Novavax, a small American company based in Gaithersburg, Maryland, supplied with immense support from the U.S. government under the Trump Administration, recently announced results of a clinical trial of its COVID-19 vaccine in the U.S. and Mexico. 

Researchers, after concluding a 29,960-person trial, have determined that the Novavax two-shot inoculation provides potent protection against the coronavirus demonstrating an overall efficacy of 90.4 percent

The vaccine’s results positively compare with those developed by Pfizer-BioNTech and Moderna and higher than the one-shot vaccine from Johnson & Johnson. In addition, the Novavax vaccine showed an efficacy of 100 percent at preventing moderate or severe disease.

However, in spite of these impressive results, the vaccine’s future in the U.S. remains uncertain and may be needed more in other countries. 

Novavax officials say they will not seek emergency authorization from the Food and Drug Administration [FDA] until the end of September. But with three other authorized vaccines already available in great supply, medical experts believe that Novavax may be advised to apply for a full license which could require extra months. Video

Here in the U.S. and in other leading nations, COVID-19 vaccinations have been steadily increasing, driving infections down to numbers that haven’t been seen since the beginning of the pandemic. The decline in infections and deaths have prompted most U.S. cities and states to relax restrictions that have been in place for well over a year. 

As for the three authorized vaccines developed by Pfizer, Moderna and Johnson & Johnson, they have collectively already filled the need in the U.S. However, in poorer nations around the globe that continue to face numerous challenges in both obtaining and administering doses, the Novavax vaccine could lead to a significant decline in infections and deaths. 

Novavax Chief Executive Stanley Erck told reporters that the company would probably secure its first authorization in countries like Britain, the European Union, India or South Korea before getting the green light in the U.S. 

“I think the good news is that the data are so compelling that it gives everybody an incentive to pay attention to our filings,” he said. 

Still, vaccine experts expect that with the inevitability of ever-emerging variants, the U.S. will at some point need booster shots – something which the protein-based technology used in the Novavax vaccine may do a particularly good job at amplifying protection, even if people have previously been vaccinated with a different formulation.

“They may be really the right ones for boosters,” said Dr. Luciana Borio, acting chief scientist at the FDA from 2015 to 2017.

 

More About Novavax and the Trump Administration 

Last year, the Trump administration’s Operation Warp Speed program awarded Novavax a $1.6 billion contract for 100 million future doses. The company won the support despite never having brought a vaccine to market in over three decades. 

In January, Novavax announced that its 15,000-person trial in Britain found that the vaccine had an efficacy of 96 percent against the original coronavirus. Against Alpha, a virus variant first identified in Britain, the efficacy fell slightly to 86 percent. 

In South Africa, where Novavax ran a smaller trial on 2,900 people and the Beta variant was dominant, the company found an efficacy of just 49 percent. But the South Africa trial incurred complications given the fact that a number of the volunteers were HIV-positive which is known to impede vaccines. Further, the study was so small that it was difficult to estimate how much protection the vaccine provided HIV-negative volunteers.

 

Future Benefits of the Novavax Vaccine 

Novavax will apply for authorization in the U.S. after it completes developing a quality control test.

“You have to test them every way from Sunday to show that under any conditions you get the same answer – and that takes time,” Erck said.  

Dr. Paul Offit, a professor at the University of Pennsylvania and a member of the FDA’s vaccine advisory panel, said he welcomes Novavax’s highly-effective vaccine. 

“The more the merrier,” he said. “I think there’s room for many more vaccines because we’re going to be dealing with this virus for years, if not decades.”

One virologist who recently completed a new study on variants expected to be published soon in a scientific journal, agreed that the Novavax vaccine will yield significant results in the future both in the U.S. and abroad. 

“Novavax may be used as a booster in the U.S. but it certainly will be the first vaccine a lot of people are going to see around the world,” said Dr. Matthew Frieman, University of Maryland School of Medicine.  

Leave a comment

Your email address will not be published.