The moment the world has restlessly been waiting for during a viral pandemic claiming more than 1.2 million people has arrived. Pfizer, a New York City-based drug company and its German partner BioNTech, made a huge announcement Monday offering compelling evidence that their vaccine is our answer to defeating COVID-19 and getting back to normal.
The vaccine's phase III trial results which included more than 43,000 volunteers with no evidence of prior coronavirus infection, had a remarkable more than 90% effectiveness in preventing the disease. If the results are accurate, this level of protection would be higher than the regular yearly flu vaccine and be on par with highly effective childhood vaccines for diseases such as measles or chickenpox.
Even better, Pfizer stated that there have been no serious side effects or safety concerns at this time.
This promising news vastly exceeds expectations creating cautious optimism and relief among scientists worldwide. This could be the monumental game changer our world needs most right now.
Operation Warp Speed and Pfizer
Vice President Mike Pence took to Twitter to publically thank President Trump and Pfizer of their public-private partnership with the Trump administration's Operation Warp Speed vaccine initiative. While Pfizer's senior vice president and head of vaccine research and development, Kathrin Jansen, publicly distanced the company from Operation Warp Speed, stating, "We were never part of Warp Speed. We have never taken any money from the U.S. government, or from anyone," this is not entirely true.
What is true is that Pfizer did not accept money for research or is receiving payments upfront into developing a vaccine for COVID-19. However on July 22, a purchase promise was agreed upon with the Trump administration's Operation Warp Speed to buy at least $1.95 billion of a vaccine (at least 100 million doses) developed by Pfizer if their vaccine was authorized and approved by the Food and Drug Administration. This deal very likely was a huge incentive for Pfizer to expedite their vaccine development process and thankfully looks to be successful.
Health and Human Services Secretary Alex Azar stated that Operation Warp Speed will help assist with ingredients, assisting distribution of syringes, needles, and dry ice for shipment, and with overall planning and distribution of the vaccine.
Pfizer's vaccine will require two doses, administered three weeks apart, to achieve high effectiveness. Researchers with the trial stated that the highest level of virus-neutralizing antibodies appeared within one week after the second dose was given to volunteers.
Possible concerns
Naturally, the monumental task of distributing worldwide millions of doses of a vaccine will not be easy. A very legitimate concern is how the distribution of this vaccine can be done as smoothly as possible. There will be the anticipated difficulty in getting 100% of the public to return for the second follow-up shot.
Another challenge will be distributing the vaccine in areas of the world that lack widespread electricity as the vaccine requires to be shipped and stored at super-cold temperatures of minus 94 degrees Fahrenheit (minus 70 degrees Celcius), which is about 50 degrees colder than any vaccine currently used in the United States. This will take large amounts of dry ice to meet storage requirement as most doctor's offices, pharmacies and state labs do not have freezers that go that low.
These obstacles and others will certainly need to be addressed. With skilled guidance, cooperation, and patience, we can do this as we proceed with the vaccine's distribution in the near future.
Distribution plans and other drug companies' ongoing trials
The ability to come up with a vaccine within a year is historical and groundbreaking. The leadership of both the president and vice-president along with Pfizer and BioNTech has set us on track for a goal that has never been achieved before and we are lucky to witness this phenomenal event.
Currently, Pfizer plans to seek the Food and Drug Administration's approval for emergency authorization of the two-dose vaccine later this month once it has collected two months of safety data that is recommended. If granted, the plan is to have manufactured by the end of 2020, 50 million doses that could be available, enough to protect 25 million people and then to produce up to 1.3 billion doses in 2021.
Pfizer is not the only drug company working hard to develop an effective and safe vaccine for protection against COVID-19. Both Moderna and AstraZeneca have ongoing trials that likely will also have promising results that can only add to our ability to tackle this coronavirus.
Final thoughts
Both President Trump and Vice-President Mike Pence deserve high praise for their insight and tireless relentless push to find a long-lasting solution to ending our battle with COVID-19. They clearly understand what's at stake if vaccine development drags on much longer. They get it. They have the foresight to see further harm to the economy, harm to the education of our children, harm to our overworked healthcare system, and harm on the mental and emotional psyche of a nation weary and worried of this viral pandemic. I personally thank them both for fast tracking vaccine development and for leading our nation on a path that took courage to stand up to COVID-19.
Dr. David Samadi is regarded as one of the leading prostate surgeons in the U.S., with a vast expertise in prostate cancer treatment and Robotic-Assisted Laparoscopic Prostatectomy. Dr. Samadi is a medical contributor to Newsmax TV and is also the author of The Ultimate MANual, Dr. Samadi's Guide to Men's Health and Wellness, available online both on Amazon and Barnes & Noble. Visit Dr. Samadi's websites at robotic oncology and prostate cancer 911. Read Dr. David Samadi's Reports – More Here.
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