Novavax Researcher Says No Chance Of A ‘Shortcut’ In Vaccine Safety

3 possible coronavirus vaccines are kept in a tray at Novavax laboratories in Gaithersburg, Md., in March 2020. The business has moved into stage 3 trials in the U.K.

Andrew Caballero-Reynolds/AFP via Getty Images

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Andrew Caballero-Reynolds/AFP through Getty Images

3 potential coronavirus vaccines are kept in a tray at Novavax labs in Gaithersburg, Md., in March 2020. The business has moved into phase 3 trials in the U.K.

Andrew Caballero-Reynolds/AFP via Getty Images

” I dont think that theres going to be any opportunity that theres going to be some shortcut made,” states Gregory Glenn, Novavax president of research study and advancement.

Novavax was among nine companies to openly pledge to not send their vaccines for Food and Drug Administration review till theyve been shown to be safe in trials. Novavax has actually never ever prior to brought a vaccine to market.

The trial is taking location in the U.K., where researchers plan to enlist up to 10,000 adults of different ages in the next 4 to 6 weeks. Half the participants will get a placebo and half will get the companys vaccine.

Companies are working to establish vaccines at an unmatched rate. Many Americans are concerned about the safety of a fast-tracked procedure, done under the province of a president who opposes his own health authorities.

A minimum of a quarter of individuals will be over the age of 65, the business states, and it will also “focus on groups that are most affected by COVID-19, including racial and ethnic minorities.”

The business expects to start a U.S. trial with 30,000 volunteers in mid-October.

Novavax, a vaccine maker in Maryland, is ending up being the 10th coronavirus vaccine prospect to enter the last phase of testing, called phase 3.

He talks with NPRs All Things Considered about why the vaccine trial is happening in the U.K. and how to reassure Americans that any vaccine will be safe. Here are excerpts:

However this is likewise a vaccine trial that has actually been more politicized, maybe, than any other one. Im interested in how the politics of this are affecting the company and science aspect of this for you.

We went to the U.K. because they have a really excellent trial network and we felt that the attack rate would be high, the transmission would zoom up in the winter season, which it looks like its going to do. …

The CEO of Novavax was one of 9 pharmaceutical executives who came together to assure the general public in a published statement that their vaccines will be safe and efficient, not a rush job that would potentially hurt anyones health. It is sensational in a method that they would feel they need to do that. Would you comment on the fact that they felt they had to?

Look, I have mixed feelings since our M.O. here is to be transparent. We understand the FDA [has] a formula that theyre not going to deviate from. So I do not think that theres going to be any opportunity that theres going to be some faster way made. However theres a lot worry in so lots of locations about vaccination that … its sensible to reassure the public thats the case.

Why did you select the U.K. for your vaccine trial, specifically instead of here in the U.S., where Novavax is based?

The CEO of Novavax was one of 9 pharmaceutical executives who came together to assure the public in a released declaration that their vaccines will be safe and efficient, not a rush job that would potentially harm anybodys health. They didnt know how vaccines work. My group is focused on creating persuading evidence that the vaccine is safe.

And the U.K. infection rate zooming up, as you put it, is a good thing for you since youre searching for places on the planet where a lot of individuals are contaminated and your vaccine may deal with them.

If we are successful there, we will get a license for our vaccine in the U.K. and Europe, and after that opens the door for many countries that otherwise would not require screening, however normally they would depend on the package of information either from the FDA or Europe for them to release their vaccine in their own country. So this opens the door for a great deal of the world in terms of a regulative approval and licensure for them to take advantage of a highly competent regulative authority that we have in the U.K.

I kind of neglect it all. My group is concentrated on producing persuading proof that the vaccine is safe. The FDA has actually set out the path to approval. Theres absolutely nothing unclear about what has actually to be done. Im a pediatrician. I think vaccinations have extremely favorably affected the world. Therefore thats how I look at the day. My day is, Im going to get up and develop that proof that will lead to utilization and conserving the world.

Art Silverman and Christopher Intagliata produced and edited the audio interview.

If we succeed thereProsper we will get a license for our vaccine in the U.K. and Europe, and then that opens the door for many countries that otherwise would not require testing, but normally however would rely on the package of information either info the FDA or Europe for them to deploy their vaccine in their own country. The more cases in your trial setting, the much faster you collect the evidence that the vaccine works.

They didnt know how vaccines work. They didnt understand how you did, that you even did trials to show how they work, and so on. And anything we can do to help the public self-confidence is excellent.

Precisely. The way it happens in the trial is you need cases, right? So you undoubtedly could not show anything if there are no cases. The more cases in your trial setting, the much faster you collect the evidence that the vaccine works.