In a study published mid July in the New England Journal of Medicine, researchers reported the results of the first Covid-19 vaccine to be tested on humans. The trial which involved 45 healthy volunteers was researching the safety of the drug. Though early tests have also offered some chances of efficacy.
Modern therapeutics was in the race to develop a a vaccine for the disease which has ground the world to a stop. Moderna was one of the first to develop the vaccine with researchers from National Institute of Allergy and Infectious Diseases also partnering up in this undertaking. The preliminary results were first released in May. This July study publication describes those results.
There were 45 participants, between the ages of 18-55 over two states, Washington and Atlanta. The first volunteer was inoculated on March 16 around 2 months from the date of the first publication of the COVID-19 genetic sequence. The study did not have a placebo control group as just the safety was under the microscope all the participants were given varying doses by two injections over a period of 30 days.
No serious side effects were reported with any of the dosing levels, minor aches and pain, some fatigue and headache was exhibited amongst the participants. As a side study all participants did produce antibodies to the virus which were as effective as natural antibodies harvested from patients that had recovered in lab tests against actual samples of the virus
The current study suggests that the vaccine would need to be administered as a two stage primer-booster process as the responses were much better after the second shot. “We saw robust responses after the second vaccination,” says Dr. Lisa Jackson, lead author of the NEJM study. “It seems that two doses are needed, which is what is expected from this type of vaccine and from a vaccine against an emerging virus that hasn’t been present in the population. The immune system needs to be set up by the first dose to then respond more vigorously to the second one.”
It’s not clear at this point how long would this immune response last. The study participants will be kept under close observation for a year to see long term effects of the vaccine and its efficacy. The stage two trials are already under planning and will have a sample size of 300 people with a 150 people placebo control and a double blind method of administration.
As the pandemic shows no sign of slowing down across the USA, FDA has already authorized the phase 3 study of 30,000 people.
While this is all great news and a promising step an actual viable vaccine that can be mass administered will take some time to hit the shelves we can only hope that that time is short.