitalized during a median hospital length of stay of seven days. Read more.