12/10/2020
I am grateful to be among the first group to potentially receive the Pfizer vaccine pending FDA Emergency Use Authorization. Iโm scheduled to get the vaccine in 10 days if all goes according to plan. Follow along and Iโll share my experience. Also check out this article I wrote about the vaccine development process. Please like and share if you found it helpful.
๐๐๐๐ ๐
๐๐ ๐ ๐๐๐๐๐๐ ๐๐๐๐๐๐
What You Need to Know About the Coronavirus-19 Vaccine
by Dr. Rachel Gandre
๐ ๐๐๐๐๐-19 ๐๐ข๐ค๐ค๐ช๐ฏ๐ฆ ๐ช๐ด ๐๐ฐ๐ฎ๐ช๐ฏ๐จ--๐๐ถ๐ต ๐๐ช๐ญ๐ญ ๐ช๐ต ๐๐ฆ ๐๐ข๐ง๐ฆ?
Pfizer and Moderna have applied for an Emergency Use Authorization from the Food and Drug Administration for their coronavirus vaccine. The FDA process is expected to take a few weeks, and an advisory committee to review the vaccine has been scheduled for early December. Some Americans could get their first dose of the vaccine in about a month.
As scientists around the world have diligently worked to help us understand this virus and the disease it causes, it is important to realize that we will continue to learn more about the virus in the years to come.
SARS-CoV-2 infections can be a minor hindrance or lead to severe disease or even death. The best way to stop the virus and return to a more normal life is through immunity. Immunity can be achieved in one of 2 ways--through natural illness or through vaccination. ๐๐ญ๐ฌ ๐ข๐ฆ๐ฉ๐จ๐ซ๐ญ๐๐ง๐ญ ๐ญ๐จ ๐ฉ๐จ๐ข๐ง๐ญ ๐จ๐ฎ๐ญ ๐ญ๐ก๐๐ญ ๐ก๐๐ซ๐ ๐ข๐ฆ๐ฆ๐ฎ๐ง๐ข๐ญ๐ฒ ๐๐๐ง ๐จ๐ง๐ฅ๐ฒ ๐๐ ๐ข๐ง๐๐ฎ๐๐๐ ๐๐ฒ ๐ฏ๐๐๐๐ข๐ง๐๐ญ๐ข๐จ๐ง. ๐๐๐ฏ๐๐ซ ๐ข๐ง ๐ก๐ข๐ฌ๐ญ๐จ๐ซ๐ฒ ๐ก๐๐ฌ ๐๐ง๐ฒ ๐ฏ๐ข๐ซ๐ฎ๐ฌ ๐๐๐๐ง ๐๐ฅ๐ข๐ฆ๐ข๐ง๐๐ญ๐๐ ๐๐๐๐๐ฎ๐ฌ๐ ๐จ๐ ๐ข๐ฆ๐ฆ๐ฎ๐ง๐ข๐ญ๐ฒ ๐ข๐ง๐๐ฎ๐๐๐ ๐๐ฒ ๐ง๐๐ญ๐ฎ๐ซ๐๐ฅ ๐ข๐ง๐๐๐๐ญ๐ข๐จ๐ง. Since illness could lead to severe disease or death, vaccination is a better alternative as long as safe and effective vaccines can be developed.
Pediatricians and parents alike are no strangers to the life saving benefits of vaccines. Understandably, I've had a few questions about the safety of the upcoming COVID-19 vaccine. Most people are concerned that vaccine studies will move too fast, without fully establishing safety and effectiveness.
๐๐ก๐๐ญ ๐ญ๐ก๐ ๐๐จ๐ฅ๐ข๐จ ๐๐๐๐๐ข๐ง๐ ๐๐๐ง ๐๐๐๐๐ก ๐๐ฌ ๐๐๐จ๐ฎ๐ญ ๐ญ๐ก๐ ๐๐๐๐๐-๐๐ ๐๐๐๐๐ข๐ง๐
In the early 1950s the most feared epidemic disease was polio, a virus which every year paralyzed or killed over 50,000 Americans, mostly children. Movie theaters sat empty, swimming pools were padlocked, hospital wards were lined with children in iron lungs. Parents were frightened to let their children go outside. Travel between affected cities was restricted and public health officials imposed quarantines on homes and towns where polio cases were diagnosed (sound familiar?). Thanks to the polio vaccine, dedicated healthcare professionals, and parents who vaccinate their children on schedule, polio has been eliminated in this country for over 30 years. On a personal note, my mom contracted polio in the early 1950s as a toddler. It's disheartening to think that she could have been spared lifelong pain and disability had the vaccine been available to her.
