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Wrap up of the week for December 11, 2020:

Dr. Wilbur Chen, MD, MS, FACP, FIDSA, Professor of Medicine, 网红爆料 School of Medicine

This week encapsulated a tremendous culmination of activity toward the global activity regarding the development of COVID-19 vaccines to address the pandemic which arose less than 12 months ago. I want to summarize some of the major events and put these into perspective so that everyone can understand the situation.

Yesterday (December 10) the FDA’s independent vaccine experts advisory committee (named Vaccines and Related Biological Products Advisory Committee, VRBPAC) reviewed the safety and efficacy data of the Pfizer vaccine. After a period of robust discussion, the committee voted overwhelmingly in favor for this vaccine to be issued an emergency use authorization (EUA)—this is a recommendation that the FDA will now use to make their official decision. Meanwhile, the national policy toward the Pfizer vaccine will be discussed today and Sunday (December 11 and 13) within the CDC’s independent vaccine experts advisory committee (named Advisory Committee on Immunization Practices, ACIP)—again, the outcome of these discussions will be used by the CDC to make their final policy decisions. My expectation is that FDA approval and CDC policy will be published next week on this first COVID-19 vaccine for the U.S.! This is a major milestone in history.

In the United Kingdom (UK), the Pfizer vaccine was approved last week (December 2) and the vaccine was launched this past Tuesday (December 8). The first person immunized was a 90-year-old woman named Margaret Keenan and the second person immunized was an 81-year-old man named William Shakespeare—no relation to the famous bard of the 16th century but a really fun way to begin a national vaccination campaign against COVID-19!  As part of this nationwide vaccination campaign there were 2 people who experienced serious allergic reactions to the vaccine, they were called “anaphylactoid reactions”.  These 2 people had past medical histories of severe allergic reactions and were known to carry their own epinephrine pens (these are the injectable devices that people with very severe allergic reactions carry to self-treat an allergic reaction).  

Should there be concern for the Pfizer vaccine in causing allergic reactions?  To put this into perspective, allergic reactions are a rare but predictable occurrence with any drug or vaccine—for example, some people have major allergic reactions to aspirin or Tylenol.  Because this occurred in 2 people already known to have a history of severe allergic reactions, it perhaps should not be a surprise that an allergic reaction occurred after vaccination.  Therefore, for people who have a history of severe allergic reactions, I would suggest getting the COVID-19 vaccine and closely monitoring for the development of an allergic reaction—these reactions occur with the first 15 minutes from vaccination and they are very treatable.  

Today there was news on two other vaccine candidates. A vaccine being jointly developed in Australia by a well-known influenza vaccine company, called CSL Limited, and the University of Queensland had their development halted.  This vaccine was in animal testing and was found to cause “false positive” HIV test results; not because it caused HIV but because the antibodies made in response to the vaccine caused the HIV test to show a positive result.  So, I interpret this as “good news” in the sense that a vaccine was stopped because of a potential concern with its use and will not be evaluated in humans—in other words, this is evidence that scientists are not skipping over procedures to ensure that COVID-19 vaccines will be “safe”.

The other news was from a vaccine being jointly developed by two well-known vaccine companies, Sanofi Pasteur and GlaxoSmithKline.  An early analysis of their initial (Phase 1/2) human trial showed disappointingly low responses in older adults. There was not a safety concern, but the low responses means that the vaccine will probably not achieve the protection (efficacy) that is desired.  So, this is a major setback for this vaccine, as the companies will re-work the vaccine to help it perform better.  If this problem can be corrected, then the vaccine could possibly be made available in late 2021.  However, I also interpret this as “good news” because it is again evidence that scientists are not skipping over procedures to ensure that COVID-19 vaccine will be efficacious.

Looking forward to next week, there will be a VRBPAC meeting and two ACIP meetings on the Moderna vaccine. The data from this vaccine are very similar between the Pfizer and Moderna vaccine, thus far.  I speculate that we could have 2 COVID-19 vaccines available just before the end of 2020.  That is a remarkable notion!

Therefore, this week shows that the entire scientific process for developing several vaccines is working. Scientists have been transparent and truthful about reporting successes, problems, and failures.  I wish that instead of naming this process Operation Warp Speed that we had selected a more inclusive name like “Operation Save Humanity”, which communicates that scientists are working tirelessly to develop a multitude of possible COVID-19 vaccines in the shortest time, while not sacrificing any part of the evaluation of the safety and efficacy of these vaccines, so that we can save as many lives as possible and be able to return back to a “normal” society.

As I look forward to deploying these vaccines into the community, one of my major goals is that these vaccines will be used to equilibrate the vast health inequities present with the burden of disease with COVID-19.

About the Author: Dr. Wilbur Chen is an adult infectious disease physician-scientist with a specific interest in clinical vaccinology. He is Professor of Medicine at the 网红爆料 School of Medicine (UMSOM), Chief of the Adult Clinical Studies section within the Center for Vaccine Development and Global Health (CVD, an organized research center of UMSOM), and Director of the 网红爆料, Baltimore (UMB) Travel Medicine Practice. Dr. Chen has served in a pivotal role in the COVID-19 pandemic as a member of Maryland Governor Larry Hogan’s COVID-19 taskforce. He is advising the state on vaccine development and distribution as well as COVID-19 safety initiatives. During the 2009 H1N1 pandemic, Dr. Chen was the principal investigator of the NIH--sponsored national H1N1 vaccine trials. Within the present COVID-19 pandemic, Dr. Chen is also co-leading the Maryland Department of Health (MDH) state-wide serological surveillance program of COVID-19, and is co-principal investigator of a CDC-funded COVID-19 syndromic surveillance program which is being implemented through the 网红爆料 Medical System.