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Wrap up of the week for December 18, 2020:

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

Well, we experienced another week of tremendous of events in the development of COVID-19 vaccines. For the second week in a row, I want to summarize some of the major events and put these into perspective so that everyone can understand the situation.

Yesterday (December 17) the FDA’s independent vaccine experts advisory committee (VRBPAC) reviewed the safety and efficacy data of the Moderna vaccine—last week was the same type of review for the Pfizer vaccine. After robust discussion, VRBPAC voted nearly unanimously for this vaccine to be issued an emergency use authorization (EUA). The national policy toward the Pfizer vaccine will be finalize on Saturday (December 19) by the CDC’s independent vaccine experts advisory committee (ACIP). On Sunday (December 20) the ACIP will finalize the targeted populations for Phase 1b and 1c in the allotment of the limited doses of COVID-19 vaccines. My expectation is that FDA approval will be announced later this evening. Therefore, by this weekend there will be two COVID-19 vaccines available to deploy for the U.S.!

There has been heightened attention toward the occurrence of rare severe allergic reactions with the Pfizer vaccine. This week we learned of a case of anaphylaxis in a middle-aged female health care worker in Alaska (Bartlett Regional Hospital, Juneau) with no known history of allergies.  Approximately 10 minutes after vaccination this individual felt flushed (warmth and redness of the face and torso) and later had some shortness of breath and a rapid heart rate. This person was treated promptly and is anticipated to fully recover. The important lesson from these events is that they are rare, serious, and treatable when recognized early. However, we do not suggest that these individuals receive a second dose of the same vaccine. A widely adopted policy is for observing people for at least 15 minutes after vaccination if they have no history of allergy and for 30 minutes if they have a history of severe allergies.      

Another notable mention toward safety is that Bell’s Palsy has been observed in both the Pfizer and Moderna vaccine studies. Bell’s Palsy is a sudden weakness of the facial muscles—sometimes known as a facial droop. It is mostly a temporary condition that improves over a few weeks. Bell’s Palsy is known to occur after many common viral infections, such as cold sores and genital sores (herpes simplex), infectious mononucleosis, influenza, and mumps. In the general population it is estimated that Bell’s Palsy occurs at a rate of 15-30 cases per 100,000 people.  In the Pfizer study involving ~44,000 participants, there were 4 cases of Bell’s Palsy among vaccinees and no cases among placebo recipients.  In the Moderna study involving ~30,000 participants, there were 3 cases of Bell’s Palsy among vaccinees and 1 case among placebo recipients.  Currently the information does not definitively point blame to the vaccines, as these cases of Bell’s Palsy are not higher than that expected in general. However, scientists will be following carefully for additional cases of Bell’s Palsy.

What are some of the ways that scientists are using to try and make sure these vaccines are “safe”?  All manufacturers of approved drugs, vaccines, and devices must commit to ongoing safety monitoring of their product after it is released on the market—this is called Post-Market Surveillance. This reporting to the FDA is being required from Pfizer and will be required from Moderna, when approved.  Also, the FDA and CDC co-sponsor a decades-long surveillance system, called Vaccine Adverse Event Reporting System (VAERS), which any person can use to report an adverse event for any vaccine, including COVID-19 vaccines. https://vaers.hhs.gov/index.html  In addition, there also has a new program called V-SAFE, a smartphone-based tool that uses text messaging and web surveys to provide personalized health check-ins after you receive a COVID-19 vaccination. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/vsafe.html  These systems put together will continue to help scientists to collect and evaluate any safety concerns with these vaccines.

Therefore, with the two COVID-19 vaccines, which have both demonstrated very high efficacy, there is promise and hope for the coming New Year.  I tried to put these safety concerns into perspective and I still believe that there is great benefit, which outweighs the limited and treatable safety concerns that are known thus far. Scientists continue to be transparent and truthful about reporting new findings with the vaccines. I continue to urge that everyone practice universal masking when outside the home and to plan for safe practices when celebrating the winter holidays. When COVID-19 vaccines are offered to you, I hope you will accept it and understand the true value of the vaccine.

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.