The Novavax, Inc. Covid-19 vaccine candidate has just been proven safe and effective in inducing an immune response in the test subjects. NVX-CoV2373, the working product name of the vaccine, was subjected to Phase1-2 clinical trials where initial results for Phase 1 were already available in August.
131 healthy adult volunteers underwent a randomized, placebo-controlled trial, where they were given either the standard drug or just a placebo. Out of the total number, 83 received the booster, 25 received the vaccine excluding the booster, and the remaining 23 received the placebo. After 21 days, a second dose was administered.
The volunteers for the trial were from Australia, all below 60 years old. Covid-infected and Covid-recovered patients were still not involved in the trial since it was still in a phase where safety was the top factor to be determined along with an ability to produce an immune response in the body.
They were closely monitored for 35 days since the first administration for signs of complications. The volunteers went through swab testing before, during, and after the 35 days. On the 35th day, only one case of mild fever was reported, which only lasted for one day following the second dose. The rest did not show severe or unmanageable adverse reactions for both after the first and second dosing.
Virus-neutralizing antibodies were shown to have been produced after the second shot in the patients who were administered with the vaccine and booster combination. The antibody levels exponentially multiplied at least four to six times more than those of the recorded levels in patients who recovered from Covid-19.
Elevated levels of T-cells were also shown to have been produced in 16 volunteers. The booster seemed to be a good idea.
Novavax is set to proceed to the next phase according to the R&D president of the pharmaceutical firm, Dr. Gregory Glenn.
"Novavax is committed to generating the safety, immunogenicity and efficacy data that will support confident usage of the vaccine, both in the US and globally, and the data published today further bolsters our conviction that this is possible,” says Glenn.
The scope of the trial’s results does not extend too far due to the small number of participants and lack of diversity. Only healthy volunteers were tested as well so no available data for those with existing Coronavirus infection is available.