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Ask Dr. Halverson: COVID-19 vaccine — why I trust the science

web 4 17 Halverson photo
By Dr. Jim Halverson
As efforts to develop a safe and effective COVID-19 vaccine continue, the percentage of Americans who say they would get the vaccine at this time has declined sharply since earlier this year. According to a poll of over 10,000 Americans taken earlier this month, about half (51 percent) now say they would definitely or probably get a vaccine to prevent COVID-19 if it were available to them at this time.
Nearly as many (49 percent) say they would definitely or probably not. Seventy one percent of Americans said they would get the vaccine in a similar poll in May. This is a significant problem, as achievement of control over the coronavirus depends on a high degree of immunity in our population which only a vaccine can deliver.
What has created this decline in confidence?
The media
From the first mention of “the race for a coronavirus vaccine” the media message has been one of speed, rather than safety. One can easily get the misconception that companies are competing for first place as if only 1 vaccine can be approved. This is of course, incorrect, but leads many to believe that the vaccines that are initially approved will have had insufficient study to guarantee that they are safe and effective.
The government
Operation Warp Speed was formed in late March to bring together a massive private and public effort to accelerate the development, manufacturing and distribution of a COVID-19 vaccine, predominantly in the United States. Nearly 10 billion dollars have been spent thus far to help in development and production of several vaccines. While the goals are laudable, the name, Warp Speed, (sounding like something out of science fiction) and the messaging have been difficult to trust. With the involvement of public funds, politics has often been the focus of the message, especially in an election year. Vaccine delivery has become a “campaign promise” as people are given the impression that our government can influence when a vaccine is approved. In addition, the CDC, which is not directly involved with the vaccine, has done a very poor job in getting out reliable messages about the coronavirus on many different occasions, leading to further public distrust of government leadership.

 

The internet
 For millions of Americans the internet has become their main source of information. False, unproven and often outlandish claims as well as antivaccine messages are prevalent on the internet. This creates a significant obstacle for medical science to be trusted by people. It should be each of our responsibilities to be fully and properly informed to understand the facts about vaccine safety and development.
What is the truth?
Unprecedented oversight
In June, the Food and Drug Administration (FDA) established very high standards that vaccines have to meet to be considered for approval. There is meticulous oversight and strict regulatory guidelines for vaccines that are in development. They must show at least a 50 percent reduction in the incidence of both mild and severe COVID-19 cases and be significantly safe (similar to placebo). Studies must enroll at least thirty thousand participants who are randomly assigned to get either the vaccine or placebo in a double blinded study. Participants need to report any symptoms daily following vaccination for the first 2 weeks and then weekly for 18 months. 
Refusal to be politically influenced
In an effort to address concerns that political pressure might lead to approval of a vaccine before data has been fully evaluated, the vaccine manufacturers have gone to extraordinary lengths to reassure us that the process is safe and reliable. Leading vaccine manufacturers have taken the unusual step of publicly disclosing full clinical study protocols for their late stage randomized, blinded, placebo- controlled trials. After the companies pledged in a signed cooperative declaration to collect sufficient data to demonstrate product safety and efficacy before seeking FDA approval, Moderna made public its 135 page study protocol. Pfizer and Astra-Zeneca have done the same. These 3 companies are currently among the leading candidates to develop a successful vaccine and are setting the standard for other companies to follow.
Outstanding science 
In addition, outstanding medical scientists around the world have been closely monitoring the virus since early this year. It is known that both the virus and the vaccines produce neutralizing antibodies and that these antibodies have thus far lasted for several months.  They know that the virus mutates very slowly, so new vaccines may not need to be developed frequently. They will be involved in the extensive review of the clinical data presented by the manufacturer to the FDA when considering approval of the vaccine.

 

My conclusion
The effort to produce safe and effective vaccines is unprecedented. It is being overseen by medical scientists who are meticulous in their oversight. They are inspired by the Hippocratic Oath which states, “Above All Do No Harm”, and not by the need to be reelected or please their constituents. They are seeking the truth.
I will take the vaccine when it is approved and offered to me, as will my wife and our adult children. We trust medical science and the approach that medicine takes to helping people. We want to protect ourselves, our extended family, our friends, our coworkers and the people of the communities in which we live. 
Stay properly informed, stay committed, stay positive, stay safe and stay well.

 

— Dr. Jim Halverson is a longtime Ojai physician who writes a weekly column on COVID-19 for the Ojai Valley News.

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