FDA Approves First COVID-19 Vaccine

More than 92 million individuals in the US have received the Pfizer/BioNTech COVID-19 Vaccine under emergency use authorization (EUA). The vaccine has repeatedly demonstrated to be safe and effective in reducing the risk of severe disease, hospitalization, and death.

After reviewing hundreds of thousands of pages of data, the FDA has officially granted the Pfizer/BioNTech vaccine full approval for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine will now be formally referred to as Comirnaty.

Official FDA press release here: https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine

At this time, the vaccine will continue to be available under emergency use authorization (EUA) for individuals 12-15 years of age and for the administration of the third dose in certain immunocompromised individuals.

See all FDA details here: https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/comirnaty-and-pfizer-biontech-covid-19-vaccine

See all Frequently Asked Questions (FAQs) here: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/comirnaty-and-pfizer-biontech-covid-19-vaccine-frequently-asked-questions

Pfizer has said it expects to have vaccine trial data on children ages 5-11 by the end of September, and the company could apply to have its vaccine authorized for those younger ages shortly after. The company also has said data for even younger children, ages 2 to 5, could be available shortly after.

Moderna submitted its data about a month later for formal FDA review so stay tuned.

Safe and effective vaccines are critical public health tools that we in the United States are very privileged to have access to. Vaccines backed by rigorous science have historically eliminated some of the world's most horrific diseases. Vaccination is critical for public health, individual health, protection of the most vulnerable, the immune-compromised, and those who can not get vaccinated yet such as children. Vaccination also prevents the development of future variants that may one day be completely vaccine resistant, a grave concern we hope to never see. Lastly, vaccination prevents the overwhelming strain on our nation's health systems, many of which are at capacity with COVID cases and can not care for regular emergencies and critical care such as accidents, heart attacks, strokes, cancer, surgeries, etc.

Please get vaccinated. #ThisIsOurShot

SalivaDirect: Spitting Is Now Encouraged

SalivaDirect received emergency use authorization (EUA) FDA approval today.

What's the big deal about SalivaDirect:

👉uses saliva that can be collected in any sterile container; no more long, uncomfortable swabs. (PS- there are reported shortages of the preferred thinner swabs, which means larger, thicker swabs are being used. Not fun.)

👉it's an approved protocol, not a kit. Any approved lab will be able to run these tests with materials they already have. A huge positive considering all the challenges we face with supply chain shortages.

👉costs a few dollars to run, not $150+ per test. This is important bc we need inexpensive testing so people can opt to test as frequently as needed. Think schools, universities, essential workers, and those returning to their offices in the coming months.

👉most accurate of currently available saliva tests at about 90% accuracy. Take 2 tests in a row if you need to be sure and boost accuracy to 99%. Think about pregnancy tests: does anyone ever really take just one?

👉rapid turnaround time, with about 90 results processed in about 3 hours. Laboratory tests can be pooled for processing: think a whole class or office can be pooled into a single test & we'd only need to test individually if the pooled test comes up positive. Currently, swab tests are taking 5-7 days to get results. We haven't even started school yet, hit flu season, nor do we have high cases like other parts of the country.

👉 it's being studied with the NBA, one of the most frequently tested groups of individuals in the world.

More about SalivaDirect here: https://covidtrackerct.com/about-salivadirect/

What's all the Buzz about Convalescent Plasma?

Vaccine development is not the only effort science is racing to develop and evaluate as part of our toolkit against COVID19.

Four former FDA Commissioner's have collaborated on this piece highlighting the latest on the study of convalescent plasma: https://www.washingtonpost.com/opinions/2020/08/03/4-former-fda-commissioners-blood-plasma-might-be-covid-19-treatment-we-need/?utm_content=buffer634f9&utm_medium=social&utm_source=twitter

The basis behind convalescent plasma is to use the defense system of antibodies from a person who has recovered from COVID19 to boost the immune response of a newly infected person.

If you have recovered from COVID19, consider donating plasma: https://thefightisinus.org/en-us#home

Donated plasma may be used for 2 different powerful routes:

1) Direct transfusion to a patient critically ill with COVID19

2) Development of plasma derived therapy

Excellent graphic detailing these 2 routes here: https://thefightisinus.org/images/TwoPaths.pdf

The federal government’s ACTIV program, also part of Operation Warp Speed, is standing up trials of promising treatments, including convalescent plasma and synthetic antibodies that work through mechanisms similar to plasma to neutralize the virus. For more information on the details of COVID19 trials: https://www.nih.gov/research-training/medical-research-initiatives/activ