A Second Safety Incident Report Associated with COVID-19 Vaccine AZD1222

A Second Safety Incident Report Associated with COVID-19 Vaccine AZD1222

AstraZeneca followed Moderna and Pfizer to release specifics about the vaccine trial protocol to help alleviate public concern. TrialSite has noticed more chatter throughout the media about general public concerns in regards to the COVID-19 vaccines. A growing sense of politization, regardless of political persuasion, concerns all. AstraZeneca’s clinical trial, at least in the United States, appears under greater scrutiny due to the disclosure that not one but two UK clinical trial participants developed serious neurological illness during the actual trial. Why so much concern? Apparently, the company hasn’t offered up any details about the nature of the illness, whether they are absolutely connected to the Oxford vaccine, and finally growing concern in America about political encroachment into what is typically the domain of regulators, physicians and scientists all adds up to a potentially game changing situation. While AstraZeneca secured over $1 billion from the U.S. government for the Phase 3 clinical trial and up to 400 million doses of the experimental product. AstraZeneca ensured waiver of product liability—a standard practice.

Growing Tension in U.S.

According to a recent report in New York Times, the UK company’s clinical trials have triggered real fret about another report of a safety incident, totaling two now for the experimental vaccine AZD1222. Mark Slifka PhD, a vaccine expert at Oregon Health and Science University, conveyed, “If there are two cases, then this starts to look like a dangerous pattern.” Slifka continued, “If a third case of neurological disease pops up in the vaccine group, then this vaccine may be done.”  As TrialSite has reported, the clinical trial is still on hold in the United States but has resumed in the UK, Brazil, India and South Africa. TrialSite has commissioned a documentary on the study.

According to a biostatistician and expert in vaccine-based clinical trial design at University of Florida, Natalie Dean, PhD, who also was quoted in the New York Times article, “This is an unprecedented situation, and public confidence is such a huge part of the success of this endeavor.”

Based on the AstraZeneca protocol disclosure, the vaccine needs to have 50 percent effectiveness; a U.S. Food and Drug Administration (FDA) threshold in promulgated guidance associated with COVID-19. Eric Topol, MD, with Scripps Research, San Diego shared with the New York Times that the protocol revealed a weakness in all of the studies. Namely that when evaluating vaccine effectiveness, the sponsors include relatively mild cases of COVID-19 and this may lead to uncertainty in regards to correlating the vaccine to prevention of moderate to severe cases.

AstraZeneca Waives Liability

As is often the case with pharmaceutical manufacturers, clinical trials often include exemption from liability claims—and that’s the case with AstraZeneca. As reported in Reuters July 30, the UK-based pharmaceutical company ensured that it secured protection from future product liability claims in association with AZD1222 in most countries.

Ruud Dobber, an AstraZeneca executive informed Reuters, “This is a unique situation where we as a company simply cannot take the risk if in…four years the vaccine is showing side effects.” 

U.S. Government Awards $1 Billion for AZD1222

On May 21, under the current administration’s Operation Warp Speed, the U.S. Biomedical Advanced Research and Development Authority gave the British pharmaceutical giant over $1 billion in funding for the Phase 3 clinical development of AZD1222, assurance of up to 400 million doses of the investigational product.

What happens if the product is shelved? Does the U.S. taxpayer get its money back?

Informal TrialSite Survey

TrialSite has spoken with a couple dozen people via online sources and over the telephone. There does appear to be almost palpable, growing concern about politicization of science. Few people spoken with would be willing to be first in line to take any of these vaccines. The pharmaceutical companies and government agencies should ensure that public confidence strengthens in the process. TrialSite is investing in a documentary peering into the vaccine trial process.