This week more alarm bells went off as the head of the FDA made a statement supporting approval of a SARS-CoV-2 vaccine before Phase 3 trials are completed. Phase 3 trials are the final necessary phase in which a larger number of subjects are either given a placebo or the real thing, looking for signs of efficacy and adverse events. This is a key last step looking for unexpected side effects or harm to the patients. If the data shows the drug or vaccine does the job it was designed for and there are no significant harms observed, the FDA then approves the drug or vaccine. Sometimes, the data does not support approval- either the study drug is not as effective as it should be or harmful side effects are observed. A panel of experts reviews the data. If approval occurs, the FDA continues to look for more rare side effects that show up later so they can warn pharmacists and prescribers. These steps are important for me and other providers to feel safe prescribing a drug or vaccine and important for patients’ safety. It is also why you get a long list of possible side effects when you pick up your medicine.
More alarms went off a couple days later, when the CDC announced plans advising states to get ready for a vaccine distribution by November 1, just before the election. Fauci says it is unlikely one could be ready, not impossible. He is more optimistic for a November/December timeline, which is good news. The president contradicted this and says approval should come in October. It could just be wishful thinking on his part, but worrisome, if a vaccine were to be pushed through for political purposes. Fortunately, there has been a lot of pushback from different people and entities, trying to reassure us that a vaccine will not be pushed through without good data. Some states are holding their ground and will not accept a vaccine that has not be fully vetted. The head of the vaccine task force agreed that approval is unlikely and says he will quit if politics get in the way of a safe and effective vaccine. The UN says it will not approve vaccines until proven safe and effective, as well. Even the pharmaceutical companies are on board because they know rolling out a vaccine too quickly for political purposes can have bad outcomes. That happened when Gerald Ford pushed through the new swine flu vaccine in 1976, causing a big increase in Guillain-Barré cases, which ultimately gave fodder to the anti-vaxxers and has left many people avoiding the flu vaccine ever since.
All of this drama is not helping us feel better and can make us worry more. I am planning to write more about why I am hopeful about finding a vaccine that is effective, skepticism about some of the vaccine candidates, and about the difficulties that will happen over who gets priority and distribution challenges. I still think November and December is an overly optimistic timeline. It pains me that Trump has declined to have us join the global effort for a safe vaccine led by the World Health Organization. What a loss for us.
In the meantime, we know how to stay safe. It is easy to forget and ease up our habits. We are all longing for companionship and human contact; but especially now over the long Labor Day weekend, please stay sensible.
Wash your hands, cover your nose, keep safe six, and enjoy being outdoors.
And finally, my caveat is that this is my experience and my opinions, which are subject to change as more information is available, and not related to the organization I work for. Thanks for reading.
https://www.nytimes.com/2020/09/02/opinion/coronavirus-vaccine-trump.html rushing vaccine