The first US COVID-19 vaccine to be approved on human trials is the Moderna vaccine candidate, mRNA- 1237. Moderna vaccine has successfully passed the first phase of human trial and has published the report on the New England journal of medicine ensuring the safety of the vaccine. When we think of vaccines, it about giving a little bit of virus to the person and their bodies are gonna make the antibodies in response to that or the other one where they give the dead or attenuated virus and see how the body responds. The Moderna one is a genetic vaccine. Moderna is a whole new different kind of vaccine. What they did is they took the blueprint of a little piece of the virus, and they used that essentially to inject into the body. Then the body creates this piece of the virus over and over again which results in antibody formation. Moderna showed early preliminary results a month ago, which showed 8 people out of 45 have produced antibodies.
What dose producing antibodies mean? How does it contribute in virus protection?
The results showed that when they gave even small doses of this vaccine to the people who got the virus, their bodies started to produce antibodies. They produced antibodies at the same level when they are being infected. Originally when we get infected our bodies produce antibodies, when we take the vaccine, our bodies produce antibodies. So the more vaccine you give the more antibodies were produce in doing so it begins to neutralize the effect of the virus. This is what everyone is trying to achieve. The goal of whether the vaccine will have an impact on the virus. The neutralizing effect is the ultimate aim of all vaccine production. And Moderna seems to be achieving it. Even if the data are given was very little and the number of people who produced antibodies was also little, but this seems to be an optimistic factor. Moderna, the first US-based vaccine to enter human trial has reported its result of phase 1 in the New England Journal of Medicine on Tuesday. The results suggest there is nothing in the first-period view of the study of the vaccine candidate to suggest that anything has derailed, which is a positive note. But experts suggest it very early to decide whether a vaccine is efficient or not or will it be ready by the timeline given by Moderna.
Moderna gave a dose of vaccine to 45 healthy individuals between the ages of 18- 55, followed by a second dose about 28 days later. Hence this is a two-dose vaccine that they are looking at here to try and get the response they are hoping for. The reports suggest that it seems “relatively safe”– meaning that there were no significant side effects that can stop the trail. But they did see some side effects.
They gave the medication at different dosing ranging from middle to high dosage. But any person who has injected this vaccine did show some side effects. Many even showed multiple side effects which were noted in 45 healthy people the ages of 18 – 55 during phase 1. Moderna plans to focus major attention on these side effects area. Many health professionals think this is very fast-paced, as Moderna has ended phase 1 and plans to begin Phase 3 on July 27 which typically gets years to get to that point while Moderna has done this in months. Moderna has planned to start phase 3 with 30,000 Americans across the country. Phase 3 is the most critical stage because that where they can prove that there is immunity for those individuals who get this vaccine.
When first started they were just using the lowest dose (i.e.) 25 microgram and then giving it two shorts one month apart. But they were told as a part of the trial to figure out the various dosing regimens which started the 100 microgram dosing and 250 microgram dosing. So during the phase 1 trial, the 45 people were divided into three parts with 15 getting a lower of 25 micrograms, 15 getting the 100 micrograms while the rest getting the highest dosage. Moderna reports that side effects were seen in the increase rate on people with high dosage. These were healthy individuals which caused more concern because the majority of populations affected by COVID-19 are the elderly who are most vulnerable so if the vaccine doesn’t have an impact on them then it would be a total waste. But the 100 microgram dose seems to be where they are going to be focusing their attention for the results suggest they had side effects but not as higher as the other dosage. The real goal of this entire phase one study was to measure the safety more than anything else. So they didn’t have any factor that suggests them to stop the trail and this seems to be an optimistic point and place for improvement.
Multiple vaccine candidates are being approved but it’s also possible that none of them will be even close to 100 % effective. Experts wish for them to at least arrive at the level of flu vaccine which is 40-60 % effective and there Is also a question of how long will the immunity lasts. Whether you need to get booster shorts or not, every year or often is unknown. Another concern is the anti-vaccination movements. So at least 80 % should be tested by the vaccine to know its full effectiveness.
Till now the scientists suggest that the data does look promising but require further research. As we have seen a lot of the vaccines are being allowed for trials. Moderna is the first to give a period view review among US candidates. This is significant in and of itself. But it’s only an early data. The big question is does it work? Is it going to protect so the people don’t get a virus? Does being the first necessarily equate with being the ideal candidate? We don’t know the answer to that. This vaccine did appear to make antibodies in the people it was given to, but how well will those antibodies work. We have to wait and see these other trials. We always like to have a correlative measure, like measuring something in inches or meters, but in this case, we do not have something to say this works X amount well yet. The only way to know that is when they get to test it on large groups of people to see it protects them. So that’s basically what Moderna plans to be doing in the next couple of months from starting at the end of this month to find out. Well, for now, it looks generally safe, let’s wish for it stays safe in older people and people with preexisting conditions, and let’s also hope it works in protecting the people against the infection.