COVID-19 Vaccine Trials Can’t Tell If The Shots Will Save Lives, Protect The Elderly

Since the COVID-19 outbreak, the scientists have been trying to find an effective vaccine for the viral disease. Despite suffering many setbacks, many vaccines are now in the final stages of trials.

All of us are waiting for the vaccine to hit the market so that it can bring an end to the global health crisis. No doubt the vaccines are being hailed as the solution to the COVID-19 pandemic but the trials currently underway are not designed in a way that can tell us if they will save lives, according to a drug development expert from the prestigious British Medical Journal (BMJ).

Writing in The BMJ medical journal, Associate Editor Peter Doshi, said that several COVID-19 vaccine trials are now in their most advanced (phase 3) stage, but what will it mean exactly when a vaccine is declared “effective”?

Vaccine May Not Reduce Transmission Or Mortality Rate

Now we may assume that the successful phase 3 studies means that we have a proven way of keeping people from getting very sick and dying from COVID-19. People also view vaccines as a robust way to interrupt viral transmission.

Yet the current phase 3 trials are not actually set up to prove either, Doshi said. “None of the trials currently underway are designed to detect a reduction in any serious outcome such as hospitalisations, intensive care use, or deaths. Nor are the vaccines being studied to determine whether they can interrupt transmission of the virus,” he wrote

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Trials Focusing Only On Mild Disease

He continued to explain that all ongoing phase 3 trials that have released their details are now evaluating mild, not severe, disease symptoms. They will be able to report final results once around 150 participants develop the symptoms.

In Pfizer and Moderna’s trials, the individuals with only a cough and positive lab test would bring those trials one step closer to their completion. Yet Doshi argued that vaccine manufacturers have done little to dispel the notion that the severe COVID-19 was what was being assessed.

Inadequate Data To Look Into Hospitalization Rate: Moderna

Moderna, for example, called hospitalisations a “key secondary endpoint” in statements to the media. But Tal Zaks, Chief Medical Officer at Moderna, told The BMJ that their trial lacks adequate statistical power to assess that endpoint. Moderna’s trial will not be able to demonstrate prevention of hospitalisation because the size and duration of the clincal trial would need to be immensely increased to collect the necessary data, confirmed Zaks.

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Benefit For The Elderly Is Also Not Looked Into

But Doshi raised another important issue that few or perhaps none of the current vaccine trials appear to be designed to find out whether there is a benefit in the elderly, despite their obvious vulnerability to COVID-19.

He warned, there can be little basis for assumption that any benefit against hospitalisation or mortality of elderly, if the elderly is not enrolled into vaccine trials in sufficient numbers to determine whether there is a reduction in cases in this population. Doshi said that we still have time to advocate for changes to ensure the ongoing trials address the questions that most need answering.

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