Solving COVID: July 15, 2020

'Good news' from Moderna's vaccine trial, Pfizer CEO sets sights on October for FDA approval, and more

A coronavirus vaccine.
(Image credit: Illustrated | AP Images, iStock)

1. Moderna's COVID-19 vaccine candidate shows immune-boosting results

The results from the first phase of Moderna's coronavirus vaccine trial are out, and the promising findings are in line with some early data released in May. The study, published Tuesday in The New England Journal of Medicine, found the experimental mRNA vaccine — which requires two doses, one month apart — induced coronavirus immune responses in all 45 participants, as scientists had hoped. There were some mild side effects, including fatigue, chills, and fevers, but The Associated Press notes those aren't uncommon with other vaccines, and there have been no major safety concerns. "No matter how you slice this, this is good news," Dr. Anthony Fauci, the nation's top infectious disease expert, told AP. In July, Moderna will begin a 30,000-person study to prove if the shots are strong enough to protect people from the virus. While the first phase does indicate the vaccine produces antibodies, it's less clear if the levels of antibodies are enough to actually fend off infection.

The New England Journal of Medicine The Associated Press

2. Pfizer CEO suggests FDA could approve vaccine candidate by October

The CEO of Pfizer is confident in the company's coronavirus vaccine candidate, which he says could potentially receive approval from the FDA by October. The first clinical data on Pfizer's COVID-19 candidate showed it generated neutralizing antibodies at levels 1.8 to 2.8-times higher than those found in patients who recovered from COVID-19. There were, however, some side effects, including fevers. "What we learned is that this vaccine can neutralize the virus," CEO Albert Bourla told Time. "For me, it was the moment when I saw the data, plus many other data that we haven't published yet, [that] made me say that until now I was thinking if we have a vaccine. Now I'm discussing when we're going to have a vaccine." Bourla said the company should know more about the vaccine candidate's efficacy in September, "for a potential approval in October, if we are lucky." Pfizer said it's looking to "manufacture up to 100 million doses by the end of 2020 and potentially more than 1.2 billion doses by the end of 2021."

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3. Remdesivir significantly reduces risk of coronavirus death, Gilead claims

Data shows the drug remdesivir significantly reduced the risk of death in severely sick COVID-19 patients, biopharmaceutical company Gilead Sciences, which makes the drug, announced Friday. Remdesivir reduced the risk of death by 62 percent when compared to normal care, Gilead claims its data shows. Gilead noted this is an "important finding that requires confirmation in prospective clinical trials." Gilead developed remdesivir as a potential treatment for Ebola and has been testing it on coronavirus patients for months. Late last month, Gilead said each dose of remdesivir will cost $520, totaling more than $3,000 over the course of a typical coronavirus treatment.


4. Tuberculosis vaccine in late-stage trial as COVID-19 protection

Texas A&M College of Medicine is leading a consortium of research hospitals and medical schools in a Phase 4 trial to determine if the century-old tuberculosis vaccine can help blunt the damage from COVID-19. The hope is that the vaccine ramps up the immune system to fight off the disease. "Scientists have known for decades that the tuberculosis vaccine ... improves immunity against some viruses," The Texas Tribune reported back in May. The TB vaccine has been used more than a billion times around the world, but it's not commonly used in the U.S., except to fight bladder cancer. Jeffrey Cirillo, the Texas A&M microbial pathogenesis and immunology professor leading the trial, told Politico the goal is to enroll 1,800 test subjects. A similar trial is being conducted in the Netherlands. If the TB vaccine is found to be effective, it could be used either as a stop-gap measure until a coronavirus vaccine arrives, or in tandem with that vaccine to make it more effective.


5. Study suggests an annual coronavirus booster shot may be necessary

A study from King's College in London suggests people may lose their COVID-19 immunity within months. The study analyzed the immune responses of more than 90 patients and health-care workers, with blood tests revealing 60 percent developed a strong antibody response during their infections, but only 17 percent retained the same potency three months later. In some cases, antibody levels weren't detectable. The results of the study indicate it could be challenging to develop herd immunity or a one-and-done vaccine. But Professor Robin Shattock of Imperial College London said even if reinfection is possible, subsequent cases would likely "be less severe" because people "will still retain immune memory." If the King's College study proves accurate, this wouldn't mean there's no hope for a vaccine, but rather, like the flu, an annual coronavirus booster shot may be necessary for "sustained levels of protective antibodies."

The Guardian

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