More good news about a COVID-19 vaccine was announced Monday.
The National Institutes of Health and vaccine maker Moderna is following Pfizer’s promising news last week. And amidst a surge in COVID-19 cases and more restrictions as we approach the holidays there appears to be some light at the end of the tunnel.
Dr Richard Novak is head of Infectious Disease at UIC and described the latest phase 3 results from Moderna’s COVID-19 vaccine trial.
“We learned the vaccine it appears to be highly efficacious, almost 95 percent effective, at controlling coronavirus disease. (It is) really shockingly good news. It’s fantastic news,” he said. “It’s rare you have a vaccine with that level of efficacy. It’s wonderful. We were hoping for 50 percent efficacy and here we got something almost 95 percent effective. That’s what we call a home run in the vaccine business.”
Novak has been testing vaccines for decades. He’s running the Moderna trial at University of Illinois at Chicago, one of a hundred testing sites helping to enroll a total of 30,000 people around the country.
The first Chicago participants rolled up their sleeves back in July. But the study slowed in October to allow for recruitment of more minority participants.
“We worked very hard,” Novak said. “My whole staff has been working night and day around the clock to get this vaccine study done and we’re excited to get this result.”
The interim results released by the NIH focus on safety and efficacy data from 95 cases of coronavirus. Only five of the cases were in those who received the experimental vaccine, that’s compared to 90 cases that occurred in the placebo group.
“None of the serious cases were in vaccine recipients. They were all in placebo recipients,” Novak said. “So in other words cases in the vaccine group were mild cases.”
The experimental vaccine introduces a modified spike protein to the body that triggers the immune system to produce antibodies. When the body sees the actual SARS-CoV-2 virus, the antibodies bind to it and prevent the virus from invading our cells.
“Knowing the vaccine is effective is great news but we still need to complete the regulatory process,” Moderna president Stephen Hoge said. “Which involved completing the study, generating more data and then we need to get busy manufacturing.”
“My guess is the FDA will approve it fairly quickly,” Novak said.
There will be a staged-release; First responders, healthcare workers and high-risk groups will be offered the vaccine first.
One of the advantages of the Moderna vaccine is how it’s stored which will ultimately help make distribution easier.
“It’s very stable,” Novak said. “It can be stored in a regular freezer. It doesn’t need a minus 80 and it’s stable for six months in a regular freezer. And it’s even stable for about 30 days in a refrigerator.”
But even with the promising results, Novak said there are challenges ahead.
“There’s still always a challenge of convincing people that it’s a good idea to get the vaccine,” he said. “But I think 95 percent efficacy is going to go a long way toward convincing people it’s a good idea.”
Now it’s a waiting game, the FDA requires a two month observation period before a manufacturer can apply for emergency use authorization. In the meantime, the vaccine is already in production and being stockpiled as part of operation warp speed.