Published: Sat, November 21, 2020
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Dr. David Samadi: Moderna's COVID Vaccine Adds to Confidence of Ending Pandemic

Dr. David Samadi: Moderna's COVID Vaccine Adds to Confidence of Ending Pandemic

The application includes safety data on about 100 children 12-15 years old. Once the FDA grants Pfizer and BioNTech authorization, they plan to ship millions of doses of the vaccine within 24-hours.

Pfizer said it would ask the Food and Drug Administration on Friday to allow emergency use of its coronavirus vaccine. "As a company located in Germany in the heart of Europe, our interactions with the European Medicines Agency (EMA) are of particular importance to us and we have continuously provided data to them as part of our rolling review process".

What does emergency use of a COVID-19 vaccine mean? Dr. Anthony Fauci, the nation's top infectious disease expert, says he believes a vaccine won't be widely available until April.

Pfizer said almost 42% of global participants and 30% of US participants in the Phase 3 study have racially and ethnically diverse backgrounds.

The FDA has also said emergency use regulations don't require them to conduct inspections of manufacturing plants ahead of a vaccine authorization as they normally would with regular approval.

Seen purely from a clock time perspective, Pfizer's dash to the finish line has broken all vaccine development speed records, and on a totally new technology platform called mRNA - which has no benchmarks yet.

The efficacy rates of both vaccines elated public health officials. Earlier this year, U.S. government offered to pay Pfizer $19.5 per dose for 100 million doses of its vaccine, with the option to buy an additional 500 million doses.

That messenger RNA, or mRNA, instructs the body to make some harmless spike protein, training immune cells to recognize it if the real virus eventually comes along. That stimulates the immune system to make antibodies to fend off the disease if people encounter the actual virus.

FDA will take that recommendation into account when it decides whether to authorize the vaccine.

The vaccine must be stored at -70 degrees Celsius (-94 degrees Fahrenheit), temperatures much colder than those of a standard freezer.

Moderna's human trial involving 30,000 US citizens began on July 27 (the same date as Pfizer's human trial.) Researchers were mindful of choosing ethnically diverse participants that included 37 percent from communities of color (Hispanic, Black, Asian or multiracial) and 42 percent from high risk populations of participants over age 65 or who had co-morbidities of diabetes, obesity or heart disease.

While mRNA technology has been around for decades, it has rushed to the front of the pack in the race to create a vaccine for a virus that disease scientists didn't know about at this time previous year.

"When I heard the over 90% efficacy, I felt I was living a dream", CEO Albert Bourla said Tuesday during an interview at the STAT Summit.

Current U.S. numbers - more than quarter of a million deaths have been reported with 2,200 registered just on Thursday - have alarmed authorities enough to advise that people stay at home for next week's Thanksgiving holiday, when Americans usually travel from coast to coast to be with their families. The Pfizer and Moderna vaccines have been the only ones to report any results from late-stage trials.

The hope that many scientists and physicians feel about unprecedented scientific success in developing a remarkably effective vaccine has been tempered by a grim reality.

He said he could not predict how long the review would take but the federal government said ealrier the final green light would probably come in December.

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