COVID-19 Updates – Part 1
USFDA APPROVES FIRST COVID-19 VACCINE
On August 23 the U.S. Federal Drug Administration approved Pfizer-BioNTech’s COVID-19 Vaccine. It will now referred to as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine will be available for emergency use for individuals 12 through 15 years of age.
For the last eight months, the Pfizer-BioNTech COVID-19 Vaccine was approved for emergency use but this full approval is what acting FDA Commissioner Janet Woodcock, M.D. calls a “milestone as we continue to battle the COVID-19 pandemic.”
“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine.” said Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research. He went on to say, “The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S.”
One specific study that the FDA reviewed prior to approval was the effectiveness data from approximately 40,000 participants, half of which received the vaccine and the other half, a placebo. The results of this study showed that the vaccine was 91% effective in preventing COVID-19. The most common side effects were redness and swelling at the injection site, fatigue, headache, muscle, joint pain, chills, and fever.
The FDA is working with the Centers for Disease Control and Prevention to ensure that any safety concerns continue to be identified and evaluated in a timely manner. Monitoring systems are in place and the FDA is requiring the company to conduct further studies to assess the risks of myocarditis and pericarditis. Pfizer-BioNTech will also be conducting a pregnancy registry study to evaluate how the vaccine affects both pregnant women and infants, although not required by the FDA.
You can read the full press release here: https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine
COVID-19 VACCINE FOR CHILDREN UNDER 12
On August 31, 2021, the former head of the U.S. Food and Drug Administration (FDA) Dr. Scott Gottlieb said he expects that a vaccine for children ages 5 to 11 will be authorized for emergency use by winter.
Gottlieb, also a Pfizer board member, said trials are expected to start in September and submitted to the FDA in October.
According to Gottlieb, the average FDA review process is four to six weeks for potentially emergent cases.
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