Covid vax trials can't tell if the shots save lives: BMJ expert

Covid vax trials can't tell if the shots save lives: BMJ expert

Last month, AstraZeneca had to halt clinical trials after a volunteer in the United Kingdom developed transverse myelitis.

In what is probably the first of many meetings, the Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee, or VRBPAC, met on Thursday to consider Covid-19 vaccines. Last week, Pfizer Inc. received permission to test its vaccine in US kids as young as 12, one of only a handful of attempts around the world to start exploring if any experimental shots being pushed for adults also can protect children. Nor are the vaccines being studied to determine whether they can interrupt transmission of the virus, " he wrote.

According to CNN, Moderna is the first company to start USA clinical trials of a COVID-19 vaccine.

Brazilian regulator says testing of the vaccine will, however, continue even after the volunteer's death.

.

Pfizer and its German partner BioNTech have written a letter to the FDA saying that they have "an ethical responsibility" to inform members of the placebo group and called on the agency to be open to other methods to evaluate the vaccines. The Infectious Diseases Society of America states that FDA's panelists "should insist" that vaccine developers "present a compelling case" for how they will complete their trials if FDA grants early authorization of their vaccine. Also during the early vaccination stages, the government will target people at high risk for severe COVID-19, those who live in close quarters, teachers and those with limited access to vaccines, Routh said. AstraZeneca said medical confidentiality meant it could not give details on any individual volunteer, but that independent review had "not led to any concerns about continuation of the ongoing study".

A method to check the inoculation contains all the correct parts was developed by a team at Bristol University, providing greater evidence that the vaccine works.

"I think that we have done quite well - I think the demographics of the Moderna trial have markedly changed", Larry Corey, a virologist at Fred Hutchinson Cancer Research Center said in an interview last week.

Around 8,000 volunteers have been vaccinated so far in Brazil, and more than 20,000 worldwide, it said.

Professor Trudie Lang, director of the Global Health Network at the Nuffield Department of Medicine explains, "The sad event of someone dying on a vaccine trial immediately triggers the actions defined in the trial protocol that are carefully set out for all serious events".

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