But, the development of the polio vaccine by Jonas Salk predated the key role that the scientific community now plays in the testing of drugs and vaccines. The crusade against polio was led by the March of Dimes, a private charity that recruited millions of terrified parents for the vaccine trials. The amazing success of these trials led the public to demand the immediate release of the vaccine, and the government relented, allowing drug companies to ramp up production without proper oversight. In the end, one of the vaccine manufacturers produced some vaccine without properly inactivating the virus. The polio vaccine taught us that scientific standards need to be upheld, emergency or not, and that a successful vaccine requires overwhelming public trust.
I thought I'd share a little about how the COVID-19 vaccine has been developed so quickly, and why I feel safe vaccinating myself and my family as soon as a vaccine is approved by the FDA and experts have weighed in on the safety data.
1. Vaccine Design and Technology
Vaccines have come a long way since Edward Jenner started using the cowpox vaccine to induce immunity to smallpox in 1796. If early vaccines like the smallpox vaccine were compared to the first mobile phones (remember the Nokia?) then the new COVID-19 vaccine is the iPhone 12 of vaccines.
While COVID-19 is a new coronavirus, the science behind the vaccine has been in development for almost 20 years. A very smart group of scientists and global health experts have anticipated a coronavirus pandemic since the SARS and MERS (both also coronaviruses) outbreaks in 2003 and 2012. Researchers have been developing vaccines for these diseases for almost 20 years. Lessons learned from this earlier vaccine research have been used to inform strategies for developing a COVID-19 vaccine.
2. Efficiency
Due to the global health emergency, scientists are feverishly working around the clock to develop the vaccine and make it available to the public. So far, speed is being gained due to process efficiencies rather than by cutting corners or eliminating the actual steps from development. Time consuming steps involved in conducting a scientific study include obtaining funding, recruiting study participants, and collecting data.
In addition to the dedication of vaccine scientists, many factors have contributed to the efficiency of COVID 19 vaccine. For example:
Funding is being made available by Health and Human Services in order to expedite a vaccine.
Volunteer recruitment has been happening quickly, with over 500,000 Americans registered to participate in vaccine trials. Phase III trials have been as large as those for other vaccines.
Study phases are being conducted simultaneously, in parallel, instead of sequentially. This means safety is monitored on an ongoing basis, instead of stopping after each phase, collecting data, publishing that data, then having to recruit new participants for the next phase. Running trials this way gives the same end result of good data while being more efficient.
How Will We Know if a COVID-19 Vaccine is Safe?
Safety comes down to oversight and transparency. The initial results from the Pfizer and Moderna trials have indicated over 90% effectiveness at preventing COVID-19. While these striking results are good news by any standards, these claims have not yet undergone peer review.
Peer review is the evaluation of scientific work by independent experts in the same field. Peer review is designed to assess the validity and quality of scientific studies. Its ultimate purpose is to maintain the integrity of science by filtering out invalid or poor quality data. Unlike the polio vaccine studies, the data from the large phase III trials will undergo several different rounds of peer review by different, independent groups of experts in immunology, statistics, infectious diseases, virology, and vaccinology.
In addition to being reviewed by experts around the world in published journal articles, the vaccine will go through peer review for approval by the FDA. Below is a general outline of the safety steps involved in obtaining Emergency Use Authorization for medications and vaccines:
1. Ongoing trials are coded, so that during the trial the manufacturers do not know who received the vaccine and who received the placebo. During the trial, an independent group of experts monitor the data to make sure there are no concerning side effects in the trial participants.
2. Once the company submits the data to the FDA, an advisory committee of independent experts, called the Vaccine and Related Biologics Product Approval Committee reviews the data to evaluate vaccine safety and effectiveness.
3. Once a vaccine is approved by the FDA, the data undergo a third round of review by the Advisory Committee on Immunization Practices, who makes recommendations to the CDC regarding who should or should not get the vaccine and when, based on the data.
The public will be able to view trial data and observe discussions when the Vaccines and Related Biological Products Advisory Committee has its review in early December.
People think the name 'warp speed' gives the perception that shortcuts are being taken. But, as Dr. Fauci points out, "It was the reflection of the extraordinary scientific advances in these types of vaccines which allow us to do things in months that took us years before." Nothing we do in the world is risk free. Based on what we have learned about this virus over the past year, individuals will either get the disease or get the vaccine.
I hope this information will help families in our practice make informed decisions about upcoming COVID-19 vaccines that may be available
