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MY SUN DAY NEWS

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On the way

By Joanie Koplos

On November 9, American biotech and pharmaceutical giant, Pfizer, and its German biotech partner, BioNTech, announced their researched coronavirus vaccine has proven to be more than 90% effective in preventing the virus among those without evidence of prior infection.

Indeed, Dr. Albert Bourla, chairman and CEO of Pfizer, hailed the recent trial results as “a great day for science and humanity.”

He added “I believe this is likely the most significant medical advance in the last 100 years, if you count the impact this will have in public health, global economy.”

With the Covid-19 pandemic claiming over 1.2 million lives worldwide, research centers and drug makers have been working tediously throughout past months to deliver an effective and safe vaccine to the world. Pfizer’s positive results, taken from their phase three clinical study, were based on the first early analysis conducted by the Data Monitoring Committee. This independent and external group of experts oversees our country’s clinical trials to make sure of the safety of the trials’ participants. Among this trial’s 43,538 people, the analysis evaluated only 94 confirmed infections. The case (split between vaccinated individuals and those who received a placebo) showed (at seven days after the second dose) a vaccine effective rate of above 90%. The two-dose schedule then achieves this protection 28 days after the initial vaccination. It is important, however, to remember that the final efficacy percentage may vary as safety data and additional numbers continue to be collected.

Pfizer states that as early as late December, the vaccine might become available in limited use. The vaccine is hoped to be available in wide use by the third quarter of 2021. However, many scientists and U.S. officials are hoping for the vaccine to be ready in the first half of 2021. Both companies are planning to ask the U.S. Food and Drug Administration for emergency use authorization after they have two months of data, about the third week of November. The two research firms reported no serious safety concerns at this time with about 42% of the global trial adults having been chosen from ethnically and racially diverse backgrounds. The pharmaceutical companies plan to submit data (begun on July 27) from the full phase three trial for scientific peer-review publication.

In this year alone, Pfizer and BioNTech expect to produce up to 50 million vaccine doses. In 2021, they expect to produce up to 1.3 billion doses. As part of President Trumps’ Operation Warp Speed, the companies reached an agreement to supply America with 100 million doses. The problem here is the logistics of manufacturing and distributing the vaccine with its required storage temperature of minus 94 degrees Fahrenheit.

The two biotech firms’ plan to “load suitcase-sized boxes from distribution centers in Kalamazoo, Michigan and Puurs, Belgium. As many as two dozen trucks are then being planned to daily transport roughly 7.6 million doses to local airports.





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