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Company making coronavirus vaccine confident in results as testing continues in South Florida

CORAL GABLES, Fla. – The makers of the Moderna vaccine say its nearly 95% effective at protecting against the novel coronavirus.

The reported breakthrough comes as more than 11 million people across the country have been diagnosed with COVID-19.

One of the company’s testing sites is at the University of Miami for the vaccine’s phase three trials, which was developed in partnership with the National Institutes of Health.

Up next, Moderna will seek FDA authorization.

University of Miami’s Dr. Maria Luisa Alcaide spoke about the new vaccine on Monday.

“It is excitement, really, really excitement and promising news,” said Dr. Alcaide. “Once approved, it goes first to first responders.”

This news comes on the heels of last week’s announcement by Pfizer about its COVID-19 vaccine which is in advanced trials.

Nova Southeastern University’s Infectious Disaease Expert Dr. Bindu Mayi explained the biggest difference between the two is storage temperatures and related logistics for distribution.

Unlike Pfizer’s vaccine, Moderna claims that the vaccine it is developing can be stored at normal refrigeration temperatures.

“The good news for us as consumers is that in the next few months, we should have a strong roll out of either or both vaccines so individuals can get vaccinated,” said Dr. Mayi. “The Modera vaccine makes it easier to roll out these vaccines…because of the lack of that sub-zero deep freeze requirement needed by Pfizer.”

While both companies say their vaccines are highly effective, Dr. Mayi said the FDA would be reviewing those claims during an advisory committee hearing as the companies continue to seek approval.

“We will learn a lot more about the safety and the effectiveness of this data, and I think that is going to help us with acceptance of the vaccine as well as compliance,” Dr. Mayi said.

After approval, a phased-in roll-out plan for distribution is anticipated, starting with first responders followed by at-risk populations, before expanding to the general public. It is similar to how COVID-19 testing was slowly expanded as communities tried to balance supply limitations.

In short: we are still a few more months out, so until them, infectious disease experts say continue to mask-up.

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Dr. Alcaide said Moderna’s trial involved 30,000 participants and that about 200 at their testing site. She added there was a “big effort” to have a representation of ethnic minorities.

Dr. Mayi says Pfizer announced it is working on a “second generation” COVID-19 vaccine which could also require simple refrideration temperatures.

A spokeswoman for UM Health said the university is also a testing site for Johnson & Johnson’s COVID-19 vaccine in development.

UM to Launch COVID-19 Vaccine Testing Site for the COVID-19 Prevention Trials Network https://physician-news.umiamihealth.org/um-to-launch-covid-19-vaccine-testing-site-for-the-covid-19-prevention-trials-network/

In late-October Johnson & Johnson posted on its website that “Johnson & Johnson announced today that it is preparing to resume recruitment in the pivotal Phase 3 ENSEMBLE trial of its investigational Janssen COVID-19 vaccine in the United States after a temporary pause.” https://www.jnj.com/our-company/johnson-johnson-prepares-to-resume-phase-3-ensemble-trial-of-its-janssen-covid-19-vaccine-candidate-in-the-us

Amid cold chain blues, Pfizer looks to powder vaccine formula in 2021: report https://www.fiercepharma.com/vaccines/amid-cold-chain-blues-pfizer-looks-to-powder-vaccine-formula-2021-report


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