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

Direct-To-Consumer Genetic Tests: Who Are They REALLY Benefitting?

The FDA approved the Personal Genome Service Genetic Health Risk (GHR) Report for BRCA1/BRCA2 (Selected Variants), the first direct-to-consumer BRCA test by 23andMe that may be performed in the comfort of one’s home without the need for a prescription. Press releases and even the FDA announcement do not thoroughly detail the many limitations and conditions associated with the test. Individuals many incorrectly interpret what the test’s results may show or may over-extrapolate how the test is meant to be used. In healthcare, it is of essence to be considerate of people’s health literacy levels so as to encourage informed decision-making based on factual, credible information. It’s also important to be fully transparent as to how the test’s results are benefitting the actual company, in this case 23andMe, as well as other third party companies. This needs to be spelled out front and center. Not just buried in the legalese of the terms and conditions and privacy policy.

Here are the limitations, caveats, and fine print that everyone needs to know about regarding the latest FDA approved 23andMe offering:

1. The test only detects 3 out of more than 1000 BRCA mutations. BRCA1/BRCA2 breast cancer gene mutations are most common in Ashkenazi Jewish populations. This test does not benefit the general population.
2. A negative result does NOT rule out the possibility of other BRCA mutations which may pose an increased risk in cancer.
3. Not all cancers are BRCA mutation driven or hereditary. Some cancers develop sporadically. A negative result does NOT mean one has no risk for developing cancer.
4. People who test positive should seek the guidance of a medical professional and understand that they will most likely be retested in a supervised, clinical setting.
5. A positive test result may lead to fear, anxiety, and distress.
6. Patients and clinicians should NOT make medical decisions, such as opting for prophylactic surgery or anti-hormone therapy, based on 23andMe test results.
7. This test is NOT a substitute for consulting with your doctor for cancer screenings, genetic counseling, or managing lifestyle factors that may impact one’s cancer risk.
8. Anyone with a strong family history of cancer should seek professional medical guidance for appropriate management.
9. Your web behavioral, genetic, or self-reported information may be used by the company internally to improve their services or sold to third party companies for research, marketing and advertising, or commercial purposes. Read the privacy policy and the terms and conditions.

The test may only benefit a very small population of people, specifically those of Ashkenazi Jewish descent, however it is being marketed and offered to the general public. People will purchase the test for a variety of reasons. Regardless of what their reasons are, who the test benefits (or doesn’t), all of the people who submit their saliva samples for testing will have their data and results utilized in one way or another or sold to third party vendors for commercial purposes. Any improvements in company services, commercial, or research advancements that happen as a consequence of using customer data offers zero recognition or compensation for their “participation”. In the end, who really gets the most benefit?