What A Difference A Country Makes in Vaccine Trials

What A Difference A Country Makes in Vaccine Trials

Such a different point of view there is on AstraZeneca’s leading COVID-19 vaccine contender known as AZD1222 around the world. Originally developed by the University of Oxford, it’s known as Covishield in India. Now, as TrialSite has reported, the vaccine trial was put on hold due to an adverse event with at least one and possibly two patients in the UK. However, the trial has resumed in the UK and India. While the U.S. FDA is clearly concerned—and doing its job—to scrutinize the data in the United States, in the UK and India it’s full throttle forward and now there’s even discussion of commercialization by Christmas!

That’s right. The Times even reported that the vaccine candidate for COVID-19 could be available for commercial use by December. News sources in the UK and India report that a full vaccine roll-out is probably 6 months or less once approval occurs, commenting, “We are looking at closer to six months and it is likely to be far shorter than that.”

100 Million Doses

The UK government has secured a purchase of 100 million doses of the “Oxford vaccine” once it’s approved and ready for distribution.

Distribution Protocol

In the UK, first in line for the vaccine are the elderly, those over 65 who are most at risk to COVID-19. Followed are adults in high risk categories, such as ethnic minorities with comorbidities.

NHS Ready

Reports out of England suggest that the UK’s socialized medical system, known as the National Health System (NHS), is ready to almost immediately initiate mass vaccination.

But others More Conservative

But others’ points of view suggest that a more conservative approach should involve more pragmatic and feasible timelines. A Royal Society report suggests of a considerable effort forthcoming involving the vaccine’s production and distribution. Professor Nilay Shah commented, “Even when the vaccine is available, it does not mean within a month everybody will be vaccinated. We’re talking about six to nine months to a year after a vaccine is approved.” Professor Shah heads up chemical engineering at Imperial College London.

Better Safe than Sorry

TrialSite has emphasized a tried and true principal within clinical research: better safe than sorry

While Chinese vaccine makers get ever closer to commercialization in various parts of the world, Russia’s Sputnik V is already registered or approved. But its open knowledge that the vaccine makers in these countries in the “East” are essentially bypassing key steps. 

For example, in Russia, in addition to conducting questionable human challenge studies,  the authorities there decided to allow the sponsor to skip Phase 3 all together and go straight after a compressed Phase 2 study to submit for registration. 

Undoubtedly, the brightest scientific minds in places like Russia and China are working on these vaccines and there certainly is a good probability that these products are good. But the various systems and processes associated with Good Clinical Practice (GcP) and FDA’s regulatory requirements (the Gold Standard) are there for a reason.

An argument can be made that public safety merits the bypassing of traditional steps but that argument has flaws. After all, with a novel and dynamically morphing pathogen, such as COVID-19, it may make it difficult for the first wave of vaccines’ efficacy. This first group of vaccines will help but theirs is a high probability their efficacy rate may only be in the 50% range, if that.

In fact, the next batch of vaccines, Vaccine 2.0 will represent a stronger case for COVID-19 vaccination. Readers shouldn’t forget that drug makers were never able to figure out a vaccine for HIV/AIDS—billions were spent trying.

As it turns out, in the interim establishing standardized and uniform safety measures (masks , social distancing, hand-washing, etc.) while working on not only the expensive, novel therapies and prophylaxis but also considering off-label low cost options that could help, seems to be what the doctor ordered as well.