This letter is regarding the COVID-19 vaccines.
As a critical care physician at Juan Luis Hospital, I have taken care of many COVID-19 patients on St Croix, and had the heart wrenching job of telling families over the phone that their loved one had died. We now have three effective vaccines against this disease, but JFL Hospital has seen an increase in COVID-19 patients admitted over the last six weeks.
Thankfully none have died, but many have spent weeks on a ventilator or tethered to life sustaining oxygen. Ten percent of mild to moderate COVID-19 patients have significant symptoms for greater than four weeks, or Long COVID Syndrome, even if they were never hospitalized.
The COVID-19 vaccines were developed quickly and have Food and Drug Administration Emergency Use Authorization. A recent submission to Letters to the Editor implied this means the vaccines are not safe. Data does not support this conclusion.
COVID-19 vaccines were developed quickly because the U.S. Government spent tens of billions of dollars on them (https://time.com/5921360/operation-warp-speed-vaccine-spending/). Hundreds of scientists at pharmaceutical companies and the National Institutes of Health stopped working on other projects and devoted enormous amounts of time to vaccine development and manufacture, and the design and implementation of clinical trials.
Clinical trials for each vaccine enrolled 30,000 to 44,000 people, half got vaccine and half a placebo. The trial endpoints were a specific number of symptomatic COVID-19 infections in all people enrolled, then comparing how many COVID-19 cases got vaccine versus placebo. Because the number of cases were surging during trial enrollment, the trials achieved endpoints months faster than expected.
Pharmaceutical companies normally don’t manufacture a drug until after FDA approval. But Operation Warp Speed bypassed that by giving billions of dollars to pharmaceutical companies to produce millions of doses of each vaccine while the clinical trials were ongoing.
It was a risk — if the clinical trials showed the vaccine was not safe and effective, these doses would be thrown away. But it meant that mass vaccinations could begin the day after FDA emergency use authorization. The entire process was fast, but not unsafe.
The clinical trials showed the vaccines are very safe and highly effective. Want to know the details? Do research by reading the primary data:
Pfizer vaccine: https://www.nejm.org/doi/full/10.1056/NEJMoa2034577
Moderna vaccine: https://www.nejm.org/doi/full/10.1056/NEJMoa2035389
Johnson & Johnson/Janssen vaccine: https://www.nih.gov/news-events/news-releases/janssen-investigational-covid-19-vaccine-interim-analysis-phase-3-clinical-data-released
Full FDA approval of a treatment generally requires at least two large clinical trials run independently of each other and at least six months of follow up. When there are no adequate, approved, and available alternatives treatments, Emergency Use Authorization make life saving treatments available after completion of one large clinical trial with at least two months of follow up (https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained).
Multiple clinical trials are ongoing for all vaccines with Emergency Use Authorization, and full FDA approval awaits their conclusion.
Because the published trials are so large, it is highly unlikely that a new significant risk to vaccination will be found, and we already know there is significant benefit.
COVID-19 deaths and illness are now preventable! You can stop the pandemic! Please get vaccinated and stay out of our Intensive Care Unit.
— Dr. Carol Shores, St. Croix, works in the Critical Care Medicine Division at Luis Hospital.