This is the fastest I ever have worked for any vaccine throughout my 30 year career.
One thing I knew that we do not have time.
Normally, vaccines take numbers of years to develop.
So we have to work in an accelerated timeframe.
I like to do everything accomplished today. There is no tomorrow.
I've worked maybe 18-20 hour, you know, I barely sleep four hours.
People ask me if I'm tired? I don’t feel tired.
Nita Patel is a senior director in the vaccine development department at Novavax,
a small Biotech company in Gaithersburg, Maryland.
She and her team have been critical to developing a promising COVID-19 vaccine—in just ten months.
I have molecular biologist, antibody specialist, immunologist, and associates in the team,
and they are all very expert in what they do.
We are doing so many experiments, so many analyses at the same time.
One challenging thing for me having so many scientists on working different things,
is to keep them motivated that, okay, we are getting there.
One more experiment, we're going to know the answer.
Planning and communicating with every scientist every day,
sometimes couple times a day, and being with them in the lab,
it's a key to get to the point where we are today.
Patel’s passion to develop vaccines against infectious diseases led her to Novavax five years ago.
My career started as a scientist making a vaccine at Medimmune.
My dad had become handicap at a very young age because of the tuberculosis.
So that was my motivation to start my first project.
I always been in the vaccine area.
Lyme disease, human papillomavirus vaccine, malaria vaccine, RSV vaccine, influenza vaccine.
RSV vaccine was near and dear to my heart as I was instrumental in developing Palivizumab, which is also called Synagis.
That's the only one available for premature babies can save from RSV infection as a therapy.
If I can bring RSV vaccine to the market, that would be my home run for my career.
Novavax’s RSV vaccine attacks a respiratory virus that kills tens of thousands of young
kids in developing countries.
It has twice failed in clinical trials, but the company hasn’t given up on it.
Novavax has never brought a vaccine to market.
But the ones they develop share a similar approach—
using a viral protein and an adjuvant, an immune boosting compound,
to elicit an immune response in the body.
Novavax produces the coronavirus spike protein by infecting moth cells with viruses that contain the spike protein’s DNA.
After harvesting the spikes from the membrane of millions of cells,
the spikes embed in a tiny, soap-like particle.
The resulting, spike-studded cylinders are the right virus-like size
for the immune system to recognize them as a danger, scientists believe.
So there's three key features we were looking into the vaccine, and we found one which has all three.
The first one was to have to have a protein in pre-fusion form,
meaning the receptor binding domain had an upper position.
We were looking at strong ACE2 receptor binding characteristic of a protein,
as well as the stability of the protein at certain temperature,
and also the immunogenicity at the same time.
We made over 20 constructs of the COVID vaccine,
and we found one that has a right conformation.
We found the right vaccine, but there is a lot more things that we are still involved in.
We also look at the quality of the immune response, the protective immune response that our vaccine has generated.
Early clinical trials have been promising.
After exposing monkeys to SARS-CoV-2 weeks after they were vaccinated,
the virus completely failed to replicate in the animal’s noses.
But the results from larger human trials aren’t in yet.
And Novavax is just now confronting its biggest hurdle—
scaling its vaccine manufacturing.
They will have to rely heavily on partners to produce their vaccine.
Novavax says the experienced manufacturers they will work with,
like the Serum Institute of India, will help them create 2 billion doses in 2021.
Although up against larger, more seasoned competitors,
Novavax’s COVID-19 vaccine may just be their first to go the distance
and make it on the market.
I can't wait to see this vaccine deployed,
and I probably will be the first one to get it.