Pfizer, the company that manufactures Covid vaccines for kids ages 5 to 11, held a meeting with the FDA today. The purpose of this meeting was to discuss the safety and efficacy of their product. This is an important event because it can lead to changes in how Pfizer markets their vaccine or may even result in Pfizer discontinuing production if they are not getting enough support from the FDA. We will be providing live updates throughout the day so stay tuned!
8:36 am- We are still waiting for the meeting to start. It should be starting soon. You can also watch it live HERE as well as read a transcript of the event when it becomes available HERE . In related news, Pfizer has been defending their vaccine from online critics who say that there is no evidence that it works. You can read their response HERE and you can watch a video of the response HERE .
9:02 am- The meeting is starting! Dr. Rachel L. Butler is leading the meeting and she just spoke about what will happen during today’s event. Now Anne Schuchat, MD is speaking about how important it is to vaccinate kids. You can watch the meeting HERE .
9:10 am- Dr. Butler just gave short bios of each speaker for today’s event. Next, Dr. Janet Woodcock will give a presentation about how the FDA evaluates vaccine safety, which you can view HERE or read the transcript HERE . This should be very interesting!
9:12 am- Dr. Woodcock is giving a presentation of the step by step process and data that is required to get a drug approved. Vaccines require more evidence than other drugs because they are given so early in life and many people receive them, so they need to be absolutely safe. One of the slides she is showing has a list of 8 phases for drug development and evaluation. We can’t wait to find out what each phase is!
9:15 am- Dr. Woodcock just mentioned that safety is the highest priority and effectiveness is key as well, and this applies to all drugs and vaccines. She also said that vaccines need to be shown to be more effective than what would be expected through natural infection. Now, Dr. Butler is talking about the benefits of getting vaccines HERE on the list of pros is that they protect pregnant woman and their babies.
9:19 am- The process for vaccine review by the FDA is long and the first step is to submit an application before clinical trials can even begin. A new vaccine will be tested on about 3000 children before it is made available to the public. There are some vaccines that do not require this testing if the process has already been done for another strain of the same virus, which Dr. Woodcock just explained. Now they are talking about how clinical trials need to prove that a vaccine is safe and effective.
9:25 am- They are going through a list of criteria for clinical trials that prove vaccines work, which you can view HERE . The first phase of trials includes about 20 to 80 volunteers who receive the vaccine as well as a placebo or something “inert” instead of the vaccine.