Moderna's human tests suggest its vaccine may 'neutralize' coronavirus2020-05-18
Moderna’s experimental coronavirus vaccine produced antibodies that could block the virus in early human trials, raising hopes in fight against pandemic
- Early results from human trials of Moderna’s vaccine candidate showed the shot produced antibodies capable of neutralizing the virus
- The findings are from tests of the shot’s safety, however, and it’s unclear if it can actually block infection
- Shares for Moderna shot up by 25% on the heels of the Monday announcement
- Moderna has been working closely with the NIH and last week its vaccine candidate got ‘fast-track’ status from the FDA
- Here’s how to help people impacted by Covid-19
Moderna’s experimental COVID-19 vaccine produced antibodies that could ‘neutralize’ the new coronavirus in patients in a small early stage clinical trial, the company announced Monday, sending its shares up 25 percent.
The levels of the antibodies were similar to those in blood samples of people who have recovered from COVID-19, early results from the study conducted by the National Institutes of Health showed.
Participants were given three different doses of the vaccine and Moderna said it saw dose-dependent increase in immunogenicity, the ability to provoke an immune response in the body.
Moderna noted that the early trial is intended to determine the safety and side effects of the vaccine and, although the early results are promising, it’s too soon to say whether the shot candidate can actually block the virus.
The experimental vaccine that Moderna began developing in January has shown promise in human trials after early data showed it produced ‘neutralizing’ antibodies (file)
Shares for Moderna shot up by 25 percent on the heels of the company’s Monday annoucement
The vaccine, mRNA-1273, was also found to be generally safe and well tolerated in the early-stage study, the drug developer said.
Moderna leads global efforts in developing a vaccine for the new coronavirus and last week, won the US health agency’s ‘fast track’ label to speed up the regulatory review.
It is looking to begin late-stage trials in July.
The company has been racing to develop a safe and effective vaccine against the novel coronavirus that has killed more than 285,000 people globally. It expects to start a late-stage study of the vaccine in early summer.
It’s up against competitors like Johnson & Johnson and Novavax, which yesterday received more funding than any other vaccine maker from the epidemic preparedness group CEPI.
However, Moderna had a leg up in the race to create a coronavirus vaccine.
Along with its NIH and Vaccine Research Center partners, Moderna started developing a vaccine against SARS amid the 2003 outbreak of that virus, the closes cousin to the one that causes COVID-19.
It was quick to start its phase 1 trial, dosing the first participant on March 16, and hopes now to further expedite its trial process with the FDA’s fast-track designation.
Moderna is working closely with the NIH to develop its vaccine and had a leg up because it created a platform for a SARS vaccine in 2003
There are no approved treatments or vaccines for the COVID-19 respiratory illness caused by the new coronavirus, though some drugs are being used on patients under an emergency-use authorization.
The agency’s fast track status is designed to expedite the review of treatments and vaccines meant for serious conditions.
A vaccine or treatment that gets the status is eligible for more frequent meetings with the FDA.
‘Fast Track designation underscores the urgent need for a vaccine against the novel coronavirus,’ said Dr Tal Zaks, Chief Medical Officer at Moderna.
Even as parts of the US begin to reopen, expert continue to warn that we really won’t be free of coronavirus until there is a vaccine against it.
Companies like Moderna as well as research institutions sprung quickly into action to design such vaccines.
Moderna, using the platform it had created to develop a SARS vaccine, was able to create a candidate vaccine inJanuary.
By February, it shipped its vaccine to the US government.
Now, there are two Phase 1 trials the shot underway, and on May 6, Moderna’s stocks shot up after the FDA greenlit its Phase 2 study.
A Phase 3 trial is set to start late this spring or early this summer.
Fast-track status will help clear some of the red-tape that might protract the timeline between promising results from these trials to production and distribution of the vaccine.
Although the NIH has poured significant resources into Moderna’s shot, Dr Fauci noted during a Senate panel hearing on Tuesday that its important that Moderna not have a vaccine monopoly.
He urged the US to proverbially take ‘multiple shots on goal,’ in terms of developing a vaccine.
‘This is important because it’s good for global availability if we have more than one successful candidate,’ said Dr Fauci last week.
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