Clinical trial shows Modern COVID-19 vaccine on the right track

Within 12 hours of receiving the second dose of an experimental COVID-19 vaccine developed by Moderna Inc., Ian Haydon began to shiver. Then came nausea, headaches, muscle pain, and delirium. He took his temperature: 103.2 degrees.

The 29-year-old Seattle resident, one of 45 participants in the company’s Phase 1 clinical trial, knew that his body was trying to mount a defense against the vaccine. If it worked, your immune system would be ready to fight a real coronavirus infection.

As an aspiring marathon runner without any health problems, Haydon couldn’t remember feeling so sick. His girlfriend took him to urgent care. Later that night, he passed out in his apartment.

With fluids and rest, the symptoms faded. A day and a half after receiving the injection, he felt fine.

Similar side effects of Moderna’s COVID-19 vaccine were described in a report published Tuesday by the New England Journal of Medicine. Their findings confirm the company’s preliminary announcement in May that the candidate vaccine caused the production of antibodies against the coronavirus in human testers.

The results of the peer-reviewed study “are promising and support the continued development of this vaccine,” wrote Dr. Penny Heaton, executive director of the Bill and Melinda Gates Institute for Medical Research, in an editorial for the journal. “However, we must take into account the complexity of vaccine development and the work that remains to be done before COVID-19 vaccines become widely available.”

Moderna is a leader in the global race to develop a vaccine and control the COVID-19 pandemic. The 10-year-old Cambridge, Massachusetts company is one of six candidates receiving funding as part of Operation Warp Speed, a multi-million dollar federal initiative designed to accelerate vaccine development.

Your vaccine introduces genetic material from the coronavirus into the body, which responds by producing a protein that allows the virus to infiltrate a host cell. The presence of the so-called spike protein triggers the body’s immune response and induces the development of protective antibodies that can stop the virus on its way.

The technique, known as mRNA, was first developed to combat other coronaviruses (MERS and SARS), but had not advanced beyond early clinical trials.

In the new Phase 1 trial, Haydon and the other study subjects produced antibodies against the coronavirus at levels comparable to patients who had contracted and recovered from COVID-19. However, that does not necessarily mean that the vaccine can provide immunity to the disease.

“It is the first step, but it is an exciting first step,” said Dr. William Schaffner, an infectious disease expert at Vanderbilt University and medical director of the National Foundation for Infectious Diseases. “He demonstrated that this new technology, mRNA, can induce a substantial immune response. We are confident that the immune response will correlate with protection in the future. “

Dr. Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia, was more measured in his evaluation.

“It was a small dose range trial that showed that the vaccine doses were safe and induced a neutralizing antibody response similar to natural infection,” he said. “But we need a great Phase 3 test.”

Moderna recently finished enrolling candidates for the Phase 2 study, and its Phase 3 trials are expected to begin later this month.

During the phase 1 safety trial, the vaccine was administered in three doses (25 micrograms, 100 mcg, and 250 mcg) to three groups of 15 individuals. The men and women lived in Seattle and Atlanta and were between the ages of 28 and 41.

Although the study authors, led by Dr. Lisa Jackson of the Kaiser Permanente Washington Health Research Institute in Seattle, reported that “there were no serious adverse events” or hospitalizations, each group of candidates experienced side effects that were significantly worse after the second dose.

Such side effects are not unusual, Schaffner said, citing the herpes zoster vaccine.

If the Modern vaccine ends up in widespread use, he said, “we will have to inform everyone beforehand that your arm may hurt, and you will feel bad for a day or so. We have to be aware of this as well because these conditions can mimic the appearance. influenza or COVID itself. “

Three people who received 250 micrograms had their symptoms rated “severe”. Moderna no longer administers the 250 microgram dose in her trials.

Moderna is one of many biotech companies that have made the coronavirus vaccine a priority, and investors have rewarded it. The company’s shares rose from $ 18.59 on February 24, when it announced it would seek a vaccine, to $ 75.04 at the close of markets on Tuesday. It jumped an additional $ 12.06 to $ 87.10 in trading after hours after the studio launched.

With the ambitious goal of producing 300 million doses of vaccine by January, Operation Warp Speed ​​will be challenged by logistics. Even if a vaccine is shown to be effective against COVID-19, production and distribution will be daunting.

“Remember, on the first day, we won’t have enough vaccine for the entire United States,” said Schaffner. “We will implement a vaccine program as the vaccine becomes more available, and for a considerable period of time, much of the US population will not be vaccinated. We will have to continue the activities of social distancing. “

As Moderna progresses with new phases of her clinical trials, Haydon, who received the 250 mcg dose, has slowly resumed her normal routine. He has started marathon training again in hopes of running his first race by the end of the year, and they periodically draw blood to measure the level of antibodies.

But he doesn’t risk it. He still wears a mask, most stay inside and wash their hands “like a maniac.”

“I don’t feel protected,” he said. “My concern is actually not getting exposed, even more than before. What if I had to catch full COVID? I imagine that the hope of this vaccine would collapse ”.