1 Feb 20210 Comments
To date, over 26 million people in the U.S. have contracted the Covid-19 virus, with more than 433,400 resulting deaths. The current administration estimates the number of deaths could reach 600,000 before we get this pandemic under control.
But with two vaccines currently being administered in the U.S. under the FDA’s Emergency Use Authorization (EUA) mechanism, there is huge cause for optimism. A better understanding of the vaccines and the approval process may help those wondering about vaccine safety.
We listened in on a recent talk given by Dr. Barry Geller, chair of the Department of Emergency Medicine at Phelps Hospital / Northwell Health, and are sharing with you exactly what we learned.
First thing to know is that even with EUA, the FDA requires a rigorous testing process. In Phase 1, a vaccine is administered to up to 100 people to determine its overall safety, side effects, adverse reactions and immune response. In Phase 2, several hundred volunteers are given the vaccine to better determine safety and the relationship between the dose and immunity. Then in Phase 3, 1,000 or more people are vaccinated and a comparison is made between those who receive a placebo against those getting the vaccine. Safety and less common side effects would also be evaluated during this phase.
The final stage for vaccine approval is Phase 4. That is the time during which longer-term studies and ongoing surveillance is implemented to identify uncommon adverse events and complications. In the case of a pandemic, EUA is used because the urgent need for the vaccine supersedes the longer-term assessment included in Phase 4.
Now for the vaccines: the Pfizer-BioNTech and the Moderna are the ones currently being administered in the U.S. The Johnson & Johnson and the Oxford-AstraZeneca vaccines have not yet received EUA. The J & J vaccine is expected to receive EUA for a March rollout.
Moderna and Pfizer are both mRNA vaccines, and use “messenger” technology to introduce artificially generated spikes (that mimic the Corona virus spikes but are NOT the virus) into the body. Our bodies recognize the spike and begin producing antibodies that will cling to the virus spike if we become infected, preventing the virus from entering our cells. This process is called “active immunity.”
The Johnson & Johnson and AstraZeneca vaccines are viral vector vaccines. They make use of a modified harmless piece of the virus DNA, which is injected into the body and causes cells to create the mRNA immune response.
The mRNA Pfizer vaccine requires two doses, given three weeks apart. New information indicates the second dose can be given up to six weeks from the first and still maintain its phenomenal 95% effectiveness rate. The vaccine’s side effects are considered mild and include: pain at the injection site, fatigue, muscle pain, chills, headache, joint pain and fever. Full immunity is achieved one week after the second dose (or four weeks from the first).
The Moderna vaccine also requires two doses, given four weeks apart, but can be given up to six weeks apart. Both doses are needed for complete protection and full immunity is achieved two weeks after the second dose. Side effects are the same as the Pfizer vaccine with one addition: a potential for swollen lymph nodes in the under arm.
The AstraZeneca vaccine, not yet in use in the U.S., requires two doses a month apart. The effectiveness rate is 70% but it should be noted that those who did get infected after having the trial vaccine did not become seriously ill. Side effects are similar to those for the Pfizer vaccine.
What everyone is calling a “game-changer” is the Johnson & Johnson vaccine. Not only is it a single dose vaccine, it is also 70% effective and can be stored in standard refrigeration. It provides 70% immunity at day 21 and side effects include pain at the injection site, fatigue, headache, muscle pain, chills, joint pain and fever.
With the virus expected to mutate, it’s likely we will need booster vaccines at some point down the road. Eventually, according to Dr. Geller, scientists should be able to target a part of the coronavirus that does not mutate – enabling vaccines to deliver lifetime immunity, as with the smallpox vaccine.
Dr. Geller also emphasized that something not getting much attention these days, but essential to people still contracting Covid-19, are the antibody infusion therapies from Eli Lilly and Regeneron. Anyone testing positive for the virus who is 65 or older and not too sick qualifies for these treatments. These therapies can dramatically change the course of the virus – for the better. Most exciting is that Regeneron is now developing a single injection that achieves the same results as their underutilized infusion.
Geller noted that by getting a Covid vaccine, we can all contribute to “herd immunity,” which means the resumption of normal life, community safety and personal wellbeing. When pressed as to, “Why not take my chances since 99% of those contracting Covid actually survive,” he replied with two potent questions: Do you know anyone who has died from the vaccine? Do you know anyone who has died from Covid? Most likely, you can answer yes to just one of these questions, the second.
Says Geller, “So far, the vaccine has been tremendously safe and if you want to play the percentages, go with the vaccine.”
(photo: courtesy of Phelps Hospital/Northwell Health)