Vaccine research continues
FDA to discuss one on Dec. 10
Last updated 11/25/2020 at 10:33am
Multiple vaccines are being studied for prevention of COVID and one of them is being considered for emergency use for high risk populations, by the end of the year.
Pfizer's COVID-19 vaccine is under review by the FDA on Dec. 10. If approved for emergency use, it could be made available to high risk populations by the end of December. The World Health Organization reports that 15% of COVID-19 infections "severe infection, requiring oxygen and 5% are critical infections, requiring ventilation."
On Dec. 10, Pfizer intends to present information to the FDA that includes safety data from clinical trial participants. Clinical trials for the vaccine tested for efficacy (effectiveness) and safety. More information on the vaccine candidate is here: https://bit.ly/2J4WBQy. Although the FDA is considering the Pfizer vaccine on Dec. 10, that does not mean it will be approved. This summer, an FDA representative said that vaccines still must show both safety and effectiveness that meets usual standards in order to be cleared for emergency use. The "Operation Warp Speed" process for COVID-19 vaccines just means the steps to approval usually performed in a linear way are being performed all at once.
Insight on how vaccine approvals work is here with both audio and transcript available: https://bit.ly/3nVC6VX
Dr. Anthony Fauci told Stat News that the question when vaccines and treatments are tested is the impact on severe disease, which is the key concern for the virus. Most who are infected experience a form of the illness that resolves without emergency care. Severe illness from COVID-19 is what drives up hospital capacity and what can lead to a potential for ongoing medical problems or death.
Doctors say "mild" cases include those that cause very uncomfortable and sometimes unsettling illness that can impact breathing. They are described as "mild" because they do not require medical intervention, but may require a lot of couch time, lost working hours, and in the case of a pandemic-linked illness without an established best practices treatment, the anxiety in high-risk patients of wondering if the illness will advance. About 40% of COVID-19 cases are asymptomatic, according to best estimates by the CDC.
Dr. David Russian, a pulmonologist and CEO of Western Washington Medical Group, describes some mild cases of COVID-19 as "an amped up version of the flu" that can last a couple of weeks.
Those with underlying illnesses are at higher risk of advancing to severe illness and should stay in contact with their personal health care provider, if they become ill. Testing is recommended by public health officials for those who experience symptoms that could be COVID-19 include fever, dry cough, loss of taste or smell, sore throat, fatigue. Because of the likeness to flu symptoms, a flu shot is recommended this year, in interest of preserving medical resources by preventing complications from the flu.
Dr. Tomasz Ziedalski of WWMG said preventing the flu can also help preserve personal protective equipment, because as medical professionals determine whether a patient has COVID-19, more PPE is needed. Determining other ailments requires PPE as well but because treatments and prevention are available for other ailments, the amount of PPE is less.
More vaccines are also in testing. A vaccine tracker is available here: https://nyti.ms/3kZRBKt