Coronavirus vaccine trial sparks hope with ‘remarkable’ results

A vaccine for COVID-19 has produced an immune response in all volunteer candidates in Phase 1 of the study, new results said.

Xinhua Yan, a scientist in the lab at Moderna in Cambridge, Massachusetts. Picture: David L. Ryan/The Boston Globe
A vaccine for COVID-19 being developed by Moderna Therapeutics has produced an immune response in all the volunteer candidates in Phase 1 of the study, newly published results said.Dr Lisa Jackson, a senior investigator who worked on the study said the results came quickly and are “pretty remarkable”.

The trial showed the vaccine required a second dosage, given four weeks after the first, to produce an immune response in its subjects. Many of the 45 test subjects produced more of an immune response from the vaccine than people who had been infected with a mild case of the COVID-19, according to reports.

Some candidates were injected with a high dosage of the vaccine, and had mild side effects, including fatigue, chills, headache, muscle pain and pain at the site of the injection.

The results were published in the New England Journal of Medicine on Tuesday.

Moderna, a US biotechnology company working with the National Institutes of Health, is the first in America to publish results about a vaccine candidate in a peer-reviewed medical journal.

Later this month, the company’s vaccine candidate will enter Phase 3 of its trial – a large and final stage of trials before regulators consider making the vaccine available to the public.

That phase of the trial for vaccine candidate mRNA-1237 will begin on July 27 in the US.

The biotech company said if its vaccine can successfully be put to market, “the company remains on track to be able to deliver approximately 500 million doses per year, and possibly up to 1 billion doses per year, beginning in 2021”.

Dr Lisa Jackson, a senior investigator at Kaiser Permanente Washington Health Research Institute in Seattle who worked on the trial told CNN the goal of Phase 1 of the study was to “look at safety and then to look at immune responses”.

We thought the immune responses look promising, but we don’t know whether the levels we’re seeing would actually protect against infection.

Dr Jackson said it’s hard for researchers to predict the results until the efficacy trials have taken place. She said they’ve now laid the “groundwork” to provide the answers throughout Phase 2 and 3 of trials.

Dr Jackson said at this stage, the results “provided information rapidly that could be used to determine what dose to go forward with Phase 2 and Phase 3 trials”.

That’s a critically important decision to make and so having that information available so soon after the vaccine trial was initiated is pretty remarkable.

Candidates were given dosages of either 25mcg, 100mcg or 250mcg and were injected with the vaccine on March 16 and April 14.

Candidates reported some adverse effects at different doses of the vaccine. At the first dosage, five participants in the 25mcg group had adverse events, 10 in the 100mcg group had adverse events and eight in the 250mcg group had adverse events.

When given the second dose, seven of 13 participants in the 25mcg group had adverse events, all 15 in the 100mcg group had averse events and all 14 in the 250mcg group had adverse events. Three of those in the 250mcg group reported “one or more severe events” according to CNN.
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Among the reported side effects were fatigue, chills, headache and muscle pain. Some subjects who were given a higher dose of the vaccine developed severe flu-like symptoms, including Ian Haydon, from Seattle.

He said he developed a high temperature and vomited after being give the high 250mcg dose of the virus. His dosage won’t be replicated.

He said he didn’t want his experience to deter people from taking the vaccine.

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