Monthly Archives: December 2020

The U.S. Food and Drug Administration at a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Dec. 10 recommended emergency use authorization (EUA) of a COVID-19 vaccine from Pfizer, Inc., in partnership with BioNTech Manufacturing GmbH. The FDA followed that by approving the Pfizer vaccine for emergency use! The vaccine is being distributed via President Trump’s Warp Speed ultra-fast processes to Americans. Approval and distribuition of the similar Moderna vaccine should follow next week.
Info: shpr.fyi/fdaadvmtgpfizer

FDA Vaccine Approval Process
JAMA conducts weekly interview “Conversations” on current leading health and medical issues with the top people involved in those issues. The interviews are available to the public via YouTube.

Peter W. Marks, MD, PhD
Screenshot from YouTube Interview
On Oct. 6, 2020, Howard Bauchner, MD, Editor and Chief of JAMA (The Journal of the American Medical Association) and the JAMA Network had a conversation with Peter W. Marks, MD, PhD, Director of FDA’s Center for Biologics Evaluation and Research (CBER) presently working on approval of COVID vaccines.
His opening question to Marks was, “How does it feel to hear all the world asking the question, ‘When will the vaccine be approved?,’ when you lead the only organization that will answer it?”
The process starts when the Center receives from a drug company an application for approval for Emergency Use Approval (EUA) or for the full Biologic Use License. The Center is handling many such applications at all timer.
The Center for Biologic Licenses has about 250 people working in it plus they seek and incorporate input from many other organizations working on related issues.
Each application for approval, even for an EUA, is hundreds of thousands of pages long and includes:
1) detailed information about each of the typically 30,000 people who have received the vaccine on trial, as well as
2) the drug company’s analysis of that information.
The Center does its own analysis of the information, analyzing the 30,000 patients’ individual data in parallel with the drug company’s analysis.
Such applications are divided into units for analysis by pertinent units within the Center. 

Marks emphasized that safety is first and foremost in these analyses.
The primary test for any vaccine is that test patients are no different after the vaccine than before it.
The Center must balance the need for safety against the need to get the vaccine out and in use to begin saving lives. Lives are lost for every day the vaccine is delayed.
Marks said the workers are very dedicated to the work, and further described the balance that each worker must handle between their important progress toward approval of the vaccine to begin saving lives against demands of their personal lives. Most Center workers are young with children at home. He said workers sometimes get only two hours of sleep in their nights.
The process requires at least two months of follow-up on every test patient after vaccination, after the second vaccination for those that require two.
The decision to approve, or to not approve and examine further, is made at a meeting in a public venue by an Advisory Committee made up of many experts in every aspect of the vaccine. The Advisory Committee meetings are available to the public.
He described how these experts are all very knowledgeable and confident in their knowledge so their discussion may be quite argumentative as people try to convince others that their position is correct.
He said the meeting very strictly prohibits outside bias, such as political bias or bias from the drug company. For example, he said the Commissioner of the Food and Drug Administration, Dr. Stephen Hahn, his boss, would not participate in the COVID Advisory Committee meetings because he is at a political level.
After initial approval of one vaccine, the Center would continue examining it, watching for any problem among the trial patients, along with the other vaccines coming along in the approval process.
Bauchner asked Marks a “crystal ball” question, “When will we have an approved coronavirus vaccine?”
Marks’ reply was, “Possibly we could approve vaccines from some companies before the end of the year.”
I recommend readers view the entire interview using this link:
Info: shpr.fyi/fdaapprvprocs

“What we can say now is that, among 42,000 people given the vaccine, there were no serious negative effects within two months after receiving the vaccine.”

Paul A. Offitt, MD
Image Children’s Hospital
So said Paul A. Offit, MD, Children’s Hospital of Philadelphia, member of FDA Advisory Committee that recommended approval of Pfizer vaccine on Dec. 10 after being asked, “What can we tell people?”
The first people to get the vaccine will be frontline hospital and other caregivers who must be in contact with COVID-diseased patients, nursing and long term care facilities workers and patients, and those with serious vulnerabilities. All of these 20 or more million additional vaccinated people will be monitored for adverse effects. So, by the time the vaccine becomes available to us, we will have monitored many more millions of vaccinated people, some of them for up to six months, so we will have learned even more about any adverse effects.
Basic Immune System
The basics of our fantastic God-created immune system:
Info: shpr.fyi/immunity
Having enough Vitamin D can hugely improve COVID outcomes
Vitamin D deficiency on admission to hospital was associated with a 3.7-fold increase in the odds of dying from COVID-19, according to an observational study looking back at data from the first wave of the pandemic.
Nearly 60% of patients with COVID-19 were vitamin D deficient upon hospitalization, with men in the advanced stages of COVID-19 pneumonia showing the greatest deficit.  
Vitamin D is absolutely essential for good health.
Vitamin D3 (cholecalciferol) is found in oily fish, fish liver oil and egg yolks and in vitamin supplements.
Large amounts of vitamin D is also be made in our skin in sunlight. In winter, though, few of us get much sunshine.
The US Institute of Medicine suggests that an average daily intake of 400–800 IU is adequate for 97.5% of individuals.
Info: shpr.fyi/vitdcovid

Dave Bunting